Counting my change
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Neoprobe Announces Successful Meeting on Lymphoseek Phase 3 Results
Submission Plan for New Drug Application for Lymphoseek Reviewed With FDA
Conference Call Scheduled for 8:30 a.m. Tomorrow, Friday, March 12, 2010
businesswire
Press Release Source: Neoprobe Corporation On Thursday March 11, 2010, 4:05 pm
DUBLIN, OHIO--(BUSINESS WIRE)--Neoprobe Corporation (OTCBB: NEOP - News), a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that it recently met with the United States Food and Drug Administration (FDA) to review the clinical trial results of a Phase 3 investigational new drug, Lymphoseek®. The Phase 3 clinical study (NEO3-05) was conducted in subjects diagnosed with either breast cancer or melanoma. The FDA review included the efficacy and safety results of the NEO3-05 study and Neoprobe’s plans for the submission of a New Drug Application (NDA) for Lymphoseek. The NDA submission will be based on the clinical results of NEO3-05 and other already completed clinical evaluations of Lymphoseek. FDA encouraged Neoprobe to request a series of pre-NDA meetings in the coming months to review the components of the NDA prior to its formal submission. Neoprobe indicated to FDA that the Company plans to submit the NDA following satisfactory completion of these meetings.
“We are very pleased with our recent discussions with the FDA review team regarding the NEO3-05 Phase 3 clinical results,” said David Bupp, Neoprobe’s President and CEO. “The results from this meeting have clearly confirmed our pathway for the submission of a NDA approximating our previously disclosed target timeline. The potential clearance of the NDA in 2011 would position Lymphoseek to be the first radiopharmaceutical for the preoperative or intraoperative identification of lymphatic tissue. Neoprobe will be working with FDA in the coming months to prepare for a successful review of the Lymphoseek NDA, and to determine additional information that could be provided on a post-marketing basis to extend or expand the labeling from that planned for the initial NDA.”
“The performance of Lymphoseek in the Phase 3 study was excellent,” said Dr. Fred Cope, Neoprobe’s Vice President, Pharmaceutical Research and Clinical Development. “The primary and secondary efficacy endpoints of the study were met and no significant adverse events were reported that were directly attributed to Lymphoseek. The results of the Phase 3 trial have been favorably received by the members of the medical and scientific community. We plan to continue ongoing clinical evaluations of Lymphoseek that will be supportive of the NDA and subsequent amended claims for the product.”
The NEO3-05 Phase 3 study was an open label trial of node-negative subjects with either breast cancer or melanoma. It was designed to evaluate the safety and the accuracy of Lymphoseek while identifying the lymph nodes draining from the subject’s tumor site. To demonstrate the accuracy of Lymphoseek, each subject consenting to participate in the study was injected in proximity to the tumor with Lymphoseek and one of the vital blue dyes that are commonly used in lymphatic mapping procedures. The primary efficacy objective of the study was to identify lymph nodes that contained the vital blue dye and to demonstrate a statistically acceptable concordance rate between the identification of lymph nodes with the vital blue dye and Lymphoseek. To be successful, the study needed to achieve a statistical p-value of at least 0.05.
In this review meeting with FDA, the full analysis of the NEO3-5 clinical data was discussed. The protocol compliant clinical sites that participated in the NEO3-05 study contributed 136 Intent-To-Treat (ITT) subjects who provided 215 lymph nodes that contained the vital blue dye. 210 of the vital blue dye positive lymph nodes contained Lymphoseek for an overall concordance rate of 98% achieving a statistical p-value of 0.0001. In addition to the nodes identified by vital blue dye and Lymphoseek, Lymphoseek was able to identify 85 additional lymph nodes that did not contain the vital blue dye, and 18% of these nodes were found by pathology to contain cancer. There were no significant safety events related to Lymphoseek. The FDA indicated that the clinical data would be supportive of a NDA submission for Lymphoseek.
In future pre-NDA meetings, Neoprobe will continue discussions with the FDA reviewers regarding the pre-clinical and chemistry, manufacturing and control quality data modules that will be part of the NDA submission. Neoprobe will be discussing elements of the statistical analysis plan that would support the NDA, including the design of any prospective clinical evaluations to support the primary indication, and to potentially expand the future indications for Lymphoseek.
Neoprobe’s President and CEO, David Bupp, Vice President, Pharmaceutical Research and Clinical Development, Frederick Cope, Ph.D. and Vice President, Regulatory Affairs and Quality Assurance, Rodger Brown, will discuss the NEO3-05 results and FDA meeting results during a conference call scheduled for 8:30 AM EST, Friday, March 12, 2010.
The conference call can be accessed as follows:
Conference Call Information
TO PARTICIPATE LIVE: TO LISTEN TO A REPLAY:
Date: Mar. 12, 2010 Available until: Mar. 19, 2010
Time: 8:30 AM ET Toll-free (U.S.) Dial in # : (877) 660-6853
International Dial in # : (201) 612-7415
Toll-free (U.S.) Dial in # : (877) 407-8031
International Dial in # : (201) 689-8031 Replay passcode:
Account #: 286
Conference ID #: 346813
About Neoprobe
Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients. Neoprobe currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan™ CR. Neoprobe’s subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT.
Neoprobe’s strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic biomedical markets through continued investment and selective acquisitions. www.neoprobe.com
Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Neoprobe Corporation
Brent Larson, Vice President / CFO, 614-822-2330
OR
The Shoreham Group
Tim Ryan, 212-242-7777
I appreciate it. I have been invested in BIEL for a long time.I have constantly been doing DD and feel very strong that we have a real company with amazing potential.
BNVI News!
Bionovo, Inc. to Announce Fourth Quarter and Fiscal Year 2009 Financial Results on Monday, March 15, 2010
prnewswire
Companies:
o Bionovo, Inc.
Press Release Source: Bionovo, Inc. On Monday March 8, 2010, 4:00 pm
EMERYVILLE, Calif., March 8 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq:BNVI - News) announced today that it will release financial results for the fourth quarter and fiscal year 2009 ended December 31, 2009 on Monday, March 15, 2010. The Company will conduct a conference call and web cast to review the financial results on Monday, March 15, 2010 at 5:00 p.m. ET.
Interested parties can access the call by dialing (800) 860-2442 or (412) 858-4600, or can listen via a live Internet web cast, which can be found at http://bionovo.com/investors/events. A replay of the call will be available via web cast at http://bionovo.com/investors/events or by playback at (877) 344-7529 or (412) 317-0088, conference code 438591, through March 18, 2010.
About Bionovo, Inc.
Bionovo, Inc. is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical sources which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and is traded on the NASDAQ Capital Market under the symbol, "BNVI". For more information about Bionovo and its programs, visit: http://www.bionovo.com.
BNVI News!!
Bionovo, Inc. to Announce Fourth Quarter and Fiscal Year 2009 Financial Results on Monday, March 15, 2010
prnewswire
Companies:
o Bionovo, Inc.
Press Release Source: Bionovo, Inc. On Monday March 8, 2010, 4:00 pm
EMERYVILLE, Calif., March 8 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq:BNVI - News) announced today that it will release financial results for the fourth quarter and fiscal year 2009 ended December 31, 2009 on Monday, March 15, 2010. The Company will conduct a conference call and web cast to review the financial results on Monday, March 15, 2010 at 5:00 p.m. ET.
Interested parties can access the call by dialing (800) 860-2442 or (412) 858-4600, or can listen via a live Internet web cast, which can be found at http://bionovo.com/investors/events. A replay of the call will be available via web cast at http://bionovo.com/investors/events or by playback at (877) 344-7529 or (412) 317-0088, conference code 438591, through March 18, 2010.
About Bionovo, Inc.
Bionovo, Inc. is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical sources which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and is traded on the NASDAQ Capital Market under the symbol, "BNVI". For more information about Bionovo and its programs, visit: http://www.bionovo.com.
Genta Announces $25 Million Financing
Proceeds Enable Determination of Overall Survival Results from Recently Completed Phase 3 AGENDA Trial and Acceleration of Pipeline Development
businesswire
Companies:
o Genta Incorporated
Press Release Source: Genta Incorporated On Monday March 8, 2010, 8:05 am
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GETA - News) announced today that the Company has entered into definitive agreements with institutional investors for a private placement of Convertible Notes totaling $25 million in gross proceeds. The transaction is expected to close on or about March 10, 2010, subject to the satisfaction of customary closing conditions. Proceeds of the financing will be used to ensure adequate followup to determine overall survival results from Genta’s recently completed Phase 3 trial of Genasense® (oblimersen sodium) Injection plus chemotherapy as first-line treatment of patients with advanced melanoma (known as AGENDA) and to accelerate development of the Company’s pipeline products, among other uses.
“This financing provides sufficient funds for more than a year of our expanded operations”, said Dr. Raymond P. Warrell, Jr., Genta’s Chief Executive Officer. “Evaluation of a potentially significant increase in overall survival from AGENDA represents an especially high priority. We are also initiating new Phase 2a and 2b clinical trials with tesetaxel that will extend its position as the leading, development-stage, oral taxane. Assuming these new trials confirm earlier results, we envision that tesetaxel could enter Phase 3 pivotal trials in 2011. All of these potentially transforming events are now enabled with the completion of this transaction.”
Summary of Financial Terms
The $25 million of Convertible Notes issued pursuant to this transaction have a 3-year term and will be initially convertible into shares of Genta common stock at a conversion rate of 100,000 shares of common stock for every $1,000.00 of principal that is converted. This conversion rate is subject to adjustment under certain circumstances. The Convertible Notes bear an annual interest rate of 12%, payable semi-annually. The Company has the right to force conversion of the Convertible Notes if the closing price of the Company’s common stock equals or exceeds $0.25 for a 10-consecutive-trading-day period and certain other conditions are met. The Company has also issued Warrants to purchase up to $10 million of additional Convertible Notes. These Warrants expire in the fall of 2011.
Twenty (20) million dollars of proceeds from this transaction will be immediately available to the Company. The remaining $5 million of proceeds will be placed in a blocked account as collateral security for $5 million in principal amount of the Convertible Notes. The security interest in these proceeds will be released, and restrictions on the Company’s use of the proceeds terminated, if certain conditions are met.
In addition, outstanding purchase rights granted to investors in prior financings will be modified to provide that, upon exercise of such purchase rights, the investors will receive Convertible Notes similar to those issued in this transaction. The expiration of these purchase rights will also be shortened to expire in the Spring of 2011. The Company has also extended the maturity of its outstanding senior convertible notes, which otherwise have matured in June 2010, to June 2011. In return, holders of these notes were issued 3-year warrants to purchase the same number of shares of the Company’s common stock issuable upon the conversion of these notes. Additional terms of this transaction will be disclosed on a Form 8-K to be filed by the Company.
