BOSTON, May 3 /PRNewswire-FirstCall/ -- NMT Medical, Inc. announced today that results from its BEST (BioSTAR(TM) Evaluation STudy) trial are scheduled to be presented at the Late-Breaking Clinical Trials session at the EuroPCR meeting on Tuesday, May 16, 2006 at 10:45 a.m. (ET), in Paris, France. EuroPCR is the largest interventional cardiology meeting in Europe.
BEST is a multi-center study, which is evaluating the Company’s new bioabsorbable collagen matrix technology, designed to promote biological closure of structural heart defects such as PFO (patent foramen ovale). The BioSTAR(TM) implant is delivered through a minimally invasive, catheter-based procedure. Data from the clinical trial will be presented by Michael Mullen, M.D., Interventional Cardiologist at Royal Brompton Hospital, London and Chief Investigator for the BEST study in the United Kingdom.
Approximately 60 patients were enrolled in the BEST study and were followed for six months. The study was designed to gain European commercial approval for BioSTAR(TM) through the CE Mark process. Approval is currently expected by year-end 2006.
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 cardiac sources of migraine headaches, stroke and other potential brain attacks through minimally invasive, catheter-based procedures. NMT Medical is investigating the potential connection between a common cardiac defect called a PFO and brain attacks such as migraine headaches, stroke and 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 20,000 PFOs have been closed 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 500,000 Americans experience a TIA.
The Company also serves the pediatric interventional cardiologist with a broad range of cardiac septal repair implants delivered with nonsurgical catheter techniques. 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 scheduled presentation of BEST results at EuroPCR and expected European commercial approval -- 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, a potential delay 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 “Certain Factors That May Affect Future Results” included in Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Company’s Annual Report on Form 10-K for the year ended December 31, 2005, and subsequent filings with the U.S. Securities and Exchange Commission.
Contact: John E. Ahern President and Chief Executive Officer NMT Medical, Inc. (617) 737-0930 jea@nmtmedical.com
NMT Medical, Inc.
CONTACT: John E. Ahern, President and Chief Executive Officer of NMTMedical, Inc., +1-617-737-0930, jea@nmtmedical.com
Web site: http://www.nmtmedical.com/
