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3-12-13: HeartWare Prices Public Offering at $86.45 (1.5mm shares)
"HeartWare Announces Pricing of Public Offering of Common Stock"
FRAMINGHAM & SYDNEY, March 12, 201: HeartWare International, Inc. (Nasdaq: HTWR, ASX: HIN) ("HeartWare") announced today the pricing of a public offering of 1,500,000 shares of common stock at a price per share of $86.45 pursuant to an effective shelf registration statement filed with the SEC. HeartWare also granted the underwriters an option to purchase up to an additional 225,000 shares to cover over-allotments, if any.
HeartWare intends to use the net proceeds from the offering for working capital and general corporate purposes, including, but not limited to, research and development, expansion of manufacturing capabilities, selling and marketing activities, capital investments in information systems, facilities and infrastructure, and general and administrative support functions to support growth and the acquisition or licensing of or investment in complementary products, technologies or businesses.
J.P. Morgan Securities LLC is acting as the sole book-running manager for the offering. Canaccord Genuity Inc., Credit Suisse Securities (USA) LLC and Lazard Capital Markets LLC are acting as co-managers of the offering. Perella Weinberg Partners served as independent capital markets advisor to HeartWare on this offering.
The offering does not require the prior approval of HeartWare's stockholders under the requirements of the Australian Stock Exchange. . .
http://phx.corporate-ir.net/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1795082
3-12-13: HeartWare Given New $87 Price Target at UBS (HTWR) – from $95
UBS AG lowered their price target on shares of HeartWare (NASDAQ: HTWR) from $95 to $87 in a research note issued on Tuesday. The firm currently has a “neutral” rating on the stock.
http://www.mideasttime.com/heartware-given-new-87-00-price-target-at-ubs-ag-htwr/2436/
3-11-13: Heartware (HTWR) Plans 1.5M Share Offering
March 11, 2013 5:35pmET Price: $87.50 +0.45%
http://www.streetinsider.com/Equity+Offerings/Heartware+(HTWR)+Plans+1.5M+Offering/8175179.html
Heartware International, Inc. (NASDAQ: HTWR) announced its intention to offer, subject to market and other conditions, 1,500,000 shares of common stock pursuant to an effective shelf registration statement filed with the SEC. HeartWare also intends to grant the underwriters an option to purchase up to an additional 225,000 shares to cover over-allotments, if any.
HeartWare intends to use the net proceeds from the offering for working capital and general corporate purposes, including, but not limited to, research and development, expansion of manufacturing capabilities, selling and marketing activities, capital investments in information systems, facilities and infrastructure, and general and administrative support functions to support growth and the acquisition or licensing of or investment in complementary products, technologies or businesses.
J.P. Morgan Securities LLC is acting as the sole book-running manager for the offering.
3-7-13: Another Article on 13yo HVAD Recip. Kyah DeSimone (WCVB) - includes VIDEO
3-7-13: ”Cape Teen With Artificial Heart Returns To School”
• Kyah DeSimone awaits heart transplant
http://www.wcvb.com/health/Cape-teen-with-artificial-heart-returns-to-school/-/9848730/19192150/-/format/rsss_2.0/-/rac0pj/-/index.html
3-6-13/SeekingAlpha: “HeartWare Is Premium-Priced Growth, But Could Still Go Higher”…
3-6-13: ”HeartWare Is Premium-Priced Growth, But Could Still Go Higher”
By Stephen Simpson (SeekingAlpha)
http://seekingalpha.com/article/1253131-heartware-is-premium-priced-growth-but-could-still-go-higher?source=feed
HTWR’s CEO D.Godshall at Barclays 3-12-13 11:15amET Webcast
“HeartWare Presentation at the Barclays Capital 2013 Global Healthcare Conference To Be Webcast [on Tue. 3-12-13 11:15amET]”
FRAMINGHAM & SYDNEY, March 6, 2013: HeartWare International, Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the Barclays Capital 2013 Global Healthcare Conference at 11:15amET on Tuesday, March 12, 2013. The conference is being held March 12-14, 2013 at the Loews Miami Hotel, Florida.
A live webcast of the Company's presentation at the conference will be available via a link provided at http://www.heartware.com . A replay of the webcast will be available for 30 days at the site after the presentation.
http://phx.corporate-ir.net/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1792984
3-4-13: Elsevier Report, “HTWR Touts Early Success In U.S. Launch Of HVAD”…
3-4-13: ”HeartWare Touts Early Success In U.S. Launch Of HVAD”
By Reed Miller, “The Grey Sheet” – Elsevier Business Intelligence
Executive Summary
“HeartWare sold 134 HVAD ventricular assist systems in the U.S. following FDA approval in Nov. 2012 and continues to rapidly add more centers to its customer base.”
http://www.elsevierbi.com/Publications/The-Gray-Sheet/39/9/HeartWare-Touts-Early-Success-In-US-Launch-Of-HVAD
3-1-13: F/U Article on 13yo HVAD Recip. Kyah DeSimone (DailyMail.uk)
3-1-13: ”The teenager who carries her heart [HVAD] in her purse: Boston girl, 13, carries battery for 'artificial heart' in handbag and charges it through a car cigarette lighter”
• Kyah DeSimone, 13, of Hyannis, Mass., suffered rare heart failure at the age of 10 and has since been waiting for a donor organ
• In the meantime the junior high student has a titanium pump (Heartware’s HVAD”) making her heart beat and keeping her alive
• She carries a purse with a battery to power the artificial heart which is wired through her abdomen
• She can even charge it through a car cigarette lighter while she's on the move
By Katie Davies, DailyMail.UK
http://www.dailymail.co.uk/news/article-2286836/Kyah-DeSimone-Boston-girl-13-carries-battery-artificial-heart-handbag.html
In most respects she's a normal teenager with a love of hanging out with friends and talking fashion, but 13-year-old Kyah DeSimone from Boston carries a purse with her that matters more than the recent trends - it powers her artificial heart [Heartware’s HVAD]. The teenager was rushed to hospital from a sleepover when she was just 10 years old. Doctors were shocked to realize she was suffering from heart failure as a result of dilated cardiomyopathy, a condition which slowly means the heart is too weak to pump.
She has since been forced to make the agonizing wait for a heart transplant and, in the meantime, carries a purse with her at all times which includes a battery powering a chest pump or 'artificial heart' which keeps her alive. Doctors had to fight to win the energetic teen the titanium pump, which has been surgically implanted into her chest, and is powered by a small portable battery.
The small metal device wasn't yet approved for children but doctors asked for an emergency exemption saying they had no choice. Her frantic mother, Denise, a nurse, had little option but to watch and wait. 'I knew it was heart failure when I saw it,' she told ABC News. 'We didn't know if she would make it through the night," she said. 'It was the worst thing to watch, ever.'
Dr. Christina VanderPluym, a pediatric cardiologist at Boston Children's Hospital, treated DeSimone and argued for the (HVAD) pump.
'In the past, we would just allow these kids to pass peacefully,' she said. 'But now we have ventricular assist devices small enough to put in children, and that's what we were able to use in Kyah.' We had to ask for an emergency exemption. It took a lot of work by lot of different people to make this happen.'
Within an hour the device turned the Massachusetts teen's chance of surviving around. With the pump, her heart can pump 5 litres compared to one. She was kept in hospital for 2 months before being allowed to leave with her little black bag. It contains a battery pack and iPod sized monitor and connects to the pump through a wire in her abdomen.
PIC: ”How it works: This graphic by the FDA shows how Kyah's pump works. It fixes to her aorta and left ventricle and is powered via a wire through her abdomen. She carries her battery in a purse.”
'This battery pack is her life support,' Dr VanderPluym added. When's she in their Hyannis home she can plug the pump in to the wall and she has four back-up batteries in case it runs out. In the car she can even use use an adapter to get power from the cigarette lighter. 'I can feel it inside, vibrating,' she said. 'It's very noisy. It's a little nerve-racking.' She says she remains positive about the possibilities of getting a transplant and in the meantime has plans to decorate the bag so it fits in with her fashion-hungry teenage life.
The pump - known as a Heartware Ventricular System (HVAD) - was approved for use in children by the FDA just 9 days after Kyah's implant was approved.
PIC: ”Emergency: Kyah DeSimone was rushed to hospital from a sleepover after suffering heart failure. The teen pictured with her mum, right, and doctor, left, now has an (HVAD) artificial heart.”
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Article about 13yo HVAD Recip., Kyah DeSimone (with 5min. Video)…
3-1-13: ”Teen Takes Artificial Heart (HVAD) to School as She Waits for Transplant”
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=85163948
3-1-13: Article about 13yo HVAD Recip., Kyah DeSimone (with 5min. Video)
3-1-13: Teen Takes Artificial Heart (HVAD) to School as She Waits for Transplant”
http://abcnews.go.com/Health/HeartHealth/boston-teen-heads-back-school-artificial-heart/story?id=18610692&singlePage=true
By KATIE MOISSE - March 1, 2013
Kyah DeSimone loves hip-hop dance, basketball, sleepovers and fashion. But the 13-year-old Bostonian carries a weight on her shoulder that few middle schoolers can imagine: the black purse that powers her partial artificial heart, and the looming prospect of a heart transplant. Diagnosed with dilated cardiomyopathy at age 10, Kyah lived with the slow stretching of her heart until it became too weak to pump. In October 2012, she was rushed from a friend's sleepover to a local hospital.
SEE 5:10 VIDEO (ABC25/WJXX): http://abcnews.go.com/Health/video/teen-heads-back-school-artificial-heart-18601475
"I'm a nursing student, and I knew it was heart failure when I saw it," said Kyah's mom, Danielle DeSimone, recalling the horror of spotting the textbook pattern on Kyah's electrocardiogram. Kyah was transferred to Boston Children's hospital, where doctors stabilized her with drugs. But it was a temporary fix. She needed a new heart. And until one came, there was only one option: a titanium pump (Heartware’s HVAD), (then) yet to be approved for children in the U.S., surgically implanted in her chest.
"In the past, we would just allow these kids to pass peacefully," said Dr. Christina VanderPluym, a pediatric cardiologist at Boston Children's Hospital. "But now we have ventricular assist devices small enough to put in children, and that's what we were able to use in Kyah."
Boston Children's Hospital - Kyah Desimone, 13, has an artificial heart that keeps her alive while she waits for a transplant.
Perhaps most famous for carrying former VP Dick Cheney through his 20-month wait for a transplant, ventricular assist devices, or VADs, are growing in popularity with the country's transplant waiting list. But the small, implantable device doctors wanted for Kyah (Heartware’s HVAD) was not approved for pediatric patients.
"We had to ask for an emergency exemption," said VanderPluym, recalling the rush to file paperwork with the U.S. FDA before they could order the device and learn how to use it. "It took a lot of work by lot of different people to make this happen." For Danielle DeSimone, the 48-hour process felt like a lifetime. "We didn't know if she would make it through the night," she said, describing how her once athletic daughter became violently ill, shedding pounds from her tall, thin frame. "It was the worst thing to watch, ever."
DeSimone said it's a "miracle" Kyah survived until November 11, the day doctors connected the shiny (HVAD) pump to her thirsty arteries. Within an hour, Kyah's cardiac output -- the volume of blood pumping through her heart -- swelled to 5 liters from one. "It was a drastic improvement," said VanderPluym, comparing the device to a "garden hose to the aorta." But Kyah wasn't out of the woods yet. Within a week she developed a blood clot, requiring open heart surgery. She also battled infections and eerie hallucinations from the medications, according to her mom.
After a 2-month stay in the hospital, Kyah got to go home. And this week, she returned to school -- a first for an American pediatric VAD patient, according to VanderPluym, who talked to Kyah's classmates about the life-saving power pack she wears over her shoulder, which connects to her artificial heart through a wire into her abdomen. Inside the black bag, a battery pack and a monitor the size of an iPod keep the pump running smoothly as Kyah's name rises on the transplant waiting list.