This press release is not an offer to sell or the solicitation of an offer to buy, nor shall there be any sales of the securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. The securities were offered only to accredited investors. The securities referenced herein have not been registered under the Securities Act of 1933, as amended, or any state securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company’s research platform: DNA/RNA-based Medicines and Small Molecules. Genasense® (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genasense® is being developed as an agent that may enhance the effectiveness of anticancer therapy. The Company is currently collecting long-term followup data on durable response and overall survival from the recently completed randomized Phase 3 study of Genasense® in patients with advanced melanoma (the AGENDA trial). The leading drug in Genta’s Small Molecule program is Ganite® (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. The Company has developed proprietary oral formulations of the active ingredient in Ganite®, which have completed preliminary clinical study as a potential treatment for diseases associated with accelerated bone loss. The Company is developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Genta intends to evaluate the clinical activity of tesetaxel in a range of human cancers. Ganite® and Genasense® are available on a “named-patient” basis in countries outside the United States. For more information about Genta, please visit our website at: www.genta.com.
Safe Harbor
This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words “potentially”, “anticipate”, “could”, “calls for”, and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:
* the Company’s ability to obtain necessary regulatory approval for its product candidates from regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency;
* the safety and efficacy of the Company’s products or product candidates;
* the commencement and completion of any clinical trials;
* the Company’s assessment of its clinical trials;
* the Company’s ability to develop, manufacture, license, or sell its products or product candidates;
* the Company’s ability to enter into and successfully execute any license and collaborative agreements;
* the adequacy of the Company’s capital resources and cash flow projections, or the Company’s ability to obtain sufficient financing to maintain the Company’s planned operations;
* the adequacy of the Company’s patents and proprietary rights;
* the impact of litigation that has been brought against the Company; and
* the other risks described under Certain Risks and Uncertainties Related to the Company’s Business, as contained in the Company’s Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2008 and its most recent quarterly report on Form 10-Q.
Contact:
Genta Investor Relations
908-286-3980
info@genta.com
Genta Announces $25 Million Financing
Proceeds Enable Determination of Overall Survival Results from Recently Completed Phase 3 AGENDA Trial and Acceleration of Pipeline Development
businesswire
Companies:
o Genta Incorporated
Press Release Source: Genta Incorporated On Monday March 8, 2010, 8:05 am
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GETA - News) announced today that the Company has entered into definitive agreements with institutional investors for a private placement of Convertible Notes totaling $25 million in gross proceeds. The transaction is expected to close on or about March 10, 2010, subject to the satisfaction of customary closing conditions. Proceeds of the financing will be used to ensure adequate followup to determine overall survival results from Genta’s recently completed Phase 3 trial of Genasense® (oblimersen sodium) Injection plus chemotherapy as first-line treatment of patients with advanced melanoma (known as AGENDA) and to accelerate development of the Company’s pipeline products, among other uses.
“This financing provides sufficient funds for more than a year of our expanded operations”, said Dr. Raymond P. Warrell, Jr., Genta’s Chief Executive Officer. “Evaluation of a potentially significant increase in overall survival from AGENDA represents an especially high priority. We are also initiating new Phase 2a and 2b clinical trials with tesetaxel that will extend its position as the leading, development-stage, oral taxane. Assuming these new trials confirm earlier results, we envision that tesetaxel could enter Phase 3 pivotal trials in 2011. All of these potentially transforming events are now enabled with the completion of this transaction.”
Summary of Financial Terms
The $25 million of Convertible Notes issued pursuant to this transaction have a 3-year term and will be initially convertible into shares of Genta common stock at a conversion rate of 100,000 shares of common stock for every $1,000.00 of principal that is converted. This conversion rate is subject to adjustment under certain circumstances. The Convertible Notes bear an annual interest rate of 12%, payable semi-annually. The Company has the right to force conversion of the Convertible Notes if the closing price of the Company’s common stock equals or exceeds $0.25 for a 10-consecutive-trading-day period and certain other conditions are met. The Company has also issued Warrants to purchase up to $10 million of additional Convertible Notes. These Warrants expire in the fall of 2011.
Twenty (20) million dollars of proceeds from this transaction will be immediately available to the Company. The remaining $5 million of proceeds will be placed in a blocked account as collateral security for $5 million in principal amount of the Convertible Notes. The security interest in these proceeds will be released, and restrictions on the Company’s use of the proceeds terminated, if certain conditions are met.
In addition, outstanding purchase rights granted to investors in prior financings will be modified to provide that, upon exercise of such purchase rights, the investors will receive Convertible Notes similar to those issued in this transaction. The expiration of these purchase rights will also be shortened to expire in the Spring of 2011. The Company has also extended the maturity of its outstanding senior convertible notes, which otherwise have matured in June 2010, to June 2011. In return, holders of these notes were issued 3-year warrants to purchase the same number of shares of the Company’s common stock issuable upon the conversion of these notes. Additional terms of this transaction will be disclosed on a Form 8-K to be filed by the Company.
This press release is not an offer to sell or the solicitation of an offer to buy, nor shall there be any sales of the securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. The securities were offered only to accredited investors. The securities referenced herein have not been registered under the Securities Act of 1933, as amended, or any state securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company’s research platform: DNA/RNA-based Medicines and Small Molecules. Genasense® (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genasense® is being developed as an agent that may enhance the effectiveness of anticancer therapy. The Company is currently collecting long-term followup data on durable response and overall survival from the recently completed randomized Phase 3 study of Genasense® in patients with advanced melanoma (the AGENDA trial). The leading drug in Genta’s Small Molecule program is Ganite® (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. The Company has developed proprietary oral formulations of the active ingredient in Ganite®, which have completed preliminary clinical study as a potential treatment for diseases associated with accelerated bone loss. The Company is developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Genta intends to evaluate the clinical activity of tesetaxel in a range of human cancers. Ganite® and Genasense® are available on a “named-patient” basis in countries outside the United States. For more information about Genta, please visit our website at: www.genta.com.
Safe Harbor
This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words “potentially”, “anticipate”, “could”, “calls for”, and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:
* the Company’s ability to obtain necessary regulatory approval for its product candidates from regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency;
* the safety and efficacy of the Company’s products or product candidates;
* the commencement and completion of any clinical trials;
* the Company’s assessment of its clinical trials;
* the Company’s ability to develop, manufacture, license, or sell its products or product candidates;
* the Company’s ability to enter into and successfully execute any license and collaborative agreements;
* the adequacy of the Company’s capital resources and cash flow projections, or the Company’s ability to obtain sufficient financing to maintain the Company’s planned operations;
* the adequacy of the Company’s patents and proprietary rights;
* the impact of litigation that has been brought against the Company; and
* the other risks described under Certain Risks and Uncertainties Related to the Company’s Business, as contained in the Company’s Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2008 and its most recent quarterly report on Form 10-Q.
Contact:
Genta Investor Relations
908-286-3980
info@genta.com
FDA Decision Expected Soon For ParaMax, Paradigm Medical (OTC:PDMI)
Written by Staff and Wire Reports Daily Profiles, Small and Micro Cap Mar 7, 2010
The FDA decision on Paradigm Medical Industries, Inc. (OTC: PDMI) lead device candidate ParaMax for Glaucoma early detection is expecting anytime soon.
Paradigm team has been very busy these last months, preparing the release of fantastic new devices, auditing in regards to the FDA visit of their facility, all the while continuing talks of securing a financial and marketing partner.
With the mistakes of the old management, things were a little slow in getting back on track. The new management has been in place for one year now, the progress and the reorganization is nearly completed. Paradigm is still in talk with different partners but now they are being very selective in selecting the right one that will benefit the company the most.
CEO said that things are coming along very well right now and they are back on track. The next level should be right in the corner with their new device ParaMax awaiting FDA approval and with a coming financial partner secured; this could be the real new start for Paradigm.
CEO said in a recent phone call interview that he is expecting to receive the FDA approval for their ParaMax any day now and it is going to revolutionize the glaucoma world.
Paradigm has many products to address the optometrist market but we will focus here on the 3 new products with the biggest potential.
Products:
Corneal topography — also known as videokeratography or corneal mapping — represents a significant advance in the measurement of the corneal curvature. Most corneal topographers evaluate 8,000 to 10,000 specific points across the entire corneal surface. By contrast, the Paravue processes more than 100,000 points. It also offers corneal wave front analysis with 2, 3 or 4 maps available for comparison.
1. Paravue 300 is a corneal topographer, (measures the curvature of cornea). The Paravue is a sophisticated topographer utilizing Placido Disk Technology and an advanced software to provide accurate and detailed analysis of the anterior corneal surface. It is FDA approved and is manufactured by CSO, (Italy). Paradigm will begin promoting it as soon as funding issues are resolved. It’s a very impressive piece of equipment!
1. Surveyor 500 is also a corneal topographer, but also included is a Scheimpflug rotating camera. This was first of its kind. The rotating camera was a big hit for Occulus with its Pentacam. It had no competitors and sold for over $55,000 USD. The Surveyor has same camera and includes one of finest topographers with it at approximately the same price to physicians! Release is same situation as Paravue 300.
According to the World Health Organization, approximately 60 million people suffer from glaucoma, making it one of the leading causes of blindness. It is estimated that the market is growing by approximately 10% per year, and it is expected to reach a value of $4 billion in 2010 (Decision News Media). Steve Davis, CEO of Paradigm believes that they have the product that will capture the bulk of that market with their FDA approved ParaMax device.
1. Paramax is also from CSO and is being sold as Retimax outside the US. Paradigm has exclusive arrangement to represent this early glaucoma detection device in the US! It is in review by the FDA. Latest information states that all paperwork has been submitted and work completed for submission. It’s now up to the FDA as to the release date. Paradigm is very anxious to add this piece to their product line and look forward to the opportunities it creates.
Glaucoma:
Everyone is at risk for glaucoma. According to the Glaucoma Research Foundation, approximately 1 out of every 10,000 babies in the U.S. is born with glaucoma. Certain groups also posses an increased risk, such as senior citizens. In fact, the Glaucoma Research Foundation found that people over the age of 60 are 6 times more likely to develop glaucoma than younger people. This group alone represents a very large number of people, especially as the baby boomer population is reaching these later ages.
Financial:
The CEO stated many times that we will not have to worry about the company doing a reverse split. Steve Davis is against this method.
November last year, shareholders have approved the increase in the authorized number of shares, although the Board of Directors has no immediate plans to issue a significant number of additional shares of common stock.
