Given Imaging Ltd. (GIVN)

[DewDiligence]

[Deleted]

[airwolker]

... Chief Financial Officer of Given Imaging Ltd. ...

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LabStyle Innovations Appoints Zvi Ben-David as New Chief Financial Officer

Brings 25 years of medical device finance and accounting expertise to LabStyle

Current CFO Gadi Levin to remain in transition as advisor and business development consultant

CAESAREA, Israel, Jan. 8, 2015 /PRNewswire/ -- LabStyle Innovations Corp. (OTCQB:DRIO), developer of the Dario™ Diabetes Management Solution, announced today that Zvi Ben-David will be joining LabStyle as the company's new Chief Financial Officer, Treasurer and Secretary effective immediately.

LabStyle also announced that Gadi Levin, the company's current Chief Financial Officer who played an important role in the company's growing finance and operational functions, will remain in the role of advisor and business development consultant for at least the first half of 2015 as Mr. Ben-David transitions to his new role.

Mr. Ben-David joins LabStyle with 25 years of financial and accounting experience, particularly with public and private medical device public companies. Among his previous roles, he served as corporate vice president and Chief Financial Officer of Given Imaging Ltd., a medical diagnostic company (formerly NASDAQ:GIVN), where he was a part of the founding team and also helped lead the company's growth from a start up to a $65 million annual revenue commercial enterprise as well as its successful initial and follow-on public offerings. Following his tenure at Given, Mr. Ben-David served as Chief Financial Officer of Ultrashape Medical Ltd., where he led the company through two major rounds of funding totally $35 million to an initial public offering on the Tel Aviv Stock Exchange and ultimately its acquisition by Syneron Medical in 2012. Recently, Ben-David has been an independent medical device entrepreneur and investor.

"We are very pleased to welcome Zvi as LabStyle's new chief financial officer," said LabStyle's Acting Chairman, President and Chief Executive Officer Erez Raphael. "Zvi's extensive experience, strong reputation and rich background leading the finance, accounting and operational functions of public medical device companies is a perfect fit for LabStyle as we seek to establish recurring sales and expand our marketing efforts into new jurisdictions. In short, Zvi has been successful in growing companies just like ours, and thus I am confident that with his leadership, we will continue to improve LabStyle's operating and financial efficiency and be in an improved position to grow our market presence and drive shareholder value."

Commenting on Mr. Levin's achievements and future with LabStyle, Mr. Raphael continued, "Our management and board of directors are very grateful for all that Gadi has done for LabStyle. He played an essential role in advancing the company from the research and development phase, through to the targeted soft launch and initial revenue generation. He was also instrumental in completing several financings for us, including the most recent $4.2 million financing, and we look forward to his continuing support of LabStyle in a consulting role as Zvi transitions into his new role."

Mr. Levin stated, "I congratulate Zvi on his appointment. His many years of relevant industry and capital markets experience will be pivotal as LabStyle moves from initial revenues to more substantial growth. It has been an honor and pleasure to play such a strategic role in all of LabStyle's achievements, and I look forward to dedicating my time now at LabStyle solely to my role as advisor and in the area of business development. In addition to my consulting role at LabStyle, I am working actively to harness the experience from my tenure here, as well as other expertise gained over the years, to assist Israeli startups to reach their potential."

About LabStyle Innovations

LabStyle Innovations Corp. (OTCQB:DRIO) develops and commercializes patented technology providing consumers with laboratory-testing capabilities using smart mobile devices. LabStyle's flagship product is the Dario™ Diabetes Management Solution. Dario™ received CE mark certification in September 2013 and began a world rollout in select countries in December 2013. LabStyle filed a Premarket Notification Application, also known as a 510(k), with the US Food and Drug Administration (FDA) for the Dario™ smart meter (Dario™ Blood Glucose Monitoring System) in December 2013. LabStyle is pursuing patent applications in multiple areas covering the specific processes related to blood glucose level measurement as well as more general methods of rapid tests of body fluids using mobile devices and cloud-based services. For more information: www.myDario.com and http://myDario.investorroom.com.

Cautionary Note Regarding Forward-Looking Statements

This news release and the statements of representatives and partners of LabStyle Innovations Corp. (the "Company") related thereto contains or may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "plan," "project," "potential," "seek," "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect the Company's results include, but are not limited to, regulatory approvals, product demand, market acceptance, impact of competitive products and prices, product development, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks, and the risks associated with the adequacy of existing cash resources. Additional factors that could cause or contribute to differences between the Company's actual results and forward-looking statements include, but are not limited to, those risks discussed in the Company's filings with the U.S. Securities and Exchange Commission. Readers are cautioned that actual results (including, without limitation, the performance of the new Company executive described herein) may differ significantly from those set forth in the forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Contacts:
Press

Brenda Zeitlin
LabStyle Innovations
1 800 896 9062
[e-mail]

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/labstyle-innovations-appoints-zvi-ben-david-as-new-chief-financial-officer-300017769.html

SOURCE LabStyle Innovations Corp.

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Given Imaging’s potential market is in the hundreds of millions of dollars.

Days before becoming part of Covidien, Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) achieved a significant milestone: US Food and Drug Administration (FDA) approval for PillCam COLON. The FDA has allowed Given Imaging, manufacturer of camera pills for digestive tract diagnosis, to market the pill for use in patients after an incomplete optical colonoscopy. According to company data, this means roughly 750,000 patients each year, such that Given Imaging’s potential market is in the hundreds of millions of dollars.

The pill was approved for visualization and detection of colon polyps in patients after an incomplete optical colonoscopy, with adequate preparation. This includes, for the most part, small-framed women, and patients with particularly long intestinal tracts, or a history of stomach surgeries. The pill received clearance under the direct de novo classification for devices with low to moderate risk that have no precedent on the market.

"The clearance of PillCam COLON by the FDA represents a pivotal moment in the evolution of Given Imaging as a GI medical device leader,” said Given Imaging President and CEO Homi Shamir. “We look forward to working closely with the U.S. gastroenterology community to bring this clinically-proven, diagnostic tool to patients who need to have a thorough colorectal exam following an incomplete colonoscopy. While we believe that PillCam COLON will ultimately play an important role in both the global colorectal cancer diagnostic and screening market, this initial indication is an important first step. To this end, we are making good progress in advancing additional clinical studies that should support the expanded indications."

In the past two months, Given Imaging received approval to market the pill in Japan, as well as approval to market their next-generation pill, SB3, for small intestine diagnosis, in Japan and the US.

Given Imaging’s shareholders, the foremost among them being IDB Holding Corp. Ltd. (TASE:IDBH), recently approved the sale of the company, for close to $1 billion, to Covidien. The deal will be completed by the end of February.

Published by Globes [online], Israel business news - www.globes-online.com - on February 3, 2014

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Given Imaging's disgruntled shareholder sells stake

Discovery Equity Partners sent a sharply worded letter recently accusing Given Imaging of bad management and failure to create shareholder value.

12 December 13 16:34, Shiri Habib-Valdhorn

Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) shareholder Discovery Equity Partners is not waiting for the closing of the sale of the company to Covidien plc (NYSE: COV), and has sold its entire 3.7% stake of 1.2 million shares. This is the private equity fund, which a few weeks ago sent a sharply worded letter to Given Imaging's board of directors, accusing it of bad management and failure to create value for shareholders.
In the letter in early October, Discovery Group said that a sale to a strategic buyer could be expected to achieve a value of $26-30 per share. This estimate was 30-50% above Given Imaging's share price at the time.
On December 8, Given Imaging announced the sale of the company at $30 per share to Ireland's Covidien for almost $1 billion. Given Imaging's share price jumped on the news, closing the premium between the share price and the sale price. Trading volume was very heavy, especially on Monday, when Discovery Equity Partners apparently sold its stake for $30-35 million.
Discovery Equity Partners invested in Given Imaging in early 2011, when its share price was $11-16. Discovery has made a handsome return in the investment.
Published by Globes [online], Israel business news - www.globes-online.com - on December 12, 2013

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Sold out my entire holdings in GIVN,
adding to CANF, hopefully lucky streak
continues!!!

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Shareholder Alert: Bronstein, Gewirtz & Grossman, LLC Announces Investigation of Given Imaging Ltd.

Monday 9 December 2013

NEW YORK, Dec. 9, 2013 /PRNewswire/ -- Bronstein, Gewirtz & Grossman, LLC is investigating potential claims against the Board of Directors of Given Imaging Ltd. ("Given Imaging" or the "Company") (NasdaqGS:GIVN) related to the proposed acquisition of the Company by Covidien PLC. The transaction is valued at around $860 million or $30 per share.

This investigation concerns whether the Board of Directors of Given Imaging breached their fiduciary duties to stockholders by failing to adequately shop the Company before agreeing to enter into the proposed transaction, and whether the Company has disclosed all material information to shareholders about the transaction.

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Given Imaging fails to go it alone

Shiri Habib-Valdhorn

It's impossible call an exit of almost $1 billion disappointing, but Given Imaging is joining the list of Israeli companies that could not go it alone any longer.

8 December 13 16:31, Shiri Habib-Valdhorn

The timing of the sale of Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) is a bit surprising. The company is due to receive at any moment the hoped-for US Food and Drug Administration (FDA) approval of its Pillcam Colon 2 capsule. Usually FDA approval boosts a company's value, so why not wait to sell the company until after the approval has been obtained? In this case, the pending approval is already included in the company's valuation (and delays in the regulatory process are always possible, although the company is optimistic that the approval will be obtained this year). In any case, for Given Imaging, FDA approval is not a do or die alternative; it already sells a range of endoscopic capsules in the US and around the world.
Given Imaging has already obtained marketing approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for a different capsule, with a market potential of hundreds of millions of dollars, and will begin sales in a month. The FDA approval will add another potential market of $1.5 billion. Again, why sell now? Because despite the market potential, an opportunity to create value for shareholders has popped up, and they won't have to wait to educate the market about the new PillCams, which would involve marketing new products.
In October, in a letter to Given Imaging's board, Discovery Group partner Mark Buckley demanded an immediate share repurchase program and the sale of the company to a larger strategic buyer. Discovery Group owns 3.7% of Given Imaging. He claimed that a sale to a strategic buyer could be expected to achieve a value of $26-30 per share - 30-50% above Given Imaging's closing price on Nasdaq at the time. He probably did not believe that a deal would soon be made at the upper end of his estimate.
Given Imaging was unperturbed by the letter, stating in response, "The board of directors will discuss the letter and respond at a time of its choosing." This nonchalant response may have been because the board knew that talks were underway, or maybe not. Company executives said that it was easy for outsiders to talk about selling at a high price when reality does not meet expectations. It turns out that this small shareholder called it correctly.
"I am always disappointed to hear about an exit when I think that something else was possible. I am referring to cases in which there is a product with a good chance of reaching market, and it would be possible to build around it large independent activity in the global market. This isn't something bombastic, and Given Imaging is an example of a company that has done it," former Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) CEO Israel Makov told "Globes" in an interview several years ago. It is impossible call an exit at almost $1 billion with a handsome premium is disappointing, but Given Imaging is joining the list of Israeli companies that could not go it alone any longer.

Published by Globes [online], Israel business news - www.globes-online.com - on December 8, 2013

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Covidien buys Given Imaging for $860m

Given Imaging CEO: After thoroughly evaluating our options we determined that this deal is in the best interests of Given Imaging.

8 December 13 12:35, Globes correspondent


Irish healthcare company Covidien plc (NYSE: COV) has acquired IDB Holding Corp. Ltd. (TASE:IDBH) unit capsule endoscope developer Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) for $860 million, net of cash and investments acquired. Covidien is paying $30 per share, a 15% premium on the share's closing price on Nasdaq on Friday night when the company had a market cap of $753 million.
IDB subsidiary Discount Investment Corporation (TASE: DISI) owns 14.7% of Given Imaging, subsidiary Elron Electronic Industries Ltd. (TASE: ELRN), owns 21.2%, including 8.3% through RDC, its joint venture with Rafael Advanced Defense Systems Ltd. in equal shares. Discount Investment said that it would make $142 million on the sale, Elron said that it would make $204 million, and RDC will make $80 million.
Covidien said, "This transaction provides Covidien additional scale and scope to serve the multibillion dollar global gastrointestinal (GI) market and supports the company’s strategy to comprehensively address key global specialties and procedures. We believe Given Imaging is one of the most attractive specialty procedure areas. Acquiring Given will enable Covidien to significantly expand its presence in a $3 billion GI market”
Covidien added, "Given Imaging provides one of the broadest technology platforms for visualizing, diagnosing and monitoring the digestive system, including its flagship PillCam, an innovative swallowed capsule endoscope.
Covidien group president medical devices & US said, "Adding Given’s portfolio of diagnostics to our portfolio accelerates Covidien’s strategy of providing physicians with products that support the patient along the care continuum from diagnosis to treatment. It also confirms our leadership in developing less-invasive screening, diagnosis and treatment solutions that can improve patient outcomes and lower healthcare costs.”

Given Imaging president and CEO Homi Shamir said, “Given Imaging revolutionized GI diagnostics over 12 years ago with the launch of PillCam and created an entirely new diagnostic category - capsule endoscopy. The combination of Covidien’s established global presence and Given Imaging’s innovative capabilities has the potential to transform this market. After thoroughly evaluating our strategic options we determined that this transaction is in the best interests of Given Imaging, its shareholders and employees and provides unique benefits to patients globally.”
Covidien has previously acquired three Israeli medical device companies, all of them in 2012 - respiratory monitor developer Oridion for $346 million, bronchial tubes endoscope maker superDimension for $300 million, and hernia mesh company PolyTouch for $40 million.
Published by Globes [online], Israel business news - www.globes-online.com - on December 8, 2013

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Covidien to swallow Given Imaging for $860M. •

<Thanks Dew!>

5:19 AM
Covidien (COV) has agreed to acquire Given Imaging (GIVN), an Israeli provider of an ingestible camera for diagnosing stomach problems, for $860M.
The offer of $30 a share represents a premium of 27% over Given's closing price on Nasdaq on Friday. Shares in Tel Aviv have jumped 21%.
"We believe GI (gastrointestinal) is one of the most attractive specialty procedure areas," said Covidien's (COV) Bryan Hanson. "Acquiring Given will enable Covidien to significantly expand its presence in a $3B GI market."
Covidien intends to finance the transaction, which is expected to be completed by March 31, with cash on hand.
The Irish-based firm forecast that Given will add $40-50M a quarter in incremental revenue. The acquisition is seen as being neutral to operating margin and adjusted EPS in FY 2014, and then as adding to those metrics in 2015 and beyond.
Given shareholders that control 44% of the company have approved the deal, including Elron Electronic Industries (ELRNF).

(PR)

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Covidien Announces Definitive Agreement to Acquire Given Imaging

Sunday 8 December 2013

Advances Covidien strategy to more comprehensively address key specialties and procedures globally
Adds Given Imaging’s broad suite of minimally invasive gastrointestinal diagnostic and monitoring solutions
Accelerates development of world-class gastrointestinal portfolio focused on serving patient from diagnosis to treatment
Accretive to earnings per share beginning in fiscal 2015
Covidien plc (NYSE: COV) and Given Imaging Ltd. (Nasdaq: GIVN) today announced a definitive agreement under which Covidien will acquire all of the outstanding shares of Given Imaging for $30.00 per share in cash, for a total of approximately $860 million, net of cash and investments acquired. This transaction provides Covidien additional scale and scope to serve the multibillion dollar global gastrointestinal (GI) market and supports the Company’s strategy to comprehensively address key global specialties and procedures.

Given Imaging provides one of the broadest technology platforms for visualizing, diagnosing and monitoring the digestive system, including its flagship PillCam®, an innovative swallowed capsule endoscope.

“We believe GI is one of the most attractive specialty procedure areas. Acquiring Given will enable Covidien to significantly expand its presence in a $3 billion GI market,” said Bryan Hanson, Group President, Medical Devices & U.S., Covidien. “Adding Given’s portfolio of diagnostics to our portfolio accelerates Covidien’s strategy of providing physicians with products that support the patient along the care continuum from diagnosis to treatment. It also confirms our leadership in developing less-invasive screening, diagnosis and treatment solutions that can improve patient outcomes and lower healthcare costs.”

“Given Imaging revolutionized GI diagnostics over 12 years ago with the launch of PillCam and created an entirely new diagnostic category -- capsule endoscopy. The combination of Covidien’s established global presence and Given Imaging’s innovative capabilities has the potential to transform this market,” said Homi Shamir, President and CEO, Given Imaging Ltd. “After thoroughly evaluating our strategic options we determined that this transaction is in the best interests of Given Imaging, its shareholders and employees and provides unique benefits to patients globally.”

Given Imaging is dedicated to developing innovative diagnostic and monitoring technologies for the digestive system. The company’s broad portfolio includes the PillCam, a minimally-invasive, non-sedation, swallowed optical endoscopy technology for the small bowel, esophagus and colon. In total, Given Imaging has seven product lines across 21 GI disease states. The company also offers industry-leading GI functional diagnostic solutions including ManoScan® high resolution manometry, Bravo® capsule-based pH monitoring, Digitrapper® pH-Z monitoring and SmartPill® motility monitoring systems.