"Junior high can be terrifying, especially when you're coming in with a device you're completely dependent on," said VanderPluym. "This battery pack is her life support."
ARTIFICIAL HEART PUMP A BRIDGE TO TRANSPLANT
When she's at home, Kyah can plug herself into the wall. If there's a power outage, the city has a backup generator on standby, in case her four back-up batteries run out. And if she's in a car, she can use an adapter to get power from the cigarette lighter. The artificial heart, called a Heartware Ventricular System (“HVAD”), was FDA-approved for use in kids Nov. 20, 2012 -- 9 days after Kyah became one of a handful of American kids using the pump as a "bridge" to a transplant. Because it's continuous flow, meaning it doesn't contract and relax like a real heart, Kyah hears a constant hum instead of having a pulse.
"I can feel it inside, vibrating," she said. "It's very noisy." Kyah, who wore skinny jeans and a loose gray t-shirt with a heart on the chest for her first day back at school, doesn't love the black bag. But her mom hopes to change that. "We talked about bedazzling the bag," said Danielle DeSimone. "I'm sure we could do something." But mother and daughter hope the bag and the device it powers are a very temporary fix. "It's a little nerve-racking," Kyah said of the indefinite wait for a transplant. "I guess I'll just stay positive."
CEO D.Godshall to present at R.James 3-5-13 1:05pmET Webcast
HeartWare Presentation At Raymond James 34th Annual Inst. Investors Conference To Be Webcast [on 3-5-13 1:05pmET]”
http://phx.corporate-ir.net/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1790631
FRAMINGHAM & SYDNEY, Feb. 28, 2013: HeartWare International, Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the Raymond James 34th Annual Institutional Investors Conference at 1:05pmET on Tuesday, March 5, 2013. The conference is being held March 3-6 at the JW Marriott Grande Lakes in Orlando.
A live webcast of the Company's presentation at the conference will be available via a link provided at http://www.heartware.com .
Replay of 2-27-13 Q4’12 Conf. Call (also, SA Transcript)…
Q4 2012 HeartWare Intl. Earnings Conference Call
Wednesday, Feb. 27, 2013, 8:30amET
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-presentations
2-27-13=> http://edge.media-server.com/m/p/kqhz6z95/lan/en
...DG's way with words => "at at one end of the bell curve we have the "Evangelical Sites"..."in their passion for the HVAD"
Seeking-Alpha Transcript:
2-27-13: http://seekingalpha.com/article/1230021-heartware-international-s-ceo-discusses-q4-2012-results-earnings-call-transcript?part=single
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2-27-13: HTWR Q4’12 Financials, $32.7mm, U.S. up 60% to $13.4mm. Full-Yr revs of $110.9mm
HeartWare Reports Q4/2012 Revenue Of $32.7mm; Full Year 2012 Revenue Of $110.9mm
• Q4/2012 U.S. Revenue of $13.4mm; 60% Increase from Q4/2011; Reflects FDA Approval and First Month of Commercialization in U.S.
• Globally more than 3,000 advanced heart failure patients have received the HeartWare System
• Conference call today at 8:30amET
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=85067982
2-27-13: HTWR Q4’12 Financials, $32.7mm, U.S. up 60% to $13.4mm. Full-Yr revs of $110.9mm, now more than 3000 global HVAD implants, Cash=$102.8 at 12-31-12...
HeartWare Reports Q4/2012 Revenue Of $32.7mm; Full Year 2012 Revenue Of $110.9mm
• Q4/2012 U.S. Revenue of $13.4mm; 60% Increase from Q4/2011; Reflects FDA Approval and First Month of Commercialization in U.S.
• Globally more than 3,000 advanced heart failure patients have received the HeartWare System
• Conference call today at 8:30amET
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1789795
FRAMINGHAM & SYDNEY, Feb. 27, 2013: HeartWare International, Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenue of $32.7 million [1-7-13 prelim-revs PR said Q4=$32mm] for the fourth quarter ended December 31, 2012, a 42% increase compared to $23.1 million in revenue for the same period of 2011. For the fiscal year 2012, the Company generated revenue of $110.9 million, a 34% increase compared to revenue of $82.8 million in the fiscal year 2011.
"Our results for the fourth quarter reflect positive initial trends in the commercial launch of the HeartWare® Ventricular Assist System in the U.S., following approval from the Food and Drug Administration (FDA) on November 20, 2012, and continued strong support from our international customers," explained Doug Godshall, President and CEO. "Today, more than 3,000 advanced heart failure patients globally have received the HeartWare® System."
During the fourth quarter of 2012, revenue from international markets increased approximately 31% to $19.3 million, from $14.7 million in the fourth quarter of 2011. U.S. revenue, which reflects FDA approval late in the year, was $13.4 million in the fourth quarter of 2012, an increase of 60% from $8.4 million in the fourth quarter of 2011. Currency fluctuations decreased revenue by 1 percent in the fourth quarter compared to the same period in 2011.
For the year ended December 31, 2012, revenue increased approximately 34% to $110.9 million, compared to $82.8 million in 2011, supported by 53% commercial revenue growth internationally. Currency fluctuations decreased revenue by 6 percent compared to the same period in 2011.
"With 345 HVAD® pumps sold during the fourth quarter, the largest number in any quarter to date, the total number of pumps sold in 2012 was 1,217, compared to 932 pumps sold in 2011," added Mr. Godshall. "Our team has been working diligently to expedite the training of additional hospitals in the U.S., and since FDA approval 18 new U.S. sites have been trained, with 2 more in training this week."
Total operating expenses for the fourth quarter of 2012 were $35.4 million, as compared to $30.8 million in the same period of 2011.
Research and development expense was $22.2 million for the fourth quarter of 2012, as compared to $17.9 million in the same period of 2011. Increased development costs are a result of continuing clinical trial costs and research and development costs related to advancing HeartWare's pipeline technologies, including the MVAD® platform and a fully implantable system, as well as other early research initiatives.
Selling, general and administrative expenses were $13.3 million in the fourth quarter of 2012, compared to $12.9 million in the fourth quarter of 2011. The increase in selling, general and administrative expenses is related to continued growth supporting commercial activity outside of the U.S., preparation for and rollout of the commercial launch in the U.S., and an overall increase in corporate infrastructure to support the Company's rapid growth.
Net loss for the fourth quarter of 2012 was $21.1 million, or a $1.46 loss per basic and diluted share, compared to a $21.6 million net loss, or a loss of $1.53 per basic and diluted share, in the fourth quarter of 2011. For the fiscal year ended December 31, 2012, the Company recorded a net loss of $87.7 million, or a $6.15 loss per basic and diluted share, compared to a $55.1 million net loss, or a loss of $3.94 per basic and diluted share, in fiscal 2011.
At December 31, 2012, the Company had $102.8 million of cash, cash equivalents and investments.
HeartWare will host a conference call on Wednesday, Feb. 27, 2013 at 8:30amET to discuss the Company's financial results, highlights from the fourth quarter and business outlook. The call may be accessed by dialing 1-888-846-5003 five minutes prior to the scheduled start time and referencing "HeartWare." For callers outside the U.S., please dial +1-480-629-9856.
A live webcast of the call will also be available at the Company's website ( http://www.heartware.com ) by selecting "HeartWare Q4 2012 Conference Call" under the section titled "Corporate Presentations" on the Home Page. A replay of the conference call will be available through the above weblink immediately following completion of the call. . .
Q4-2012 Financials & CC on 2-27-13 8:30amET
FRAMINGHAM & SYDNEY, Feb. 19, 2013: HeartWare International, Inc. (NASDAQ: HTWR, ASX:HIN) has scheduled a conference call to discuss its financial results for the 3 months ended Dec. 31, 2012, at 8:30amET on Wednesday, Feb. 27, 2013. The Company plans to release the financial results prior to the conference call.
The conference call with management will discuss the Company's financial results, highlights from Q4-2012 and business outlook. The call may be accessed by dialing 1-888-846-5003 five minutes prior to the scheduled start time and referencing "HeartWare." For callers outside the U.S., please dial +1-480-629-9856.
A live webcast of the call will also be available at the Company's website ( http://www.heartware.com ) by selecting "HeartWare Fourth Quarter 2012 Conference Call" under the section titled "Corporate Presentations" on the Home Page. A replay of the conference call will be available through the above weblink immediately following completion of the call.
Link to replay of CEO D.Godshall’s 2-13-13 Leerink-Swann presentation…
=> http://leerink.metameetings.com/webcasts/healthcare13/directlink.php?p=70
CEO D.Godshall to present at Leerink-Swann Feb13 8:30amET
”HeartWare Presentation at Leerink Swann Global Healthcare Conf. to be Webcast [Feb13 8:30amET]”
FRAMINGHAM & SYDNEY, Feb. 8, 2013: HeartWare International, Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the Leerink Swann Global Healthcare Conference at 8:30amET on Wednesday, February 13, 2013.
The conference is being held February 13-14 at the Waldorf-Astoria in New York. A live webcast of the Company's presentation at the conference will be available via a link provided at http://www.heartware.com . A replay of the webcast will be available for 90 days at the site after the presentation.
. . .
2-8-13: Northland analyst Suraj Kalia misinterprets CMS announcement and downgrades THOR & HTWR, “following the CMS's announcement to initiate a National Coverage Decision analysis for VAD therapy”, when in fact the 2-7-13 CMS announcement he’s reacting to involves a potential EXPANSION of approved VAD implant centers. Mind boggling…
No question the analyst that made this inexplicable misinterpretation had to be:
SURAJ KALIA, SR. ANALYST, NORTHLAND EQUITY RESEARCH
…See: Northland Securities – Coverage Universe
…Medical Technology: THOR, HTWR, 12 others…
http://www.northlandsecurities.com/equity/northland_stocks.pdf
Oddly, Suraj Kalia is the only one of the 10 Northland analysts that show no BIO or picture here:
http://www.northlandsecurities.com/equity/research_research.html
Here is the CMS 2-7-13 announcement that Suraj Kaila either failed to read, or was incapable of comprehending. What’s being considered by CMS is an additional pathway to VAD Center accreditation, something Dr. Kaila misinterprets that as a Negative to VAD manufactures…
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2-7-13: “National Coverage Analysis (NCA) Tracking Sheet for Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00432R)”
Ventricular assist devices (VADs) or left ventricular assist devices (LVADs) are mechanical blood pumps that are surgically attached to one or both intact ventricles of a damaged or weakened native heart to assist in pumping blood.
VAD coverage requirements are addressed in section 20.9 of the Medicare National Coverage Determination (NCD) Manual (Pub. 100-03) entitled NCD for Artificial Hearts and Related Devices”. Medicare covers VADs for 3 indications: postcardiotomy (after open-heart surgery); bridge-to-transplant (while patients await heart transplantation) and destination therapy (for patients not eligible for heart transplantation.)
DET NORSKE VERITAS HEALTHCARE, INC. (DNV) HAS FORMALLY REQUESTED A RECONSIDERATION OF THE NCD TO INCLUDE THE DNV MECHANICAL CIRCULATORY SUPPORT CERTIFICATION PROGRAM AS AN ACCEPTABLE CREDENTIAL FOR FACILITIES QUALIFYING UNDER THIS NCD. On Nov. 14, 2012 we convened a Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting to review available evidence on the management of heart failure with the use of VADs including the role, if any, of facility VAD-specific certification. In response to this reconsideration request and the recommendations of the MEDCAC panel, CMS IS OPENING THIS RECONSIDERATION. The scope of our review does not include non-durable devices that are intended for temporary in-hospital use.
http://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=268
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And here is the 2-8-12 update from Northland’s Suraj Kalia which clearly misinterprets the CMS announcement:
2-8-13: Northland Securities downgraded Thoratec following the CMS's announcement to initiate a National Coverage Decision analysis for VAD therapy. The firm believes there is now significant uncertainty regarding VADs and margins. Price target is $35.
http://finance.yahoo.com/news/thoratec-downgraded-market-perform-outperform-121347215.html
Just an unbelievable dereliction of duty and professionalism by this Northland analyst. It’s so bad, it even raises the spectrum of motive in my opinion. Is he that dumb, or did he do this for some other reason? At the very least, whenever I see something written by “Northland analyst Suraj Kalia” in the future, I’ll turn around and run away as fast as I can. If he did it once, he surely can do it again.