About Steve Davis, new CEO of Paradigm:
Mr. Davis brings over 25 years of experience in global healthcare and medical devices markets and over 14 of those in the ophthalmic arena to Paradigm Medical Industries, Inc. Stephen has also served as the President and CEO for Zinetics Medical, Inc. Salt Lake City, Utah for nine years. Stephen was successful in raising over $2.7 million for Zinetics Medical and spearheaded the purchase of Zinetics Medical by Medtronic for over $50 million. He served as Site Director for Medtronic Functional Diagnostics for a year after the conclusion of the sale of Zinetics Medical. Prior to those responsibilities, Stephen was the Western Area Director for Barnes-Hind Hydrocurve and held additional responsibilities as a Regional Vice-President and District Sales Manager. He possesses a stellar background in the areas of strategic planning, start-up ventures, P&L and has a successful record in developing business in preparation for acquisition. Mr. Davis also has an extensive knowledge of the International markets. Stephen has a B.S. from Brigham Young University and additional studies in International Business and Finance.
Conclusion:
These are the best times of the company; Paradigm could soon emerge from their past difficulties and gain investors attraction as soon as ParaMax is approved and a financial partner is secured. We have also been told that a new designed company website is coming very soon and that Paradigm will be more devoted to their shareholders by providing regular updates and information.
Clever investors would do their own due diligence and discover that it might be the good time to invest and take a long position on this company poised for a recovery.
Disclosure: No Positions
TheMarketFinancial is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies, unless otherwise stated.
Remember Robert and Paul have around 1.5 million dollars,in total, of their own money in the game and their shares are restricted,which gives me a little more confidence that they are working their tails off to make this product successful.Robert told me once, that he has rarely used his own money in a venture,but he did here.There are never guarantees,but I like this one. GLTA
me too!
According to my DD,both should happen this month.
Maybe IHub pulls PRS' from different sources,this one was from PR NEWS WIRE.
My etrade.com and yahoo
Production schedule should be the next thing we here about.This is the month I was told that should happen.
EVRN NEWS!!
Nature's Peak Products Along With Company President Paul Wilkinson Were Recently Featured on Segment of Lifetime TV Network's Nationally Broadcast Show 'The Balancing Act'
Nature's Peak CEO Paul Wilkinson appeared on a January 22nd, 2010 segment of the Lifetime TV Network show 'The Balancing Act' which focused on healthy eating.
prnewswire
Press Release Source: Everock, Inc. On Friday March 5, 2010, 11:29 am
SANTA CRUZ, Calif., March 5 /PRNewswire-FirstCall/ -- Everock, Inc. (Pink Sheets:EVRN.pk - News) announced today that the heightened public attention they've received for VeggieDip and VeggieSpread , as a result of being featured on a recent segment of the hit TV show "The Balancing Act", has generated outstanding new opportunities for the Company.
"Our phones have been ringing off the hook with consumers, retailers and distributors interested in our all natural sandwich spreads and vegetable dips," said Paul Wilkinson, CEO of Everock/Nature's Peak.
"This positive momentum and interest is what we were hoping for to help us push forward with our upcoming production and execute on our roll-out plans."
Wilkinson appeared on the January 22, 2010 edition of "The Balancing Act." On the segment, he and host Kristy Villa demonstrated how easy it is for you to replace mayonnaise with Nature's Peak as a healthier option and with tasty recipes ideas—without sacrificing any taste.
The segment airs again today March 5, 2010. A streaming video version of the show is available on both www.naturespeak.com and www.thebalancingact.com.
"The theme of the show allowed us to really drive home the point that Nature's Peak all natural sandwich spreads and vegetable dips are a delicious and healthy alternative to plain mayonnaise."
About Everock:
Everock produces a line of all-natural gourmet vegetable dips and sandwich spreads marketed under the Nature's Peak brand.
Both VeggieDip and VeggieSpread are 100% all-natural, vegetarian, Kosher and gluten-free, contain no preservatives, artificial ingredients, trans-fats, or sugars. There are six flavors in each product line, including novel delicious flavor combinations.
Nature's Peak products are marketed through its master broker to natural food stores, specialty groceries as well as regional and national grocery chains. Our products will also be available to restaurants, delis and other food service providers across America.
Visit our website at www.NaturesPeak.com to learn more about our products and to discover new and delicious recipe ideas.
Forward Looking Statements:
This press release contains certain "forward-looking" statements, as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. Statements, which are not historical facts, are forward-looking statements. The Company, through its management, makes forward-looking public statements concerning its expected future operations, performance and other developments. Such forward-looking statements are necessarily estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that other factors will not affect the accuracy of such forward-looking statements. It is impossible to identify all such factors, factors that could cause actual results to differ materially from those estimated by the Company. They include, but are not limited to, the Company's ability to develop operations, the Company's ability to consummate and complete an acquisition, the Company's access to future capital, the successful integration of acquired companies, government regulation, managing and maintaining growth, the effect of adverse publicity, litigation, competition, sales and other factors that may be identified from time to time in the Company's public announcements.
This press release is provided for information purposes only and is not intended to constitute an offer to sell or a solicitation of an offer to buy securities.
Biel moves to Pink Sheets Current Information
http://www.otcmarkets.com/pink/quote/quote.jsp?symbol=biel#getQuote
Great News- Biel moves to Pink Sheets Current information
http://www.otcmarkets.com/pink/quote/quote.jsp?symbol=biel#getQuote
Biel - PinkSheet submitted Letter
http://www.otcmarkets.com/otciq/ajax/showFinancialReportById.pdf?id=29674
BioElectronics – New Information Posted to Pinksheets.com
by Joe on March 4, 2010
A quick update on BIEL:
Notice on the www.pinksheets.com website that BIEL has posted a new attorney letter. This is a requirement to get upgraded to “Current Information.” Congrats to the management team for getting this done. Appears, the pinks people will be upgrading to its highest level very soon!!! Full reporting status with SEC likely around the corner. Will be exciting to see.
Andy Whelan will be conducting an interview answering shareholder questions. If you want to chime in to make your voice heard relative to what you want him to answer, post your question here on the blog and I will do my best to have it included. Should be an informative Q and A session.
Joe Noel
Biel News...
BioElectronics – New Information Posted to Pinksheets.com
by Joe on March 4, 2010
A quick update on BIEL:
Notice on the www.pinksheets.com website that BIEL has posted a new attorney letter. This is a requirement to get upgraded to “Current Information.” Congrats to the management team for getting this done. Appears, the pinks people will be upgrading to its highest level very soon!!! Full reporting status with SEC likely around the corner. Will be exciting to see.
Andy Whelan will be conducting an interview answering shareholder questions. If you want to chime in to make your voice heard relative to what you want him to answer, post your question here on the blog and I will do my best to have it included. Should be an informative Q and A session.
Joe Noel
New MCLN 10K Annual Report
Form 10-K for MEDCLEAN TECHNOLOGIES, INC.
3-Mar-2010
Annual Report
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.
Forward Looking Statements
The Company is including the following cautionary statement in this Annual Report on Form 10-K for any forward-looking statements made by, or on behalf of, the Company including its former wholly-owned subsidiary Aduromed Corporation. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance and underlying assumptions and other statements which are other than statements of historical facts. Certain statements contained herein are forward-looking statements and accordingly involve risks and uncertainties which could cause actual results or outcomes to differ materially from those expressed in the forward-looking statements. Our expectations, beliefs and projections are expressed in good faith and are believed by us to have a reasonable basis, including without limitation, management's examination of historical operating trends, data contained in our records and other data available from third parties, but there can be no assurance that management's expectation, beliefs or projections will result or be achieved or accomplished. In addition to other factors and matters discussed elsewhere herein, the following are important factors that, in our view, could cause actual results to differ materially from those discussed in the forward-looking statements: technological advances by our competitors, changes in health care reform, including reimbursement programs, changes to regulatory requirements relating to environmental approvals for the treatment of infectious medical waste, capital needs to fund any delays or extensions of development programs, delays in the manufacture of new and existing products by us or third party contractors, market acceptance of our products, the loss of any key employees, delays in obtaining federal, state or local regulatory clearance for new installations and operations, changes in governmental regulations, availability of capital on terms satisfactory to us and continuing good relations with MedAssets . We are also subject to numerous Risk Factors relating to manufacturing, regulatory, financial resources and personnel as described in this Annual Report. We disclaim any obligation to update any forward-looking statements to reflect events or circumstances after the date hereof.
Results of Operations
Year Ended December 31, 2009 Compared to the Year Ended December 31, 2008
Net Revenue
Total revenue for 2009 was $2,547,006 compared with $2,098,067 for 2008. Of the revenue increase of $448,939 or 21.4%, $507,935 was attributable to an increase of revenues derived from sales of our MedClean system, which was partially offset by a $58,996 decrease for the sale of consumables, component parts and service contracts. Contract backlog as of December 31, 2009 was $657,673.
Revenues from our MedClean system for 2009 were $1,245,411 compared to $737,476 in 2008, an increase of $507,935. The increased revenue was attributable to new contracts in 2008 executed in 2009 and our ability to accelerate system installations into the second half of 2009 on existing contracts in backlog.
Revenues derived from the sale of consumables, component parts and service contracts decreased to $1,301,595 compared to $1,360,591 in the prior year. The revenue was attributable to orders for goods and services from a consistent install base of hospitals that have previously purchased our MedClean system.
Historically, orders for the MedClean system are contracted by purchase order and are billed in 3 increments. Typically, clients are invoiced on contract signing, delivery of components, and completion of installation and start-up.
Revenues derived from the sale of units may continue to fluctuate dramatically from period to period due to several factors including; the length of the sales cycle with any given customer, current and future market conditions with regard to financing programs available to customers, and our ability to focus and execute new acquisition options. The Company expects to add rental and per pound usage acquisition options to our currently available one-time purchase and leasing programs. These new programs will be focused on generating recurring revenue in an effort to add predictability to our future revenue generation.
Gross Profit
The gross profit for 2009 was $1,281,442 (50.3% of total revenue) compared with a gross profit in 2008 of $389,819 (18.6% of total revenue).
In 2009, we introduced a revised sale pricing structure for our products with higher gross profit margins as compared to prior years. As such, our gross profit margins increased from 18.6% to 50.3%, or a 170% increase. In addition, our total gross profit increased due to our increase in revenue from the comparable period, last year. By carefully managing the business we have been able to ensure that we are invoicing for all services performed and therefore, have been able to increase our total gross profit and revenue as compared to the prior year.
The components of costs of revenues for products include direct materials, depreciation, shipping and rigging costs and contract labor primarily used to install, repair and maintain our equipment.
Operating Expenses
Total operating expenses for 2009 was $6,637,130 compared with $5,076,944 for 2008, an increase of $1,560,186 or 30.7%.