The transaction is subject to customary closing conditions, including Given Imaging shareholder approval and the receipt of certain regulatory approvals, and is expected to be completed by March 31, 2014. The Boards of Directors of both companies have approved the transaction, and the Boards of Directors of DIC, Elron and Rdc, owners of 44 percent of Given's outstanding shares, have approved voting in favor of the transaction. DIC has also entered into a customary voting agreement with Covidien.

Financial Highlights

Covidien intends to finance the transaction through cash on hand and will report Given Imaging within the Medical Devices business segment. Upon closing of the transaction, Covidien expects Given Imaging will add between $40 and $50 million per quarter in incremental revenue to the Medical Devices segment.

On a reported U.S. GAAP basis, the transaction is expected to be dilutive to both operating margin and earnings per share (EPS) in fiscal 2014. On an adjusted basis, excluding one-time items and transaction costs, management expects the transaction to be neutral to both operating margin and EPS in fiscal 2014. The transaction is expected to be accretive to operating margin and EPS both on a U.S. GAAP and on an adjusted basis in fiscal 2015 and beyond. From a “cash earnings” standpoint, which excludes the impact of amortization, the transaction is expected to be accretive immediately after it closes.

Covidien management is not changing any of its guidance as a result of this transaction.

Supporting materials are now available on the Investor Relations section of Covidien’s website: http://investor.covidien.com

About Covidien

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien develops, manufactures and sells a diverse range of industry-leading medical device and supply products. With 2013 revenue of $10.2 billion, Covidien has more than 38,000 employees worldwide in more than 70 countries, and its products are sold in over 150 countries. Please visit www.covidien.com to learn more about our business.

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SOLD!!!


$30 Apiece - 1 Billion $$$

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Given Imaging Advances Most in Four Months on Buyout
By Matthew Kanterman - Nov 25, 2013 11:13 PM GMT+0200


Given Imaging Ltd. (GIVN) jumped the most in four months in New York after the daily financial Globes said three companies are in talks to buy the Israeli maker of swallowable cameras.
Shares of the Yokneam, Israel-based company advanced 6.7 percent to $22.63, the most since July 15. The stock traded at a premium of $1.11 to Tel Aviv, according to data compiled by Bloomberg.
Given Imaging and the unnamed companies are in negotiations for a deal that would value the Israeli developer at as much as $800 million, a 12 percent premium to the close today, Globes reported on its website today, without saying how it obtained the information. Discovery Group, which owns about 4 percent of Given Imaging’s shares, said on Oct. 2 that it wants the company to resume exploring sale process after ending a search for a possible merger in January.
“It’s a very strong, attractive, consumable business and a strategic acquirer that already has a gastroenterology sales force could wipe out a significant portion” of their expenses, Bryan Brokmeier, an analyst at Maxim Group LLC, said by phone from New York today. “They do have some shareholders who are pushing them to sell themselves and there’s a lot of synergies to a strategic buyer of acquiring Given.

Fujifilm Holdings Corp. (4901), Olympus Corp. (7733) and Boston Scientific Corp. (BSX) are potential buyers, according to Maxim Group.

A spokeswoman for Given Imaging declined to comment when contacted by telephone. Denise Kaigler, a senior vice president of corporate affairs and communications at Boston Scientific in Natick, Massachusetts, said the company doesn’t comment on speculation in an e-mailed statement. Representatives for Fuji and Olympus couldn’t be reached by e-mail after normal business hours in Tokyo.
To contact the reporter on this story: Matthew Kanterman in New York at [e-mail]

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Given Imaging Ltd. (GIVN) was a big mover last session, as the company saw its shares rise by nearly 7% on the day. The move came on solid volume too with far more shares changing hands than in a normal session. This continues the recent trend for the company as the stock experienced a peak and a subsequent fall over the last month, but gained nearly 11%.

This medical appliances and equipment firm has seen one negative revision in the last one month and its Zacks Consensus Estimate moved lower over the same time frame, suggesting there may be trouble down the road. So make sure to keep an eye on this stock going forward to see if yesterday’s move higher can last.

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3 cos interested in buying Given Imaging

The asking price for the endoscopic capsule developer is reportedly $750-800 million, a 20% premium on the market cap.
25 November 13 17:59, Gali Weinreb and Shiri Habib-Valdhorn


Sources inform ''Globes'' that Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) has resumed talks, which might lead to the sale of the company, almost a year after calling them off. The developer of the PillCam endoscopic capsule for diagnosis of bowel diseases has a market cap of $675 million, following a 21% rise in its share price since the beginning of the year. The asking price reportedly reflects a company value of $750-800 million, a 20% premium on the current market cap, and the intention is to close a deal by the end of the year. The sources said that three companies are interested in acquiring Given Imaging, two as strategic investors and the third as a financial investor.
Given Imaging declined to comment on the report.
Over a year ago, Given Imaging confirmed that it intended to consider "strategic options" to create value for shareholders, and that talks had begun with several parties interested in acquiring the company. Potential buyers mentioned at the time included Fujifilm Holdings Corporation (TSE:4901) unit Fujinon, Johnson & Johnson (NYSE: JNJ), and Samsung Electronics Co. Ltd. (KSX: 5930; LSE: SMSN). When Given Imaging could not obtain the company value it wanted, its board of directors ended the talks. It reportedly reviewed offers at a company value of $700-750 million, but Given Imaging's controlling shareholder, Nochi Dankner's IDB Holding Corp. Ltd. (TASE:IDBH) had apparently hoped for more, possibly as much as $1 billion.
After the talks were called off, Discount Investment Corporation (TASE: DISI), through which IDB controls Given Imaging, announced that it wanted to sell its 46% stake in the company (held directly and through subsidiary Elron Electronic Industries Ltd. (TASE: ELRN) and Rafael Development Corporation, Elron's joint venture with Rafael Advanced Defense Systems Ltd.). The reason for the decision was IDB's financial distress.

New multibillion dollar markets

Today's Given Imaging is in a different place from where it was a year ago. Since the talks for the sale of controlling interest were ended, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has approved the company's upgraded PillCam capsule and the company has obtained insurance indemnification for it. The company will able to begin sales of the upgraded capsules in early 2014, opening a market worth hundreds of millions of dollars. The company hopes to obtain US Food and Drug Administration (FDA) approval by the end of the year. US marketing approval and insurance indemnification will add another $1.7 billion market.
In its full-year guidance for 2013, Given Imaging project earnings per share of $0.80-0.88 on $195-205 million revenue, although it recently said that it expects to only achieve the lower threshold of the guidance. It had $142 million in cash at the end of September.

Published by Globes [online], Israel business news - www.globes-online.com - on November 25, 2013

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Given Imaging Receives Reimbursement Approval for PillCam COLON(R) in Japan Effective January 1, 2014

Monday 11 November 2013

Given Imaging (Nasdaq:GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced that Japan's Central Social Insurance Medical Council (Chuikyo) has approved the recommendation by the Japanese Ministry of Health, Labor and Welfare (MHLW) to provide reimbursement for Given Imaging's PillCam COLON. With this approval, Chuikyo established a reimbursement of 83,100 JPY, or roughly $840.00 USD (using current exchange rate), per capsule that is scheduled to go into effect on January 1, 2014. This decision follows regulatory clearance of PillCam COLON in July of this year by Japan's Pharmaceuticals & Medical Devices Agency (PMDA). The MHLW will determine the final indication for use for PillCam COLON in December as well as the amount for the professional fee.
PillCam COLON

A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=22126

"We thank the Japanese government for moving so quickly to provide reimbursement for PillCam COLON so that more patients can have access to a safe and effective diagnostic and screening tool for detecting diseases of the colon," said Homi Shamir, President and CEO, Given Imaging. "We are training our team now so that we can maximize this opportunity in 2014."

Screening guidelines in Japan call for everyone over 40 to undergo a fecal occult blood test (FOBT). Compliance with screening remains low and only 27% of the population actually gets tested.1 After a physician identifies blood in a patient's stool, which can be a strong indication of colon cancer or other diseases, only 58% of these patients proceed to have a recommended colonoscopy to confirm the diagnosis due to a variety of reasons.2 PillCam COLON's ease of use and minimally-invasive profile could appeal to those patients.

About Given Imaging Ltd.

Since pioneering the field of capsule endoscopy in 2001, Given Imaging has become a world leader in GI medical devices, offering health care providers a range of innovative options for visualizing, diagnosing and monitoring the digestive system. The company offers a broad product portfolio including PillCam® capsule endoscope for the small bowel, esophagus and colon. The company also offers industry-leading GI functional diagnostic solutions including ManoScan® high resolution manometry, Bravo® capsule-based pH monitoring, Digitrapper® pH-Z monitoring, and SmartPill® motility monitoring systems. Given Imaging is committed to delivering breakthrough innovations to the GI community and supporting its ongoing clinical needs. Given Imaging's headquarters are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia, Vietnam, Hong Kong and Brazil. For more information, please visit givenimaging.com.

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Should Given Imaging Look For A Buyer?
Nov 8 2013, 13:13

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)

Given Imaging (GIVN), an Israel-based medical device company, was recently urged by investment firm Discovery Group to sell itself. The investment firm believes that the company has been undervalued due to mismanagement. The big question is whether Given Imaging should look for a buyer. If the company decides to do so it could generate significant interest as, in my opinion, it is an attractive takeover target.

Confident on its own

This is not the first time that talk of a sale has surrounded Given Imaging, which manufactures diagnostic products for the visualization and detection of disorders of the gastrointestinal tract. In fact, the company had been considering the option in October last year.

Given Imaging had announced that in order to maximize growth and enhance shareholder value it was exploring its strategic alternatives, including a possible sale. The company backed out from this in January this year, but is revisiting the idea now under pressure to create value for shareholders.

Creating value for shareholders

Given's stock has gained a little under 20% in 2013 so far, underperforming the broader market. Conmed (CNMD), which like Given focuses on surgical devices and equipment for minimally invasive procedures and monitoring, has gained nearly 27% in 2013 so far. It is therefore not surprising that Discovery Group, which has a 3.7% stake in Given Imaging, has urged the company's Board of Directors to create value for shareholders by putting itself up for sale.

In a letter to the Board, the investment firm urged the Board to look for a strategic buyer for the company. Discovery believes that the company could fetch a substantial premium in a sale. In addition, the investment firm urged the Board to implement a $50 million share repurchase or dividend to capitalize on Israel's expiring "Trapped Profits Law". According to Discovery, the move would allow the company to benefit from lower corporate tax rates.

Discovery said in the letter that Given Imaging's stock has been "chronically undervalued in the public markets during the past several years primarily due to mismanagement."

Attractive takeover target

Given Imaging is definitely an attractive takeover target, given some of the developments in recent months. In September, Given Imaging's PillCam SB 3 system received clearance from Japan's Pharmaceuticals and Medical Devices Agency (PMDA). The clearance is significant for Given Imaging as Japan is the world's second largest healthcare market.

The PillCam SB 3 system has been also granted 510(k) clearance by the FDA in the U.S. this year. PillCam SB was first cleared for use by the FDA in 2011. Homi Shamir, CEO of Given Imaging, believes that the third generation PillCam SB will enhance the clinical experience for the company's large base of existing U.S. customers and expand the market for the product among new physicians who have not been performing PillCam procedures.

Given Imaging could receive a major boost if the company's PillCam Colon is cleared by the FDA. In fact, FDA clearance for PillCam Colon could attract some potential buyers to the company. The device has already been cleared by PMDA in Japan for diagnosis of colonic disease when colonoscopy is required but difficult to conduct. Shamir believes that the PMDA's decision could expand the company's potential customer base in Japan from approximately 1,000 today to potentially 10,000. One can expect a similar impact in the U.S. once the device is cleared by the FDA.

Who could buy Given Imaging?

Olympus, which is a major player in the endoscopy devices market, could be interested if Given Imaging puts itself up for sale. While Olympus dominates the global endoscopy devices market with a significant market share, new technologies such as capsule endoscopy are expected to be key growth drivers going forward.

Sale best way forward for Given Imaging

Discovery Group believes that Given Imaging could fetch between $26 and $30 per share in a sale. That represents a premium of between 30% and 50%. A sale will certainly be the best way forward for Given Imaging as the company has the potential to generate significant value for shareholders in the near-term.

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The government has therefore proposed a one year lowering of the tax rate on profit distributions made by such multinationals.

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Read these items, i cannot answer your question!

The Israeli Finance Minister announced a temporary provision that would provide an incentive for certain companies owned by multinational investors to repatriate "trapped earnings." The main objective of the incentive is to encourage Israeli companies to distribute dividends out of undistributed profits that were tax-exempt under Israel's Approved Enterprise regime. If enacted, the draft bill may affect certain Israeli companies significantly.

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The government will collect more than NIS 3 billion in revenues from trapped profits, Minister of Finance Yuval Steinitz told a conference of the CFO Forum and Kesselman & Kesselman pwc Israel today.
"Over the past week, we received a lot of disinformation and ignorance about the trapped dividends law, which the Knesset passed this week by a large majority. For 20 years, we collected pennies from the trapped profits, and no one made a peep. When I decided to collect billions of shekels to prevent burdening the public and the business sector, the opposition woke up with a disinformation campaign that we were forgiving companies," said Steinitz.
The Knesset plenum passed the trapped profits bill on Monday in a 36:21 vote, out of 120 MKs.
Steinitz went on to assert that the government did not forgive corporations on their taxes, saying that no taxes had ever been collected on the trapped profits. "What did we forgive? After all, for 10 or 20 years, we collected nothing. The purpose of the law is to collect more taxes, and I see newspaper headlines saying that we should send the companies a tax bill of NIS 20 billion. How can we send such a bill to someone who does not owe taxes? Until a company withdraws dividends, they are not liable to taxes. We believe that collecting taxes on trapped dividends will yield much more than NIS 3 billion, which we set as the threshold."
Steinitz slammed his critics from the Left, saying, "I hear politicians talking about distribution, but they have no strategy for growth. They talk about distributing the fruits of the tree, but they have no idea how to grow a tree and its fruit. I hear two friends and political colleagues [Labor Party chairwoman] MK Shelly Yachimovich and [Meretz chairwoman] MK Zehava Gal-On talk about abolishing the Law for Capital Investments. They say that there is no need to give breaks to the export sector, that it's a kind of discrimination, and everything should be uniform, and that there should not be a differential companies tax. These are populist slogans that will destroy companies and growth in Israel.
"At the same time, they talk about raising the companies tax rate to 32%. This is immediate damage to the economy, for domestic companies, but especially for export industries, which invest here even though they could operate anywhere in the world. This means investment flight from Israel and the export of companies that already operate here. This is a step that would cause unemployment and anyone who causes mass unemployment will cause terrible and awful social harm."

http://www.globes.co.il/serveen/globes/docview.asp?did=1000796429

Israeli Knesset Approves 'Trapped Profit' Law
by Lorys Charalambous, Tax-News.com, Cyprus
15 November 2012
Israel’s Knesset has passed a law that will reduce the amount of tax payable by multinational companies seeking to distribute dividends or invest profits abroad, in return for these companies investing at least 50% of their profits in the country.

Under the old Law for the Encouragement of Capital Investment, qualifying industrial companies' profits were not taxable until distributed as dividends. However, this led to large scale profit retention by these companies. The government has therefore proposed a one year lowering of the tax rate on profit distributions made by such multinationals.

The ‘trapped profits’ law, approved by the Knesset in its second and third readings on November 5, will lower the amount payable by multinationals by 40% to 60%, depending on how much the company is willing to invest in Israel. However, the tax rate of a company benefiting from the trapped profits law cannot fall below 6%.

The law specifies that the company must invest in "industrial enterprise, in assets used by the enterprise, in R&D or in the salaries of new employees" and that tax benefits will only be available if the company commits to reinvest at least half of the freed profits in Israel. The proposals will also change the tax treatment of dividend distributions from such profits in the hands of the recipient.

http://www.tax-news.com/news/Israeli_Knesset_Approves_Trapped_Profit_Law____58251.html

[DewDiligence]

Is the 10% tax on "trapped profits" a one-time opportunity with a set expiration date?

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Given Imaging pays tax on trapped profits

Given Imaging said that it would pay a 10% tax rate on $54 million of profits.