2-8-13: HeartWare Warns On HVAD Heart Pumps… fail in less than 0.004% of some 2,900 implants… None of the confirmed events have resulted in harm to the patient… a repair may be necessary… Leerink-Swann, “We believe this recall will prove to be a non-event…”
2-8-13: ”HeartWare Warns On HVAD Heart Pumps”
http://www.massdevice.com/news/heartware-warns-hvad-heart-pumps
by MassDevice staff
• HeartWare tells cardiac surgeons to inspect a component of its HVAD heart pump that's failed in a small number of patients.
HeartWare International (NSDQ:HTWR) said it's issuing a "field correction" to cardiac surgeons, advising them to check a component of its HVAD implanted heart pump that's been reported to fail in less than 0.004% of some 2,900 implants.
The Framingham, Mass.-based company said the rear portion of the left ventricular assist device's driveline connector housing became partially or fully separated from the front of the driveline connector after extended use in 11 of 2,900 cases.
"In the unlikely event of a separation, a repair may be necessary. If left unattended, electrical connection to the controller could be affected and a VAD stop alarm could result. None of the confirmed events have resulted in harm to the patient," according to a press release. "In the event of a separation, hand-tightening of the connector housing may be sufficient as a temporary measure; however, healthcare professionals are instructed to contact HeartWare to arrange for an inspection and permanent repair by a HeartWare clinical engineer. No product replacement or exchange is required."
HeartWare said it's in the process of changing its manufacture of the device to prevent future occurrences. The action is not expected to have much of an effect on HeartWare's finances, according to the release.
"We believe this recall will prove to be a non-event as it should not impact: 1) HTWR's ability to continue to drive U.S. bridge-to-transplant (BTT) market share and 2) [operating expenses] in a meaningful way," Leerink Swann analyst Danielle Antalffy wrote in a note to investors this morning. "Some key additional points from our follow-up call with HTWR: (1) Of the 11 patients who experienced a driveline disconnection, 6 had alarms sound and none of the 11 suffered serious adverse events; (2) This issue occurred on average 590 days after implant and involved both U.S. and EU patients; (3) HTWR is implementing a manufacturing fix that will directly attach the driveline housing to the cable, which should eliminate risk of disconnection. This manufacturing fix will be rolled out on Feb. 15th; (4) HTWR does not have to remove or replace any product from the market; (5) FDA has not yet classified the recall. Because these are life-saving devices, we believe FDA will likely classify this as Class I – the most serious level – much like other LVAD recalls in the past."
2-5-13: Canaccord raises PT for HTWR to $114 from $107
2-5-13: ”HeartWare PT Increased to $114 by Analysts at Canaccord Genuity”
Research analysts at Canaccord Genuity upped their target price on shares of HeartWare (NASDAQ: HTWR) from $107 to $114 in a report released on Tuesday. The firm currently has a “buy” rating on the stock.
http://www.dailypolitical.com/finance/stock-market/canaccord-genuity-raises-price-target-on-heartware-htwr.htm
CEO D.Godshall to present at Leerink-Swann Feb13 8:30amET
”HeartWare Presentation at Leerink Swann Global Healthcare Conf. to be Webcast [Feb13 8:30amET]”
FRAMINGHAM & SYDNEY, Feb. 8, 2013: HeartWare International, Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the Leerink Swann Global Healthcare Conference at 8:30amET on Wednesday, February 13, 2013.
The conference is being held February 13-14 at the Waldorf-Astoria in New York. A live webcast of the Company's presentation at the conference will be available via a link provided at http://www.heartware.com . A replay of the webcast will be available for 90 days at the site after the presentation.
. . .
Nov2012: Scientific Paper of HVAD implanted into a Pt. with “Congenitally Corrected Transposition Of The Great Arteries”…
”Case Report: Heartware Ventricular Assist Device Placement In A Patient With Congenitally Corrected Transposition Of The Great Arteries”
J Thorac Cardiovasc Surg 2013;145:e23-e25
2013 The American Association for Thoracic Surgery
http://jtcs.ctsnetjournals.org/cgi/content/extract/145/2/e23
Jiapeng Huang, MD, PhD a,b,*, Mark S. Slaughter, MD c
a Dept of Anesthesiology, Jewish Hospital & St Mary’s Healthcare, Louisville, KY
b Dept of Anesthesiology and Perioperative Medicine, Univ. of Louisville,
c Division of Thoracic & Cardiovascular Surgery, Dept of Surgery, Univ. of Louisville
Received for publication June21, 2012; revisions received Oct10, 2012; accepted for publication Nov6, 2012.
Address for reprints: Jiapeng Huang, MD, PhD, 200 Abraham Flexner Way, Louisville, KY 40202.
2-1-13: HVAD Data Updated at STS’13 in LA
2-1-13: ”HeartWare Left Ventricle Assist Device (HVAD) Shows Low Rate of Adverse Events”
Presented at STS’13, By Ed Susman
http://www.docguide.com/heartware-left-ventricle-assist-device-shows-low-rate-adverse-events?tsid=5
LOS ANGELES – Feb. 1, 2013 -- More than 90% of patients with severe heart failure who were implanted with the HeartWare left ventricular assist device survived at least 180 days, with the device designed as a bridge to transplantation, according to a study published in the 49th Annual Meeting of the Society of Thoracic Surgeons (STS).
In addition to achieving survival at 180 days, Mark Slaughter, MD, University of Louisville Jewish Hospital, Louisville, Kentucky, noted that the latest modification of the device accomplished the bridge to transplantation with few adverse events.
"Survival remains high despite a very low --21% -- transplantation rate," the authors noted in their oral presentation on January 29. "Ischaemic strokes with any level of disability defined as a modified Rankin Score greater than 0 declined from 0.089 events per patient year (5.1% of patients) to 0.047 events per patient year (2.8% of patients) with changes in pump design. Aspirin & anticoagulation were increased without an increase in bleeding."
It is recommended that patients on the device take 325 mg aspirin per day and reach an anticoagulation target of INR 2.0 to 3.0. "Following those changes, pump exchange rates decreased by 55% to 0.027 events per patient year," said Dr. Slaughter.
The primary endpoint of the trial was survival at 180 days -- defined as patients being alive on the original device, or being transplanted or having the device explanted for recovery and alive at 60 days post removal. Failure of treatment was death, the need to exchange the device or death after explantation that occurred within 60 days. Originally 140 patients were assigned to treatment with the HeartWare device, but continued access protocols eventually allowed 256 additional patients into the study. In the combined continued access protocol patients and in the bridge-to-transplant patients, the average age was 53.2 years. About 70% of the patients were male, 68% were white, and 36.7% had an ischemic cause of heart failure. The left ventricular ejection fraction was 17%, 95.5% of the patients were in NYHA class IV, and more than 80% were in INTERMACS 1 to 3. Survival in ADVANCE continued access protocol was 97% at 60 days, 91% at 180 days, and 84% at 360 days. At 360 days, 4.5% of patients had a device exchange, 6.9% had died while on the original device, 21.4% had gone on to transplant or achieved recovery, 67.1% were alive with the original device in place, and 88.5% were alive with the device in place or had achieved cardiac recovery (or had gone on to receive a transplant).
"Quality of life scores improved significantly as well," said Dr. Slaughter. After 180 days, patients had improved their distance on the 6-minute walk test from 69.5 meters at baseline to 254.9 meter (P < .001). The EuroQOL score increased from 44.3 points at baseline to 71.7 points at 180 days (P < .001). The Kansas City Cardiomyopathy Questionnaire score at baseline was 36.6, which improved to 67.5 at 180 days (P < .001).
[Presentation title: ADVANCE Trial Update]
HeartWare mgt. to meet with Lazard Cap. on 1-28-13
"Meeting to be held in Los Angeles on Jan.28 2013, hosted by Lazard Capital."
http://www.theflyonthewall.com/permalinks/entry.php/HTWRid1774653/HTWR-HeartWare-management-to-meet-with-Lazard-Capital
HTWR mentioned in 1-23-13 Wedbush THOR Update
Thoratec Corp (THOR-Neutral):
Q4 Outlook: INTERMACS Data Suggest Lighter U.S. Implant Volumes
Updating Estimates; Reiterate NEUTRAL
Price: $36.84 Target: $36.00
• INTERMACS numbers suggest possible downtrend in U.S. HeartMate II utilization following strong Q3.
• Lowering Q4:12 estimates to reflect INTERMACS trends and FASTER-THAN-EXPECTED HVAD BTT LAUNCH; our revised forecast is more in line with consensus.
• Reiterate NEUTRAL and $36 fair value.
ANOTHER ARTICLE on Singapore’s 1st HVAD Recipient, Madam Helen Tan…
1-16-13: “Enjoying A New Lease On Life [via HVAD]”
http://www.yourhealth.com.sg/content/enjoying-new-lease-life
AsiaOne/YourHealth - The New Paper
SINGAPORE - Last week, Madam Helen Tan, 57, was unveiled as the first heart transplant candidate in Singapore to be implanted with the Heartware Ventricular Assist System (“HVAD”). The device is a smaller & lighter mechanical heart pump meant to help advanced heart failure patients improve their heart's function while waiting for a transplant.
Unlike previous generations of such devices [like Thoratec’s Heartmate II], which require a small pocket to be surgically created below the heart to fit the pump, this device fits in a sac in which the heart is enclosed called the pericardium.
Madam Tan suffers from a condition known as dilated cardiomyopathy, in which the heart is weakened & enlarged. Her heart was unable to pump enough blood to the rest of the body and was functioning at only about 25-30% capacity when the implant was done on Sept 26 last year (9-26-2012).
The New Paper takes a look at the new device.
HOW THE MINIATURISED PUMP WORKS
1. Blood flows from the aorta into integrated inflow cannula
2. The electromagnetically suspended impeller spins as blood flows past the grooves. The only moving part, it spins without the use of ball bearings. Revolutions per minute: 2,400 to 3,200
3. Blood flows back to aorta via the outflow graft at up to 10 litres a minute
ADVANTAGES
• Smaller and lighter
• Faster recovery
• Fits next to the heart without the need to create a pocket underneath the heart as required by previous generations of heart pumps [like HMII]
THE OPERATION
National Heart Centre Singapore performed the 4-hour open heart surgery on Sept 26 last year. The sewing ring is first sutured to the heart followed by an incision on the inside of the ring. An apical coring tool is used to remove the tissue within the sewing ring. The pump is inserted and secured in place, followed by the placement of the driveline. The other end of the outflow graft is finally attached to the aorta. The controller and the batteries can be worn either around the patient's waist or over the shoulder.