In 2009, we incurred a $3,264,179 non cash charge to operations for the fair value of vesting options and warrants as compared to $1,938,118 in 2008 and $619,389 in 2009 for stock based compensation as compared to $817,250 in 2008; a net increase of $1,128,200 with other operating costs increasing by $431,986.
In the second half of 2009, we reduced our operating expenses significantly as compared to the first half of 2009 through cost cutting measures. Please note our discussion under Net Loss below.
Interest (Income) Expense
Interest and other income for 2009 was $1,047 compared with $49,585 of interest and other income in 2008 on reduced cash balances available for investment. The Company invests its excess cash in a money market account. In 2008, the Company recognized a one-time gain of $32,775.
Interest expense and amortization for 2009 was $13,024 compared with $3,192,459 in 2008. Interest expense in 2008 was associated with the bridge loan and other interest bearing notes of $106,250. Reduced borrowings accounted for the interest in 2009. Additionally, in 2008 we recognized non-cash amortization expense for warrants issued amounting to $3,086,209 issued as a result of the MRA.
Net loss
Net loss for 2009 was $(5,368,515) compared to a net loss in 2008 of $(7,829,999).
For the 6th month period For the 6th month period
ending 06/30/2009 ending 12/31/2009 YTD
Total Revenues $ 772,183 $ 1,774,823 $ 2,547,006
Cost of Sales $ 507,657 $ 757,907 $ 1,265,564
Gross Profit $ 264,526 $ 1,016,916 $ 1,281,442
34 % 57 % 50 %
Total Operating Expense $ 4,810,621 $ 1,826,509 $ 6,637,130
Income (loss) from operations $ (4,546,095 ) $ (809,593 ) $ (5,355,688 )
Total Other income and expense $ 5,790 $ 7,038 $ 12,827
Net income (loss) $ (4,551,885 ) $ (816,631 ) $ (5,368,515 )
During 2009 the company took measures to reduce non-essential operating expenses through staff reduction and outsourcing certain business functions. The net effect of the expense reduction programs and business restructuring began to take effect in the second half of 2009. Results of operations for the second half of 2009, net of one-time severance fees ($200,151), stock based consulting fees not related to operations of ($619,389) and legal/professional fees not related to operations $(33,240) resulted in net income of $36,149, after consideration of one-time, non recurring costs.
Financial Condition
Liquidity and Capital Resources
The Company's cash on hand and working capital as of December 31, 2009 and 2008 are as follows:
2009 2008
Cash on hand $ 534,425 $ 1,922,401
Working capital (deficit) $ (229,469) $ 626,293
During 2009, the Company purchased $25,449 in fixed assets. The Company anticipates purchasing approximately $20,000 in additional fixed assets in 2010.
Net cash used in operating activities totaled $1,914,551 in 2009.
Our accounts receivable balance may have dramatic swings from one period to another depending upon the timing and the amount of milestone billings included in the balance at the end of any accounting period. There are three milestone billings representing a percentage of the contract value for each installment and our payment terms are ``upon receipt''. Receivable balances are typically paid within 15 days of the invoice date. Billings for maintenance contracts and consumables are due within 45 days and are more numerous but much smaller in value than milestone billings. We review our outstanding receivable balances on a regular basis to ensure that the allowance for bad debt is adequate. Due to the varying nature in the timing and amounts of the receivable balances as noted above, the change in the allowance for doubtful account will not necessarily correlate with the increase or decrease in the accounts receivable balance. The accounts receivable balance as of December 31, 2009 was $144,117 net of an allowance of $15,589. The $32,167 decrease in the accounts receivable balance reflects no outstanding milestone billings from contracts in backlog.
Our inventory balance may have dramatic swings from one period to another depending upon the expected installation date of our MedClean systems and our accounts payable balances can have similar swings depending on payment terms and any volume purchases or discounts we may take advantage of from time to time. During 2009, the Company decreased its inventory on hand by $70,717 to $815,634. The accounts payable and accrued liabilities balance as of December 31, 2009 was $253,742.
In November and December 2009, we received $597,480 in gross proceeds for the exercise of 95,676,105 warrants and options to purchase our common stock.
To supplement its cash resources, the Company has been pursuing a number of alternative financing arrangements with various investment entities. We are currently looking to secure additional working capital to provide the necessary funds for us to execute our business plan through various sources, including bank facilities, bridge loans and equity offerings. However, we continue to incur significant operating losses and the resultant reduction of our cash position. We cannot assure that we will be able to obtain additional funding, and the lack thereof would have a material adverse impact on our business.
Critical Accounting Policies
The preparation of financial statements in conformity with U.S. generally accepted accounting principles ("GAAP") requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities. A summary of the critical accounting policies and the judgments that we make in the application of those policies is presented in Note 1 to our consolidated financial statements.
Our consolidated financial statements are based on the selection of accounting policies and the application of accounting estimates, some of which require management to make significant assumptions. Actual results could differ materially from the estimated amounts. The following accounting policy is critical to understanding and evaluating our reported financial results:
Accounting for Stock-Based Compensation
We account for our stock options and warrants using the fair value method promulgated by Accounting Standards Codification subtopic 480-10, Distinguishing Liabilities from Equity ("ASC 480-10") which addresses the accounting for transactions in which an entity exchanges its equity instruments for goods or services. Therefore, our results include non-cash compensation expense as a result of the issuance of stock options and warrants and we expect to record additional non-cash compensation expense in the future.
Revenue recognition
Prior to 2009 we recognized revenues from fixed-price and modified fixed-price construction type contracts on the percentage-of-completion method measured by the percentage of cost incurred to date to estimated total cost for each contract. That method was used because the contracts were long term in nature and management considered total cost to be the best available measure of progress on the contracts. Beginning in 2009, we changed its product mix to short term contracts subject to customer acceptance upon completion. Therefore, we recognize revenues upon completion of the system installation. Clients will be invoiced upon the following milestones, contract signing, delivery of components, and the completion and acceptance of installation and start-up.
Contract costs include all direct material and labor costs and those indirect costs related to contract performance. Selling, general and administrative costs are charged to expense as incurred. Provisions for estimated losses on uncompleted contracts are made in the period in which such losses are determined. Changes in job performance, job conditions, and estimated profitability may result in revisions to costs and income, which are recognized in the period in which the revisions are determined. Changes in estimated job profitability resulting from job performance, job conditions, contract penalty provisions, claims, change orders, and settlements, are accounted for as changes in estimates in the current period.
Revenues from direct sales of our mobile unit will be recognized as we ship units. We provide a one year warranty on the systems installs. We also obtain a one year warranty on the system components from the component manufacturer, thereby mitigating potential warranty costs. Accordingly, we have accrued no reserve for warranty. On the installed base after the warranty term has expired, the Company offers a maintenance agreement of one or more years to the customer. The Customer is billed for, and pays for the maintenance agreement in advance. Revenues from such maintenance agreements are recognized ratably over the lives of the maintenance agreements, with the excess of the amount collected over the amount recognized as deferred revenue. At December 31, 2009 and 2008 we had $236,500 and $136,691 in deferred revenue from maintenance agreements.
Revenues from the sale of accessories, repairs and replacement parts are recognized when shipped to the customer in accordance with a valid contract or order agreement. The contract or order agreement specifies delivery terms and pricing, and is considered to reasonably assure collection from the customer.
Revenues and cost from multi-year rental contracts on our mobile unit will be recognized ratably over the life of the rental contract.
Recent accounting pronouncements
In October 2009, the FASB issued ASU 2009-13, Multiple-Deliverable Revenue Arrangements, (amendments to FASB ASC Topic 605, Revenue Recognition) ("ASU 2009-13") and ASU 2009-14, Certain Arrangements That Include Software Elements, (amendments to FASB ASC Topic 985, Software) ("ASU 2009-14"). ASU 2009-13 requires entities to allocate revenue in an arrangement using estimated selling prices of the delivered goods and services based on a selling price hierarchy. The amendments eliminate the residual method of revenue allocation and require revenue to be allocated using the relative selling price method. ASU 2009-14 removes tangible products from the scope of software revenue guidance and provides guidance on determining whether software deliverables in an arrangement that includes a tangible product are covered by the scope of the software revenue guidance. ASU 2009-13 and ASU 2009-14 should be applied on a prospective basis for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010, with early adoption permitted. The Company does not expect adoption of ASU 2009-13 or ASU 2009-14 to have a material impact on the Company's consolidated results of operations or financial condition.
In January 2010, the FASB issued Accounting Standards Update 2010-02, Consolidation (Topic 810): Accounting and Reporting for Decreases in Ownership of a Subsidiary. This amendment to Topic 810clarifies, but does not change, the scope of current US GAAP. It clarifies the decrease in ownership provisions of Subtopic 810-10 and removes the potential conflict between guidance in that Subtopic and asset derecognition and gain or loss recognition guidance that may exist in other US GAAP. An entity will be required to follow the amended guidance beginning in the period that it first adopts FAS 160 (now included in Subtopic 810-10). For those entities that have already adopted FAS 160, the amendments are effective at the beginning of the first interim or annual reporting period ending on or after December 15, 2009. The amendments should be applied retrospectively to the first period that an entity adopted FAS 160. Adoption of ASU 2010-02 did not have a material impact on the Company's consolidated results of operations or financial condition.
In January 2010, the FASB issued Accounting Standards Update 2010-01, Equity (Topic 505): Accounting for Distributions to Shareholders with Components of Stock and Cash (A Consensus of the FASB Emerging Issues Task Force). This amendment to Topic 505 clarifies the stock portion of a distribution to shareholders that allows them to elect to receive cash or stock with a limit on the amount of cash that will be distributed is not a stock dividend for purposes of applying Topics 505 and 260. Effective for interim and annual periods ending on or after December 15, 2009, and would be applied on a retrospective basis. Adoption of ASU 2010-01 did not have a material impact on the Company's consolidated results of operations or financial condition.
Effective July 1, 2009, the Company adopted FASB ASU No. 2009-05, Fair Value Measurements and Disclosures (Topic 820) ("ASU 2009-05"). ASU 2009-05 provided amendments to ASC 820-10, Fair Value Measurements and Disclosures - Overall, for the fair value measurement of liabilities. ASU 2009-05 provides clarification that in circumstances in which a quoted price in an active market for the identical liability is not available, a reporting entity is required to measure fair value using certain techniques. ASU 2009-05 also clarifies that when estimating the fair value of a liability, a reporting entity is not required to include a separate input or adjustment to other inputs relating to the existence of a restriction that prevents the transfer of a liability. ASU 2009-05 also clarifies that both a quoted price in an active market for the identical liability at the measurement date and the quoted price for the identical liability when traded as an asset in an active market when no adjustments to the quoted price of the asset are required are Level 1 fair value measurements. Adoption of ASU 2009-05 did not have a material impact on the Company's consolidated results of operations or financial condition.