6 November 13 13:52, Globes' correspondent


Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) reported double-digit revenue growth to reach an all-time high for the third quarter, beating the analysts' revenue and earnings per share consensus, but will only make the lower end of its full-year guidance.
Revenue rose 10% to $54 million for the third quarter from $45.4 million for the corresponding quarter of 2012. GAAP-based net profit rose 8% to $6.5 million ($0.20 per share) for the third quarter from $6 million for the corresponding quarter.
GAAP-based net profit rose 8% to $6.5 million ($0.19 per share) for the third quarter from $6 million for the corresponding quarter, and non-GAAP net profit rose 4% to $8.2 million ($0.25 per share) from $7.9 million.
Given Imaging beat the analysts' consensus of $0.23 earnings per share on $53.1 million revenue.
Cash flow from operations was $11.7 million for the third quarter, and the company had $142.4 million in cash and cash equivalents at the end of September.
Given Imaging has decided to take advantage of Israeli government's program for releasing trapped profits at lower tax rates. Given Imaging said that it would pay a 10% tax rate on $54 million of profits for which taxes had not been previously provided (instead of 25%), and will use the net proceeds in a manner that is in the best interests of the company and its shareholders.
"We are very pleased that we achieved quarterly revenue of $50 million for the first time ever, in addition to solid earnings and cash flow this quarter," said Given Imaging president and CEO Homi Shamir. "2013 has proven to be a pivotal year for Given Imaging both financially as well as in terms of our progress in achieving several critical milestones. PillCam SB3 was cleared in the US, as well as Japan where we also obtained approval for PillCam Colon. The momentum should continue with our plans to launch PillCam Colon in Japan in the first half of 2014 upon obtaining reimbursement, and obtain FDA clearance for PillCam Colon, which we expect this quarter. These achievements should have a positive impact on 2014 sales."
Published by Globes [online], Israel business news - www.globes-online.com - on November 6, 2013

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Multiple New Studies Discuss Clinical Benefits of Given Imaging's PillCam(R) COLON at United European Gastroenterology Week Monday 14 October 2013


- Ten abstracts including more than 1,200 patients to be presented on PillCam COLON -

- Topics range from confirming the diagnostic yield of PillCam COLON and validating feasibility of PillCam COLON in a general practice setting -

Given Imaging Ltd, (Nasdaq:GIVN), a world leader in gastrointestinal medical devices and pioneer of capsule endoscopy, today announced that ten abstracts highlighting the clinical utility of PillCam COLON were presented during United European Gastroenterology Week (UEG Week) taking place October 12-16, 2013 at the Internationales Congress Centrum Berlin where Given Imaging is exhibiting at Hall 15.1, Booth #7.

"The growing body of data supporting both the clinical accuracy for PillCam COLON and patient preference for a non-invasive, radiation-free colorectal exam strengthen our efforts to expand access to PillCam COLON in Europe and markets across the globe," said Homi Shamir, president and CEO, Given Imaging.

Highlights of the ten studies presented at UEG Week include:

Patients prefer PillCam COLON because of concern about pain and embarrassment related to colonoscopy.
PillCam COLON shows significantly higher diagnostic yield compared to CTC in polyps 6 mm or larger.
Use of PillCam COLON following incomplete colonoscopy reveals new lesions in 60% of patients resulting in therapy modifications for 45% of these patients.
Head-to-head, retrospective comparison of PillCam COLON versus colonoscopy finds PillCam COLON generated 90% sensitivity and 96% specificity on a per-lesion basis for detecting flat lesions shown to have a higher risk of being cancerous.
"As utilization of PillCam COLON increases, we are generating useful information about its use in a range of settings and for different indications including polyp detection rates," said Jean-Christophe Saurin, M.D., Ph.D., French Society of Digestive Endoscopy. "These quantifiable outcomes underscore that PillCam COLON is an interesting colonic screening option for patients who cannot or prefer not to have a traditional colonoscopy, but studies on acceptance in these patients are warranted."

"French Multicenter Experience of Colon Capsule Endoscopy in Real Practice: Primary Results of the Colon Capsule Endoscopy Observatory 'ONECC'" (poster #1337) was conducted by Dr. Saurin and colleagues to analyze survey results from a 161-user, 116-center French database of PillCam COLON procedures. Researchers evaluated the feasibility of using PillCam COLON in a general practice setting and the indications for which PillCam COLON was being used. Survey results from 585 PillCam procedures showed that PillCam COLON detected polyps in 253 patients, of which, significant polyps were discovered in 125 patients, or 28% of all the PillCam COLON procedures. Researchers also discovered that PillCam was used equally among three indications: patients with previous incomplete colonoscopy, patients contraindicated for colonoscopy and patients who refused colonoscopy. Of these indications, PillCam COLON detected significant polyps in 20.4% of patients with previous incomplete colonoscopy, 23.1% of patient contraindicated for colonoscopy and 14.5% of patients who refused colonoscopy. Based on the broad indications used for PillCam COLON and the significant polyp detection rate, researchers confirmed the practical application of PillCam COLON in a general practice setting.
"Patients Perception of Colonoscopy: Astonishing Reasons for Colon Capsule Endoscopy Preference" (poster #791) validated patient preference for a non-invasive colorectal exam. Researchers from the Department of Gastroenterology and Hepatology at the Institute for Clinical and Experimental Medicine in Prague, Czech Republic led by Marek Benes, M.D. conducted a 100 patient survey analysis to find that 42% of patients reported they will never undergo a screening colonoscopy even though 45% of this subgroup had a positive family history of colorectal cancer. The top reason for preference for PillCam COLON over colonoscopy was due to concerns about privacy and embarrassment experienced with colonoscopy, with 38% of patients reporting this as their top concern. Concern of pain was the second most common reason to prefer PillCam COLON over colonoscopy, with 35% of patients reporting this as a concern.
"Flat Colorectal Lesions At Pillcam Colon Capsule Endoscopy" (oral presentation #432) was a head-to-head, retrospective comparison of PillCam COLON versus colonoscopy to evaluate the ability of PillCam COLON to diagnose flat colonic lesions. Led by Cristiano Spada, M.D., Catholic University, Rome, Italy, researchers collected data from patients who underwent PillCam COLON followed by a traditional colonoscopy. Physicians were able to identify 27 conventional polyps with colonoscopy and 25 conventional polyps with PillCam COLON. In one patient, PillCam COLON visualized an 11 mm flat lesion that was not confirmed by colonoscopy. PillCam COLON generated 90% sensitivity and 96% specificity on a per-lesion basis. Based on these findings, researchers concluded that PillCam COLON has high accuracy for detecting flat lesions.
The utilization of PillCam COLON following incomplete colonoscopy was highlighted in UEG Week abstracts including:

"Colon Capsule Endoscopy Versus CT-Colonography in the Evaluation of Patients with Incomplete Traditional Colonoscopy: A Prospective Comparative Trial" (oral presentation #431) presented by Cristiano Spada, M.D., and colleagues from the Catholic University in Rome, Italy. Patients in the study underwent both CT-colonography (CTC) and PillCam COLON with the goal of identifying polyps and masses that were at least six millimeters and located in segments of the colon that could not be examined in the previous incomplete colonoscopy. Both PillCam COLON and CTC successfully completed the colonic exam in 98% of patients due to 2% of patients refusing CTC due to air insufflation. Of the 98 patients included in the analysis, PillCam COLON identified polyps at least six millimeters in size in 19 patients, while CTC identified only seven patients. Resulting sensitivity and specificity for PillCam COLON was 100% and 91% respectively and 35% and 92% respectively for CTC. Researchers concluded that both exam modalities were effective in completing a colonic exam, however PillCam COLON had a significantly higher diagnostic yield compared to CTC in identifying polyps six millimeters or larger.
"Utility of Colon Capsule Endoscopy After an Incomplete Colonoscopy - Multicenter Spanish Study" (poster #793) led by Oscar Nogales, M.D., Hospital General Universitario Gregorio Marañón, Department of Gastroenterology, Madrid, Spain analyzed the use of PillCam COLON 98 patients with previous incomplete colonoscopies. Overall, PillCam COLON was able to identify new lesions in in 60% of patients. Within this group, therapy modifications resulted for 45% of the patients. Polyps were the most frequent finding with 41% of patients having a polyp identified by PillCam COLON. Additional findings by PillCam COLON included diverticulae, neoplasia and solitary colonic ulcers. Based on these results, researchers concluded that Pillam COLON is a useful diagnostic tool to identify a significant number of lesions in unexplored regions of the colon following incomplete colonoscopy and, as a result, may produce favorable therapeutic changes for these patients.

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Extensive New Data on Given Imaging's Broad Portfolio of Innovative GI Products to be Presented at ACG & UEG Week

Thursday 10 October 2013

Given Imaging Ltd, (Nasdaq:GIVN), a world leader in gastrointestinal medical devices and pioneer of capsule endoscopy, today announced that more than 150 studies confirming the value of Given Imaging's portfolio of extensive products in detecting and monitoring gastrointestinal diseases will be presented during the upcoming American College of Gastroenterology (ACG) 2013 Annual Scientific Meeting and Post Graduate Course and United European Gastroenterology Week (UEG Week).
"With the approval of PillCam COLON and PillCam SB 3 in Japan and the clearance of PillCam SB 3 in the U.S., 2013 has been a milestone year for Given Imaging. We expect this momentum to continue to be fueled by positive data presented at these conferences confirming existing and new product indications," said Homi Shamir, president and CEO, Given Imaging. "A wide range of data, including ten PillCam COLON studies, underscore our leadership in detecting and monitoring GI diseases, including colorectal cancer, Crohn's disease, obscure GI bleeding and gastroparesis."

The 2013 American College of Gastroenterology Annual Scientific Meeting

Given Imaging will be at booth #1200 at ACG taking place October 11 - 16, 2013 in San Diego, California. Key abstracts being presented during the meeting include:

PillCam® SB capsule endoscopy:

"Capsule Endoscopy (CE) Can Improve Outcomes in Crohn's Disease: An Evaluation of Pre- and Post-treatment CE" (poster 426) presented by Dr. Neel K. Mann and Dr. Simon Lo on Sunday, October 13 from 3:30 – 7 p.m. PDT.
Bravo® pH-monitoring:

"Four-Day Two-Phase Wireless pH Monitoring for Evaluation of Esophageal Symptoms Refractory to High Dose PPI: Utility in Clinical Practice" (poster 14) presented by Dr. Louis Wilson on Sunday, October 13 from 3:30 – 7 p.m. PDT.
SmartPill® motility monitoring:

"Clinical Utility and Diagnostic Yield of 165 Wireless Capsule Studies at a Tertiary Referral Center" (poster 1684) presented by Dr. Zubin Arora on Tuesday, October 15 from 10:30 a.m. - 4 p.m. PDT.
ManoScan® high resolution manometry:

"Alterations in Esophageal Function on High Resolution Esophageal Manometry in the Elderly" (poster 1216) presented by Dr. Stephanie Worrell on Tuesday, October 15 from 10:30 a.m. - 4 p.m. PDT.
United European Gastroenterology Week 2013

Given Imaging will be at booth #7 located in Hall 15.1 at UEG Week taking place in Berlin, Germany October 12-16, 2013. Key abstracts being presented during the meeting include:

PillCam® COLON capsule endoscopy:

"Colon Capsule Endoscopy Versus CT-Colonography In The Evaluation Of Patients With Incomplete Traditional Colonoscopy: A Prospective Comparative Trial" (oral presentation 431) presented by Dr. Cristiano Spada on Wednesday, October 16 from noon - 12:12 p.m. CEST.
"French Multicenter Experience of Colon Capsule Endoscopy in Real Practice: Primary Results of the Colon Capsule Endoscopy Observatory "ONECC"" (poster1337) presented by Dr. Jean-Christophe Saurin on Wednesday, October 16 from 9 a.m. – 5 p.m. CEST.
PillCam® SB capsule endoscopy:

"Why Should We Still Use Capsule Endoscopy In Inflammatory Bowel Diseases?" (oral presentation 430) presented by Dr. Lucia Marquez on Wednesday, October 16, 2013 from 11:48 a.m. – noon CEST.
Bravo® pH monitoring:

"The Real Prevalence Of Functional Heartburn: The Lesson Of Prolonged Wireless pH Monitoring" (poster 1598) presented by Dr. Roberto Penagini on Wednesday, October 16 from 9 a.m. – 5 p.m. CEST.
ManoScan® high resolution manometry:

"Prevalence Of Relaxation Disorders Of The Lower Esophageal Sphincter In Patients Undergoing High-Resolution Manometry" (poster 1585) presented by Dr. Jutta Keller on Wednesday, October 16 from 9 a.m. – 5 p.m. CEST.

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Given Imaging shareholder demands immediate sale

Discovery Group slams Given Imaging, claiming, "Failed execution of its business strategy, weak financial performance, and loss of management credibility."

2 October 13 10:58, Shiri Habib-Valdhorn

Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) shareholder The Discovery Group Holdings LLC, which owns 3.7% of the company, has written to the company's board of directors urging it to implement a $50 million share repurchase and a subsequent sale of the company to a larger strategic buyer. Discovery Group claims that a sale to a strategic buyer could be expected to achieve a value of $26-30 per share. This estimate is 30-50% above Given Imaging's closing price of $19.85 on Nasdaq on Tuesday, giving a market cap of $624 million.
Discovery Group says that Given Imaging has until November 15, 2013 to take advantage of Israel's Trapped Profits Law amendment, and that the company had $130 million in "idle cash" at the end of June. It asserts that Given Imaging has been chronically undervalued in the public markets primarily due to mismanagement.
"Failed execution of its business strategy, weak financial performance, loss of management credibility with investors, and an inefficient capital structure have all contributed to the company’s poor stock market performance," says Discovery Group partner Mark Buckley. "We no longer believe Given Imaging can attain its true intrinsic value in the public markets.
Buckley adds, “By returning excess cash to shareholders and conducting a full auction process to sell the Company, the Board will remove the execution risk that exists under the current management regime while providing shareholders with an attractive return."
Given Imaging develops and sells a range of endoscopic diagnostic capsules for the gastrointestinal tract. It is controlled by Nochi Dankner's IDB Holding Corp. Ltd. (TASE:IDBH). Given Imaging sought a buyer in 2012, but dropped the idea after failing to achieve the asking price. IDB has been trying to sell the company in recent months, but has yet to find any takers.
Chicago-based Discovery Group invested in Given Imaging in early 2011, citing the company's "transformative and disruptive technology and large untapped end-markets" as reasons for its investment.
Given Imaging said in response, "The board of directors will discuss the letter and respond at a time of its choosing."
Published by Globes [online], Israel business news - www.globes-online.com - on October 2, 2013

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Given Imaging Receives Clearance for the Third Generation PillCam(R) SB System in Japan
News Continues Given Imaging's Series of Regulatory Successes During 2013

YOQNEAM, Israel, Sep 23, 2013 (GLOBE NEWSWIRE via COMTEX) -- Given Imaging Ltd, GIVN -0.32% , a world leader in gastrointestinal medical devices and pioneer of capsule endoscopy, today announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval for the PillCam SB 3 system. The innovative technology in this third-generation system will provide physicians throughout Japan, the world's second largest healthcare market, with the most advanced PillCam capsule endoscopy technology to detect and monitor small bowel diseases, such as Crohn's disease.

Videos accompanying this release are available at

http://www.globenewswire.com/newsroom/prs/?pkgid=21089

http://www.globenewswire.com/newsroom/prs/?pkgid=20409

A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=20408

"Approval of the PillCam SB 3 system in Japan underscores our global commitment to providing physicians with innovative tools to detect and monitor abnormalities of the gastrointestinal tract," said Homi Shamir, President and CEO, Given Imaging. "The approval of the PillCam SB 3 system in Japan builds upon our recent regulatory momentum that includes PillCam COLON in Japan and PillCam SB 3 in the U.S. Japan is a critically important healthcare market and we look forward to working with physicians there to integrate PillCam SB 3's benefits into clinical practice."

Each component of the PillCam SB 3 system, including the capsule, recorder, sensor belt, and software, has been enhanced to work together to improve image quality, tissue coverage and efficiency. New adaptive frame rate technology also allows the capsule to automatically increase the rate at which images are taken when it senses it is moving more quickly through the digestive tract. Improvements in the new system's RAPID for PillCam software enable even smarter video compilation which is 40% more efficient than with PillCam SB 2. The company expects to begin recognizing sales of PillCam SB 3 in Japan in 2014.

"With its higher resolution and improvement in capturing images of the small bowel mucosa, the new PillCam SB 3 capsule endoscopy system provides us with enhanced performance and efficiency," said Tetsuya Nakamura, M.D., Ph.D., Professor and Director, Department of Medical informatics, Dokkyo Medical University. "With these improvements, along with recently receiving an expanded indication, PillCam SB will continue to play an important role in the diagnosis and treatment of small bowel diseases in Japan."

Given Imaging will be participating in the upcoming Japan Digestive Disease Week (JDDW) conference taking place between October 9th -12th, 2013 in Tokyo. Company representatives will be available to share information about the newest features and capabilities of the PillCam SB 3 system along with Given Imaging's entire portfolio of gastrointestinal screening, diagnostic and monitoring products.

About PillCam SB 3

The PillCam SB 3 capsule is a minimally invasive procedure to visualize and monitor small bowel abnormalities associated with Crohn's disease, iron deficiency anemia (IDA) and obscure GI bleeding (OGIB). The PillCam measures 11 mm x 26 mm and weighs less than four grams. Now in its third generation, PillCam SB 3 contains an imaging device and light source and transmits images at a rate between two and six images per second. Initially cleared by the U.S. Food and Drug Administration in 2001, PillCam SB is an accurate, patient-friendly tool used in patients two years and older by physicians to visualize the small bowel. PillCam SB 3 builds on Given Imaging's unique expertise and collaborative efforts as an industry leader that includes more than 2 million uses of PillCam capsules in patients worldwide and more than 1,900 clinical studies.