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Earlier articles & a YouTube News Report on Singapore HVAD Lady, Madam Helen Tan:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83217011
1-15-13: HTWR mentioned in Zacks THOR Update…
1-15-13: ”Thoratec Downgraded By Zacks to Neutral - Analyst Blog”
By Zacks.com
http://www.nasdaq.com/article/thoratec-downgraded-to-neutral-analyst-blog-cm207784
On 1-14-2013, we downgraded Thoratec Corp. (THOR), a leader in mechanical circulatory assistance devices, to Neutral based on growing competition and a more challenging outlook. The company's Q3 2012 revenues and earnings per share beat the Zacks Consensus Estimates. While past results have often been good, Thoratec faces growing competition from HeartWare Intl. (HTWR). Thoratec's monopoly in the U.S. market, in the case of the bridge-to-transplant (BTT) indication, has come to an end following FDA approval, in Nov.2012, for HeartWare's Ventricular Assist System (“HVAD”) as a BTT for patients with end-stage heart failure. HeartWare has already received CE Mark approval in Europe. Expected market share losses to HeartWare for the BTT indication will result in a slower growth profile for Thoratec. The growth rate in the Destination Therapy (DT) market where the company faces no near-term competition will therefore determine its prospects in the medium term. Overall, the market may be broad enough to accommodate several players, assuming clinical comparability. Thoratec’s lack of pipeline visibility and relative lack of milestones represents a concern. Thoratec's 3rd-gen. pump (HeartMate III) is still in the early stages of development. Its next-generation device may not be commercially available in the U.S. for the next couple of years. The small size of the company may restrict its ability to raise resources. The absence of strategic alliances may hinder its ability to develop new products. The unified product line of the company (Thoratec) and its lack of product diversification are related areas of concern.
1-7-13: Article on 1st Commercial HVAD in U.S. - Froedtert & The Medical College of Wisconsin…
1-7-13: ”New Device (Heartware’s HVAD) Can Keep Heart Patients Alive”
By Erica Breunlin, Milwaukee BizTimes, "Innovations"
http://www.biztimes.com/article/20130107/MAGAZINE03/301049987/-1/ENEWSLETTERS08/New-device-can-keep-heart-patients-alive
Physicians from the Advanced Heart Failure Program at Froedtert & The Medical College of Wisconsin (MCW - http://www.froedtert.com ) pioneered the first operation in the nation outside clinical trials of the latest Ventricular Assist Device (VAD), which works to improve the lives of patients suffering from end-stage heart failure. The device, also known as the HeartWare HVAD, is a mechanical pump that assists the heart in pumping blood. Surgeons attach the device to the patient's heart to advance blood flow and heart function. The device is powered externally, typically through battery and electrical power.
The first patient, who Froedtert had been in the process of caring for, had been living on medications until his heart disease became too disabling. He developed medical therapy refractory in which he remained symptomatic to the point that he couldn't do anything without feeling tired and short of breath. His heart weakened to the point that Froedtert's medical team had no other options, said Dr. Claudius Mahr, cardiologist at Froedtert & MCW, who manages heart failure patients across a continuum of care through medications, devices and transplants. "Once it got to the point that his heart got so weak that it couldn't supply his kidneys any more, we knew we had to do something sooner rather than later," Mahr said.
Physicians operated in early December after the device received FDA approval in November. The patient had a left ventricular assist device (LVAD) implanted to pump blood to the aorta from the left ventricle. A right ventricular assist device (RVAD) sends blood to the pulmonary artery from the right ventricle, and a BiVAD pumps blood to both ventricles. In its 3rd generation, the device is much smaller than previous versions – about the size of a golf ball – with fewer moving parts it's less prone to wear. It fits in the same cavity the heart is positioned in and is magnetically levitated. It's also gentle on red blood cells and is lubricated by the patient's own blood. The HeartWare HVAD can be used as a bridge to transplant to sustain a patient for potentially years until a donor heart becomes available. The device can also function as permanent therapy, or "destination" therapy, for patients who do not medically qualify as transplant candidates.
"It's much easier to implant, and I think that the patient's discomfort & ability to get up and around sooner is much improved, and it will be able to be used in a much wider range of patients," said Dr. Robert Love, cardiothoracic surgeon at Froedtert & MCW, who performed the open heart surgery to secure the device.
In this first operation, the device is serving as a bridge to transplant. Physicians hope to be able to bridge the patient to transplantation successfully, at which point the HeartWare HVAD will be removed. Immediately following the operation, patients rest in the intensive care unit for a few days until they're stable enough to come off their intravenous medications and can be managed with heart failure medications. On average, patients remain in the hospital for 2 weeks to be closely monitored after these kinds of devices are implanted. They can usually resume much of their daily routine once released from the oversight of doctors. While the device has been studied extensively in clinical trials as a bridge to transplant, it is in the process of being evaluated as a solution for destination therapy. Although every patient responds a little differently, physicians do know that people can survive for several years with the device alone even if they never get a transplant, Mahr said.
Froedtert has had a considerably higher success rate implementing a VAD as a bridge to transplant than the national average rate. In terms of using the device as destination therapy, Froedtert is certified by the Joint Commission, a national health care certification organization. "I think we have a great team of dedicated experts working together collaboratively for the interest of our patients," Mahr said. "It's a remarkable group of individuals of various disciplines who work together to provide the best care for our patients."
The health care provider's success can also be attributed to its careful selection of patients who will benefit most from a VAD. "We make sure that they're optimally managed on medicines and that they truly can't improve on medicines," Love said. According to Mahr, 100,000 patients living with end-stage heart failure would potentially benefit from a heart transplant, but only 2,200 heart transplants are performed in the United States each year due to a shortage of donor availability. "The math is it's just not available for as many people who would need it," Mahr said. So the VAD offers a viable alternative for heart failure patients who aren't making strides with medication.
While Mahr acknowledges that this latest version of the VAD (HVAD) has revolutionized the medical field, he also recognizes the lack of resources and capable physicians to address the medical needs of every individual battling heart failure, which remains a significant public health problem. "There's a lot of demand on the part of our patients and unfortunately not enough to meet that demand, so we just provide the best care we are able," he said.
1-14-13: Interesting SA Article comparing Sunshine Heart’s C-Pulse to LVADS.
Bottom Line: ”SSH’s C-pulse system's operation & purpose and its target market are quite different to the LVADs from Thoratec & Heartware... It is important to point out that a counterpulsation device is aimed to augment native heart function and is fundamentally different from total artificial hearts, left ventricular assist devices and heart transplants which are meant to be a total replacement or an alternative to the native heart. Thus, the counterpulsation device is considered non-obligatory and not life-supporting. “
1-14-13/SA: ”Sunshine Heart: When Drugs Don't Work And LVADs Are Too Risky”http://seekingalpha.com/article/1110671-sunshine-heart-when-drugs-don-t-work-and-lvads-are-too-risky
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http://www.sunshineheart.com/c-pulse
"The C-Pulse System’s design is based on proven balloon counter-pulsation technology to assist the heart by reducing the workload of the left ventricle. During inflation of the balloon, blood flow is increased to the coronary arteries, thereby providing additional oxygen which is vital to a failing heart. During deflation, the workload or pumping required by the left heart is reduced. The balloon inflation and deflation is synchronized to the patient’s ECG, similar to a pacemaker."
1-11-13: “Top Cardiovascular Technology Trends of 2012”
By Haley David, The Advisory Board Co.
http://www.advisory.com/Research/Technology-Insights/The-Pipeline/2013/Top-cardiovascular-technology-trends-of-2012
With 2013 in full swing, we’ve taken a step back to review the major CV technology stories of 2012. From devices gaining FDA approval to therapies demonstrating paradigm-shifting potential, 2012 was a year of significant innovation across CV services. To help CV leaders nationwide distill the most impactful new research, data, and FDA approvals, we’ve broken down the 4 top stories of 2012 and what you need to know in 2013.
1. New TAVR devices, expanded indications alter CV landscape. . .
2. Renal denervation shows promise for resistant hypertension (HTN). . .
4. FIRM ablation on the horizon. . .
3. FDA Approves HeartWare HVAD, New Device Enters Monopolized Market
In the heart failure terrain, an exciting new device -HeartWare’s HVAD- entered the market in 2012. In November, the device was FDA approved for bridge-to-transplant (BTT) indications. The HeartWare system includes a small pump that can be fully implanted in the pericardial space without requiring an abdominal pocket. In addition, the magnetically levitated, centrifugal pump decreases mechanical wear-and-tear, likely increasing device durability.
With a new device entering this previously monopolized market, there are a few important considerations to keep in mind:
• Cost implications: while the (HVAD) device’s cost has not been released, competition with Thoratec’s HeartMate II may result in an eventual decrease in VAD direct costs
• Destination therapy designation: though only FDA approved for BTT patients, the HVAD’s ENDURANCE trial is underway to assess the HVAD's use for destination therapy. The trial also compares the HVAD directly to Thoratec’s HeartMate II.
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WHAT 2013 HOLDS FOR CARDIOVASCULAR TECHNOLOGY
Given these exciting advances in 2012, there are several trends we will be tracking closely in 2013:
• Continued focus on renal denervation
• Understanding the mechanism sustaining AF
• Transcatheter mitral valve repair development
In 2013, beyond continued evolution of TAVR, we will likely see an enhanced focus on transcatheter mitral valve repair including developments with the MitraClip. While device’s vendor voluntarily recalled the system, results from the EVEREST II trial suggest procedural potential in surgically ineligible and high-risk mitral regurgitation (MR) patients.
SOURCES:
1. Heartwire. “Biggest Cardiology Stories of 2012”
2. Cath Lab Digest. “American College of Cardiology Names Top Cardiovascular Stories of 2012.” http://www.cathlabdigest.com/American-College-Cardiology-Names-Top-Cardiovascular-Stories-2012
Wedbush conclusion (1-10-13): "With a potential best-in-class device in a growing market, the strongest technical pipeline in the LVAD industry, as well as what we predict will be a successful U.S. commercial launch, we reiterate our HTWR OUTPERFORM rating (FV=$105)."
1-10-13: Wedbush HTWR Update, “HVAD commercial transition occurred more quickly than we anticipated…”
1-10-13: ” HeartWare Intl. (HTWR/Outperform): Thoughts on Q4:12”
Wedbush Analyst: Akiva Felt
HTWR Preannounce Beat; Reiterate OUTPERFORM – Target $105
• Updating model following Q4:12 revenue pre-announcement.
• US revenues: HVAD commercial transition occurred more quickly than we anticipated; strong implant run-rate out of the gate.
• International revenues: flat q/q and below expectations; attributing mostly to typical lumpiness for now, but not ruling out some share loss to THOR.
• Reiterate OUTPERFORM and $105 fair value.
1-9-13: Orig. Article from Singapore Heart Center on 1st HVAD recipient, Madam Helen Tan…
1-9-13: ”New Pump Gives Heart Patients New Life” (The Straits Times)
By Poon Chian Hui, Natl. Heart Center Singapore
THERE was a time when just 15 minutes of housework left Madam Helen Tan out of breath. That was before she became the first patient in Singapore to be fitted with a new type of potentially life-saving [HVAD] heart pump. The titanium device - which is designed for those awaiting transplants - was inserted into her chest in a 4-hour operation. Doctors say it will provide a valuable new option for heart patients who have stopped responding to medication.
PHOTO: NATIONAL HEART CENTRE SINGAPORE
“Madam Helen Tan with (from left) Dr C. Sivathasan, Dr David Sim and Associate Professor Lim Chong Hee from the National Heart Centre Singapore medical team. Prof Lim led the 4-hour surgery to have Madam Tan fitted with the titanium heart pump.”
In Madam Tan's case, it has allowed her to lead a far fuller life than she could have enjoyed at the height of her heart problems last year, when she used to get tired simply doing household chores. "I had to lie down and rest," said the 57-year-old in Mandarin. "Sometimes, I even got breathless while talking to someone." This went on for a month before the mother of two decided to take the plunge last September and have the pump fitted. The HeartWare ventricular assist device (HVAD) is both smaller and lighter than its predecessors, allowing it to fit inside the body more easily. It weighs just 160g and is about the size of a golf ball.