In September 2009, the FASB issued Accounting Standards Update 2009-12, Fair Value Measurements and Disclosures (Topic 820): Investments in Certain Entities That Calculate Net Asset Value per Share (or Its Equivalent). This update provides amendments to Topic 820 for the fair value measurement of investments in certain entities that calculate net asset value per share (or its equivalent). It is effective for interim and annual periods ending after December 15, 2009. Early application is permitted in financial statements for earlier interim and annual periods that have not been issued. Adoption of ASU 2010-12 did not have a material impact on the Company's consolidated results of operations or financial condition.
Inflation
Our opinion is that inflation has not had, and is not expected to have, a material effect on our operation.
Climate Change
Our opinion is that neither climate change, nor governmental regulations related to climate change, have had, or are expected to have, any material effect on our operations.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk.
Not Applicable.
New MCLN 10K Annual Report!!
Form 10-K for MEDCLEAN TECHNOLOGIES, INC.
3-Mar-2010
Annual Report
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.
Forward Looking Statements
The Company is including the following cautionary statement in this Annual Report on Form 10-K for any forward-looking statements made by, or on behalf of, the Company including its former wholly-owned subsidiary Aduromed Corporation. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance and underlying assumptions and other statements which are other than statements of historical facts. Certain statements contained herein are forward-looking statements and accordingly involve risks and uncertainties which could cause actual results or outcomes to differ materially from those expressed in the forward-looking statements. Our expectations, beliefs and projections are expressed in good faith and are believed by us to have a reasonable basis, including without limitation, management's examination of historical operating trends, data contained in our records and other data available from third parties, but there can be no assurance that management's expectation, beliefs or projections will result or be achieved or accomplished. In addition to other factors and matters discussed elsewhere herein, the following are important factors that, in our view, could cause actual results to differ materially from those discussed in the forward-looking statements: technological advances by our competitors, changes in health care reform, including reimbursement programs, changes to regulatory requirements relating to environmental approvals for the treatment of infectious medical waste, capital needs to fund any delays or extensions of development programs, delays in the manufacture of new and existing products by us or third party contractors, market acceptance of our products, the loss of any key employees, delays in obtaining federal, state or local regulatory clearance for new installations and operations, changes in governmental regulations, availability of capital on terms satisfactory to us and continuing good relations with MedAssets . We are also subject to numerous Risk Factors relating to manufacturing, regulatory, financial resources and personnel as described in this Annual Report. We disclaim any obligation to update any forward-looking statements to reflect events or circumstances after the date hereof.
Results of Operations
Year Ended December 31, 2009 Compared to the Year Ended December 31, 2008
Net Revenue
Total revenue for 2009 was $2,547,006 compared with $2,098,067 for 2008. Of the revenue increase of $448,939 or 21.4%, $507,935 was attributable to an increase of revenues derived from sales of our MedClean system, which was partially offset by a $58,996 decrease for the sale of consumables, component parts and service contracts. Contract backlog as of December 31, 2009 was $657,673.
Revenues from our MedClean system for 2009 were $1,245,411 compared to $737,476 in 2008, an increase of $507,935. The increased revenue was attributable to new contracts in 2008 executed in 2009 and our ability to accelerate system installations into the second half of 2009 on existing contracts in backlog.
Revenues derived from the sale of consumables, component parts and service contracts decreased to $1,301,595 compared to $1,360,591 in the prior year. The revenue was attributable to orders for goods and services from a consistent install base of hospitals that have previously purchased our MedClean system.
Historically, orders for the MedClean system are contracted by purchase order and are billed in 3 increments. Typically, clients are invoiced on contract signing, delivery of components, and completion of installation and start-up.
Revenues derived from the sale of units may continue to fluctuate dramatically from period to period due to several factors including; the length of the sales cycle with any given customer, current and future market conditions with regard to financing programs available to customers, and our ability to focus and execute new acquisition options. The Company expects to add rental and per pound usage acquisition options to our currently available one-time purchase and leasing programs. These new programs will be focused on generating recurring revenue in an effort to add predictability to our future revenue generation.
Gross Profit
The gross profit for 2009 was $1,281,442 (50.3% of total revenue) compared with a gross profit in 2008 of $389,819 (18.6% of total revenue).
In 2009, we introduced a revised sale pricing structure for our products with higher gross profit margins as compared to prior years. As such, our gross profit margins increased from 18.6% to 50.3%, or a 170% increase. In addition, our total gross profit increased due to our increase in revenue from the comparable period, last year. By carefully managing the business we have been able to ensure that we are invoicing for all services performed and therefore, have been able to increase our total gross profit and revenue as compared to the prior year.
The components of costs of revenues for products include direct materials, depreciation, shipping and rigging costs and contract labor primarily used to install, repair and maintain our equipment.
Operating Expenses
Total operating expenses for 2009 was $6,637,130 compared with $5,076,944 for 2008, an increase of $1,560,186 or 30.7%.
In 2009, we incurred a $3,264,179 non cash charge to operations for the fair value of vesting options and warrants as compared to $1,938,118 in 2008 and $619,389 in 2009 for stock based compensation as compared to $817,250 in 2008; a net increase of $1,128,200 with other operating costs increasing by $431,986.
In the second half of 2009, we reduced our operating expenses significantly as compared to the first half of 2009 through cost cutting measures. Please note our discussion under Net Loss below.
Interest (Income) Expense
Interest and other income for 2009 was $1,047 compared with $49,585 of interest and other income in 2008 on reduced cash balances available for investment. The Company invests its excess cash in a money market account. In 2008, the Company recognized a one-time gain of $32,775.
Interest expense and amortization for 2009 was $13,024 compared with $3,192,459 in 2008. Interest expense in 2008 was associated with the bridge loan and other interest bearing notes of $106,250. Reduced borrowings accounted for the interest in 2009. Additionally, in 2008 we recognized non-cash amortization expense for warrants issued amounting to $3,086,209 issued as a result of the MRA.
Net loss
Net loss for 2009 was $(5,368,515) compared to a net loss in 2008 of $(7,829,999).
For the 6th month period For the 6th month period
ending 06/30/2009 ending 12/31/2009 YTD
Total Revenues $ 772,183 $ 1,774,823 $ 2,547,006
Cost of Sales $ 507,657 $ 757,907 $ 1,265,564
Gross Profit $ 264,526 $ 1,016,916 $ 1,281,442
34 % 57 % 50 %
Total Operating Expense $ 4,810,621 $ 1,826,509 $ 6,637,130
Income (loss) from operations $ (4,546,095 ) $ (809,593 ) $ (5,355,688 )
Total Other income and expense $ 5,790 $ 7,038 $ 12,827
Net income (loss) $ (4,551,885 ) $ (816,631 ) $ (5,368,515 )
During 2009 the company took measures to reduce non-essential operating expenses through staff reduction and outsourcing certain business functions. The net effect of the expense reduction programs and business restructuring began to take effect in the second half of 2009. Results of operations for the second half of 2009, net of one-time severance fees ($200,151), stock based consulting fees not related to operations of ($619,389) and legal/professional fees not related to operations $(33,240) resulted in net income of $36,149, after consideration of one-time, non recurring costs.
Financial Condition
Liquidity and Capital Resources
The Company's cash on hand and working capital as of December 31, 2009 and 2008 are as follows:
2009 2008
Cash on hand $ 534,425 $ 1,922,401
Working capital (deficit) $ (229,469) $ 626,293
During 2009, the Company purchased $25,449 in fixed assets. The Company anticipates purchasing approximately $20,000 in additional fixed assets in 2010.
Net cash used in operating activities totaled $1,914,551 in 2009.
Our accounts receivable balance may have dramatic swings from one period to another depending upon the timing and the amount of milestone billings included in the balance at the end of any accounting period. There are three milestone billings representing a percentage of the contract value for each installment and our payment terms are ``upon receipt''. Receivable balances are typically paid within 15 days of the invoice date. Billings for maintenance contracts and consumables are due within 45 days and are more numerous but much smaller in value than milestone billings. We review our outstanding receivable balances on a regular basis to ensure that the allowance for bad debt is adequate. Due to the varying nature in the timing and amounts of the receivable balances as noted above, the change in the allowance for doubtful account will not necessarily correlate with the increase or decrease in the accounts receivable balance. The accounts receivable balance as of December 31, 2009 was $144,117 net of an allowance of $15,589. The $32,167 decrease in the accounts receivable balance reflects no outstanding milestone billings from contracts in backlog.
Our inventory balance may have dramatic swings from one period to another depending upon the expected installation date of our MedClean systems and our accounts payable balances can have similar swings depending on payment terms and any volume purchases or discounts we may take advantage of from time to time. During 2009, the Company decreased its inventory on hand by $70,717 to $815,634. The accounts payable and accrued liabilities balance as of December 31, 2009 was $253,742.
In November and December 2009, we received $597,480 in gross proceeds for the exercise of 95,676,105 warrants and options to purchase our common stock.
To supplement its cash resources, the Company has been pursuing a number of alternative financing arrangements with various investment entities. We are currently looking to secure additional working capital to provide the necessary funds for us to execute our business plan through various sources, including bank facilities, bridge loans and equity offerings. However, we continue to incur significant operating losses and the resultant reduction of our cash position. We cannot assure that we will be able to obtain additional funding, and the lack thereof would have a material adverse impact on our business.
Critical Accounting Policies
The preparation of financial statements in conformity with U.S. generally accepted accounting principles ("GAAP") requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities. A summary of the critical accounting policies and the judgments that we make in the application of those policies is presented in Note 1 to our consolidated financial statements.
Our consolidated financial statements are based on the selection of accounting policies and the application of accounting estimates, some of which require management to make significant assumptions. Actual results could differ materially from the estimated amounts. The following accounting policy is critical to understanding and evaluating our reported financial results:
Accounting for Stock-Based Compensation
We account for our stock options and warrants using the fair value method promulgated by Accounting Standards Codification subtopic 480-10, Distinguishing Liabilities from Equity ("ASC 480-10") which addresses the accounting for transactions in which an entity exchanges its equity instruments for goods or services. Therefore, our results include non-cash compensation expense as a result of the issuance of stock options and warrants and we expect to record additional non-cash compensation expense in the future.
Revenue recognition
Prior to 2009 we recognized revenues from fixed-price and modified fixed-price construction type contracts on the percentage-of-completion method measured by the percentage of cost incurred to date to estimated total cost for each contract. That method was used because the contracts were long term in nature and management considered total cost to be the best available measure of progress on the contracts. Beginning in 2009, we changed its product mix to short term contracts subject to customer acceptance upon completion. Therefore, we recognize revenues upon completion of the system installation. Clients will be invoiced upon the following milestones, contract signing, delivery of components, and the completion and acceptance of installation and start-up.