The risks of PillCam capsule endoscopy include capsule retention, aspiration and skin irritation. Endoscopic placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.

[midastouch017]

Shares Of Given Imaging Undervalued With Recent Approvals And Pending Colon Pill
Aug 15 2013, 08:47 | about: GIVN (Given Imaging Ltd.)
Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in GIVN over the next 72 hours. (More...)

Shares of medical company Given Imaging (GIVN) traded up 7% on Tuesday after the approval of the company's PillCam SB3 in the United States. That approval, along with a recent deal in Japan, and several upcoming FDA decisions, shares of Given Imaging have plenty more room to run.

On Tuesday, the FDA issued 501 (K) clearance on the new PillCam SB3. The device has huge upside and is a great upgrade from the previous PillCam SB2. The new pill capsule has 30% higher image resolution, an adaptive frame rate technology, and improved processing engine. The new device will also be used for detecting several diseases. The PillCam SB3 will be used to detect and monitor small bowel abnormalities, obscure gastrointestinal bleeding, and iron deficiency anemia.

Chief executive officer Homi Shamir had this to say of the pill's approval, "We believe PillCam SB3 will both enhance the clinical experience for our large base of existing U.S. customers and expand the market for this product among new physicians who have not been performing PillCam procedures." Essentially Shamir is saying this pill works better and covers more areas. This therefore should create new revenue streams from different sectors for Given Imaging.

Back in July, the Japanese Pharmaceutical & Medical Devices Agency approved the PillCam Colon, a device used by medical professionals in replace of the colonoscopy. This approval is huge for Given Imaging, since Japan remains the world's second-largest healthcare market. According to this Reuters article, Given's base of 1000 physician offices in Japan could grow to 10,000 offices. Total PillCam Colon sales could hit 1 million units sold. Reimbursement from Japan is expected to start in the first half of 2014.

The approval of the PillCam Colon in Japan now makes the device available in parts of Europe, Latin America, Canada, and Japan. The PillCam Colon is currently under the FDA approval process. The device is expected to be approved in the fourth quarter of 2013.

This pending approval is a huge catalyst for Given Imaging going forward. The 7% share price increase today will be copied and likely surpassed on the heels of a PillCam Colon approval in the United States. This New York Times article points out the ridiculously high costs of colonoscopies in the United States. The test has an average cost of $1185 versus the $100s charged in other countries. The operation has been moved from doctor's offices to hospital to capture additional revenue for doctors and hospitals.

The PillCam Colon could change all of this, as it would provide another option for patients and doctors. There are an average of 10 million colonoscopies performed in the United States every year. This creates a huge market for Given Imaging. The colonoscopy is the most expensive screening test Americans routinely undergo. The industry racks up $10 billion in annual costs, thanks to higher costs and higher volume of patients undergoing the test. If Given can capture a fraction of the colonoscopy industry, it could equal its current annual revenue from the PillCam Colon alone.

Last week, Given Imaging reported record second-quarter revenue. Total revenue increased 11% to $49.5 million. Given also saw record sales of its PillCam SB capsules with a total of 62,700. Earnings per share grew 35% in the quarter to $0.22. Gross margin also increased to 78.3% in the second quarter, a small gain from last year's 78.2%.

In the second quarter, total revenue broke down by region as follows:

Americas: $30.7 million, +8%
EMEA: $12.5 million, +18%
APAC: $6.3 million, +15%
PillCam sales broke down as follows:

Americas: 36,000, -2%
EMEA: 17,500, +13%
APAC: 9,300, +30%
Total PillCam sales increased 6% in the second quarter from the prior year. The impressive gain of 30% in the APAC region is set to grow further once the PillCam Colon begins seeing revenue in Japan.

Shamir had this to say of second-quarter earnings and the future, "Looking ahead, we expect the recent and significant regulatory milestone the clearance of PillCam Colon in Japan as well as the pending FDA decisions regarding PillCam SB3 and PillCam Colon to enable us to accelerate growth in 2014 and beyond."

The PillCam SB platform has been huge for Given Imaging. Since the launch of the original device in 2001, over 2 million pills have been swallowed by people around the world. The device was originally used to help doctors visually see the small bowel in patients. The device has since been expanded into uses for the esophagus and colon as well.

Shares of Given Imaging appear to be undervalued on a price-to-earnings basis. At Tuesday's closing price of $17.39, shares trade at 31 times fiscal 2013 estimates of $0.55. Shares trade at 20 times fiscal 2014 estimates of $0.88. However, Given Imaging currently has a cash base equal to $3.27 per share and reasonable debt of $68,000. When cash is taken out of the equation, shares trade at 26 and 16 times fiscal 2013 and fiscal 2014 estimates respectively. Analysts expect Given to post revenue gains of 7.3% and 12.4% in fiscal 2013 and fiscal 2014. This seems conservative with the approval in Japan and pending approval in the United States. I expect to see Given or analysts raise guidance, which should trickle down to stronger earnings per share.

Even with Tuesday's approval, shares of Given trade below their 52-week high ($19.48). The company has a $552 million market capitalization and trades well below prices in the $30s and $40s it once saw. I believe the PillCam story is not over. After Given receives FDA approval for the colon pill in the U.S., shares will hit new 52-week highs. I also expect Given to go after different areas of the body and expand its already successful capsule endoscopy technology.

Buy shares of Given Imaging to capture the potential revenue gains from Japan, new medical areas, and the potential FDA approval for the colon test in the U.S. The company has huge growth coming and shares trade at extreme discounts to value and growth.

[midastouch017]

Given Imaging Receives FDA Clearance for Next Generation PillCam(R) SB 3

Given Imaging Ltd, (Nasdaq:GIVN), a world leader in GI medical devices and the pioneer of capsule endoscopy, today announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for the next generation PillCam, SB 3, to detect and monitor small bowel abnormalities associated with Crohn's disease, obscure gastrointestinal (GI) bleeding and iron deficiency anemia.

"With more than 2 million procedures conducted since the first generation of the product was introduced, PillCam SB has had a significant impact on patient care in the U.S. and across the globe," said Homi Shamir, President and CEO, Given Imaging. "We believe PillCam SB 3 will both enhance the clinical experience for our large base of existing U.S. customers and expand the market for this product among new physicians who have not been performing PillCam procedures."

The PillCam SB 3 system combines a 30% improvement in image resolution with adaptive frame rate technology to deliver more detailed small bowel images and coverage. In addition, PillCam SB 3's video processing engine has been significantly improved. Proprietary algorithms in the system's new software enable even smarter video compilation that is 40% more efficient than PillCam SB 2.

"Patients with complicated diseases involving the small bowel, such as Crohn's disease, often struggle to comprehend what is happening inside their bodies and how it can be better managed," said Felice H. Schnoll-Sussman, M.D., Director, Jay Monahan Center for Gastrointestinal Health, New York-Presbyterian Weill Cornell Medical Center. "The improved image resolution and overall efficiency of the PillCam SB 3 system in capturing and analyzing images of the small bowel has potential to have a meaningful impact on patient care."

"Our goal as we set out to reimagine and improve the PillCam platform was not just to provide physicians with more information, but to provide them with better and more actionable information. By delivering more detail, more coverage and improving the overall efficiency of our technology platform, we have achieved this with PillCam SB 3," said Homi Shamir. "Given Imaging is committed to helping physicians integrate PillCam SB 3 into clinical practice and improving patient access to this new innovative technology both in the U.S. and across the globe."

The U.S. clearance of PillCam SB 3 represents the second regulatory milestone for Given Imaging in 2013. In July, the Company reported that PillCam COLON has been cleared by Japan's Pharmaceuticals & Medical Devices Agency. PillCam SB 3 will be available in the U.S. beginning in Q4 2013.

About PillCam® SB 3

The PillCam SB 3 capsule is a minimally invasive procedure to visualize and monitor small bowel abnormalities associated with Crohn's disease, iron deficiency anemia (IDA) and obscure GI bleeding (OGIB). The PillCam measures 11 mm x 26 mm and weighs less than four grams. Now in its third generation, PillCam SB 3 contains an imaging device and light source and transmits images at a rate between two and six images per second. Initially cleared by the U.S. Food and Drug Administration in 2001, PillCam SB is an accurate, patient-friendly tool used in patients two years and older by physicians to visualize the small bowel. PillCam SB 3 builds on Given Imaging's unique expertise and collaborative efforts as an industry leader that includes more than 2 million uses of PillCam capsules in patients worldwide and more than 1,900 clinical studies.

The risks of PillCam capsule endoscopy include capsule retention, aspiration and skin irritation. Endoscopic placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.

[midastouch017]

Given Imaging: Slightly Undervalued - Strong Upside Potential But Also Some Risks
Aug 5 2013, 11:59 | about: GIVN (Given Imaging Ltd.)
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)

Given Imaging, Ltd. (GIVN) is an Israeli high-tech, small-cap medical company offering innovative products primarily for the gastrointestinal medical treatment, with the flagship, breakthrough product being its camera-in-a-pill called PillCam COLON, which offers ingestible pill containing a camera as a minimally-invasive alternative to a traditional colonoscopy.

source: company materials

The company has been capitalizing on partnership with a company called RDC, which has first rights to commercially exploit defense technologies developed within Rafael Advanced Defense Systems, Ltd., a leading Israeli defense systems developer. This partnership facilitates finding innovative civil applications for breakthrough military technology advancements and provides Given Imaging with access to cutting-edge, patented technology to establish and maintain a competitive advantage.



The recent July 2013 Japanese approval for the PillCam product greatly changes the future company's outlook to the upside. Japan is the world's second-largest market after the U.S., with a sizeable and growing elderly population, ensuring growing future demand for colonoscopic medical treatments many years or even decades into the future. In the U.S., Given Imaging filed for an FDA approval, and the company expects to receive a positive regulatory sign-off by the start of the fourth quarter of 2013, following detailed European studies and Japanese regulatory clearance. The Japanese sign-off and the pending U.S. clearance are the two main and very strong catalysts for Given Imaging's strong future growth of EPS and stock price.

At the current price of $15.50, the company trades at a 17.63 forward P/E ratio, which is not cheap by itself. However, coupled with the great growth prospects after the substantial increase of the total addressable market due to the Japanese approval and pending U.S. approval, the company is expected to grow 25% per year. For many companies, I would be very suspicious if somebody promised me a 25% CAGR for five years. Indeed, there are risks. I think the 25% growth is achievable and provides a 50% upside by valuing a stock at $23.25.

Nevertheless, I am using a more conservative 15% EPS growth, which provides room for errors and setbacks in the company's future strategy execution. Even at my lower 15% EPS growth, the company's fair value is $16 and the stock is currently approximately 3% undervalued, trading at $15.50. Given Imaging is long-term buy, but with major downside risks and volatility ahead.

Primarily, there are two major recent developments that potentially could have a strong impact on the short-term stock performance:

1. The company no longer explores its sale or merger and plans to focus on its growth strategy

In 2012, the company explored options of a potential sale or merger to realize and maximize shareholder value, but ended these intends in January 2013. After a thorough exploration, the executive committee of the Board of Directors appointed to oversee this process unanimously concluded that the "continued execution of the company's operating plan, supplemented by additional acquisitions and alliances," provides the best opportunity at this time to enhance value for all of the company's shareholders. This is a potentially positive development as the stock will start attracting long-term small-cap growth stock investors. Short-term speculators betting on a takeover price spike had enough time since January to dispose of their speculative long positions.

2. Majority stakeholders seeking to sell their stake as the company emerges from its early stage

The company has one major beneficial owner of a 45.2% stake, the Discount Investment Corporation, Ltd. (TASE: DISI), which directly owns 15% of ordinary shares and indirectly the remainder of its total stake by having a 50.3% ownership in Elron Electronic Industries Ltd. (ELRNF.PK). Elron is a technology holding company focused on financing early-stage startups and usually seeking an exit after successful development of the company. It directly holds a 21.6% stake according to the latest SEC form 13D/A, as of March 25, 2013.

This majority stakeholder announced in January 2013 that it intends to seek and consider a sale of its 45.2% stake of Given Imaging's outstanding shares it owns, directly or indirectly, in one block. This is a major factor for potential investors to consider.

DIC is also in a strategic partnership with the aforementioned Rafael Advanced Defense Systems through a jointly owned subsidiary RDC, ensuring the access to the cutting-edge military R&D and patents.

Until this large 45.2% stake is sold, the company's stock could be under pressure and volatile. There have been some large volume spikes in the number of shares traded, but based on my analysis of the total and daily volume, the 45.2% stake could not have been entirely offloaded through the open market transactions yet, not even a majority of it, and this large stake is unlikely to be sold in the open market. And the majority owner indeed expressed its intentions to sell the stake in one block and didn't rule out a transaction outside of the public market.

Savvy investors should look out for any future dips below the $15 area, as in May to June 2013 period, which was primarily caused by the risk associated with the pending Japanese PillCam regulatory approval, and view them as a great buying opportunity in the long run, as the company is very likely to continue receiving positive approvals in further markets.

Company background

Since pioneering the field of capsule endoscopy in 2001, Given Imaging has become a world leader in GI medical devices, offering health care providers a range of innovative options for visualizing, diagnosing and monitoring the digestive system. The company offers a broad product portfolio including its flagship product, the PillCam capsule endoscope, a disposable, miniature video camera contained in an ingestible pill, for visualizing the small bowel, esophagus and colon. More than 1.9 million patients worldwide to date have benefited from the use of PillCam. The company also offers industry-leading GI functional diagnostic solutions, including ManoScan high-resolution manometry, Bravo capsule-based pH monitoring, Digitrapper pH-Z impedance and the SmartPill GI monitoring system.

The company's headquarters, research and development laboratories and manufacturing facilities are located in Yoqneam, Israel. Operating subsidiaries are located in the United States, Germany, France, Japan, Australia, Brazil, Vietnam and Hong Kong. Given Imaging's technology currently is marketed in the United States and more than 70 other countries.

Sales breakdown

A substantial portion of the company's revenues to date have resulted from sales of the PillCam SB capsule and, to a lesser extent, the Bravo system and the high resolution manometry products. For the future, the majority of its revenues will continue to come from sales of the PillCam SB capsule. Sales of the PillCam SB capsule contributed $116.6M, or 65% of the total 2012 revenue. Sales in the U.S. accounted for $109.5M, or 61%, of 2012 revenues. In 2012, $42.4M, or 23.4%, of total revenues came from sales to distributors, with the rest being direct sales through the company's sales force.

Competitors

Olympus Corporation has a competing capsule endoscopy system for the small bowel, which it is selling in the United States, Europe, Japan, Australia and other countries. In addition, other companies are selling capsule endoscopy systems for the small bowel in Europe, Asia and Australia and possibly other countries. The company also has a number of competitors in and outside the U.S. in the field of manometry and pH measurement.

Indirect competitors also include large and well-established manufacturers of traditional technologies for detecting gastrointestinal disorders (gastrointestinal endoscopes), mainly Olympus, Hoya, and Fuji Film. The principal manufacturers of equipment for radiological imaging are GE Healthcare Systems (GE), Siemens Medical Solutions (SI), Philips Medical Systems Ltd. and Toshiba Corporation.

Sources of growth

PillCam products are core to the company and a strong driver of future sales rise. The company sold its first capsule in 2001 and eight years later it reached 1M capsules sold. It took Given Imaging just four years to sell an additional 1M capsules. However, acquisitions provided most of the past company's growth, putting a big risk and question mark over long-term ability to continue acquiring new businesses to achieve growth.

a) Organic growth

Given Imaging's revenues from sales of capsule endoscopy equipment have not grown in the expected manner. If the company is unable to complete additional acquisitions or grow acquired businesses, its revenue growth could slow down.

b) Regional growth

At the moment, the Asia/Pacific region is the source of the fastest growth with 20% YoY increase. And this positive trend is likely to continue, with Japan and Australia driving the growth at the moment and China expected to add in the future to its current so-so performance for the company. Nevertheless, China enjoys much lower prices than Japan and Australia, so profitability will definitely stem from Japanese and Australian sales, with an average price per capsule of $800 in Japan.

c) Expansion of use cases for existing products

To date, the PillCam SB capsule, which accounts for a significant majority of the company's revenues, has been used primarily for detection of obscure gastrointestinal bleeding. The company strives to expand the use and increase utilization of the PillCam SB capsule for the detection and monitoring of additional small bowel abnormalities, such as Crohn's disease.

d) Acquisitions

In the last few years, the company's revenue growth has been largely due to acquisitions, primarily the April 2010 acquisition of Sierra Scientific Instruments LLC and the 2008 acquisition of the Bravo business. In October 2012, the company acquired virtually all of the assets of The Smart Pill Corporation, and expect such these assets to generate several million additional dollars in revenue in 2013, accounting for roughly 1 to 2%.

e) No share buybacks and dividends

Being in a relatively early growth stage of its lifecycle, the company doesn't pay any dividends and doesn't perform share buybacks. It reinvests all profits back into the business or performs acquisitions.