Doctors at the National Heart Centre Singapore said that unlike previous generations of pumps [ie, Thoratec HMII], it does not require them to create a pocket underneath the heart to house it. This means surgery can be completed in about 4 hours - down from 5 hours before - said Dr. C. Sivathasan, co-director of the centre's heart and lung transplant programme. Another advantage is that its size makes it more suitable for groups that tend to be small in build, such as women and people from Asia. Patients are also able to take lower doses of blood thinning drugs than with the older devices. The medication prevents blood clotting inside the pump. HeartWare costs $160,000 without any subsidy. Including three weeks in hospital, the total bill comes to about $300,000.
Heart pumps are meant for those with advanced heart failure who no longer respond to medication. Patients are given the devices while they await a transplant. So far, 4 people in Singapore have been fitted with the HeartWare HVAD, while more than 2,500 have used it worldwide since 2006. The device fits right next to the heart and can pump up to 10 litres of blood every minute. A cable runs through a hole in the abdomen, linking the pump to a pack outside the body that carries a controller and batteries to drive the mechanism.
At home, patients can plug the device into an electrical socket in the wall while they sleep, said Associate Professor Lim Chong Hee, who led Madam Tan's surgery. He added that having this new option available in Singapore is "a big deal" as heart failure is set to become the next epidemic among heart diseases. In Singapore, it accounts for about 5,000 hospital admissions a year.
Meanwhile, Madam Tan is regaining her strength. Her heart function has risen from 25% to 70%. And although she gave up her job at a chocolate factory in 2007, she now hopes to return to work. "Previously, my pace of talking was even slower than an old lady," she joked. "Now, I can talk non-stop, go out, cook for my family, do the laundry and play with my grandchildren."
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1-8-13 VIDEO NEWS Report (2:05):
1-9-13: Followup article on Vanderbilt First In Tenn. HVAD Commercial Implant
= = = = = = =FOLLOWUP ARTICLE:
1-9-13: “Vanderbilt Medical Center First In State To Implant New Heart Assist Device”
http://www.tennessean.com/article/20130109/NEWS07/301090143/Vanderbilt-Medical-Center-first-state-implant-new-heart-assist-device
Excerpt:
“The advantage of the pericardial placement should lead to decreased procedure time and shorter hospitalization time,” Maltais said. “The device can be implanted in adults with smaller body types and has greater versatility in patients with congenital heart disease.” - Dr. Simon Maltais, Surgical Director for the Heart Transplant and Ventricular Assist Device programs.
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1-9-13: ”VHVI First in State (Tenn) to Implant New Ventricular Assist Device [HVAD]”
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83241856
…”We are excited to bring this cutting edge technology to Vanderbilt patients. The HeartWare pump has greater versatility due to its smaller size, allowing us to extend left ventricular assist device therapy to a broader patient population awaiting heart transplantation,” said Mary Keebler, M.D., medical director for the Vanderbilt Ventricular Assist Device program…
1-9-13: Vanderbilt Univ/MC 1st in Tenn. to Implant the HVAD for BTT
1-9-13: ”VHVI First in State (Tenn) to Implant New Ventricular Assist Device [HVAD]”
by Kathy Whitney, Vanderbilt Unit. Medical Ctr. Reporter
http://news.vanderbilt.edu/2013/01/vhvi-first-in-state-to-implant-new-ventricular-assist-device
On Monday, Vanderbilt Heart & Vascular Institute became the first heart program in Tennessee to implant the HeartWare ventricular assist system (“HVAD” VAS) as a bridge to transplantation. The miniature circulatory support device gained FDA approval in November for this purpose.
Simon Maltais, M.D., Ph.D., surgical director for the Heart Transplantation & Ventricular Assist Device programs, implanted it in a 31-year-old Nashville patient with advanced heart failure. The HeartWare VAS features a minaturized, full output device design that is implanted in the pericardial space of the heart. “The advantage of pericardial placement should lead to decreased procedure time and shorter hospitalization time. The device can be implanted in adult patients with smaller body types and has greater versatility in patients with congenital heart disease,” Maltais said.
The new ventricular assist device [“HVAD”] is made by HeartWare Intl. The system is currently the leading ventricular assist device implanted in patients outside of the United States. The device had been implanted in more than 2,500 patients globally. Maltais had experience with surgical implantation of the device as part of a clinical trial at the Mayo Clinic in Rochester, Minn., before coming to Vanderbilt in 2011. The Ventricular Assist Device team worked with HeartWare International Inc. to train key providers and staff to prepare to offer this new device.
“We are excited to bring this cutting edge technology to Vanderbilt patients. The HeartWare pump has greater versatility due to its smaller size, allowing us to extend left ventricular assist device therapy to a broader patient population awaiting heart transplantation,” said Mary Keebler, M.D., medical director for the Vanderbilt Ventricular Assist Device program. The program offers a full spectrum of devices for patients with advanced heart failure. The addition of HeartWare VAS provides another option that assists patients to live an ambulatory lifestyle while waiting for their heart transplant.
PHOTO: Team members working with the new “HVAD” ventricular assist system include (L-R): Mark Wigger, M.D., Mary Keebler, M.D., Simon Maltais, M.D., Beverly Jones, N.P., Casey West, N.P., Kayela Floyd, R.N., and Alaina Knight, R.N.
1-9-13: 3 Articles & VIDEO on Singapore’s 1st HVAD Recipient, Helen Tan
1-8-13 VIDEO NEWS Report (2:05):
Webcast Replay of D.Godshall’s 1-7-13 JPM Presentation (SanFran)
http://www.heartware.com
=> http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-presentations
DIRECT: http://jpmorgan.metameetings.com/webcasts/healthcare13/directlink.php?ticker=HTWR
2 Separate Recordings:
HeartWare International Inc. (CEO Doug Godshall Presentation)
Webcast: 31st Annual J.P. Morgan Healthcare Conf.
Jan. 7, 2013, 10:30AM PT
HeartWare International Inc. (Q&A)
Webcast: 31st Annual J.P. Morgan Healthcare Conf.
Jan. 7, 2013, 11AM PT
Last 2 Yrs, HTWR’s REVS projections were low – we’ll see what comes in the early Feb. 10-Q, but I bet that the $110mm Est. for 2012 turns out low…
On 1-10-2011 at the JPM Conf., Doug Godshall gave a prelim. read of Q4’10 revs at ~$20mm. On 2-24-2011, the final Q4 revs figure was announced at $20.9mm.
On 1-9-2012 at the JPM Conf., Doug Godshall gave a prelim. read of Q4’11 revs at ~$22mm. On 2-16-2012, the final Q4 revs figure was announced at $23.2mm.
On 1-7-2013 in the JPM Conf. PR, HTWR gave a prelim. read of Q4’12 revs at ~$32mm. On 2-xx-2013, the final Q4 revs figure was announced at $___._mm.
Yearly Revs progression: $332k => $24.2mm => $55.2mm => $82.8mm => ~$110mm (2008 – 2012)
1-7-13: HTWR’s prelim. 2012 Revs: Q4=$32mm, CY=$110mm (+40%/Q4, +33%/CY)
1-7-13: "HeartWare Intl. Announces Preliminary Q4/2012 Revenues”
http://www.marketwatch.com/story/heartware-international-announces-preliminary-fourth-quarter-2012-revenues-2013-01-07
FRAMINGHAM & SYDNEY, Jan. 7, 2013: HeartWare International, Inc. , a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that it expects total revenues for Q4 2012 will be approx. $32 million, bringing expected full-year 2012 revenues to approx. $110 million.
"These results reflect positive initial trends in the commercial launch of the HeartWare Ventricular Assist System [HVAD] in the U.S., as approximately 40% of Q4 revenues were derived from domestic sales," explained Doug Godshall, President and CEO. "In addition, we remain optimistic about long-term global market growth prospects and HeartWare's role in stimulating that growth. This sentiment is bolstered by our observed revenue growth of approx. 40% in Q4 over Q4/2011, and approx. 33% growth in full-year 2012 revenues over 2011."
These preliminary results are being provided in conjunction with the Company's presentation to the investment community today at the 31st Annual J.P. Morgan Healthcare Conference. HeartWare's presentation commences at 10:30amPST (1:30pmEST) at the Westin St. Francis Hotel in San Francisco. A live webcast of the Company's presentation at the conference will be available via a link provided at http://www.heartware.com . A replay of the webcast will be available for 90 days at the site after the presentation.
The financial estimates presented above are preliminary and remain subject to management's final review as well as audit by the Company's independent registered accounting firm. The Company intends to report complete Q4 and full-year 2012 financial results in late February. Details regarding the timing of the release of those results, as well as details of a conference call and publicly available webcast, will be announced in a subsequent news release.
ABOUT HEARTWARE INTERNATIONAL
HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure. The HeartWare Ventricular Assist System features the HVAD pump, a small full-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HeartWare System is approved in the United States for the intended use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure, has received CE Marking in the European Union and has been used to treat patients in 27 international countries. The device is also currently the subject of a U.S. clinical trial for destination therapy. For additional information, please visit the Company's website at http://www.heartware.com .
HTWR gives $149k Grant to Clev-Clin. researcher K.Fukamachi for MVAD studies. (not sure when it was awarded - newsletter dated Dec. 2012)...
Kiyotaka Fukamachi, MD, PhD, Biomedical Engineering, received a 1-year, $149K award from HeartWare, Inc. (Framingham, MA), for "Acute evaluation of HeartWare MVAD in a pacing-induced heart failure model in sheep." Nader Moazami, MD, Thoracic and Cardiovascular Surgery, is a co-investigator on the study.
This research evaluates the performance of a miniaturized left ventricular assist device (about one third the size of the company's device for humans) in an animal model. The tiny device may one day allow surgeons to implant it under minimally invasive procedures in people, avoiding the risks to the patient of full "rib-cracking" (median sternotomy) surgery.
http://www.lerner.ccf.org/news/notations/16/12/4.php
HTWR’s D.Godshall to present 1-7-13 JPM HC Conf./SanFran (1:30pmET webcast)
“HeartWare Presentation At The 31st Annual J.P. Morgan Healthcare Conference To Be Webcast [1-7-2013 1:30pmET]”
http://phx.corporate-ir.net/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=1770899
FRAMINGHAM & SYDNEY, Australia, Jan. 3, 2013: HeartWare International, Inc. (NASDAQ: HTWR - ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the 31st Annual J.P. Morgan Healthcare Conference at 10:30amPT (1:30pmET) on Monday, January 7. The conference is being held January 7-10 at the Westin St. Francis Hotel in San Francisco.
A live webcast of the Company's presentation at the conference will be available via a link provided at http://www.heartware.com . A replay of the webcast will be available for 90 days at the site after the presentation.
Link to webcast replay of 12-13-12 Oppenheimer presentation (incl Slideshow) by CEO Doug Godshall…
Get to it thru here:
http://ir.heartware.com/phoenix.zhtml?p=irol-eventDetails&c=187755&eventID=4873272
or directly here:
http://www.veracast.com/opco/healthcare2012/main/player.cfm?eventName=2041_heartw
12-12-12: WISN TV Report on James Kropidlowski’s new HVAD – “the first patient in the country to receive the new, smaller HVAD device, made by the company HeartWare, since it was approved by the FDA." Includes 2:20 must-see VIDEO…
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12-12-12: ”Device [HVAD] Offers Fresh Hope For Heart Patients”
MILWAUKEE - There's fresh hope for heart failure patients in Milwaukee.
"What did The Tin Man need? Needed a heart. Had to go see The Wizard, and that's what I'm doing -- seeing the wizard," said James Kropidlowski of West Bend. That wizard is Froedtert cardiologist Dr. Claudius Mahr, who, along with surgeon Dr. Robert Love, implanted into Kropidlowski a 3rd generation ventricular assist device (VAD – Heartware’s “HVAD”).
It's much smaller than previous devices, about the size of a golf ball. Hospital officials said Kropidlowski, 53, was the first patient in the country to receive the new, smaller device, made by the company HeartWare since it was approved by the FDA.