Contract costs include all direct material and labor costs and those indirect costs related to contract performance. Selling, general and administrative costs are charged to expense as incurred. Provisions for estimated losses on uncompleted contracts are made in the period in which such losses are determined. Changes in job performance, job conditions, and estimated profitability may result in revisions to costs and income, which are recognized in the period in which the revisions are determined. Changes in estimated job profitability resulting from job performance, job conditions, contract penalty provisions, claims, change orders, and settlements, are accounted for as changes in estimates in the current period.
Revenues from direct sales of our mobile unit will be recognized as we ship units. We provide a one year warranty on the systems installs. We also obtain a one year warranty on the system components from the component manufacturer, thereby mitigating potential warranty costs. Accordingly, we have accrued no reserve for warranty. On the installed base after the warranty term has expired, the Company offers a maintenance agreement of one or more years to the customer. The Customer is billed for, and pays for the maintenance agreement in advance. Revenues from such maintenance agreements are recognized ratably over the lives of the maintenance agreements, with the excess of the amount collected over the amount recognized as deferred revenue. At December 31, 2009 and 2008 we had $236,500 and $136,691 in deferred revenue from maintenance agreements.
Revenues from the sale of accessories, repairs and replacement parts are recognized when shipped to the customer in accordance with a valid contract or order agreement. The contract or order agreement specifies delivery terms and pricing, and is considered to reasonably assure collection from the customer.
Revenues and cost from multi-year rental contracts on our mobile unit will be recognized ratably over the life of the rental contract.
Recent accounting pronouncements
In October 2009, the FASB issued ASU 2009-13, Multiple-Deliverable Revenue Arrangements, (amendments to FASB ASC Topic 605, Revenue Recognition) ("ASU 2009-13") and ASU 2009-14, Certain Arrangements That Include Software Elements, (amendments to FASB ASC Topic 985, Software) ("ASU 2009-14"). ASU 2009-13 requires entities to allocate revenue in an arrangement using estimated selling prices of the delivered goods and services based on a selling price hierarchy. The amendments eliminate the residual method of revenue allocation and require revenue to be allocated using the relative selling price method. ASU 2009-14 removes tangible products from the scope of software revenue guidance and provides guidance on determining whether software deliverables in an arrangement that includes a tangible product are covered by the scope of the software revenue guidance. ASU 2009-13 and ASU 2009-14 should be applied on a prospective basis for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010, with early adoption permitted. The Company does not expect adoption of ASU 2009-13 or ASU 2009-14 to have a material impact on the Company's consolidated results of operations or financial condition.
In January 2010, the FASB issued Accounting Standards Update 2010-02, Consolidation (Topic 810): Accounting and Reporting for Decreases in Ownership of a Subsidiary. This amendment to Topic 810clarifies, but does not change, the scope of current US GAAP. It clarifies the decrease in ownership provisions of Subtopic 810-10 and removes the potential conflict between guidance in that Subtopic and asset derecognition and gain or loss recognition guidance that may exist in other US GAAP. An entity will be required to follow the amended guidance beginning in the period that it first adopts FAS 160 (now included in Subtopic 810-10). For those entities that have already adopted FAS 160, the amendments are effective at the beginning of the first interim or annual reporting period ending on or after December 15, 2009. The amendments should be applied retrospectively to the first period that an entity adopted FAS 160. Adoption of ASU 2010-02 did not have a material impact on the Company's consolidated results of operations or financial condition.
In January 2010, the FASB issued Accounting Standards Update 2010-01, Equity (Topic 505): Accounting for Distributions to Shareholders with Components of Stock and Cash (A Consensus of the FASB Emerging Issues Task Force). This amendment to Topic 505 clarifies the stock portion of a distribution to shareholders that allows them to elect to receive cash or stock with a limit on the amount of cash that will be distributed is not a stock dividend for purposes of applying Topics 505 and 260. Effective for interim and annual periods ending on or after December 15, 2009, and would be applied on a retrospective basis. Adoption of ASU 2010-01 did not have a material impact on the Company's consolidated results of operations or financial condition.
Effective July 1, 2009, the Company adopted FASB ASU No. 2009-05, Fair Value Measurements and Disclosures (Topic 820) ("ASU 2009-05"). ASU 2009-05 provided amendments to ASC 820-10, Fair Value Measurements and Disclosures - Overall, for the fair value measurement of liabilities. ASU 2009-05 provides clarification that in circumstances in which a quoted price in an active market for the identical liability is not available, a reporting entity is required to measure fair value using certain techniques. ASU 2009-05 also clarifies that when estimating the fair value of a liability, a reporting entity is not required to include a separate input or adjustment to other inputs relating to the existence of a restriction that prevents the transfer of a liability. ASU 2009-05 also clarifies that both a quoted price in an active market for the identical liability at the measurement date and the quoted price for the identical liability when traded as an asset in an active market when no adjustments to the quoted price of the asset are required are Level 1 fair value measurements. Adoption of ASU 2009-05 did not have a material impact on the Company's consolidated results of operations or financial condition.
In September 2009, the FASB issued Accounting Standards Update 2009-12, Fair Value Measurements and Disclosures (Topic 820): Investments in Certain Entities That Calculate Net Asset Value per Share (or Its Equivalent). This update provides amendments to Topic 820 for the fair value measurement of investments in certain entities that calculate net asset value per share (or its equivalent). It is effective for interim and annual periods ending after December 15, 2009. Early application is permitted in financial statements for earlier interim and annual periods that have not been issued. Adoption of ASU 2010-12 did not have a material impact on the Company's consolidated results of operations or financial condition.
Inflation
Our opinion is that inflation has not had, and is not expected to have, a material effect on our operation.
Climate Change
Our opinion is that neither climate change, nor governmental regulations related to climate change, have had, or are expected to have, any material effect on our operations.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk.
Not Applicable.
GNVC NEWS!!
New Research Reveals Mechanism By Which TNFerade(TM) Suppresses Metastases
prnewswire
Press Release Source: GenVec, Inc. On Wednesday March 3, 2010, 8:23 am
GAITHERSBURG, Md., March 3 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq:GNVC - News) announced the publication of new preclinical research revealing mechanisms by which TNFerade(TM) suppresses cancer metastases through activation of the immune system.
This preclinical study, "Ad.Egr-TNF and Local Ionizing Radiation Suppress Metastases by Interferon-Beta-Dependent Activation of Antigen-specific CD8+ T Cells," authored by investigators from the University of Chicago and Harvard Medical School, appears in the recent issue of Molecular Therapy. The results illustrate that local treatment of an animal tumor with TNFerade suppresses metastases to lymph nodes by activating CD8+ T cells. Activation of these anti-tumor cells is mediated by Interferon-Beta, a known potent immune regulator.
"Although enhanced local control of cancer can contribute to improvements in patient survival, any suppression of metastases is an important aspect of cancer treatment. These exciting preclinical data may help explain the encouraging results being seen with TNFerade in the clinic," noted Mark Thornton, M.D., M.P.H., Ph.D., GenVec's Senior Vice President of Product Development.
About TNFerade(TM)
TNFerade is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNF-alpha), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNF-alpha in the tumor. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers.
About GenVec
GenVec, Inc. is a biopharmaceutical company developing novel therapeutic drugs and vaccines. GenVec's lead product, TNFerade(TM), is currently in a pivotal clinical study (PACT) in locally advanced pancreatic cancer. TNFerade has also been and is currently being evaluated for its potential use in the treatment of several other cancers, including esophageal cancer, rectal cancer, and head and neck cancer. In addition, GenVec uses its proprietary adenovector technology to develop vaccines for infectious diseases including influenza, HIV, malaria, foot-and-mouth disease, respiratory syncytial virus (RSV), and HSV-2. GenVec also discovers and develops novel treatments for hearing loss and balance disorders through a worldwide collaboration with Novartis. Additional information about GenVec is available at www.genvec.com and in the company's various filings with the Securities and Exchange Commission.
Investor Contact:
GenVec, Inc.
Danielle M. DiPirro
(301) 944-1877
ddipirro@genvec.com
Media Contact:
Tiberend Strategic Advisors, Inc.
Andrew Mielach
(212) 827-0020
amielach@tiberendstrategicadvisors.com
GNVC NEWS!!
New Research Reveals Mechanism By Which TNFerade(TM) Suppresses Metastases
prnewswire
Companies:
o GenVec Inc.
Press Release Source: GenVec, Inc. On Wednesday March 3, 2010, 8:23 am
GAITHERSBURG, Md., March 3 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq:GNVC - News) announced the publication of new preclinical research revealing mechanisms by which TNFerade(TM) suppresses cancer metastases through activation of the immune system.
This preclinical study, "Ad.Egr-TNF and Local Ionizing Radiation Suppress Metastases by Interferon-Beta-Dependent Activation of Antigen-specific CD8+ T Cells," authored by investigators from the University of Chicago and Harvard Medical School, appears in the recent issue of Molecular Therapy. The results illustrate that local treatment of an animal tumor with TNFerade suppresses metastases to lymph nodes by activating CD8+ T cells. Activation of these anti-tumor cells is mediated by Interferon-Beta, a known potent immune regulator.
"Although enhanced local control of cancer can contribute to improvements in patient survival, any suppression of metastases is an important aspect of cancer treatment. These exciting preclinical data may help explain the encouraging results being seen with TNFerade in the clinic," noted Mark Thornton, M.D., M.P.H., Ph.D., GenVec's Senior Vice President of Product Development.
About TNFerade(TM)
TNFerade is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNF-alpha), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNF-alpha in the tumor. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers.
About GenVec
GenVec, Inc. is a biopharmaceutical company developing novel therapeutic drugs and vaccines. GenVec's lead product, TNFerade(TM), is currently in a pivotal clinical study (PACT) in locally advanced pancreatic cancer. TNFerade has also been and is currently being evaluated for its potential use in the treatment of several other cancers, including esophageal cancer, rectal cancer, and head and neck cancer. In addition, GenVec uses its proprietary adenovector technology to develop vaccines for infectious diseases including influenza, HIV, malaria, foot-and-mouth disease, respiratory syncytial virus (RSV), and HSV-2. GenVec also discovers and develops novel treatments for hearing loss and balance disorders through a worldwide collaboration with Novartis. Additional information about GenVec is available at www.genvec.com and in the company's various filings with the Securities and Exchange Commission.
Investor Contact:
GenVec, Inc.
Danielle M. DiPirro
(301) 944-1877
ddipirro@genvec.com
Media Contact:
Tiberend Strategic Advisors, Inc.