Financial results

In the first quarter of 2013, the company returned to solid sales growth in both the EMEA and APAC regions, which demonstrate record Q1 revenue growth of 5% and 20%, respectively. However, the total revenue growth in the quarter was below our expectations due mainly to a shortfall in sales execution in the America regions where sales fell 11% YoY. However, the company believes that the Americas region will be back on track in the second quarter and later in the year.

Profitability

On a GAAP basis, net loss for the first quarter of 2013 was $200M, or $0.01 per share, compared to net income of $200M, or $0.01 per share in the same quarter of last year. On a non-GAAP basis, net income for Q1 2013 was $1.5M, or $0.05 per share on a fully diluted basis compared to $1.8M or $0.06 per share on a fully diluted basis in the first quarter of 2012. Japan's yen had a negative impact of $400M on the company's profits this quarter and the trend is expected to continue in Q2.

Financial outlook

The company will hold its second quarter results conference call on August 8. However, during its first quarter conference call, it reassured investors that it will meet its previously given 2013 full year guidance as the current Q2 sales until May 1 are above the year-ago levels and outlook is strong. The company has zero debt and almost $3 cash per share, or 20% of its share price.

Valuation

a) Upside scenario

If the company manages to grow at the 25% annual EPS growth rate in the next five years as the analysts estimate, the fair valuation using a FDCF method would be approximately $23.25 per share, 50% above the current price.

b) My realistic scenario

As mentioned in the opening paragraphs, I expect a much lower 15% annual EPS growth than what the average analysts. Therefore, my fair value comes at $16, 3% above the current share price.

c) Downside scenario

At zero growth following the meeting of the next year's expected average EPS guidance of $0.88 per share would value the company at $8.80 per share. The investment has a substantial downside risk at current price levels.

d) Liquidation value

Incidentally, the rough liquidation value is also very close to a $7.20 price at which the stock would trade at a price-to-book ratio of 1, which can be viewed as a range at which the stock would liquidate. This represents a 50% worst-case scenario downside risk, though, assuming that all assets could be disposed of at full book prices, which is an optimistic assumption. Realistically, the liquidation value would offer a 60 to 70% downside from the current stock price.

Risks

a) Reimbursement coverage

Demand for Given Imaging products depends largely on the eligibility of the procedures performed using the products for reimbursement through government-sponsored healthcare payment systems and private third-party payers. Reimbursement practices vary significantly from country to country and in general, the process of securing reimbursement coverage takes longer outside of the U.S.

b) Management communication style

During the latest conference call, management refused to give any details regarding the reasons for its U.S. sales fall or what specific actions it took to remedy the situation. For me, this is not enough for me as an investor, and it gives me a feeling that the company doesn't really want me as an investor.

c) Return to investors

In the past decade, the return to investors was dismal. The stock gained less than 3% per year annually, underperforming its benchmark S&P 600 small cap index by roughly 130% as well as the broad large-cap S&P 500 by some 50% in total for the 10-year trailing period. The stock had a huge run-up in 2004 though, so traders who timed the exit well made a windfall.


Conclusion/Recommendation

Given Imaging is a company with excellent growth potential. However, with many downside risks, offering a symmetric risk/reward scenario of substantial upside and downside. The stock is fairly valued (3% undervalued) based on my growth outlook, which is much more conservative than what average analysts expect. Nevertheless, there are many risks and challenges that could get in the way of the company's growth efforts, as Given Imaging relies primarily on acquisitions-driven growth and faces tough, larger competitors.

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Given Imaging's parent company, IDB Holding Corp. Ltd. (TASE:IDBH), controlled by Nochi Dankner, wants to sell the company.

I' d say at~ $18-21.....the sooner, the better!!!

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Given Imaging's PillCam Colon approved in Japan

Japan’s Pharmaceuticals & Medical Devices Agency approved the capsule for diagnosing colonic disease instead of a colonoscopy.
15 July 13 14:57, Shiri Habib-Valdhorn


Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) today announced that Japan’s Pharmaceuticals & Medical Devices Agency (PMDA) has cleared the company's PillCam Colon endoscopic capsule for diagnosis of colonic disease when colonoscopy is required but difficult to conduct, including patients unwilling or unable to undergo colonoscopy.
"The clearance of PillCam Colon in Japan, the world's second largest healthcare market, represents an important accomplishment for Given Imaging," said Given Imaging president and CEO Homi Shamir. "The decision could expand our potential customer base in Japan from 1,000 today to potentially 10,000 and will help in enhancing adherence to screening guidelines for over one million potential patients."
Screening guidelines in Japan call for everyone over 40 to undergo a fecal occult blood test (FOBT). Compliance with screening remains low and only approximately 25% of the population actually get tested. After a physician identifies blood in a patient’s feces (which can be a strong indication of colon cancer or other diseases), only 54.7%of these patients proceed to have a recommended colonoscopy to confirm the diagnosis due to a variety of reasons. PillCam Colon’s ease of use and minimally-invasive profile could appeal to those patients.
"Meaningful sales of PillCam Colon capsule will commence immediately after obtaining reimbursement," said Shamir, although he declined to provide specifics. "I do not want to discuss financial numbers at this time, because the level of indemnification is not known."
Given Imaging also expects the US Food and Drug Administration (FDA) to approve the PillCam Colon by the end of September. It received EU CE Mark in September 2009 and is commercially available throughout Europe, Latin America, Canada, and parts of Asia.
Given Imaging's parent company, IDB Holding Corp. Ltd. (TASE:IDBH), controlled by Nochi Dankner, wants to sell the company.

Published by Globes [online], Israel business news - www.globes-online.com - on July 15, 2013

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Given Imaging's PillCam(R) COLON Cleared in Japan, World's Second Largest Healthcare Market

Today : Monday 15 July 2013

Significantly Broadens Given Imaging's Potential Capsule Endoscopy System Customer Base


Given Imaging Ltd, (Nasdaq:GIVN), a world leader in gastrointestinal medical devices and pioneer of capsule endoscopy, today announced that PillCam® COLON has been cleared by Japan's Pharmaceuticals & Medical Devices Agency (PMDA) for diagnosis of colonic disease when colonoscopy is required but difficult to conduct, including patients unwilling or unable to undergo colonoscopy.

A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=19862

"We thank the PMDA for its very efficient review process and for granting a broad indication for PillCam COLON," said Homi Shamir, President and CEO, Given Imaging. "The clearance of PillCam COLON in Japan, the world's second largest healthcare market, represents an important accomplishment for Given Imaging. The decision could expand our potential customer base in Japan from approximately 1,000 today to potentially 10,000 and will help in enhancing adherence to screening guidelines for over 1,000,000 potential patients."

Screening guidelines in Japan call for everyone over 40 to undergo a fecal occult blood test (FOBT). Compliance with screening remains low and only approximately 25% of the population actually get tested.1 After a physician identifies blood in a patient's feces (which can be a strong indication of colon cancer or other diseases), only 54.7% of these patients2 proceed to have a recommended colonoscopy to confirm the diagnosis due to a variety of reasons. PillCam COLON's ease of use and minimally-invasive profile could appeal to those patients.

"The number of deaths due to colorectal cancer in Japan continues to increase at an alarming rate," said Akira Terano, MD, PhD, Emeritus president, Dokkyo Medical University, president, Japanese Association for Capsule Endoscopy (JACE). "Colorectal cancer is now the leading cause of cancer death in women in Japan and the incidence rate for colorectal cancer in men and women is expected to be at the top of the list in the population of Japan by 2020. PillCam® COLON is a less invasive medical device which would be able to drive higher compliance. I believe that PillCam® COLON would make a huge contribution for early detection and treatment of colon cancer by applying it in the clinical setting. JACE would undertake the central role in research, education and the upgrading of the medical system for the capsule endoscopy of the colon. I believe PillCam COLON will be widely accepted into the clinical practice for patients who are not able or unwilling to undergo a colonoscopy due to physical or psychological reasons or who do not have a convenient access to a medical (colonoscopy) facility near their place of residence."

"Our top priority is to provide physicians and patients with an alternative colorectal exam option to ensure every patient, including those who are unable or unwilling to get a colonoscopy, has the opportunity to undergo a colorectal exam," Shamir said. "Meaningful sales of PillCam COLON capsule will commence immediately after obtaining reimbursement."

Reimbursement in Japan is expected to become effective during the first half of 2014, subject to government discretion. PillCam COLON received the CE Mark in September 2009 and is commercially available throughout Europe, Latin America, Canada, and parts of Asia. PillCam COLON is pending U.S. Food and Drug Administration (FDA) clearance and is not cleared for marketing or available for commercial distribution in the U.S. and certain other countries.

1 Ministry of Health, Labor and Welfare, 2007 Health Review of Japanese Households,– 2007

2 "Nationwide Survey Committee of Mass Screening for Digestive Organs of the Japanese Society of Gastroenterological Cancer Screening: annual report of 2008 of the nationwide survey of mass screening for digestive organs," Journal of Gastroenterol Cancer Screening, vol. 49, pp. 73-112, 2011.

About PillCam® COLON

The PillCam COLON video capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source; it measures 11 mm X 31 mm. PillCam COLON is designed to be ingested by the patient and transmit up to 35 frames per second for approximately 10 hours to a recording device worn by the patient. Data are transferred from the device to a computer that uses RAPID software to compile the video data and enable the physician to review and report the results of the PillCam study.

The risks of PillCam capsule endoscopy include capsule retention, aspiration and skin irritation. The risks associated with colon preparation are allergies or other known contraindication to any preparation agents or medications used for the PillCam COLON regimen, according to laxative medication labeling and per physician discretion. After ingesting the PillCam capsule and until it is excreted, patients should not be near any source of powerful electromagnetic fields, such as one created by an MRI device. Medical, endoscopic or surgical intervention may be necessary to address these complications, should they occur. A normal or negative capsule endoscopy examination does not exclude the possibility of colon polyps or colon cancer.

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Given Imaging Study May Help Approvalt
By Leslie Picker - May 22, 2013 4:50 PM GMT+0300

Results from Given Imaging Ltd. (GIVN)’s latest clinical study of a pill-sized camera used to identify colon cancer probably will help the Israeli manufacturer secure U.S. regulatory approval this year, Chief Executive Officer Homi Shamir said.
“The PillCam Colon’s potential is enormous,” Shamir said in a phone interview yesterday from Orlando, Florida. “The data we presented will help us get regulatory approval by the end of” the third quarter, the beginning of the fourth quarter.
Physicians can detect pre-cancerous tumors with PillCam Colon, a capsule-sized camera that’s comparable to a colonoscopy, according to trial results that Given Imaging reported yesterday. New York-traded shares of the Yokneam, Israel-based company fell 1.9 percent, erasing their premium to Tel Aviv, after the stock in Israel surged 5.3 percent as the company reported data on products. The Bloomberg Israel-US Equity Index of the largest Israeli companies traded in the U.S. dropped for the first time in six days.
Given Imaging, which sells its video capsules to peek into the small bowel and esophagus, is seeking approval from the U.S. Food and Drug Administration and Japan’s Pharmaceuticals and Medical Devices Agency for its PillCam Colon for patients who can’t undergo or complete an examination of the large intestine and rectum. About 143,000 cases of colon and rectal cancer are expected to be diagnosed this year in the U.S., according to the National Cancer Institute.
Pricing Estimate
CEO Shamir said pricing of the PillCam Colon will be similar to the PillCam SB, its device for the small bowel which was introduced in 2001 and costs about $500 per capsule. Colonoscopies can cost $800 to $1,200, James Goodwin, a professor at University of Texas Medical Branch in Galveston, told Bloomberg News in March. Inappropriate use of the procedure may cost about $500 million a year for Medicare, the U.S. health program for the elderly and disabled, he said.
The data is “good enough to get FDA approval,” Jeremy Feffer, an analyst at Cantor Fitzgerald LP, said by phone yesterday. Feffer has a buy rating for Given Imaging stock. “It’s cheaper to cover, it’s going to help an increased screen compliance and it’s keeping with the move toward minimally invasive technology.”
Given Imaging also said yesterday new studies confirm the value of PillCam SB in diagnosing, monitoring and managing Crohn’s disease and other conditions of the small bowel.
The company’s total sales will rise 6.9 percent to a record $193 million in 2013, according to the average of two analysts’ estimates compiled by Bloomberg. Revenue will jump 13 percent and 25 percent, respectively, in 2014 and 2015, the data show. Yet analysts covering the stock are the most pessimistic in 13 months. Given Imaging is rated 3.8 by analysts, according to a scale devised by Bloomberg where 1 indicates a sell and 5 denotes buy.
‘Always longer’
While PillCam Colon will probably be approved in the U.S., sales won’t come through until doctors start using it, said Stephen Brozak, an analyst at WBB Securities LLC.
“Adoption is always longer than people would like,” Brozak, who has a hold rating on Given Imaging, said in a phone interview yesterday from Clark, New Jersey.
Given Imaging slipped to $16.08, retreating from a two-month high. The stock declined 3.4 percent to 58.49 shekels, or $15.88 in Tel Aviv today.

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8:50 AM Given Imaging (GIVN) rises 2.34% premarket after saying several studies presented at Digestive Disease Week highlight the value of the company's SmartPill for the "evaluation and diagnosis of different motility conditions." The studies suggest "an expanded role" for the device, the company says.

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Given Imaging Announces New Data Confirming SmartPill(R) Improves Diagnosis and Clinical Management of Patients With Motility I

Monday 20 May 2013

Given Imaging Ltd, (Nasdaq:GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced several studies confirming an expanded role for SmartPill in diagnosing gastrointestinal motility disorders. All data were presented at Digestive Disease Week® (DDW) taking place May 18 - 21, 2013 at the Orange County Convention Center, Orlando, FL where Given Imaging is exhibiting at booth #1059 throughout the conference.
"The SmartPill motility monitoring system gives us a complete GI profile that allows us to recognize multiregional transit irregularities in patients with possible upper or lower GI dysmotility," said Braden Kuo, M.D., Director, Gastrointestinal Motility Laboratory, Massachusetts General Hospital. "These new studies add to the growing body of data showing that SmartPill is an extremely valuable tool enabling us to diagnose and treat motility disorders for better patient care."

A key poster presentation, Wireless Motility Capsule Alters Diagnosis and Affects Clinical Management in Patients with Suspected Gastrointestinal Dysmotility, poster Mo2092, presented by Shreya Raja, M.D., Division of Gastroenterology and Hepatology, Johns Hopkins School of Medicine, and colleagues, retrospectively examined how SmartPill findings affect clinical care. The study reviewed numerous data points including pressure, pH and temperature data collected by SmartPill to determine the diagnostic yield of wireless motility capsule and assess changes in 51 consecutive patients with suspected dysmotility. Clinical management decisions after the SmartPill procedure, including medication changes, referrals for additional diagnostic tests, and outside referrals, were also analyzed. Results show that data collected by SmartPill impacts patient care by altering diagnosis and clinical management. Alteration in diagnosis was frequent and change in medication was made for the majority of patients with abnormal testing results. Furthermore, normal SmartPill testing changed clinical management in over 50% of cases.

Several additional studies presented during DDW highlight the value of SmartPill for the evaluation and diagnosis of different motility conditions. Studies include:

Potential Role for Ileocecal Valve Dysfunction and Small Intestinal Dysmotility in Bacterial Overgrowth As Assessed by Wireless Motility Capsule, poster Mo2059, presented by Bani Chander Roland, M.D., Department of Internal Medicine, Johns Hopkins School of Medicine, and colleagues, assessed the relationship of ileocecal valve (ICV) pressures with lactulose breath test (LBT) results, characterized the relationship of prolonged small bowel transit time (SMTT) with LBT, and assessed the relationship of gastric/small bowel pH and pressures with LBT using SmartPill testing. Results show that low ICV pressures are significantly associated with small intestinal bacterial overgrowth (SIBO). Furthermore, prolonged SBTT is also highly associated with SIBO. There is no association between delayed SBTT and low ICV pressure, suggesting that these mechanisms independently contribute to SIBO. These findings may help clarify SIBO pathogenesis and lead to more patient-specific treatment strategies.


Use of Additional Wireless Motility Capsule (WMC) Parameters Improves Gastrointestinal Landmark Identification, poster Mo2104, presented by Sonia Yoon, M.D., GI Medicine, Massachusetts General Hospital, and colleagues, sought to identify gastric emptying (GET), and small bowel (ICJ) and colonic transit times by pH alone and to determine if utilization of SmartPill motility monitoring which include other parameters could increase the yield and precision in determining GI transit landmarks. The results of 168 patients showed that SmartPill analysis using the additional parameters such as frequency and amplitude, FFT analysis and temperature increases the yield for landmark identification compared to pH alone.


