Healthcare Industry News: Atrial Septal Defect
News Release - May 16, 2006
Clinical Trial Data from NMT Medical's BEST Trial Presented at EuroPCRPositive Data Presented from Company's BioSTAR(TM) Bioabsorbable Septal Repair Implant Trial
PARIS, May 16 (HSMN NewsFeed) -- NMT Medical, Inc. (NASDAQ: NMTI ), 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, announced today that the preliminary clinical results from its BEST (BioSTAR(TM) Evaluation STudy) trial were presented at the Late Breaking Clinical Trials session at EuroPCR in Paris. EuroPCR is the largest interventional cardiology meeting in Europe.
The multi-center BEST trial is designed to evaluate NMT's new bioabsorbable septal closure technology in subjects with patent foramen ovale (PFO) or Atrial Septal Defect (ASD). The trial is being led by Michael Mullen, MD, Interventional Cardiologist at Royal Brompton Hospital, London.
Dr. Mullen reported on the six-month follow-up period of 57 patients enrolled in the study. At 30 days post implant with BioSTAR(TM), complete closure rate was achieved in 88.5% of the study subjects. At six months, the complete closure rate increased to 96.4%. No major safety issues were observed. The average procedure time to close the septal defect with BioSTAR(TM) was approximately 40 minutes.
BioSTAR(TM) is NMT's first implant in a series of new, advanced septal closure technologies designed to provide a bioabsorbable option for patients with heart defects like PFO. BioSTAR(TM) incorporates a collagen matrix on the proven STARFlex® alloy framework. Over time, 90% - 95% of the implant is absorbed and replaced with the patient's native tissue providing a more natural, biological closure. The BioSTAR(TM) collagen also is a platform for adding biological response modifiers (genes, cells, proteins and drugs). The BioSTAR(TM) implant used in the BEST trial provided an elutable heparin substrate designed to minimize the thrombus formation that occasionally occurs in all intra-cardiac devices.
Dr. Mullen said, "BEST is a well-designed, multi-center study. Echo evaluations: baseline, implant, 30 days and six months were reviewed by an echo core lab. The preliminary results from BEST demonstrate that BioSTAR(TM) is a safe and effective septal repair implant that provides a more rapid and complete closure of PFO and small ASDs. BioSTAR(TM) shows consistent edge to edge sealing of the septal wall with a low profile. Since 90% to 95% of the implant is absorbed and replaced with native tissue, BioSTAR(TM) offers clear advantages to patients such as future trans-septal access to the left atrium."
"We are pleased with the positive results reported today on our BioSTAR(TM) technology," said John E. Ahern, NMT's President and Chief Executive Officer. "As planned, we will now use the BEST clinical trial results to file for CE Mark approval, which we currently expect to receive within the next several months. We continue to believe that, if approved, BioSTAR(TM) will give us a strong competitive advantage over current PFO closure implants. These results announced today are further proof that NMT is the leader in PFO closure and that we maintain a strong and expanding technology pipeline."
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 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, the receipt of CE Mark approval 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, Quarterly Report on Form 10-Q for the quarter ended March 31, 2006 and subsequent filings with the U.S. Securities and Exchange Commission.
Source: NMT Medical
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