Andrew Mielach
(212) 827-0020
amielach@tiberendstrategicadvisors.com
I am very bullish on APPA going in the PDUFA date of March 18th.
Also, a lot of institutional buying!
On my watch list
I agree
good job!
Will follow
Looking for an entry point
Vion has been a roller coaster
I agree CCCP will be a huge addition...Congrats!
FDA Sets March 22 for ODAC Meeting to Review CTI's New Drug Application for Pixantrone
prnewswire
Press Release Source: Cell Therapeutics, Inc. On Monday March 1, 2010, 12:00 pm
SEATTLE, March 1 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration's ("FDA") Oncologic Drugs Advisory Committee ("ODAC") will review CTI's New Drug Application ("NDA") for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL") on March 22, 2010. The meeting was to take place on February 10, 2010, but the FDA postponed the meeting because of severe weather conditions in the Washington, D.C. area. Following the vote at the rescheduled ODAC meeting, the FDA is expected to make a final decision on approval of CTI's NDA for pixantrone by April 23, 2010.
"Our team is well-prepared to deliver an evidenced-based presentation to the ODAC panel, which we expect will provide a persuasive argument to the clinicians on the panel for the approval of pixantrone," said James A. Bianco, M.D., CEO of CTI. "The ODAC meeting is an important milestone in the review process, and we look forward to discussing the efficacy and safety data for pixantrone with the members of the panel and the FDA review team." Dr. Owen O'Connor, Chief of Hematology Oncology at NYU Cancer Institute, and Dr. John Leonard, Chief of Lymphoma Myeloma at Weill Corner Cancer Center will be presenting on behalf of CTI.
ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. The FDA regulations indicate that although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the FDA.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.celltherapeutics.com.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of the securities of CTI. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective for the treatment of relapsed or refractory, aggressive NHL as determined by the FDA (including ODAC), that the FDA may postpone the ODAC meeting again, CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
F: 206.272.4434
E: deramian@ctiseattle.com
www.celltherapeutics.com/press_room
Investors Contact:
Ed Bell
T: 206.272.4345
Lindsey Jesch Logan
T: 206.272.4347
F: 206.272.4434
E: invest@ctiseattle.com
www.celltherapeutics.com/investors
NEPH NEWS!!
Nephros Signs Canadian Distribution Agreement with Bellco Health Care Inc.
prnewswire
Press Release Source: Nephros, Inc. On Thursday February 25, 2010, 1:27 pm
RIVER EDGE, N.J., Feb. 25 /PRNewswire-FirstCall/ -- Nephros, Inc. (OTC Bulletin Board:NEPH.ob - News), a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, today reported that is has signed an exclusive distribution agreement with Bellco Health Care Inc. ("BHC Medical") to sell and market Nephros' OLpur™ MD 220 filter for on-line HDF therapy in Canada.
Under the terms of the Agreement, Nephros and BHC Medical will work together to promote the sale and distribution of Nephros' OLpur™ MD 220 filters through various advertising and promotional campaigns and by working with and training BHC's sales and support staff.
"Bellco Medical is an ideal partner for the Canadian market," said Ernest Elgin, President and CEO of Nephros. "They are a leading provider of End-Stage Renal Disease treatment systems who embrace leading-edge dialysis technologies such as our OLpur™ MD 220 HDF therapy."
"We are excited for the opportunity to present the OLpur™ MD220 to the Canadian dialysis community, and we anticipate it being a crucial component of the therapy package that we promote to clinicians to conduct the most advanced dialysis modalities available today", said Denis Carrier, CEO of BHC Medical.
End-Stage Renal Disease (ESRD) Products
Nephros completed the patient treatment phase of the U.S. clinical trial evaluation of the OLpur™ H2H™ module and OLpur™ MD 220 filter during the second quarter of 2008. The Company submitted the clinical data to the U.S. Food and Drug Administration ("FDA") with the 510(k) application for U.S. marketing approval of these products in November 2008. Following its review of the application, the FDA requested additional information from us. Nephros replied to the FDA inquiries on March 13, 2009. We have made inquiries to the FDA about the status of our application and have been informed that our application is still under review. As of February 24, 2010, Nephros has not received a formal decision or a request for additional information from the FDA for this 510(k) application. Nephros believes that, if approved, its technology would be the first FDA-approved on-line HDF therapy available in the U.S.
About BHC Medical
Bellco Health Care Inc. (BHC Medical), located in Toronto, Ontario Canada, is a leading provider of Renal Care Products to the Canadian healthcare community. As a marketing and support partner to several international manufacturers, BHC Medical offers a complete array of advanced medical devices, consumables, water treatment technologies, disinfectants and pharmaceuticals. For more information about BHC Medical, please visit their website at http://www.bhcmedical.ca.
About Nephros, Inc.
Nephros, Inc., headquartered in River Edge, New Jersey, is a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification.
The Nephros hemodiafiltration ("HDF") system is designed to improve the quality of life for the End-Stage Renal Disease (ESRD) patient while addressing the critical financial and clinical needs of the care provider. ESRD is a disease state characterized by the irreversible loss of kidney function. The Nephros HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods, particularly with respect to substances known collectively as "middle molecules." These molecules have been found to contribute to such conditions as dialysis-related amyloidosis, carpal tunnel syndrome, degenerative bone disease and, ultimately, mortality in the ESRD patient. Nephros ESRD products are sold and distributed throughout Europe and are currently being used in over fifty clinics in Europe.
The Nephros Dual Stage Ultrafilter (DSU) is the basis for the Nephros line of water filtration products. The patented dual stage cold sterilization ultrafilter has the capability to filter out bacteria and, due to its exceptional filtration levels, filter out many viruses, parasites and biotoxins. Sale of the DSU has begun at several major U.S. medical centers for infection control. The DSU has also been selected for further development by the U.S. Marine Corps for purification of drinking water by soldiers in the field.
For more information about Nephros, please visit our website at http://www.nephros.com.
Forward-Looking Statements
Statements in this news release that are not historical facts constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Such statements may be preceded by words such as "may," "plans," "expects," "believes," "hopes," "potential" or similar words. For such statements, Nephros claims the protection of the PSLRA.
Forward-looking statements are not guarantees of future performance, are based on assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond Nephros' control. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include the risks that Nephros may not be able: (i) to obtain additional funding when needed or on favorable terms; (ii) to continue as a going concern; (iii) to obtain appropriate or necessary governmental approvals to achieve its business plan or effectively market its products; (iv) to have its technologies and products accepted in current or future target markets; (v) to demonstrate in pre-clinical or clinical trials the anticipated efficacy, safety or cost savings of products that appeared promising to Nephros in research or clinical trials; or (vi) to secure or enforce adequate legal protection, including patent protection, for its products. More detailed information about Nephros and the risk factors that may affect the realization of forward-looking statements is set forth in Nephros' filings with the SEC, including Nephros' Annual Report on Form 10-K for the fiscal year ended December 31, 2008. Investors and security holders are encouraged to read these documents on the SEC's website at http://www.sec.gov. Nephros does not undertake to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.
Nephros Signs Canadian Distribution Agreement with Bellco Health Care Inc.
prnewswire
Press Release Source: Nephros, Inc. On Thursday February 25, 2010, 1:27 pm
RIVER EDGE, N.J., Feb. 25 /PRNewswire-FirstCall/ -- Nephros, Inc. (OTC Bulletin Board:NEPH.ob - News), a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, today reported that is has signed an exclusive distribution agreement with Bellco Health Care Inc. ("BHC Medical") to sell and market Nephros' OLpur™ MD 220 filter for on-line HDF therapy in Canada.
Under the terms of the Agreement, Nephros and BHC Medical will work together to promote the sale and distribution of Nephros' OLpur™ MD 220 filters through various advertising and promotional campaigns and by working with and training BHC's sales and support staff.
"Bellco Medical is an ideal partner for the Canadian market," said Ernest Elgin, President and CEO of Nephros. "They are a leading provider of End-Stage Renal Disease treatment systems who embrace leading-edge dialysis technologies such as our OLpur™ MD 220 HDF therapy."
"We are excited for the opportunity to present the OLpur™ MD220 to the Canadian dialysis community, and we anticipate it being a crucial component of the therapy package that we promote to clinicians to conduct the most advanced dialysis modalities available today", said Denis Carrier, CEO of BHC Medical.
End-Stage Renal Disease (ESRD) Products
Nephros completed the patient treatment phase of the U.S. clinical trial evaluation of the OLpur™ H2H™ module and OLpur™ MD 220 filter during the second quarter of 2008. The Company submitted the clinical data to the U.S. Food and Drug Administration ("FDA") with the 510(k) application for U.S. marketing approval of these products in November 2008. Following its review of the application, the FDA requested additional information from us. Nephros replied to the FDA inquiries on March 13, 2009. We have made inquiries to the FDA about the status of our application and have been informed that our application is still under review. As of February 24, 2010, Nephros has not received a formal decision or a request for additional information from the FDA for this 510(k) application. Nephros believes that, if approved, its technology would be the first FDA-approved on-line HDF therapy available in the U.S.
About BHC Medical
Bellco Health Care Inc. (BHC Medical), located in Toronto, Ontario Canada, is a leading provider of Renal Care Products to the Canadian healthcare community. As a marketing and support partner to several international manufacturers, BHC Medical offers a complete array of advanced medical devices, consumables, water treatment technologies, disinfectants and pharmaceuticals. For more information about BHC Medical, please visit their website at http://www.bhcmedical.ca.
About Nephros, Inc.
Nephros, Inc., headquartered in River Edge, New Jersey, is a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification.
The Nephros hemodiafiltration ("HDF") system is designed to improve the quality of life for the End-Stage Renal Disease (ESRD) patient while addressing the critical financial and clinical needs of the care provider. ESRD is a disease state characterized by the irreversible loss of kidney function. The Nephros HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods, particularly with respect to substances known collectively as "middle molecules." These molecules have been found to contribute to such conditions as dialysis-related amyloidosis, carpal tunnel syndrome, degenerative bone disease and, ultimately, mortality in the ESRD patient. Nephros ESRD products are sold and distributed throughout Europe and are currently being used in over fifty clinics in Europe.
The Nephros Dual Stage Ultrafilter (DSU) is the basis for the Nephros line of water filtration products. The patented dual stage cold sterilization ultrafilter has the capability to filter out bacteria and, due to its exceptional filtration levels, filter out many viruses, parasites and biotoxins. Sale of the DSU has begun at several major U.S. medical centers for infection control. The DSU has also been selected for further development by the U.S. Marine Corps for purification of drinking water by soldiers in the field.
For more information about Nephros, please visit our website at http://www.nephros.com.
Forward-Looking Statements
Statements in this news release that are not historical facts constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Such statements may be preceded by words such as "may," "plans," "expects," "believes," "hopes," "potential" or similar words. For such statements, Nephros claims the protection of the PSLRA.