Small Intestinal Transit Time Is Prolonged in Patients with Small Intestinal Bacterial Overgrowth, poster Mo2068, presented by Bani Chander Roland, M.D., Department of Internal Medicine, Johns Hopkins School of Medicine, and colleagues, analyzed the relationship of prolonged small bowel transit time (SBTT) in patients undergoing SmartPill motility monitoring with positive lactulose breath test (LBT) and to assess the relationship of prolonged gastric, colonic and whole gut transit times with positive LBT. The retrospective study looked at 72 consecutive patients who were referred for motility testing with 37 patients who underwent both SmartPill and LBT. Results showed that patients with underlying small intestinal bacterial overgrowth have significant delays in SBTT as compared to those without. The correlation between prolonged SBTT and positive LBT may be useful in identifying those patients with underlying SIBO and could suggest therapeutic options for those refractory to standard therapy.
About SmartPill® motility monitoring system

The SmartPill motility monitoring system offers a unique way to assess motility by collecting and analyzing data from within the entire GI tract via a test that can be performed in the clinic or physician's office. The test is ambulatory, allowing the patient to go about their normal routine throughout the test. As the SmartPill capsule passes through the GI tract, it transmits data to a recorder worn by the patient. Once the single-use capsule has passed from the body, study data are downloaded from the recorder to a computer. The physician then uses MotiliGI® software to display and analyze the data, providing test results in both graphical and report formats. Results are used for the evaluation of gastroparesis and chronic constipation. The SmartPill motility monitoring system was granted initial 510(k) release from the U.S. Food and Drug Administration (FDA) in July 2006.

SmartPill may not be a solution for every type of patient and is not indicated for children under the age of 18. The risks of SmartPill motility monitoring include capsule retention and aspiration. Patients should not have an MRI while SmartPill is in their body.

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Given Imaging to Host Financial Community Meeting and Webcast to Review Highlights of PillCam COLON 2 Pivotal Trial Data on May

Monday 6 May 2013

Given Imaging (Nasdaq:GIVN) today announced that the company will host a meeting with members of the financial community on Tuesday, May 21st, 2013 to review PillCam COLON 2 U.S. pivotal trial data and other highlights from Digestive Disease Week 2013, taking place in Orlando, FL, May 18 – 21, 2013. The meeting will take place at 10:00am ET, 5:00pm Israel time.
Homi Shamir, President and CEO of Given Imaging will be joined by Dr. Samuel Adler, Chief, Division of Gastroenterology, Bikur Holim Hospital, Jerusalem, Dr. Douglas K. Rex, Distinguished Professor of Medicine, Indiana University School of Medicine, and Dr. Cristiano Spada, Digestive Endoscopy Unit, Catholic University of Rome, Italy.

A live audio webcast will be available in the investor relations section of the company's website, www.givenimaging.com. To participate in the live teleconference, please dial the following numbers approximately fifteen minutes prior to the start of the meeting: U.S. and Canada, 877-334-1964 (toll-free); callers in other countries should dial, 631-291-4574 (toll charges apply). The archived webcast will be available for thirty days on the company's website.

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Given Imaging Up For Grabs

Feb 25 2013, 11:41 | about: GIVN
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)

I last wrote about Given Imaging Ltd. (GIVN) in July 2011 when I postulated that Given was overvalued at $20.35 per share. The shares now trade at $16.00~ and I believe they remain overvalued. In the past 52 weeks, the shares have traded between $12.14 and $19.95. The analysts surveyed by The Wall Street Journal have target prices in the $21 to $22 range. GIVN is a Yokne'am, Israel based manufacturer of medical diagnostic equipment.

Back in October, there were reports that the company was interested in a merger or being acquired. This announcement gave the share price a short term boost. Then in January, the company announced that it was giving up on a merger or being acquired and that it would focus on implementing its operational plan. This caused the share price to drop precipitously. Subsequently, in January, Bloomberg reported that Permira Advisors LLP is considering the acquisition of a stake in Given and that Discount Investment Corp is in talks to sell all or part of its 45.5 percent stake in Given.

Given is seeking regulatory approval in Japan for its PillCam Colon 2, as an alternative to the more traditional colonoscopy. In August, it announced that it would not market the product in the US for colon cancer screening tests, which reduced the product's potential market from $4 billion a year to $1.7 billion. Japan gives the company great long-term potential, because its health system is one of the most developed in the world and almost equal in value to the US market.

Revenues were $48.7 million in the fourth quarter of 2012, compared to $48.5 million in the fourth quarter of 2011. Gross margin in the 4th quarter of 2012 was 74.6%, compared to 77.4% in 4Q11. Operating profit was $3.6 million for 4Q12 compared to $4.9 million in 4Q11. Net income decreased to $0.16 per share in 4Q12 from the year-ago 4Q11 EPS of $0.18.

Revenues were $180.4 million in FY12 as compared to $178.0 million in FY11. The gross margin declined by 50 basis points to 76.2% from 76.7% in 2011. However, the operating margin expanded to 7.7% from 7.3%. For the year, EPS was $0.46 as compared to $0.38 in 2011. Cash from operations expanded to $27.8 million in 2012 from the prior year's $19.9 million. Cash, cash equivalents, and short-term investments 93.8 million on December 31, 2012 compared to $89.1 million at the end of 2011. Long term debt is only $0.1 million.

The company expects that 2013 revenues will be between $195 million and $205 million. The analysts surveyed by Thomson Reuters provide 2013 revenue estimates in the $192.00 million to $199.2 million range. On a GAAP basis, the company estimates EPS between $0.55 and $0.63.

(click to enlarge)

With the exception of 2012, the y-o-y growth in revenues has remained in double digits. If the company hits the low end of its guidance, 2013, sales growth will be in the high single digits for the year. EPS growth on a y-o-y has been wildly unstable. For the past five years, common equity has grown at the rate of 10.8%. Analysts forecast EPS to grow at the rate of 24.5% over the next 3-5 years. My own estimate is for EPS growth to be a more moderate 13.2%.

Given has virtually no long term debt and a current ratio of 4.3. Working capital is more than sufficient to meet normal operational requirements. The company generated about $20.9 million in free cash flow.

Over the long term, receivables turnover ratio has remained in the mid-single digits with a slightly rising trend.

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At the current PE multiple of 35.7 Given is well above the industry median of 21.2. The forward multiple of 22.9 puts this stock in line with the industry. Based on my expectations for EPS growth at the rate of 13.2%, I think a more appropriate PE multiple for GIVN would be 16.3.

On a price to book basis, it would appear that the company is selling in line with the industry. By my own estimates, the PB ratio also appears to be high. Again, comparing the company's PS ratio with the industry, the share price appears to be high and my own estimate of fair value based on PS is even less.

I wrote in July that Given Imaging was overvalued and my opinion has not changed. Neither the company's level of profitability nor the anticipated growth justifies the high valuation. The company may be a potential takeover target as the controlling shareholders seek to raise cash to salvage their other business interests. On a stand-alone basis, I would be very cautious before buying shares of GIVN.

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Given Imaging sees 2013 growth

The pill camera company's fourth quarter net profit rose 3% to $7.9 million on $48.7 million revenue.

13 February 13 10:34, Globes' correspondent

Pill camera developer Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) reported net profit growth on flat revenue for the fourth quarter and full year of 2012, but forecasts growth in 2013, despite reducing its profit forecast because of a new tax in the US.
Fourth quarter revenue edged up $48.7 million from $48.5 million for the corresponding quarter 2011. GAAP-based net profit fell to $5.1 million ($0.16 per share) for the fourth quarter from $5.6 million for the corresponding quarter, but non-GAAP net profit rose 3% to $7.9 million ($0.25 per share) from $7.7 million.
Full-year revenue rose 1% to $180.5 million from $178 million in 2011. GAAP-based net profit rose 20% to $14.4 million ($0.45 per share) in 2012 from $12 million in 2011, and non-GAAP net profit rose 12% to $22.6 million ($0.72 per share) from $20.1 million.
Given Imaging beat the analysts' 2012 earnings per share consensus of $0.68, but missed the revenue consensus of $202.3 million, but beat the fourth quarter earnings per share consensus of $0.15 and revenue consensus of $48.2 million.
In its full-year guidance for 2013, Given Imaging forecasts GAAP-based earnings per share of $0.55-0.63 and non-GAAP earnings per share of $0.80-0.88 on $195-205 million revenue. It reduced its earnings per share estimate by $0.08 due to the newly imposed Medical Device Tax in the US. The guidance is below the analysts' revenue consensus of $234.6 million, but meets the earnings per share consensus of $0.85.
Cash flow from operations totaled $11 million for the fourth quarter and $27.8 million in 2012, and the company had $124.1 million in cash and cash equivalents at the end of the year.
A 6% increase in sales in the Americas to $115.1 million in 2012 from $108.8 million in 2011, was offset by a 5% drop in Europe, Middle East and Africa sales to $42.9 million from $45.1 million, and a 6% drop in Asia-Pacific to $22.5 million from to $24 million, due to weaker sales in China, Japan, and Australia. Global sales of functional GI diagnostics products rose 8% to $53 million in 2012 from $48.2 million in 2011.
Global PillCam SB (small bowel) sales rose 2% to 235,700 capsules in 2012 from 232,200 capsules in 2011. Higher sales in the Americas and Asia-Pacific were offset by lower sales in Europe and the Middle East.
"We expect 2013 to be a pivotal year for Given Imaging and our goal is to return to double-digit revenue growth as we expand the market for our comprehensive line of devices to visualize, detect, and monitor disorders in the digestive tract and introduce new, innovative products, including our next-generation capsule endoscope for the small bowel, PillCam SB3. We plan to launch PillCam SB3 in Europe this quarter and in the US later this year," said Given Imaging president and CEO Homi Shamir.

Published by Globes [online], Israel business news - www.globes-online.com - on February 13, 2013

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Permira Fund mulls buying Given Imaging

The private equity firm's representatives were in Israel last week to visit the pill camera developer's headquarters.
27 January 13 17:44, Shiri Habib-Valdhorn


Sources inform "Globes" that representatives of private equity firm Permira Fund visited the offices of Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) in Yokne'am last week as part of efforts by IDB Holding Corp. Ltd. (TASE:IDBH), controlled by Nochi Dankner, to sell the company. Permira Fund is probably not the only international investor interested in buying control of Given Imaging.
Given Imaging, which has developed a camera in a pill for gastroenterological diagnoses, has been trying to sell the entire company over the past two months but because it did not receive attractive enough offers, it decided to give up on the attempts two weeks ago.
At the same time, Given Imaging's controlling shareholder, IDB unit Discount Investment Corporation (TASE: DISI) reported that it was trying to sell its shares in the company. Discount Investment holds 46% of Given Imaging - 15.2% directly and 31% through its subsidiary Elron Electronic Industries Ltd. (TASE: ELRN) (including 9% held by Rafael Development Corporation (RDC) of which Elron owns 50.1%).
Since Given Imaging reported that it had stopped the process of selling the company, its share price has fallen 12.6%, giving the company a market cap of $493 million. The controlling core is worth $227 million but the sellers would expect a premium of tens of percentage points on this amount.
In the past, Dankner saw Given Imaging as having potential annual revenue of $1 billion. In 2012 sales totaled $190 million.
A private equity firm sounds like the most reasonable potential buyer for Given Imaging in the present situation. Until two weeks ago the company was for sale as a single unit and potential buyers were major healthcare and medical device companies that saw Given Imaging as a source of growth. From the moment that only the controlling core was for sale and not the entire company, the likelihood rose that any buyer would be a financial body which will try to grow the value of Given Imaging, and in the future realize its holding at a premium.
In the coming few months, two events are likely to influence the price of Given Imaging for the better. The company expects marketing approval for its Colon2 colon diagnostic pill in Japan within a year and a similar approval is expected subsequently in the US.
Permira Fund is a European private equity fund founded in 1985 with €20 billion of investments under management. Half of those investments are in Europe, 41% in the Middle East and the rest in Asia and North America. Investments include fashion company Hugo Boss, chipmaker Freescale and genealogy website Ancestry.com,. which it recently acquired for $1.6 billion.
In Israel, Permira acquired drip irrigation company Netafim Ltd. for €800 million in 2011. It had also acquired control of NDS in 2009, at a company value of $3.7 billion. NDS, which has major activities in Israel, was sold to Cisco last March for $5 billion.
Permira has also been linked with Partner Communications Ltd. (Nasdaq: PTNR; TASE: PTNR) in the past, and held talks to buy IDB unit Clal Insurance Enterprises Holdings Ltd. (TASE: CLIS), which did not yield results. More recently it has been linked with Caesarstone Bat Yam Ltd. (Nasdaq: CSTE).
Published by Globes [online], Israel business news - www.globes-online.com - on January 27, 2013

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Given Imaging Announces New Reimbursement Code for Its SmartPill(R) Wireless Motility Capsule Procedure
Thursday 17 January 2013

Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that effective January 1, 2013, the 2013 National Average Medicare Physician Fee allowable for its recently acquired SmartPill® Wireless Motility Capsule (SmartPill) procedure is $1,188.93. This amount differs from the previously proposed $873.28, due to avoidance of the 27% tax cut that was originally expected to go into effect in 2013. SmartPill's new Category 1 CPT code is 91112. The SmartPill procedure uses sensor-based capsule technology to measure gastric emptying, small bowel transit, colonic transit and whole gut transit times to evaluate motility disorders like gastroparesis and chronic constipation.
The company believes that this new permanent CPT code confirms the value of the SmartPill procedure and may assist in submitting claims electronically. Currently, there are favorable coverage policies for the SmartPill with Medicare Palmetto GBA (J1 & 11), with 6.2 million lives covered, and with United Healthcare, with 36 million lives covered. Additionally, it is anticipated that commercial payers will also use the new allowable amount as a benchmark for their payment based on their individual contracts.

"We are very pleased about this new reimbursement code," said Homi Shamir, President and CEO of Given Imaging. "We see this as an indication of acceptance of the SmartPill technology, which is an important and patient-friendly tool for physicians caring for patients suffering from symptoms of GI motility disorders."

Traditionally, patients with symptoms of upper or lower gastromotility disorders undergo gastric emptying scintigraphy and colonic Sitzmarks™ testing. Due to the expense of conducting these types of evaluations, SmartPill can provide a cost-effective, radiation-free alternative for measuring gastric emptying and total GI transit times along with pH, pressure and temperature of the GI tract.

About SmartPill® motility monitoring system

The SmartPill motility monitoring system offers a unique way to assess motility by collecting and analyzing data from within the entire GI tract via a test that can be performed in the clinic or physician's office. The test is ambulatory, allowing the patient to go about their normal routine throughout the test. As the SmartPill capsule passes through the GI tract, it transmits data to a recorder worn by the patient. Once the single-use capsule has passed from the body, study data are downloaded from the recorder to a computer. The physician then uses MotiliGI® software to display and analyze the data, providing test results in both graphical and report formats. Results are used for the evaluation of gastroparesis and chronic constipation. The SmartPill motility monitoring system was granted initial 510(k) release from the U.S. Food and Drug Administration (FDA) in July 2006.

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Given Imaging Ends Exploration of Possible Sale Transaction

YOQNEAM, ISRAEL, Jan 15, 2013 (MARKETWIRE via COMTEX) -- Given Imaging GIVN -1.03% today announced that it is ending its previously announced exploration of a possible sale or merger transaction as part of its evaluation of strategic options in order to maximize growth and enhance shareholder value. After a thorough exploration, the executive committee of the Board of Directors appointed to oversee the process unanimously concluded that the continued execution of the Company's operating plan, supplemented by additional acquisitions and alliances, provides the best opportunity at this time to enhance value for all of the Company's shareholders.

In addition, Discount Investment Corporation Ltd. has informed the Company that it intends to seek and consider a sale of the 45.5% of Company's outstanding shares it owns, directly or indirectly, in one block. There can be no assurance that any specific action or transaction will occur.

The Company does not undertake any obligation to update this information.

About Given Imaging Ltd. Since pioneering the field of capsule endoscopy in 2001, Given Imaging has become a world leader in GI medical devices, offering health care providers a range of innovative options for visualizing, diagnosing and monitoring the digestive system. The company offers a broad product portfolio including PillCam(R) capsule endoscope for the small bowel, esophagus and colon. The company also offers industry-leading GI functional diagnostic solutions including ManoScan(TM) high-resolution manometry, Bravo(R) capsule-based pH monitoring, Digitrapper(R) pH-Z impedance, and the SmartPill(R) GI monitoring systems. Given Imaging is committed to delivering breakthrough innovations to the GI community and supporting its ongoing clinical needs. Given Imaging's headquarters are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia, Vietnam, Hong Kong and Brazil. For more information, please visit www.givenimaging.com .

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Given Imaging files with FDA to market Pillcam Colon 2

Given Imaging originally intended the the PillCam Colon 2 capsule to replace colonoscopies, but it is now indicated as complementing them.

27 November 12 14:13, Globes' correspondent

Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) has applied to the US Food and Drug Administration (FDA) for approval to market the PillCam Colon 2 endoscopic capsule for visualization of the lower gastrointestinal tract.
Given Imaging has submitted its PillCam Colon 2 application through a direct de novo pathway. Under new guidelines specified by the FDA Safety and Innovation Act of 2012, the company believes that the direct de novo pathway may expedite the regulatory approval process by a few months.
Given Imaging originally intended the the PillCam Colon 2 capsule to replace colonoscopies, but it is now indicated as complementing them. The narrower indication reduces the target market for the product from $4 billion to $1.7 billion.

