NMT Medical Receives Study Approval for New PFO Closure Technology

BOSTON, June 29 /PRNewswire-FirstCall/ -- NMT Medical, Inc. today announced that the Company has received approvals to initiate a multi- center clinical study in the United Kingdom designed to evaluate its new BioSTAR(TM) PFO (Patent Foramen Ovale) closure technology. The NMT sponsored study, named BEST (BioSTAR(TM) Evaluation Study), will be the first in-human use of a bioresorbable collagen matrix incorporated on the STARFlex(R) platform.

Commenting on the study, John E. Ahern, NMT's President and Chief Executive Officer, said, "The approval of the BEST study is another important milestone for NMT and for our clinical researchers seeking better ways to treat their PFO patients. The goal of this multi-center study is to secure European commercial approval for our novel BioSTAR(TM) technology through the CE Mark process."

Michael Mullen, MD, Interventional Cardiologist at Royal Brompton Hospital, London, and the Chief Investigator for BEST, said, "Based on extensive preclinical research results, we believe that BioSTAR(TM) potentially offers a more natural, rapid and complete sealing of atrial level heart defects such as PFO. Once delivered, BioSTAR(TM) creates a bioscaffold that promotes native tissue deposition. During that process, the collagen matrix dissolves, leaving behind natural tissue that completely covers the STARFlex(R) alloy framework."

BioSTAR(TM) preclinical research was conducted in Germany by Christian Jux, MD, at the University of Goettingen, and Peter Wohlsein, DVM, Institute of Pathology, School of Veterinary Medicine, Hannover. Additional research support was provided by scientists at Johns Hopkins School of Medicine (Baltimore, Md.).

Ahern concluded, "For the past few years, NMT has developed numerous research and technology collaborations that are now evolving into new, improved PFO closure therapies. One important outcome of that ongoing innovation process is BioSTAR(TM), which combines an advanced biomaterial and our well established STARFlex(R) delivery platform. BioSTAR(TM) has remarkable characteristics. The collagen matrix used in BioSTAR(TM) has the potential to deliver and localize drugs, genes, cells and other materials that may further enhance PFO closure outcomes. The BioSTAR(TM) implant to be evaluated in the BEST clinical study, for example, will incorporate an ionically bound heparin substrate that elutes over time. We believe this feature improves device hemacompatibility by minimizing protein deposition that could lead to thrombus formation, a potential drawback to all current PFO closure implants."

About NMT Medical, Inc.

NMT Medical is an advanced medical technology company that designs, develops 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 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 16,000 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 study -- involve known and unknown risks, uncertainties or other factors which 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 Quarterly Report on Form 10-Q for the quarter ended March 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. [phone]