Forward-looking statements are not guarantees of future performance, are based on assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond Nephros' control. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include the risks that Nephros may not be able: (i) to obtain additional funding when needed or on favorable terms; (ii) to continue as a going concern; (iii) to obtain appropriate or necessary governmental approvals to achieve its business plan or effectively market its products; (iv) to have its technologies and products accepted in current or future target markets; (v) to demonstrate in pre-clinical or clinical trials the anticipated efficacy, safety or cost savings of products that appeared promising to Nephros in research or clinical trials; or (vi) to secure or enforce adequate legal protection, including patent protection, for its products. More detailed information about Nephros and the risk factors that may affect the realization of forward-looking statements is set forth in Nephros' filings with the SEC, including Nephros' Annual Report on Form 10-K for the fiscal year ended December 31, 2008. Investors and security holders are encouraged to read these documents on the SEC's website at http://www.sec.gov. Nephros does not undertake to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.
Genta Initiates Once-Weekly Treatment Schedule for Tesetaxel, a Novel Oral Tubulin Inhibitor,in New Dose-Ranging Study
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GETA) announced that the Company has initiated a new dose-ranging study of tesetaxel, the Company’s novel oral tubulin inhibitor, using a weekly dosing regimen. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.
“Since the activity of certain taxanes may be schedule-dependent, we plan to evaluate both dosing regimens to ensure we have maximized the potential efficacy and safety of tesetaxel in our late-stage clinical programs.”
Genta has recently completed a dose-ranging and pharmacokinetic study using tesetaxel administered once every 3 weeks, a schedule that has shown anticancer activity in several Phase 2 clinical trials. This schedule has been extensively evaluated in a series of Phase 1 and Phase 2 trials that together have enrolled more than 280 patients. Data from the recently completed study of the once-every-3-week schedule have confirmed safety findings previously reported for this regimen, and the results have been submitted for presentation to the annual meeting of the American Society of Clinical Oncology (ASCO) that is scheduled in June 2010. The new trial is the first clinical study to test an alternative dosing regimen in which the drug will be administered once weekly for 3 consecutive weeks, followed by 1 week off treatment. The goal of the study will be to establish safety and a suitable dose for extended testing in late-stage clinical trials.
“Weekly dosing schedules of other taxanes have been increasingly incorporated into so-called “dose dense” chemotherapy programs, particularly in breast cancer,” commented Dr. Loretta M. Itri, Genta’s President, Pharmaceutical Development, and Chief Medical Officer. “Since the activity of certain taxanes may be schedule-dependent, we plan to evaluate both dosing regimens to ensure we have maximized the potential efficacy and safety of tesetaxel in our late-stage clinical programs.”
About Tesetaxel
Tesetaxel is a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. However, both of these agents suffer from serious safety issues, particularly hypersensitivity reactions related to intravenous infusions that are occasionally fatal and that require careful premedication and observation. Other prominent side-effects of this drug class include myelosuppression (low blood counts) and peripheral neuropathy (disabling nerve damage).
With administration as an oral capsule, tesetaxel was developed with a goal of maintaining the high antitumor activity of the taxane drug class while eliminating infusion reactions, reducing neuropathy, and increasing patient convenience. The oral route also enables the development of novel schedules that may expand dosing options when tesetaxel is used alone or in combination with other anticancer drugs, including “all oral” chemotherapy programs. Preclinically, tesetaxel has demonstrated substantially higher activity against cell lines that were resistant to paclitaxel and docetaxel, since acquired resistance is not mediated by the multidrug-resistant p-glycoprotein.
As a late Phase 2 oncology product, tesetaxel has demonstrated anticancer activity in its initial clinical trials, and the drug has not been associated with the severe infusion reactions that are linked with other taxanes. Moreover, unlike other oral taxanes that have been developed, nerve damage has not been a prominent side effect of tesetaxel. Thus, the drug may offer substantial opportunities to improve patient convenience, safety, and anticancer activity. More than 280 patients worldwide have been treated with oral tesetaxel in Phase 1 and Phase 2 clinical trials.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company’s research platform: DNA/RNA-based Medicines and Small Molecules. Genasense® (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genasense® is being developed as an agent that may enhance the effectiveness of current anticancer therapy. The Company is currently collecting long-term followup data on durable response and overall survival from its recently completed randomized Phase 3 study of Genasense® in patients with advanced melanoma (the AGENDA trial). The leading drug in Genta’s Small Molecule program is Ganite® (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. The Company has developed proprietary oral formulations of the active ingredient in Ganite®, which have completed preliminary clinical study as a potential treatment for diseases associated with accelerated bone loss. The Company is developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Genta intends to evaluate the clinical activity of tesetaxel in a range of human cancers. Ganite® and Genasense® are available on a “named-patient” basis in countries outside the United States. For more information about Genta, please visit our website at: www.genta.com.
Safe Harbor
This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words “potentially”, “anticipate”, “could”, “calls for”, and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:
* the Company’s ability to obtain necessary regulatory approval for its product candidates from regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency;
* the safety and efficacy of the Company’s products or product candidates;
* the commencement and completion of any clinical trials;
* the Company’s assessment of its clinical trials;
* the Company’s ability to develop, manufacture, license, or sell its products or product candidates;
* the Company’s ability to enter into and successfully execute any license and collaborative agreements;
* the adequacy of the Company’s capital resources and cash flow projections, the Company’s ability to obtain sufficient financing to maintain the Company’s planned operations, or the Company’s risk of bankruptcy;
* the adequacy of the Company’s patents and proprietary rights;
* the impact of litigation that has been brought against the Company; and
* the other risks described under Certain Risks and Uncertainties Related to the Company’s Business, as contained in the Company’s Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2008 and its most recent quarterly report on Form 10-Q.
Contacts
Genta Investor Relations
908-286-3980
info@genta.com
Genta Initiates Once-Weekly Treatment Schedule for Tesetaxel a Novel Oral Tubulin Inhibitor, in New Dose-Ranging Study
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GETA) announced that the Company has initiated a new dose-ranging study of tesetaxel, the Company’s novel oral tubulin inhibitor, using a weekly dosing regimen. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.
“Since the activity of certain taxanes may be schedule-dependent, we plan to evaluate both dosing regimens to ensure we have maximized the potential efficacy and safety of tesetaxel in our late-stage clinical programs.”
Genta has recently completed a dose-ranging and pharmacokinetic study using tesetaxel administered once every 3 weeks, a schedule that has shown anticancer activity in several Phase 2 clinical trials. This schedule has been extensively evaluated in a series of Phase 1 and Phase 2 trials that together have enrolled more than 280 patients. Data from the recently completed study of the once-every-3-week schedule have confirmed safety findings previously reported for this regimen, and the results have been submitted for presentation to the annual meeting of the American Society of Clinical Oncology (ASCO) that is scheduled in June 2010. The new trial is the first clinical study to test an alternative dosing regimen in which the drug will be administered once weekly for 3 consecutive weeks, followed by 1 week off treatment. The goal of the study will be to establish safety and a suitable dose for extended testing in late-stage clinical trials.
“Weekly dosing schedules of other taxanes have been increasingly incorporated into so-called “dose dense” chemotherapy programs, particularly in breast cancer,” commented Dr. Loretta M. Itri, Genta’s President, Pharmaceutical Development, and Chief Medical Officer. “Since the activity of certain taxanes may be schedule-dependent, we plan to evaluate both dosing regimens to ensure we have maximized the potential efficacy and safety of tesetaxel in our late-stage clinical programs.”
About Tesetaxel
Tesetaxel is a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. However, both of these agents suffer from serious safety issues, particularly hypersensitivity reactions related to intravenous infusions that are occasionally fatal and that require careful premedication and observation. Other prominent side-effects of this drug class include myelosuppression (low blood counts) and peripheral neuropathy (disabling nerve damage).
With administration as an oral capsule, tesetaxel was developed with a goal of maintaining the high antitumor activity of the taxane drug class while eliminating infusion reactions, reducing neuropathy, and increasing patient convenience. The oral route also enables the development of novel schedules that may expand dosing options when tesetaxel is used alone or in combination with other anticancer drugs, including “all oral” chemotherapy programs. Preclinically, tesetaxel has demonstrated substantially higher activity against cell lines that were resistant to paclitaxel and docetaxel, since acquired resistance is not mediated by the multidrug-resistant p-glycoprotein.
As a late Phase 2 oncology product, tesetaxel has demonstrated anticancer activity in its initial clinical trials, and the drug has not been associated with the severe infusion reactions that are linked with other taxanes. Moreover, unlike other oral taxanes that have been developed, nerve damage has not been a prominent side effect of tesetaxel. Thus, the drug may offer substantial opportunities to improve patient convenience, safety, and anticancer activity. More than 280 patients worldwide have been treated with oral tesetaxel in Phase 1 and Phase 2 clinical trials.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company’s research platform: DNA/RNA-based Medicines and Small Molecules. Genasense® (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genasense® is being developed as an agent that may enhance the effectiveness of current anticancer therapy. The Company is currently collecting long-term followup data on durable response and overall survival from its recently completed randomized Phase 3 study of Genasense® in patients with advanced melanoma (the AGENDA trial). The leading drug in Genta’s Small Molecule program is Ganite® (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. The Company has developed proprietary oral formulations of the active ingredient in Ganite®, which have completed preliminary clinical study as a potential treatment for diseases associated with accelerated bone loss. The Company is developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Genta intends to evaluate the clinical activity of tesetaxel in a range of human cancers. Ganite® and Genasense® are available on a “named-patient” basis in countries outside the United States. For more information about Genta, please visit our website at: www.genta.com.
Safe Harbor
This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words “potentially”, “anticipate”, “could”, “calls for”, and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:
* the Company’s ability to obtain necessary regulatory approval for its product candidates from regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency;
* the safety and efficacy of the Company’s products or product candidates;
* the commencement and completion of any clinical trials;
* the Company’s assessment of its clinical trials;
* the Company’s ability to develop, manufacture, license, or sell its products or product candidates;
* the Company’s ability to enter into and successfully execute any license and collaborative agreements;
* the adequacy of the Company’s capital resources and cash flow projections, the Company’s ability to obtain sufficient financing to maintain the Company’s planned operations, or the Company’s risk of bankruptcy;
* the adequacy of the Company’s patents and proprietary rights;
* the impact of litigation that has been brought against the Company; and
* the other risks described under Certain Risks and Uncertainties Related to the Company’s Business, as contained in the Company’s Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2008 and its most recent quarterly report on Form 10-Q.
Contacts
Genta Investor Relations
908-286-3980
info@genta.com
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