Published by Globes [online], Israel business news - www.globes-online.com - on November 27, 2012

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Given Imaging Reports Third Quarter 2012 Results

Given Imaging (NASDAQ:GIVN)
Today : Tuesday 6 November 2012
Given Imaging Ltd. (NASDAQ: GIVN) today announced financial results for the third quarter ended September 30, 2012.
Revenues were $45.4 million in the third quarter of 2012, compared to $44.7 million in the third quarter of 2011. Excluding the negative impact of foreign currency translation, third quarter 2012 revenues were $46.3 million, a four percent increase compared to the same period last year.

Gross margin on a GAAP basis in the third quarter of 2012 was 77.5 percent, compared to 77.1 percent in the third quarter of 2011. Gross margin on a non-GAAP basis in the third quarter of 2012 was 78.3 percent, compared to 77.6 percent in the third quarter of 2011. The increase in non-GAAP gross margin is attributable mainly to improved gross margins of the functional diagnostic products.

On a GAAP basis, operating profit was $6.5 million, compared to $4.1 million in the third quarter of 2011. Non-GAAP operating profit was $8.5 million, compared to $5.8 million in the third quarter of 2011. On a GAAP basis, net income for the third quarter of 2012 increased 58 percent to $6.0 million, or $0.19 per share, compared to $3.8 million, or $0.12 per share, in the same quarter of last year. On a non-GAAP basis, net income for the third quarter of 2012 increased 47 percent to $7.9 million, or $0.25 per share on a fully diluted basis, compared to $5.3 million, or $0.17 per share on a fully diluted basis, in the third quarter of 2011.

A reconciliation of GAAP results to non-GAAP results is attached.

Cash and cash equivalents, short-term investments and marketable securities on September 30, 2012 totaled $119.1 million.

"We are pleased that our focus on increasing profitability resulted in a significant increase in third quarter net income. On the top line we achieved, a solid six percent increase in revenues in the Americas region which was driven by sales of our functional GI diagnostics products. This is the third consecutive quarter of revenue growth in the region, which represents our largest market," said Homi Shamir, president and CEO, Given Imaging. "We remain committed to enhance the growth of our company as evidenced by our recent acquisition of the assets of the SmartPill Corporation. We continue to explore additional strategic alternatives that will help make Given Imaging an even stronger company for the benefit of our customers and shareholders."

Recent Developments

PillCam® COLON 2 U.S. Regulatory Update

The Company recently had a positive meeting with the U.S. Food and Drug Administration (FDA) to discuss the process for market clearance of the PillCam COLON 2 capsule for the visualization of the colon. Based on the meeting, the company plans to submit this product for FDA clearance in the next few weeks under the direct de novo route.
PillCam COLON 2 Regulatory Submission in Japan

In September, the Company announced that it filed for PillCam COLON 2 regulatory approval in Japan. The submission to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) includes the results of the PillCam COLON 2 pivotal clinical trial which was designed to evaluate the PillCam COLON 2 as a tool to visualize the mucosal layer of the colon for pathologies including colorectal cancer.
SmartPill Acquisition

In October, Given Imaging announced the acquisition of the assets related to the SmartPill® GI Monitoring System from The SmartPill Corporation, a U.S.-based company, for $6 million and an earn-out component, based on sales of the SmartPill product between 2013 and 2016. The SmartPill System measures gastric emptying and total GI (stomach, small bowel and colon) transit times and is used to evaluate motility disorders like gastroparesis and constipation. A Category 1 CPT code with a value of $873.25 becomes effective on January 1, 2013 for the SmartPill Wireless Motility Capsule Procedure.
Strategic Alternatives Evaluation

Given Imaging recently announced that it is evaluating a range of strategic options, including preliminary non-binding indications of interest received from a number of parties relating to a possible merger or sale of the Company. The Company intends to continue to actively explore these and other alternatives, including a strategic alliance or additional acquisitions. The Board of Directors has appointed an executive committee consisting of the Chairman and two independent directors to oversee the process. The investment banking firm Barclays is assisting the Company in this process.
Third Quarter 2012 Revenue Analysis

Revenues in the Americas region in the third quarter of 2012 increased by six percent to $28.6 million from $26.9 million in the same period last year. Revenues in the EMEA region decreased by six percent to $10.1 million compared to $10.7 million in the same period last year due to lower PillCam sales in the southern European countries and the weakness of the Euro. Excluding the negative impact of foreign currency translation, revenues in the EMEA region increased by $0.3 million, or three percent compared to the same period last year. APAC revenues decreased by six percent to $6.6 million, compared to $7.1 million in the same period in 2011.

Worldwide PillCam SB sales were 58,200 capsules in the third quarter of 2012, compared to 58,900 capsules in the same period last year. PillCam SB sales in the Americas region were 35,000 capsules, compared to 34,800 capsules in the third quarter last year. PillCam SB sales in the EMEA region increased by two percent to 14,100 capsules, compared to 13,800 capsules in the third quarter of 2011, while PillCam SB sales in the APAC region decreased by 10 percent to 9,200 capsules, compared to 10,200 capsules in the same period in 2011, due to lower PillCam sales in China.

Worldwide sales of functional GI diagnostics products including the Bravo pH Monitoring System, Digitrapper pH-Z and ManoScan increased by five percent to $13.2 million in the third quarter of 2012 compared to $12.6 million in the same period last year. In the Americas region, functional diagnostics products revenue increased by 15% in the third quarter of 2012 to $10.8 million compared to $9.4 million in the same period last year. Functional GI diagnostics revenue in the EMEA region increased by four percent to $1.8 million, while revenue in the APAC region was $0.6 million.

Supplemental third quarter data can be found at www.givenimaging.com in the Investor Relations section.

Nine Month Financial Results

For the nine month period ended September 30, 2012, revenues increased by two percent to $131.8 million compared to $129.5 million in the same period last year. Revenues in the Americas region in the first nine months of 2012 increased by eight percent to $83.9 million from $78 million in the same period last year. Revenues in the EMEA region decreased by seven percent to $31.6 million compared to $33.8 million in the same period last year due to lower PillCam sales in the southern European countries and the weakness of the Euro. Excluding the negative impact of foreign currency translation, revenues in the EMEA region increased by $0.6 million, or two percent compared to the same period last year. EMEA revenues in the first nine months of 2012 denominated in local currencies increased by two percent compared to the same period last year. APAC revenues decreased by eight percent to $16.3 million, compared to $17.7 million in the same period in 2011. The decrease is attributable to weakness in sale of functional GI diagnostics products in the Far East and to lower capsule sales in the first half of 2012 in Australia and Japan.

Worldwide PillCam SB sales increased by one percent to 173,900 capsules in the first nine months of 2012, compared to 171,800 capsules in the same period last year. PillCam SB sales in the Americas region were approximately 105,200 capsules, compared to the 104,400 capsules that were sold in the first nine months of 2011. PillCam SB sales in the EMEA region increased by two percent to 44,700 capsules, compared to 44,000 capsules in the first nine months of 2011, while PillCam SB sales in the APAC region increased by three percent to 24,000 capsules, compared to 23,400 capsules in the same period in 2011.

Worldwide sales of Given Imaging's functional GI diagnostics products increased by 13 percent to $38.2 million in the first nine months of 2012 compared to $33.8 million in the same period last year. In the Americas region, functional GI diagnostics product revenue increased by 20% in the first nine months of 2012 to $30.7 million compared to $25.5 million in the same period last year due to higher sales of Sierra Scientific products. Functional diagnostics revenue in the EMEA region were $5.2 million, slightly lower than the first nine months of 2011, while revenue in the APAC region was $2.2 million compared to $2.7 million in the same period in 2011.

Gross margin on a GAAP basis in the first nine months of 2012 was 76.8 percent, compared to 76.4 percent in the same period in 2011. Gross margin on a non-GAAP basis in the first nine months of 2012 was 77.6 percent, compared to 77.0 percent in the same period in 2011.

On a GAAP basis, operating profit was $10.2 million in the first nine months of 2012, compared to $8.1 million in the same period in 2011. Non-GAAP operating profit was $16.1 million, compared to $14.5 million in the same period in 2011. On a GAAP basis, net income for the first nine months of 2012 increased 46 percent to $9.2 million, or $0.30 per share, compared to $6.4 million, or $0.20 per share, in the same period last year. On a non-GAAP basis, net income for the first nine months of 2012 increased 20 percent to $14.9 million, or $0.48 per share on a fully diluted basis, compared to $12.4 million, or $0.40 per share on a fully diluted basis, in the same period in 2011.

2012 Guidance

The Company is reaffirming its revenue guidance for fiscal year 2012. The Company expects its 2012 revenues to be between $185 million and $190 million. The Company expects that its 2012 earnings per share to be between $0.45 and $0.55 on a GAAP basis, and between $0.70 and $0.80 on a non-GAAP basis.

Conference Call / Webcast Information

Given Imaging will host a conference call on Wednesday, November 7, 2012 at 9:00am ET, 4:00pm Israel time to discuss third quarter 2012 financial results. To participate in the teleconference, please dial the following numbers fifteen minutes before the call is scheduled to begin: U.S. and Canada, 1-888-297-0339; Israel, 1-80-924-5905. Callers in other countries should dial 719-325-2492. The call will also be webcast live at www.givenimaging.com.

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Given Imaging Reports Data Showing Greater Role for Capsule Endoscopy in Detecting and Monitoring Crohn's Disease

Today : Wednesday 24 October 2012

Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced results of two studies suggesting an increased role for capsule endoscopy in detecting Crohn's lesions in the small bowel. The studies will be presented at the United European Gastroenterology Week (UEGW), Europe's largest gastroenterology conference, taking place in Amsterdam from October 20-24, 2012. Given Imaging is exhibiting at booth #56 from Oct 22-24.
"Capsule endoscopy for the detection of Crohn's disease in the small bowel has been clinically validated by a substantial and growing body of peer-reviewed research," said presenter Roberta Pica, M.D., Department of Clinical Sciences, Gastroenterology Unit at the Sapienza University of Rome. "As physicians, it's important to gather as much information as possible about the structural changes in the lining of the patient's small and large intestines to determine an accurate diagnosis and proper course of treatment. In this new study, early evidence shows that capsule endoscopy, widely considered the gold standard in small bowel visualization, is superior to magnetic resonance enterography (MRE) as a reliable tool to evaluate the type and extent of mucosal lesions associated with small bowel Crohn's disease. This information can lead to a more precise course of treatment with the goal to improve patient outcomes."

Dr. Pica and colleagues presented the results of a prospective study (P1414) comparing use of wireless capsule endoscopy (WCE) to magnetic resonance enterography (MRE) in the small bowel of 16 consecutive patients with confirmed or suspected Crohn's disease. In nine of 10 patients (90%), WCE detected significant lesions as indicated by the presence of erythema, aphthous, ulcers, fissures or mucosal hemorrhages, with four patients showing lesions in both the jejunum and ileum and five only of the terminal ileum. MRE was less accurate than WCE, detecting inflammatory lesions in 11 of 15 patients (73%), with two patients showing lesions in both the jejunum and ileum and nine in only the terminal ileum. In a group of nine patients who were evaluated with both examinations, WCE detected lesions in eight patients (90%), while MRE detected lesions in six (67%). In addition, 2 patients had a false negative on MRE and showed significant lesions in the terminal ileum with capsule endoscopy, and capsule endoscopy was able to exclude a false positive diagnosis of lymphoma suggested by MRE. The authors concluded that both tools are complementary methods for diagnosing small bowel Crohn's disease, noting that WCE represents a reliable tool in the evaluation of mucosal lesions for the direct visualization of the mucosal surface, while MRE enables physicians to diagnose specific alterations of the bowel wall.

Separately, Efstathios Saprikis, M.D., 2nd Department of Gastroenterology, Evangelismos Hospital, Athens, Greece, presented a poster (P0203) showing that small bowel capsule endoscopy in patients with established Crohn's disease is safe and associated with a low percentage of capsule retention. When capsule retention did occur, the majority of the cases were adequately managed with conservative treatment. Dr. Saprikis and colleagues identified 301 patients who underwent ileocolonoscopy prior to small bowel capsule endoscopy. Among the 301 eligible patients with established Crohn's disease, capsule endoscopy identified signs of Crohn's disease in the small bowel in 196 (65.1%). Capsule retention only occurred in five patients (1.66%). These reported capsule retention rates are in line with previously reported data as well as society guidelines for CE use in patients with suspected Crohn's or established Crohn's disease.

About United European Gastroenterology

UEG, or United European Gastroenterology, is a professional non-profit organization combining all the leading European societies concerned with digestive disease. Together, their member societies represent over 22,000 specialists, working across medicine, surgery, pediatrics, GI oncology and endoscopy. This makes UEG the most comprehensive organisation of its kind in the world, and a unique platform for collaboration and the exchange of knowledge.

UEG's mission is continually to improve standards of care in gastroenterology, and promote ever greater understanding of digestive and liver disease -- among the public and medical experts alike. As part of that work, it runs a number of education and training courses facilitated by highly respected experts. UEG also organizes UEG Week -- the largest and most prestigious meeting of its kind in Europe. UEG Week has been running since 1992, in a variety of major cities, and now attracts more than 14,000 people from across the world. For more information, please visit www.ueg.eu.

About PillCam® SB

The PillCam®SB video capsule is a minimally invasive procedure to visualize and monitor lesions associated with inflammatory bowel disease (IBD), Crohn's disease and obscure GI bleeding (OGIB). The PillCam measures 11 mm x 26 mm and weighs less than four grams. Now in its second generation, PillCam SB 2 contains an imaging device and light source and transmits images at a rate of two images per second generating more than 50,000 pictures during the course of the procedure. Initially cleared by the U.S. Food and Drug Administration in 2001, PillCam SB is clinically validated by more than 1,500 peer-reviewed studies. It is an accurate, patient-friendly tool used in patients two years and older by physicians to visualize the small bowel. PillCam SB is the gold standard in small bowel evaluation.

The risks of PillCam® capsule endoscopy include capsule retention, aspiration, or skin irritation. The risks of the PillCam patency capsule include capsule retention and aspiration. Endoscopic placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.

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Given Imaging Announces New Studies Highlighting Diverse Applications of ManoScan(TM) High Resolution Manometry

Today : Monday 22 October 2012

Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced data from numerous studies highlighting the value of ManoScan™ high resolution manometry in assessing esophageal and anorectal muscle function. The studies are being presented at the American College of Gastroenterology 2012 annual meeting taking place in Las Vegas from October 19-24, 2012. Given Imaging is exhibiting at booth #1325 throughout the conference.
Poster presentations about high resolution esophageal manometry include:

"Esophageal Dysmotility Increases with the Severity of Gastroesophageal Reflux Disease: A Study Using High Resolution Manometry and the Revised Chicago Classification Criteria," (P9) by Stephen Ou, MD, University of California-Irvine Medical Center, Orange, CA and colleagues, retrospectively reviewed 150 cases in which high resolution manometry was performed on patients presenting with GERD symptoms. Researchers from the University of California-Irvine Medical Center applied the revised Chicago Classification criteria to each previously performed case to determine the prevalence of dysmotility among the patients. The researchers concluded that esophageal dysmotility, characterized by the new Chicago Classification criteria, increases with the severity of esophageal acid exposure.



"High Resolution Manometry Metrics in the Upright Position: A Validation Study," (P579) by Andrew Read, MD, Northwestern University Feinberg School of Medicine, Chicago, IL and colleagues, found that normative ranges for high resolution manometry metrics decreased significantly when the test was performed in the upright position compared with the supine position. Researchers from the Department of Medicine, Northwestern University Feinberg School of Medicine, compared high resolution manometry metrics including integrated relaxation pressure, distal contractile integral, contractile front velocity and distal latency in tests conducted in the upright or supine position. Due to the significant decreased normative range of the metrics in the upright position, researchers suggested that the cut-off values for abnormal function should be adjusted if high resolution manometry is performed in the upright position.



"A Study of Interobserver Agreement with High Resolution Esophageal Pressure Topography and Impedance Manometry," (P582) by Erick R. Singh, MD, Georgia Health Sciences University, Augusta, GA and colleagues, used high resolution impedance and high resolution manometry testing to assess bolus transit and identify esophageal contraction patterns to give a more complete study of esophageal function. Researchers from the Division of Gastroenterology, Georgia Health Sciences University, found an incremental benefit in diagnosing esophageal dysfunction with the addition of high resolution impedance to high resolution manometry.

Poster presentations about high resolution anorectal manometry include:

"High Resolution Anal Pressure Topography in Chronic Constipation and Healthy Asymptomatic Volunteers," (P1565) by Vanessa Costilla, MD, Mayo Clinic Arizona, Scottsdale, AZ, and colleagues, presented data from one of the first studies to use high resolution anorectal manometry to compare the anorectal pressure measures of chronic constipation patients with healthy, asymptomatic patients. Researchers from Mayo Clinic Arizona and Dartmouth-Hitchcock Medical Center completed 2-D HRM using ManoScan to find that patients with chronic constipation had significantly lower anorectal resting pressure, initial squeeze pressure, terminal squeeze pressure, squeeze fatigue rate and anal canal length compared with the healthy patient group. Chronic constipation patients also demonstrated a significantly higher urge to defecate and increased balloon expulsion time compared with the healthy patient group. The researchers concluded that anorectal high resolution manometry facilitates the evaluation of anorectal dynamics.
"As we continue to learn about the clinical value of ManoScan high resolution manometry through studies such as those presented at this conference, it is clear that it provides us with important new information about esophageal pressure and motor function as well as anorectal function that can help us more effectively treat GI diseases," said John Pandolfino, MD, Northwestern Memorial Hospital, Chicago, IL. "This technology provides physicians with valuable information that could potentially help correlate patient symptoms with measurements of esophageal and anorectal function."

