Healthcare Industry News: Patent foramen ovale
News Release - October 24, 2006
NMT Medical's BioSTAR(R) Data Presented at 2006 TCT Scientific SymposiumBEST Trial Manuscript Published in American Heart Association's Journal Circulation
WASHINGTON, Oct. 24 (HSMN NewsFeed) -- NMT Medical, Inc. (Nasdaq: NMTI ), announced that detailed results from its BEST (BioSTAR® Evaluation STudy) trial were presented today at the Late-Breaking Clinical Trials and "First Report" Investigations session at the 2006 Transcatheter Cardiovascular Therapeutics (TCT) 18th Annual Scientific Symposium. In addition, the BioSTAR® clinical data manuscript received expedited review and was published online at the American Heart Association's website, http://www.circulationaha.org, and will be available in the October 2006 print edition of Circulation.
Michael Mullen, M.D., Interventional Cardiologist at Royal Brompton Hospital, London and lead investigator of the BEST trial, reported on the prospective, multi-center BEST trial, which evaluated NMT's bioabsorbable septal repair implant technology. Dr. Mullen said, "In this study, we have demonstrated the safety, feasibility and effectiveness of BioSTAR® for the closure of atrial septal defect (ASD) and Patent foramen ovale (PFO) in humans with a high rate of early and complete shunt closure. BioSTAR® is a novel septal repair implant designed to provide biological closure of atrial level defects using the patient's natural healing response. As 90 to 95 percent of the implant is absorbed and replaced with healthy native tissue, future access to the left atrium may be achieved, if necessary."
NMT previously announced it received conditional approval from the U.S. Food and Drug Administration (FDA) for inclusion of BioSTAR® in the Company's pivotal PFO/migraine trial, MIST II. The Company also currently expects to receive CE Mark approval to begin commercial sale of BioSTAR® in Europe by year end.
NMT's President and Chief Executive Officer John E. Ahern said, "BioSTAR® represents a new generation of biomaterials that NMT currently plans to offer to improve the treatment for structural heart disease. The positive results of the BEST trial demonstrate the utility of the new biomaterials to enhance septal closure outcomes. We believe BioSTAR® provides us with a strong competitive advantage and reinforces our technology leadership position in the structural heart repair field."
About NMT Medical, Inc.
NMT Medical is an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures. NMT Medical is currently investigating the potential connection between a common cardiac defect called a PFO and brain attacks such as migraine headaches, stroke and transient ischemic attacks (TIAs). A PFO can allow venous blood, unfiltered and unmanaged by the lungs, to enter the arterial circulation of the brain, possibly triggering a cerebral event or brain attack. More than 21,000 PFOs have been treated globally with NMT's minimally invasive, catheter-based implant technology. The prevalence of migraines in the United States is about 10%. Of the 28 million migraine sufferers in America, those who experience aura and have a PFO may represent a three million patient subset. Stroke is the third leading cause of death in the United States and the leading cause of disability in adults. Each year, 750,000 Americans suffer a new or recurrent stroke and an additional 500,000 Americans experience a TIA.
For more information about NMT Medical, please visit http://www.nmtmedical.com.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements - including statements regarding the BEST and MIST II trials, the Company's BioSTAR® program, regulatory approvals for the Company's products in the United States, Europe and elsewhere abroad, and the Company's investment in product development - involve known and unknown risks, uncertainties or other factors that may cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that may cause such a difference include, but are not limited to, the Company's ability to develop and commercialize new products, potential delays in the regulatory process with the U.S. Food and Drug Administration and foreign regulatory agencies, as well as risk factors discussed under the heading "Risk Factors" included in the Company's Annual Report on Form 10-K for the year ended December 31, 2005, Quarterly Report on Form 10-Q for the period ended June 30, 2006, and subsequent filings with the U.S. Securities and Exchange Commission.
Source: NMT Medical
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