VIDEO (2:20): Fresh hope for heart failure patients in Milwaukee
LINK:
Aurora's St. Luke's Medical Center implanted a dozen of the devices while they were in the testing phase, and they've implanted 2 more in the weeks since FDA approval. All for heart failure patients like Kropidlowski.
"I loved to go hiking, biking, fishing," Kropidlowski said. That was before 2010, when Kropidlowski had a heart attack, but didn't realize it until he started to see bloating in his legs and upper body. By then, a portion of his heart had been without blood for too long. The heart muscle was dead. "His heart had gotten sick to the point where really something needed to be done, and conventional medications weren't working," Dr. Mahr said. Kropidlowski would need a new heart, but the wait for a heart transplant was longer than a year to survive that wait. He needed some way of helping his sick heart pump blood.
"So the pump gets surgically implanted on top of the heart kind of like this, and then takes blood from the left ventricle, and pumps it to the body," Dr. Mahr said. Mahr said 90% of patients given this device have survived long enough to receive new hearts.
Kropidlowski is hopeful and looking forward to getting back to biking, hunting and fishing. "Just to be able to go out and enjoy life again," Kropidlowski said.
Doctors told WISN 12 News the new, smaller device is better than previous versions because it lowers the risk of infection. Implants are being done at both Froedtert as well as Aurora St. Luke's Medical Center.
http://www.wisn.com/news/health/Device-offers-fresh-hope-for-heart-patients/-/9373180/17748004/-/afcns3z/-/index.html
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Heartware’s Updated Webpage 11-21-12:
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11-20-12: FDA Approves The HVAD for BTT in U.S.!!!!!!!
=> http://investorshub.advfn.com/boards/read_msg.aspx?message_id=81695789
D.Godshall Oppenheimer presentation webcast Dec13 10amET
HeartWare Presentation at the Oppenheimer 23rd Annual Healthcare Conference to be Webcast [Dec. 13 10amET]
FRAMINGHAM & SYDNEY, Dec. 6, 2012: HeartWare International, a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that CEO Doug Godshall is scheduled to present at the Oppenheimer 23rd Annual Healthcare Conference at 10:00am EST on Thursday, December 13, 2012. The conference is being held December 12-13 at the Waldorf-Astoria in New York City.
A live webcast of the Company's presentation at the conference will be available via a link provided at http://www.heartware.com . A replay of the webcast will be available for 90 days at the site after the presentation.
http://www.marketwatch.com/story/heartware-presentation-at-the-oppenheimer-23rd-annual-healthcare-conference-to-be-webcast-2012-12-06
Webcast: http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-calendar
12-3-12/Bloomberg: “HVAD DT Interim Data Bodes Well For Eventual Approval”
12-3-12/Bloomberg Brief:
“Key Catalyst Insight: HeartWare’s (HVAD) interim Destination Therapy (DT) data bodes well for eventual approval.” - Page 8.
http://www.bloombergbriefs.com/brief/files/HealthcareFinance_120312_p1.pdf
I don’t have a subscription, so can’t see the full article.
12-3-12: G.Sachs Reits HTWR Neutral, PT 86=>84.
In a report published Monday 12-3-12, Goldman Sachs Group reiterated its Neutral rating on HeartWare International (HTWR), but lowered its price target from $86 to $84.
Goldman Sachs noted,
“Following a detailed review of the left ventricular assist device market, we maintain our Neutral rating on shares of HTWR. We reduce our 2013-2016 revenue estimates to reflect a slower launch of the company's recent US approval for the HVAD device. Longer-term, we continue to have a bullish view on LVADs in general (we model +19% growth through 2016E) and see HeartWare as an attractive fundamental and strategic asset. However, over the near-term we think expectations for the company's US product launch need to be reset. We think HTWR will remain range-bound, as we would also not expect to see material downside unless we developed strong conviction that its long-term growth prospects (primarily approval for Destination Therapy) are in jeopardy.”
http://www.benzinga.com/analyst-ratings/analyst-color/12/12/3138876/update-goldman-sachs-reiterates-neutral-rating-lowers-pt
HeartWare at Oppenheimer HC Conf. Dec12-13, NYC…
(HTWR's website doesn’t show webcast info. at this time. ??)
HeartWare Intl. at Oppenheimer’s 23rd Annual Healthcare Conf., NYC
Wed.-Thur., Dec. 12-13, 2012
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-calendar
“The Oppenheimer 23rd Annual Healthcare Conference will present a core group of public & private companies who are leaders and pioneers in the pharmaceutical, biotechnology, medical device, healthcare facility, lifescience tools and diagnostics, health technology and distribution, provider and service industries.”
11-28-12: Wunderlich Reits Heartware at HOLD; PT=$96
”Wunderlich Securities Reiterates Hold Rating, $96 PT on HeartWare Intl.”
Dwight Einhorn, Benzinga Staff Writer
In a report published 11-28-12, Wunderlich Securities reiterated its HOLD rating and $96 price target on HeartWare Intl. (HTWR).
Wunderlich Securities noted,
“We are updating our estimates for Heartware (HTWR) following last week's FDA approval of the HVAD device. While the approval was a major achievement for HTWR and contained some very positive aspects, the FDA's decision to include interim data from the ENDURANCE trial has re-ignited stroke concerns for the HVAD, an issue that has weighed on the stock for much of the past 2 years.
While the subsequent pullback in the shares has heightened our interest, we are moderating our revenue assumptions as stroke concerns could slow the pace of uptake at non-trial centers. Despite our favorable outlook for HTWR, we reiterate our Hold rating as we believe lingering stroke concerns could allow for an even more attractive near-term entry point.”
http://www.benzinga.com/analyst-ratings/analyst-color/12/11/3126710/wunderlich-securities-reiterates-hold-rating-96-pt-on-he
Link to webcast replay of 11-28-12 P.Jaffray Presentation (CEO Doug Godshall)…
HeartWare. at Piper Jaffray Healthcare Conference
2012-11-28 8:30amET
Webcast replay (25 mins): http://ir.heartware.com/phoenix.zhtml?p=irol-eventDetails&c=187755&eventID=4873266
Direct Link: http://www.media-server.com/m/p/tjt5jfdv
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Heartware’s Updated Webpage 11-21-12:
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11-20-12: FDA Approves The HVAD for BTT in U.S.!!!!!!!
=> http://investorshub.advfn.com/boards/read_msg.aspx?message_id=81695789
11-26-12/Cr.Suisse: “HeartWare Pullback a Buying Opportunity”
By: Theflyonthewall.com
http://markets.cbsnews.com/cbsnews/news/read/22845347/heartware_pullback_a_buying_opportunity
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11-26-12: Cr.Suisse Reits. Outperform, lowers PT $104=>$99, feels HVAD DT “will be approved and have a solid launch”…
“Heartware Intl. (HTWR) pullback after the Bridge to Transplant approval is viewed by Credit Suisse as being overdone. The firm is under the impression that HVAD DT risk is slightly higher, but it will be approved and have a solid launch. The firm gives the shares and Outperform rating and a $99 price target, which has dropped from $104.”
http://wallstcheatsheet.com/stocks/heartwire-international-pullback-deemed-overdone-and-4-must-see-stock-analyses.html
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11-20-12: FDA Approves The HVAD for BTT in U.S.!!!!!!! http://tinyurl.com/axrcau4
11-26-12: MedDevDaily Recap of HVAD FDA Approval
11-26-12: ”FDA Approves HeartWare VAS as a BTT for End-Stage HF”
By AMANDA PEDERSEN, Medical Device Daily Senior Staff Writer
http://www.medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=81163
It's been a long road for HeartWare Intl. (Framingham, Mass.), but the company's patience and perseverance has finally paid off. The FDA has approved the company's premarket approval application (PMA) [ see 11-20-12: http://tinyurl.com/axrcau4 ] for its HeartWare ventricular assist system (VAS “HVAD”) as a bridge-to-transplantation (BTT) therapy for patients with end-stage heart failure. HeartWare submitted the PMA nearly two years ago (Medical Device Daily, Dec. 29, 2010).
"FDA approval marks the culmination of an extensive clinical effort and represents an exciting advance in the treatment of late-stage heart failure patients," said Doug Godshall, president/CEO of HeartWare. "We wish to extend our most sincere thanks to the patients, and to their families, for participating in the study of this innovative device, and we also are grateful to each of the nurses, coordinators, surgeons and cardiologists who provided care to those patients."
Despite some safety concerns, an FDA panel decided in April the benefits outweigh the risks for the new device (MDD, April 27, 2012).
The HeartWare system features the HVAD pump, a small full-support circulatory assist device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HVAD pump, with sintered inflow cannula, weighs about 5 ounces and displaces a volume of roughly 50 milliliters. The HeartWare system is intended for use as a bridge to heart transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
"We are delighted that U.S. surgeons and cardiologists will now have access to this device for their end-stage heart failure patients," Godshall told investors, reporters and other conference call listeners last week.
Importantly, he noted that the FDA approval for BTT does not require patients to be already on the transplant list, they just have to be eligible for a heart transplant. That makes access to the device less restrictive but also makes it more difficult to estimate the size of the addressable market for the HVAD.
"What will really determine how physicians use the HVAD is their level of enthusiasm for the device. If they get great outcomes and their patients respond really favorably, as we've seen in Europe, you tend to find more patients that look like HVAD patients," Godshall said during the call. "And there will clearly be patients who you can't possibly call bridge to anything because they have either permanent contra-indications for transplant such as co-morbidities or, more likely, they're just too old to ever possibly be a BTT-anything."
Godshall explained that heart transplant committees do not generally approve older patients for transplant, but of course there are always exceptions. "People do get transplanted over 70, like Dick Cheney, but it's not norm. So our expectation is the appropriate bridge-eligible gives doctors the freedom to practice medicine and determine patients who might stop smoking and might recover from other co-morbidities, such as hypertension, and become eligible transplant candidates later." Former Vice President Dick Cheney received a heart transplant earlier this year at age 71, after first previously receiving the HeartMate II pump made by Thoratec (Pleasanton, CA.) and approved by FDA in early 2010 (MDD, Jan. 25, 2010).
The HeartWare system received CE marking in the European Union in 2009, and Australian Therapeutic Goods Administration approval in 2011. Today, more than 2,500 advanced heart failure patients globally have received the HVAD pump, according to the company.
"I've had the opportunity to work on the HVAD project since its conception over a decade ago. The goal was to develop a miniaturized device with an integrated inflow cannula that could be placed within the pericardial sac, avoiding the necessity of creating a pump pocket with its attendant infection risks, as well as simplifying the surgical insertion," said O.H. "Bud" Frazier, MD. Frazier is chief of the Center for Cardiac Support; director of cardiovascular surgery research and co-director of the Cullen Cardiovascular Research Laboratories at Texas Heart Institute (Houston). "A second goal was elimination of mechanical bearings to suspend the impeller, designed to enhance durability & blood handling characteristics. Those of us who treat these challenging end-stage heart failure patients are fortunate to have this pericardial, wearless system available for our patients."
Godshall told conference call listeners that the company is positioned to begin the commercial rollout of the HeartWare system immediately, first facilitating broad use by the 50 U.S. hospitals that participated in the clinical studies, and then with training & expansion to additional U.S. hospitals.
HeartWare's PMA submission included data from the company's pivotal ADVANCE clinical trial, an FDA approved investigational device exemption (IDE) study designed to evaluate the HeartWare system as a bridge-to-transplantation for patients with end-stage heart failure. Under ADVANCE, 140 patients at 30 hospitals in the U.S. received the HeartWare device between August 2008 and February 2010. The ADVANCE study achieved a 94% survival at 6 months and met its primary endpoint of establishing non-inferiority between the investigational device and comparator arm of the study, which was derived from contemporaneous patients from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Four supplemental allotments of patients have been granted by the FDA under a continued access protocol, encompassing more than 250 additional patients.