About ACG

The American College of Gastroenterology is a recognized leader in educating GI professionals and the general public about digestive disorders. Their mission is to serve the evolving needs of physicians in the delivery of high quality scientific, humanistic and cost-effective health care to gastroenterology patients. For more information, visit http://gi.org.

About ManoScan™ High Resolution Manometry

ManoScan high resolution manometry pioneered solid state high resolution manometry (HRM) and remains the market leader in comprehensive solutions for assessing gastrointestinal motility. Through the combination of proprietary tactile-sensing catheter technology and easy-to-use ManoView™ software, ManoScan reveals complex functional anatomy, enabling physicians to more accurately diagnose abnormalities of the gastrointestinal tract.

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Given Imaging Announces Data at UEG Week Confirms PillCam(R) SB's Role as the Diagnostic Gold-Standard for Small Bowel Diseas...

Today : Monday 22 October 2012

Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced the presentation of new data underscoring PillCam® SB's role as the gold standard for diagnosing small bowel diseases. Particularly noteworthy were studies on its use in the diagnosis of Iron Deficiency Anaemia (IDA) and celiac disease, as well as how it can optimize healthcare system resources. The studies were presented at the United European Gastroenterology Week, taking place in Amsterdam from October 20-24, 2012. Given Imaging is exhibiting at booth #56 from Oct 22-24.
"PillCam SB capsule endoscopy is well accepted as the most patient-friendly way to visualize and monitor diseases affecting the small bowel mucosa," said Christophe Cellier, MD, Hôpital Européen Georges Pompidou, Dept. de Gastroentérologie, Paris, France. "The data presented this year at UEG Week expands upon our existing knowledge by showing its value in the diagnosis and monitoring of additional conditions including IDA and celiac disease."

Key data showing the long-term value of PillCam SB in GI bleeding, Iron Deficiency Anaemia (IDA) and refractory celiac disease include:

What is the Importance of Capsule Endoscopy in Obscure Gastrointestinal Bleeding and Its Value in Predicting Bleeding in the Long-Term? (P1453). Asli Ormeci, MD, Istanbul University Istanbul Medical Faculty-Gastroenterohepatology, Istanbul, Turkey, and colleagues presented data from a 36-month study showing that the sensitivity and specificity of capsule endoscopy in predicting re-bleeding was 100% and 93% respectively. The authors concluded that the data show PillCam SB's long-term value in OGIB.



Diagnostic Yield of Small Bowel Capsule Endoscopy in Iron Deficiency Anaemia Compared to Obscure Bleeding (P1550). Based on a retrospective analysis of more than 800 patients who had prior inconclusive upper and lower GI endoscopy, Myriam Knieper, MD, Hanseklinikum Gastroenterology, Stralsund, Germany, and colleagues found that capsule endoscopy had a relevant diagnostic yield when used for IDA. The investigators concluded that small bowel capsule endoscopy could be helpful in diagnosing unexplained IDA.



Diagnostic Yield of Capsule Endoscopy in Refractory Celiac Disease (P0530). Maximilien Barret, MD, Christophe Cellier, MD, Hôpital Européen Georges Pompidou, Dept. de Gastroentérologie, Paris, France, and colleagues found concordance of capsule endoscopy with histology which could help to predict refractory celiac disease (CD). They concluded that capsule endoscopy may play a key role in the diagnostic work-up of patients with symptomatic CD and follow-up of non-responsive CD.

Additional data showing PillCam SB's economic value in an outpatient setting, as well as the benefit that standardized training has on increasing diagnostic skills include:

Diagnostic Yield and Safety of Small Bowel Capsule Endoscopy in Clinical Practice: Prospective Data from a Regional Registry (P206). Marco Soncini, MD, Sofar Ao San Carlo Borromeo, Milan, Italy, and colleagues presented data from a regional registry from 32 centers. The study found that, through shifting from an inpatient to an outpatient procedure, which provided comparable clinical results in both settings, the use of small bowel capsule endoscopy helped shorten the waiting list and thus ensured a substantial sparing of resources.



Small Bowel Capsule Endoscopy: Improvement of Diagnostic Skills After Basic Hands-On Training Courses (P769). Since capsule endoscopy is the gold-standard in the evaluation of the small bowel, Olaf Humbla, MD, Bethesda Krankenhaus Bergedorf Klinik für Innere Medizin, Hamburg, Germany, and colleagues evaluated the need and impact of formal basic courses, and found that training with hands-on demonstrations significantly improves diagnostic skills related to correct diagnosis, thus further enhancing the relevance of small bowel capsule endoscopy.

About United European Gastroenterology

UEG, or United European Gastroenterology, is a professional non-profit organization combining all the leading European societies concerned with digestive disease. Together, their member societies represent over 22,000 specialists, working across medicine, surgery, pediatrics, GI oncology and endoscopy. This makes UEG the most comprehensive organisation of its kind in the world, and a unique platform for collaboration and the exchange of knowledge.

UEG's mission is continually to improve standards of care in gastroenterology, and promote ever greater understanding of digestive and liver disease -- among the public and medical experts alike. As part of that work, it runs a number of education and training courses facilitated by highly respected experts. UEG also organizes UEG Week -- the largest and most prestigious meeting of its kind in Europe. UEG Week has been running since 1992, in a variety of major cities, and now attracts more than 14,000 people from across the world. For more information, please visit www.ueg.eu.

About PillCam® SB

The PillCam® SB video capsule is a minimally invasive procedure to visualize and monitor lesions associated with inflammatory bowel disease (IBD), Crohn's disease and obscure GI bleeding (OGIB). The PillCam measures 11 mm x 26 mm and weighs less than four grams. Now in its second generation, PillCam SB 2 contains an imaging device and light source and transmits images at a rate of two images per second generating more than 50,000 pictures during the course of the procedure. Initially cleared by the U.S. Food and Drug Administration in 2001, PillCam SB is clinically validated by more than 1,500 peer-reviewed studies. It is an accurate, patient-friendly tool used in patients two years and older by physicians to visualize the small bowel. PillCam SB is the gold standard in small bowel evaluation. The risks of PillCam® capsule endoscopy include capsule retention, aspiration, or skin irritation. The risks of the PillCam patency capsule include capsule retention and aspiration. Endoscopic placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.

[midastouch017]

Japan's Fuji in talks to buy Given Imaging for $750m

Barclays Bank source: There is no chance Nochi Dankner will agree to sell the company at a value of less than $1 billion.
21 October 12 14:29, Shiri Habib-Valdhorn


Given Imaging Ltd's (Nasdaq: GIVN; TASE: GIVN) talks for a sale are apparently most advanced with Japan's Fujinon, a unit of Fujifilm Holdings Corporation (TSE:4901). Market sources say that a deal is under discussion at a company value of $750 million for Given Imaging, a 34% premium on its $561 million market cap.
Given Imaging's share price rose a further 5.8% by mid-afternoon on the TASE today to NIS 73.85, continuing its rise since announcing last Thursday that it was in talks for a merger or sale of the company.
Elron Electronic Industries Ltd. (TASE: ELRN), a subsidiary of Nochi Dankner's IDB Holding Corp. Ltd. (TASE:IDBH) unit Discount Investment Corporation (TASE: DISI), owns 22% of Given Imaging, and Discount Investment owns 15.26%. Given Imaging has received several queries about an acquisition.

A source close to Barclays Bank, which IDB has hired to find a buyer for Given Imaging, told "Globes" today, "There is no chance Dankner will agree to sell the company value of less than $1 billion." A deal at this valuation would reflect a 78% premium for Given Imaging, which last reached such a market cap in 2004.
Dankner's need for cash is why he has put Given Imaging up for sale, even though he used to talk about its huge potential and expectations of $1 billion in annual sales, compared with its expected sales of $185-190 million in 2012. A year ago, Given Imaging president and CEO Homi Shamir told "Globes", "Nochi strongly believes in Given Imaging's great future, and he has patience."
Given Imaging develops, manufactures, and sells endoscopic capsules, the PillCam, for diagnosis of the small and large intestine. The company has longstanding ties with Fujifilm and its subsidiaries, going back to 2007 when it signed a strategic R&D and marketing cooperation agreement with Fujinon.
Fujifilm has distributed Given Imaging's PillCam Small Bowel capsule in Japan since 2009. Although, a few months ago, Given Imaging decided to market its products directly in Japan, the ties with Fujifilm remain intact, after Given Imaging terminated its distribution agreement with its other Japanese distributor, Suzuken Co. Ltd. (TSE: 9987).
Given Imaging is an attractive acquisition
Oppenheimer & Co. said today, "We believe that the company is an attractive acquisition target by a buyer from among leading medical equipment companies, alongside IDB's need to sell assets." The analysts raised their target price for Given Imaging from $18 to $27, reflecting a value of $830 million. They believe that the company's p/e ratio of 3 (below the average for small companies in the industry), plus its $100 million in cash, give a company value of $700 million.
Calculations based on Given Imaging's operating profit result in a similar valuation. However, neither the p/e ratio and operating profit method take into account the potential of the company's PillCam Colon 2 capsule for diagnosing diseases of colon, as it has not yet been approved for marketing. Oppenheimer estimates the value of this product at hundreds of millions of dollars, which is the basis for its new target price.
Given Imaging chairman Israel Makov, previously served as CEO of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA). He has frequently spoken out against the sale of Israeli companies as they move from the R&D to the sales stage. "I am constantly disappointed to hear about an exit, when I think things could have been differently," he once told "Globes" in an interview.
On another occasion, Makov said, "Given Imaging is a jewel in the crown of Israel's medical devices industry, and has the potential of becoming a jewel in the crown of Israeli industry in general." He, together with two independent directors, is overseeing the company's sale.
Published by Globes [online], Israel business news - www.globes-online.com - on October 21, 2012

[midastouch017]

Given Imaging ponders its future


Nochi Dankner's liquidity needs may spell the end of the road as an independent company.
18 October 12 23:31, Shiri Habib-Valdhorn
Is Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) coming to the end of the road as an independent company? From a notification released by the company yesterday after the close on Wall Street it emerges that it is examining "strategic options" for enhancing shareholder value. Given Imaging states that it has received "non-binding indications of interest…from a number of parties relating to a possible merger or sale of the company." Following this announcement, the company's share price shot up 14% at today's opening in New York, and it rose in Tel Aviv today too.
Given Imaging has developed a camera in a pill for examining the digestive system. It has a market cap of $472 million. The largest shareholder is Discount Investment Corporation (TASE: DISI) of the IDB Holding Corp. Ltd. (TASE:IDBH) group controlled by Nochi Dankner, which holds 15% of the company directly and another 22% via Elron Electronic Industries Ltd. (TASE: ELRN). In the past it was said that Dankner saw Given Imaging as a company that could reach annual sales of $1 billion, compared with $185-190 million projected for this year, and a target of $450 million in 2016.
However, in the light of the IDB group's liquidity needs, it would seem that Given Imaging too has been put up for sale. At its peak, in 2004, it had a market cap of $1.2 billion. A sale now, if it happens, will not bring anything like that amount, but there will be a premium over the current market cap.
Given Imaging's PillCam SB for examining the small bowel sells well, but the company's growth potential in this market is not large. The big potential lies in the PillCam Colon for examining the large intestine. The company is currently making initial progress with this device. It is close to approval in Japan, and in the US, the company is due to start discussion on approval with the Food and Drug Administration (FDA), although only as a secondary examination tool.
Its progress in the marketplace has led to increase interest in the company. Potential buyers are large medical device companies. Names that have cropped up in the past include Boston Scientific and Johnson & Johnson, and its Japanese competitor Olympus is also a possibility. Alternatively, the buyer could be a private equity fund. Given Imaging has hired Barclays Bank to assist it in the process of enhancing shareholder value.
Companies do not generally rush to report talks on an acquisition, but Given Imaging chose to do so. It could be that it is thereby officially putting itself up for sale, and inviting more players to bid. On the other hand, it is by no means certain that "non-binding indications of interest" will mature into a deal. Given Imaging states in its announcement that the possibility of a strategic partnership is also being examined, as is the possibility that it will itself continue to make acquisitions. In recent years, Given Imaging has grown through the acquisition of Sierra Scientific Instruments and of a line of products from Medtronic. It recently bought the assets of US company SmartPill for $6 million.
Published by Globes [online], Israel business news - www.globes-online.com - on October 18, 2012

[midastouch017]

Given Imaging Announces Over 80 Studies at ACG 2012 and UEG Week 2012
Date : 10/19/2012

Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that investigators will present data from over 80 studies that provide new information about the benefits of using Given Imaging's products to detect, monitor and measure a range of gastrointestinal conditions at the upcoming American College of Gastroenterology (ACG) 2012 Annual Meeting taking place October 19-24, 2012 in Las Vegas, and the 20th United European Gastroenterology Week taking place October 20-24, 2012 in Amsterdam, The Netherlands. Given Imaging's exhibition booths at both conferences will feature Given Imaging's entire product portfolio including the recently acquired SmartPill® GI monitoring system, an ingestible capsule that uses sensor technology to measure pH, pressure and temperature in the GI tract. The Company will also unveil its newest version of esophageal manometry analysis software, ManoView™ ESO v3.0.
"Given Imaging's mission is to provide physicians with innovative tools that help them better detect, monitor and, ultimately, treat GI diseases," said Homi Shamir, President and CEO, Given Imaging. "The studies that will be presented at these two important medical meetings show that our products continue to provide new, clinically-relevant information to the GI community."

Given Imaging at American College of Gastroenterology 2012 Annual Meeting

Given Imaging will be exhibiting at ACG at booth #1325. Key presentations on its PillCam capsule endoscopy platform and GI functional diagnostics products will be presented throughout the conference. On Tuesday, October 23rd, the Capsule Endoscopy Hands-on Workshop featuring PillCam capsule endoscopy will take place from 10:30 am - 1:30 pm PDT. The Esophageal Motility Hands-on Workshop featuring Bravo pH monitoring, Digitrapper pH-Z monitoring and ManoScan™ high resolution manometry will also take place from 2:00 - 4:30 pm PDT.

Given Imaging at the 20th United European Gastroenterology Week

Given Imaging will be exhibiting its products, including PillCam COLON, throughout UEGW at booth #56. During the conference, key studies on the PillCam capsule endoscopy platform, Bravo pH monitoring system and ManoScan high resolution manometry platform will be presented on Monday, October 22nd from 9 am - 5 pm CEST (3 am - 11 am EDT) including:

Safety of Small Bowel Capsule Endoscopy for Patients with Established Crohn's Disease (PO203)
Diagnostic Yield of Capsule Endoscopy in Refractory Celiac Disease (PO530)
Second-Generation Colon Capsule Endoscopy for Colorectal Cancer Screening in Patients Unable or Unwilling to Perform Colonoscopy (PO103)
Reflux Associated Symptoms Per Day and Symptom Index With Confidence Intervals: New Indices of Reflux-Symptom Association for Diagnosis of Reflux Disease that Improve Prediction of Treatment Outcome from Prolonged pH-Monitoring (PO446)
All data presented at UEGW will be embargoed until Monday, October 22th at 12:01am CEST (Sunday, October 21st at 6:01 pm EDT).

About ACG

The American College of Gastroenterology is a recognized leader in educating GI professionals and the general public about digestive disorders. Their mission is to serve the evolving needs of physicians in the delivery of high quality scientific, humanistic and cost-effective health care to gastroenterology patients. For more information, visit http://gi.org.

About United European Gastroenterology Federation

UEGF, or United European Gastroenterology Federation, is a professional non-profit organization combining all the leading European societies concerned with digestive disease. Together, their member societies represent over 22,000 specialists, working across medicine, surgery, pediatrics, GI oncology and endoscopy. This makes UEGF the most comprehensive organization of its kind in the world, and a unique platform for collaboration and the exchange of knowledge.

UEGF's mission is continually to improve standards of care in gastroenterology, and promote ever greater understanding of digestive and liver disease -- among the public and medical experts alike. As part of that work, it runs a number of education and training courses facilitated by highly respected experts. UEFG also organizes UEG Week -- the largest and most prestigious meeting of its kind in Europe. UEG Week has been running since 1992, in a variety of major cities, and now attracts more than 14,000 people from across the world. For more information, please visit www.ueg.eu.

[midastouch017]

Thanks Dew

Some badly needed breathing air!!!

[DewDiligence]

Congratulations, Dubi, on your gains! Regards, Dew

[midastouch017]

My guestimate, based on above is that GIVN will meet
pps of above 20$ before year end!

#msg-77336738