BOSTON, Nov. 29 /PRNewswire-FirstCall/ -- NMT Medical, Inc. announced today that the Company has completed patient enrollment in its BEST study (BioSTAR(TM) Evaluation STudy) in the United Kingdom. The multi-center study, which received regulatory approval in June 2005, 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.
Michael Mullen, M.D., Interventional Cardiologist at Royal Brompton Hospital, London and Chief Investigator for the BEST study in the United Kingdom, said, “Based on our initial implant experience, we are very excited by the performance of this new technology. What is remarkable about BioSTAR(TM) is that once implanted, it seems to “melt” onto the septal wall with little or no profile. We are seeing higher acute closure rates with this implant technology compared to what is currently available. I believe the concept of bioabsorbable devices for closing PFOs may now be a reality and represents a major milestone in patient management.”
Approximately 60 patients were enrolled in the BEST study and will be 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.
John E. Ahern, NMT’s President and Chief Executive Officer, said, “Completing patient enrollment in our BEST study earlier than originally anticipated is an important event for the Company and for our clinical researchers seeking better ways to treat their patients with the PFO defect. The early data on BioSTAR(TM) is encouraging and confirms what was observed in our extensive preclinical research.”
BioSTAR(TM) combines an advanced biomaterial and NMT’s proven STARFlex(R) delivery platform. Once implanted, BioSTAR(TM) creates a bioscaffold that promotes native tissue deposition. During that biological closure process, the collagen matrix dissolves leaving behind natural tissue that completely covers the STARFlex(R) alloy framework. The bioabsorbable collagen matrix used in BioSTAR(TM) also has the potential to deliver and localize drugs, genes, cells and other materials that may further enhance PFO closure outcomes. The BioSTAR(TM) implant being evaluated in the BEST clinical study incorporates an ionically bound heparin substrate that elutes over time. This feature is designed to minimize device thrombus, a potential risk with all current intra-cardiac devices.
Ahern concluded, “As the only company with five PFO-related trials underway, NMT Medical is committed to maintaining its technology and clinical research leadership position in the emerging PFO closure opportunity. BioSTAR(TM) and the BEST study, combined with our ongoing PFO/migraine and PFO/stroke trials, are an important part of our leadership strategy. As previously announced, we currently expect to commence enrollment in our pivotal PFO/migraine clinical study in the U.S., MIST II, in the first quarter of 2006. In addition, we currently expect the final results of MIST, our PFO/migraine study conducted in the United Kingdom, to be available in late March or early April 2006. We remain positive about the progress we are making and the milestones the Company achieved in 2005.”
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 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, MIST and MIST II clinical trials and studies -- 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 September 30, 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/