To help assure the continued safety and effectiveness of an approved device, FDA requires a post-approval study as a condition of approval to assess device performance in a real-world setting. HeartWare's post-approval study is a registry consisting of 600 patients who receive an HVAD and an additional 600 control patients derived from a contemporaneous group of continuous flow, intra-corporeal LVAD patients entered into the INTERMACS database. The data for both arms of the study will be entered into the INTERMACS registry by the implanting centers. Other post approval commitments include the transfer of patients from the ADVANCE IDE study into a post-approval database as well as an obligation to continue training sites in accordance with an approved training program.
In other clinical development for the HeartWare ventricular assist system, HeartWare has completed enrollment of a 450-patient destination therapy study at 50 U.S. sites. The final patients were implanted in May, with a two-year, primary endpoint follow-up period. HeartWare has requested a continued access protocol allocation for destination therapy from the FDA.
HeartWare has had a strong reputation among the investor community. The company was tagged as a good prospect for acquisition late last year in an investor note by Jason Mills of Canaccord (Toronto), who wrote that HeartWare would have a dominant position for this device type outside the U.S. by the end of 2011 (MDD, Oct. 13, 2011) [ http://investorshub.advfn.com/boards/read_msg.aspx?message_id=68077301 ]. Earlier this year the company agreed to acquire WorldHeart (Salt Lake City) for $8 million in cash and/or HeartWare common stock (MDD, April 2, 2012). Mills also predicted early last year that HeartWare would eat into Thoratec's dominance of the U.S. market, predicting a rough split of the market between the two by 2015 (MDD, Feb. 1, 2011).
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11-20-12: FDA Approves The HVAD for BTT in U.S.!!!!!!! http://tinyurl.com/axrcau4
11-21-12: Wedbush Raises PT to $105 on HeartWare as as FDA Approves HVAD
David Johnson, Benzinga Staff Writer
Wedbush Securities reiterated its Outperform rating on HeartWare International (NASDAQ: HTWR) and increased its price target from $101 to $105.
Wedbush Securities commented,
"FDA approves HVAD for Bridge-to-Transplant (BTT). The good: sintered device & non-restrictive label. The not-as-good: Label includes DT data snapshot with stroke rate imbalance. Favorable overall and maintain expectations for HVAD to take majority share of US BTT market by 2014. … We spoke with a number of US LVAD physicians at the American Heart Association (AHA) conference earlier this month and heard a unanimous opinion that the HVAD does not have a device specific thrombosis issue. Moreover, those with limited or no experience using the HVAD in clinical studies appear eager to test-drive the device.".
http://www.benzinga.com/analyst-ratings/analyst-color/12/11/3111471/update-wedbush-securities-raises-pt-to-105-on-heartware-
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11-20-12: FDA Approves The HVAD for BTT in U.S.!!!!!!!
=> http://investorshub.advfn.com/boards/read_msg.aspx?message_id=81695789
11-21-12: UBS Downgrades Heartware Post FDA Approval, PT=$95
“UBS downgraded Heartware Int'l (NASDAQ: HTWR) from Buy to Neutral posts FDA approval.”
• Heartware was downgraded at UBS to neutral from buy; $95 price target. Street revs may be aggressive, UBS said.
http://www.streetinsider.com/Downgrades/UBS+Downgrades+Heartware+Intl+(HTWR)+to+Neutral/7897203.html
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11-20-12: FDA Approves The HVAD for BTT in U.S.!!!!!!!
=> http://investorshub.advfn.com/boards/read_msg.aspx?message_id=81695789
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Heartware International, Inc. (HTWR), Framingham, Mass. http://www.heartware.com
Yahoo Quote & Profile for HTWR: http://finance.yahoo.com/q?s=HTWR
"HeartWare is developing the world's smallest implantable pumps for the treatment of advanced heart failure."
M A J O R…N E W S . . . . M A J O R…N E W S . . . . M A J O R…N E W S . . . .
2-13-09: Thoratec to buy Heartware for $282mm* (112% prem.) - deal to close during 2H'09.
50% CASH ($14.30/sh.) + 50% THOR STOCK (.6054-THOR/sh.) = ~$30.19/sh.* a/o 2-12-09.
…*Stock calcs based on THOR at $26.25. Curr. THOR-QUOTE: http://finance.yahoo.com/q?s=THOR
THOR 2-12-09 PR: http://tinyurl.com/awue9d . . . HTWR 2-16-09 PR: http://tinyurl.com/d5vrck
Reuters 2-13-09: http://tinyurl.com/chwxhu . . . Thoratec's website: http://www.thoratec.com
==> 7-29-09 FTC REJECTS THOR-HTWR Merger!! = = > http://tinyurl.com/lsk475
==> 8-1-09 Form 8-K: THOR-HTWR JOINT TERM. of Proposed Merger == http://tinyurl.com/l5t38r
==> 8-11-09: Private Placement to Raise $55mm (2.5mm sh. @ $22) ==> http://tinyurl.com/lnathp
===> 12-24-09: HeartWare Files S-3 for $100mm Mixed Shelf ==> http://tinyurl.com/y9vm39v
====> 2-3-10: Heartware Nets ~$59mm via Public Offering @ $35.50/sh. ==> http://tinyurl.com/yd4r8g4
=====> *THOR offered $282mm; a/o 6-28-12, HTWR's MktCap was $1.22billion ($86.49 x 14.14mm shares)
ABOUT HEARTWARE INTERNATIONAL (from PR, 4-12-10):
"HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices (VAD's), to treat Class IV patients suffering from advanced heart failure. The HeartWare Ventricular Assist System features the HVAD pump, a small full-output circulatory support device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. HeartWare has received CE Marking for the HeartWare System in the European Union. The device is currently the subject of a U.S. clinical trial for a bridge-to-transplant indication with enrollment completed in February 2010."
11-25-10 VIDEO: Nice description of how the Heartware HVAD pump works: http://www.youtube.com/watch?v=v8aIeoHXTMw (2:46)
4-15-11 VIDEO: "Heartware - Leading a Small Revolution" http://www.youtube.com/watch?v=Etas42f8PPE (2:31)
12-1-13: HTWR acquires Circulite’s SYNERGY Circulatory Support System, designed to treat less sick, ambulatory, chronic heart failure patients who are not yet inotrope-dependent. http://tinyurl.com/kr3vwop
CEO Doug Godshall:
HVAD™ System - a "3rd generation" Heart Pump:
• The smallest 3rd gen. Left Ventricular Assist Device
• The only centrifugal pump designed to be implanted in the chest, directly adjacent to the heart
• Only 1 moving part (Hybrid magnetic/hydrodynamic suspension)
• Designed to produce up to 10 liters of flow
• Designed for long-term reliability & optimal blood compatibility
HVAD Animated Demo: http://www.heartware.com.au/IRM/content/usa/hvad_broadband.html
MVAD™ System - a "Next Generation" Heart Pump:
The MVAD Left Ventricular Assist Device is a development-stage axial flow VAD, approx. 1/3 the size of the HVAD.
Like the HVAD pump, the MVAD pump is designed to support the heart's full cardiac output.
From the 4-28-2012 S-4: "The MVAD is a miniaturized blood pump intended for chronic heart failure patients. The device is a full-output axial flow pump with a fully suspended rotor and a displacement volume approximately one-third that of the HVAD Pump. The pre-clinical Good Laboratory Practices (GLP) in-vivo studies completed in Sept. 2011 have shown the MVAD to have similar comparable blood flow characteristics to the HVAD Pump. The MVAD is designed for pericardial implantation and initial human clinical trials are expected to commence in summer 2012. We believe it is likely that more patients will be willing to undergo a shorter, less invasive surgical procedure that may result in quicker recoveries and hospital discharge. We have taken advantage of the versatility of the MVAD design with multiple configurations specific to less invasive implantation procedures. This development has been supported by over 100 in-vivo studies. These devices may expand the potential pool of chronic heart failure patients."
There are actually 3 MVAD Versions being considered.
The MVAD utilizes an axial flow design rather than the HVAD's rotary impeller, but it retains the hydrodynamic thrust bearings and other attributes of the wide-blade impeller.
Heartware has conducted multiple preclinical studies of its 3 MVAD designs and has settled on which design will proceed into development for first-in-man implants:
3 MVAD designs all proving effective in preclinical studies…
• "Trans-Apical" MVAD - left thoracotomy or sternotomy, 1/3 size of HVAD
• "VCAN" aka "Trans-Mitral" MVAD - right thoracotomy, 1 incision for implant & anastomosis
• "LONGHORN" - subcostal incision, NO anastomosis, up to 8L/min, "30Mins Skin to Skin", avg. M.D. reaction: WOW
1-9-2012: HTWR & Dualis MedTech partner on TETS: to dev. Fully Implantable VAD System, with "with wireless, transcutaneous energy transfer system (TETS) technology exclusively for HeartWare". http://tinyurl.com/72maba6
...Doug Godshall 1-9-12/JPM: "We're delighted & most fortunate to have found such an incredible technical powerhouse to collaborate with, and we envision a long & fruitful partnership with the team in Seefeld, Germany."
Heartware's website: http://www.heartware.com
• About Us: http://tinyurl.com/cazwsw
• Products & Technology: http://tinyurl.com/b3mauo
• Clinical Trials: http://tinyurl.com/aqo2hl
• About Heart Failure: http://tinyurl.com/awzfh8
• Media Center: http://tinyurl.com/cmn9cm
• Investor Center: http://tinyurl.com/aru9db
• Press Releases: http://tinyurl.com/c35sb7
• Videos & Webcasts: http://tinyurl.com/cspt6x
• Corp. Presentations: http://tinyurl.com/bg86sv
• Qtly HTWR Shareholder Updates from CEO Doug Godshall: http://tinyurl.com/c9vxqm
. . . 1-11-10: http://tinyurl.com/yewj4p7 . . .7-31-09: http://tinyurl.com/n8sdlo
• Signup for email alerts: http://tinyurl.com/dm4py3
7-2004 article on Heartware's genesis: http://tinyurl.com/8jc78z
2008 Redomiciliation AUS->USA: http://tinyurl.com/7xk6on & http://tinyurl.com/9owp3j
4-18-08 2007 Annual Report & 94-pg Glossy PDF Slideshow: http://tinyurl.com/bbo45d
7-30-09 Annual SHM - 27-pg Glossy PDF Slideshow: http://tinyurl.com/lx9zbq
2-24-11 2010 Annual Fin. Report (Form 10-K): http://tinyurl.com/4twjq5y
2-27-12 2011 Annual Fin. Report (Form 10-K): http://tinyurl.com/7nao9oy
Excellent site lists All Heartware-related Scientific Papers: http://pubget.com/search?q=heartware
U.S. INVESTOR RELATIONS: Allen & Caron, Inc. (New York) http://www.allencaron.com
…Matt Clawson: 949-474-4300, matt@allencaron.com
• Allen & Caron's main Heartware: http://tinyurl.com/nosca9
• HTWR Corp. Backgrounder: http://tinyurl.com/mh4qne
• HTWR News Releases: http://tinyurl.com/3eaw4k7
• HTWR Media Coverage: http://tinyurl.com/lxofqk
• HTWR SEC Filings: http://tinyurl.com/9g6qg7
Yahoo Quote: http://finance.yahoo.com/q?s=HTWR . . .Yahoo Profile: http://finance.yahoo.com/q/pr?s=HTWR
StreetInsider.com - All Analysts Ratings: http://tinyurl.com/yk2h9nh
AUX Exch. Quote of CDI's in AUS$ (1:35 of Nasdaq HTWR): http://finance.yahoo.com/q?s=HIN.AX
AUD => USD exch. rate: http://tinyurl.com/cgt22f
ALL SEC filings for HTWR: http://tinyurl.com/bqas3u . . . #Shares O/S as of 2-15-2012: 14,114,055
Insider-Trans: http://tinyurl.com/bcgv42
Inst. Holdings (Nasdaq.com, upd. 45-days after q/e): http://tinyurl.com/bk7b7k
Short Interest - rolling 12-mos., updated semi-monthly: http://tinyurl.com/bunre3
IRASIA History of HTWR PR's (2005-curr.): http://tinyurl.com/dd2kza
HVAD INTL. (EUR+AUS) BTT TRIAL DATA (N=50, IMPLANTS 3/2006-12/2008): http://tinyurl.com/ycadwtb
. . . 90% overall survival at 6 mos., 84% 2-year survival, shortest CBP time: 21 mins.
