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NMT Medical Initiates Enrollment in BioSTAR(TM) Clinical Study

Posted on: Thursday, 7 July 2005, 09:01 CDT

BOSTON, July 7 /PRNewswire-FirstCall/ -- NMT Medical, Inc. today announced that the Company has initiated patient enrollment in its BEST study (BioSTAR(TM) Evaluation STudy) in the United Kingdom. The multi-center study, which recently received regulatory approval, is evaluating the Company's new bioresorbable collagen matrix PFO (patent foramen ovale) closure technology. Michael Mullen, MD, Interventional Cardiologist at Royal Brompton Hospital, London, and Chief Investigator for BEST, treated the first patients earlier this week.

Dr. Mullen said, "In anticipation of BEST study approval, all investigators were trained on using the BioSTAR(TM) technology in Germany, under the guidance of the preclinical research team led by Christian Jux, MD. Consequently, we were prepared to enroll patients in the BEST study upon receipt of the necessary regulatory approvals. We are enthusiastic about the promise of the BioSTAR(TM) technology and are excited to move this study forward."

Commenting on the study, John E. Ahern, NMT's President and Chief Executive Officer, said, "The BEST study represents important clinical research for both the Company and the medical community at large. Healthcare providers are seeking improved treatments for patients with structural heart defects like PFOs. Based on our preclinical research, we believe that BioSTAR(TM) offers a more rapid and complete sealing of the PFO defect. Once delivered by transcatheter technique, BioSTAR(TM) is designed to create a bioscaffold that promotes native tissue deposition, and during that process, the implant's collagen matrix dissolves, leaving behind the patient's natural tissue."

As previously announced, the goal of the BEST study is to secure European commercial approval for NMT's novel BioSTAR(TM) technology through the CE Mark process.

Ahern concluded, "The PFO defect has been increasingly associated with the potential for increased risk of recurrent stroke, transient ischemic attacks (TIA) and migraine headaches. NMT Medical has established the lead in clinical research in this area. The Company received the first approval for an IDE study in the United States to study the relationship between PFO and recurrent stroke and TIA with its ongoing CLOSURE I trial. NMT was first to receive approval for a PFO/migraine study called MIST (Migraine Intervention with STARFlex(R) Technology) being conducted in the United Kingdom. And now the Company is first to receive approval and initiate a clinical study to evaluate an innovative, bioresorbable PFO implant technology -- BioSTAR(TM)."

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. 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. (617) 737-0930 jea@nmtmedical.com

NMT Medical, Inc.

CONTACT: John E. Ahern, President and Chief Executive Officer, NMTMedical, Inc., +1-617-737-0930, jea@nmtmedical.com

Web site: http://www.nmtmedical.com/

Source: PRNewswire-FirstCall

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