In Jan.2009, HeartWare received CE Marking for the HVAD in the Eur.Union, and in 2011 the TGA granted approval for the device in Australia.
5-23-12 HTWR receives CE-Mark Addendum for "Destination Therapy" indication in EUROPE: http://tinyurl.com/73ch762
HVAD U.S. BRIDGE-TO-TRANSPLANT TRIAL "ADVANCE" (140 PATIENTS at 30 CENTERS):
OVERALL P.I.: Dr. Mark Slaughter, MD, Director of the Div. of Thoracic & Cardiovascular Surgery at Jewish Hospital and the Univ. of Louisville, which is one of the leading transplant centers in the U.S. He is a world-renowned expert in heart transplantation, ventricular assist devices and the surgical mgt. of heart failure. As one of the leaders in the field of ventricular assist devices, he has given 65+ invited lectures, published 50+ peer-reviewed papers and book chapters and presented 85+ papers & abstracts at national & intl. conferences.
Dr. Slaughter: "My peers and I are constantly seeking better solutions for our heart failure patients and we have been looking forward to HeartWare's HVAD for some time, We feel that the HVAD's unique technology presents a meaningful step forward in the treatment of this challenging disease."
CO-P.I.: Dr. Keith Aaronson, MD, Medical Director of the Heart Transplant Program and Co-Director of the Heart Failure and Transplant Mgt. Program at the Univ. of Michigan Medical Center. A renowned heart failure cardiologist, Dr. Aaronson is a member of the editorial board of the American College of Cardiology Cardiosource Review Journal and a reviewer for the leading American and European journals of medicine and cardiology and for the annual sessions of the American College of Cardiology, the American Heart Association, the Intl. Society for Heart & Lung Transplantation and the Heart Failure Society of America. Dr. Aaronson has authored over 50 peer reviewed pubs. & 9 book chapters. He has held leadership positions in a number of clinical trials, has authored over 100 abstracts and has presented widely at national and intl. conferences.
Dr. Aaronson: "I'm excited to be part of this effort to expand the treatment options for patients with advanced heart failure. The HVAD's small size and intrapericardial implant location have the potential to substantially improve patient comfort, while the centrifugal flow characteristics and simple device design may provide performance and durability advantages."
• 1ST U.S. HVAD IMPLANT 8-21-08: The P.I. at Washington Hosp. Center is Dr. Leslie Miller, one of the world's most renowned cardiologists and a recognized leader in the use of mechanical circulatory support systems. The surgery was performed by Dr. Steven Boyce, MD, Surgical Director, Heart Failure Program at WHC and one of the most progressive & highest volume cardiac surgeons in the USA…
Drs. Miller & Boyce: "We at Washington Hospital Center are pleased to have been the first to implant this exciting new device. The surgery was quick and without incident and the patient is recovering well. The novel configuration of the HeartWare device together with its small size allow the pump to be implanted in the pericardial space, potentially reducing the risks associated with more extensive surgery. The pump has one moving part, an impeller that utilizes a passive suspension system designed to minimize mechanical wear & friction while pumping. We look forward to WHC's continued use of the device through the course of this trial."
• 10th U.S. HVAD IMPLANT 2-10-09: The implants were performed by Dr. Edwin C McGee, Surgical director (Advanced Heart Failure Program), Northwestern Mem. Hosp., Chicago. Dr. McGee is a renowned cardiothoracic surgeon with special interest in heart failure, transplantation, mechanical assistance, coronary surgery, valve repair and aortic surgery.
Dr. McGee: "After our first implants of the HeartWare System, it's clear to us why this device is generating such enthusiasm among the clinical community. The small size of the pump allows for a relatively quick and straightforward implantation. The elimination of the abdominal pump pocket typically required to implant larger devices should translate into important clinical benefits."
2-25-10: Final (140th) patient implanted in BTT trial - CEO D.Godshall 5-3-10, "Our current priorities include the ongoing followup of patients in our U.S. BTT study... we expect the followup for the BTT study to conclude in August, and we remain on track to file a PMA with the FDA by year end."
4-7-10: FDA Approves "Continued Access Protocol" (CAP) for BTT Trial: addl. 54 patients @ 30 centers. http://tinyurl.com/32mu3db
9-3-10: FDA Approves 2nd CAP for BTT Trial: addl. 54 patients. http://tinyurl.com/356j7cq
11-14-10: U.S. "Advance" BTT Trial Data presented at AHA'10: 92% Success, 94% Survival at 6mos. http://tinyurl.com/35asu7q
1-24-11: FDA Approves 3rd CAP for BTT Trial: addl. 94 patients. http://tinyurl.com/3l4wknb
4-15-11: BTT/Advance(n=140) & CAP(n=110) data update at ISHLT'11: maintaining 94% Survival at 6mos. http://tinyurl.com/68s9una
. . .4-15-11 Webcast & Dr. Mark Slaughter's ISHLT SLIDES: http://tinyurl.com/68t7up9
10-2-11/EACTS/Lisbon: Dr. Mark Slaughter updates HVAD BTT/CAP data (n=241) http://tinyurl.com/43wk92h & http://tinyurl.com/3gelu2y
…"6mos-survival=93%; overall adverse event rates remain low; pump-exch. for thrombus now <.03/patient-year after Mar'11 adjustment in anticoagulation (325/Aspirin)."
2-14-12: Heartware announces HVAD U.S. FDA BTT PMA Approval PANEL will convene Apr. 25, 2012 http://tinyurl.com/766c4l4
3-16-12: FDA Approves 4th CAP for BTT Trial: addl. 54 patients. http://tinyurl.com/7bfw629
4-25-12: FDA Advisory Panel Approves HVAD by 9-2 Vote - see http://tinyurl.com/7oteooc & http://tinyurl.com/747h2p8
…Panel member Dr. Ralph Brindis (Oakland Kaiser MC): "I think this device is of incredible benefit to patients who are very ill."
5-23-12: Final "Advance" HVAD BTT Data Pub. in AHA Journal, "CIRCULATION" http://tinyurl.com/7a6o7t3
…D.Godshall: "As we showed at our FDA panel meeting last month, some of the more challenging adverse events we observed in this initial study cohort have improved measurably in our CAP cohort by refining post-operative management techniques and by introducing sintered inflow cannulas which appear to be contributing to decreased thromboembolic complications. We never stop seeking ways to improve outcomes for our patients and believe that continued analysis, as well as our ongoing commitment to enhancing the performance of our system, will lead to a further reduction in certain adverse events."
11-20-12: FDA Approves The HVAD for BTT in U.S.!!!!!!! http://tinyurl.com/axrcau4 & http://tinyurl.com/al3j3en & http://tinyurl.com/b6e3w5m
12-12-12: WISN/Milw's TV Report & must-see VIDEO on James Kropidlowski's new HVAD http://tinyurl.com/bemzlcr
…"the 1st patient in the country to receive the new, smaller HVAD device, made by the company HeartWare, since it was approved by the FDA."
HVAD U.S. DESTINATION THERAPY (DT) TRIAL "ENDURANCE" (450 PATIENTS, 50 CENTERS):
6-14-10 FDA IDE Approval: The U.S. DT trial is a randomized, controlled, unblinded, multi-center clinical trial to evaluate the use of the HeartWare HVAD as a DT in advanced heart failure patients. Patients will randomly receive either the HVAD, or, as part of a control group they will be implanted with any alternative LVAD approved by the FDA for destination therapy, in a 2:1 ratio. The primary endpoint of the trial is stroke-free survival at 2 years, defined as alive on the originally implanted device, transplanted or explanted due to patient recovery. Secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life.
PI's:
• Joseph G. Rogers, MD, Medical Director, Cardiac Transplant & MCS Pgm., Duke Univ. (Dr. Rogers replaced Dr. Mariell Jessup, who became Pres-Elect. of AHA in 6-2012)
• Francis Pagani, MD, PhD, Surgical Director of the Adult Heart Transplant Program and Dir.of the Center of Circulatory Support, Univ. of Michigan MC
CEO Doug Godahall, "We are fortunate to welcome to the ENDURANCE study two of the most respected, progressive and widely published heart failure physicians in the U.S., Dr. Jessup & Dr. Pagani."
…More about U.S. DT trial at HTWR's Website: http://tinyurl.com/33qvwj2
...2-24-11/Barclays/D.Godshall, "Projecting 300 DT implants by 12-31-11, and all 450 by 6-30-12." http://tinyurl.com/43yfv6u
...5-8-12: Enrollment complete in 450-pt. U.S. DT Trial: http://tinyurl.com/7yub53d
...6-17-13: FDA grants 240 addl. HVAD implants under a CAP in the Endurance DT trial: http://tinyurl.com/luowr64
1-2011: 'REVIVE-IT' HVAD Trial To Examine Earlier Heart Device Use http://tinyurl.com/3fstudb
...Protocol: http://clinicaltrials.gov/ct2/show/NCT01369407
…NIH/NHLBI & Heartware award $13.9mm to U-Mich & U-Pitt to coordinate 100-pt. study at ~10 sites - see VIDEO: http://tinyurl.com/3laudmu
...10-15-12: HTWR to W/D from REVIVE-IT HVAD Study, as predicted in recent talks by Doug Godshall… http://tinyurl.com/9gr3e5b
HVAD biVAD - ex-OUS Approval & U.S. Clinical Pathway (2012 Goals) - see http://tinyurl.com/79hcdgx
HEARTWARE'S COMPETITORS:
Thoratec's Heartmate II - http://www.thoratec.com . . . http://finance.yahoo.com/q?s=thor
XXXVentractor's VentrAssist - http://www.ventracor.com (VCR.AX) http://www.saveventracor.com => Company Liquidated 7-2009.
XXXWorld Heart's Levacor - http://www.worldheart.com . . . http://finance.yahoo.com/q?s=WHRT => Levecor term. 7-29-2011.
...3-20-12: HeartWare buys World Heart's Patent Portfolio for $8mm http://tinyurl.com/7bynf5c
Sunshine Heart's C-Pulse - http://www.sunshineheart.com . . . http://www.asx.com.au/asx/research/companyInfo.do?by=asxCode&asxCode=SHC
Jarvik Heart's Jarvik 2000 - http://www.jarvikheart.com . . .private company.
Abiomed's AB5000 Ventricle - http://www.abiomed.com . . . http://finance.yahoo.com/q?s=ABMD
Terumo Heart's DuraHeart II LVAS - http://www.terumoheart.com (acq. by Thoratec 6-2013)
MicroMed's HeartAssist5 ( 92grams, CEmark since 4-2001) - http://www.micromedcv.com/us . . .private company
SynCardia's 'Temporary Total Artificial Heart' - http://www.syncardia.com . . .private company
Other Companies with heart pumps at varying stages of clinical trials: Duraheart, Incor.
8-2011 Animation Videos of HVAD Operation: http://youtu.be/19DSt4q6T68 & http://youtu.be/w8xCYS0KEH0
. . .compare to similar video of Thoratec Heartmate II: http://youtu.be/ev_01gQVWAM
. . . ."HMII, weighing only 400 grams…" (Heartware's HVAD weighs 140 grams)
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