NMT Medical to Accelerate CLOSURE I Data Analysis Timing

Data Analysis to Now Commence in April 2010;

Potential PMA Submission for STARFlex® in Third Quarter of 2010

• Press Release
• Source: NMT Medical, Inc.
• On 8:30 am EDT, Wednesday September 16, 2009

BOSTON--(BUSINESS WIRE)--NMT Medical, Inc. (NASDAQ: NMTI - News) announced today that, upon recommendation of the CLOSURE I Executive Committee, it will commence data analysis for its landmark patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) clinical trial – originally scheduled for the fall of 2010 – in April 2010. At that time, 99.4% of all patient follow-up months will have been completed and 95.1% of patients will have completed the two-year follow-up. The results of the analysis are anticipated during the third quarter of 2010 at which point the trial will be complete, with 100% of the randomized patient follow-up available. If the results prove positive for device closure, the Company will be in a position to submit a Pre-Market Approval (PMA) application for its STARFlex® device for the stroke and TIA indication to the U.S. Food and Drug Administration (FDA).

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As previously announced, an independent group of statistical advisors determined that, with a high degree of certainty, a sufficient number of primary outcome events to demonstrate a statistically significant difference in treatment outcomes will have occurred by October 2009. By April 2010, the data is expected to have statistical power to support a primary outcome result and thus it would be scientifically appropriate to begin the analysis at that time. As a result, with FDA and Executive Committee approval, the Company has elected to initiate the data analysis process earlier than the originally planned October 2010 date.

NMT’s President and Chief Executive Officer Frank Martin said, “Since completing enrollment in late 2008, we have worked closely with the CLOSURE I Executive Committee to address the delicate balance between the medical community’s desire for more effective treatment options and the value of maximizing the amount of data we will file with the FDA. Commencing the data review in April 2010 should allow NMT to submit a PMA during the third quarter of 2010, assuming a positive outcome.”

The trial is being led by Principal Investigators Anthony Furlan, MD, and Mark Reisman, MD. Dr. Furlan is Chairman, Department of Neurology, Neurological Institute University Hospitals Case Medical Center, and Case Western Reserve University School of Medicine in Cleveland. Dr. Reisman is Director, Cardiovascular Research and Director, Cardiac Catheterization Lab, Swedish Heart and Vascular Institute in Seattle.

Dr. Furlan said, “Given the amount of data that will be collected by April 2010, it is appropriate to conduct the analysis earlier than originally planned. Based on the number and timing of primary outcome events in the trial, we expect to have sufficient data to provide enough statistical power to potentially observe a significant difference in treatment alternatives.”

Dr. Reisman agreed, “The new timeframe will maintain the scientific integrity of the study and, at the same time, accelerate timelines for analyzing and interpreting the results.”

Martin concluded, “We all are eager to uncover a possible connection between PFO, stroke and TIA and look forward to the data analysis getting underway. We would like to again acknowledge and thank the more than 190 leading stroke neurologist and interventional cardiologist investigators, their research teams, the trial’s patients, and our employees and shareholders for their continued commitment to CLOSURE I.”

A PFO is a common heart defect that may be a potential risk factor for stroke, TIA, migraine or other brain attacks in some patients. The PFO allows venous blood, unfiltered and unmanaged by the lungs, to enter the arterial blood circulation. CLOSURE I is designed to evaluate the effectiveness of NMT’s STARFlex® implant technology in preventing recurrent stroke and/or TIA due to a presumed, paradoxical embolism through a PFO. More than 190 leading stroke neurologists and interventional cardiologists at approximately 95 centers in the U.S., Canada and the United Kingdom are participating in the study. Of the 910 stroke and TIA patients enrolled, half received PFO closure in a catheter-based procedure with NMT's STARFlex® implant and half were treated with drugs alone.

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 structural heart disease through minimally invasive, catheter-based procedures. NMT is currently investigating the potential connection between a common heart defect that allows a right-to-left shunt or flow of blood through a defect like a patent foramen ovale (PFO) and brain attacks such as embolic stroke, transient ischemic attacks (TIAs) and migraine headaches. A common right-to-left shunt 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 30,000 PFOs have been treated globally with NMT’s minimally invasive, catheter-based implant technology.

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 an additional 500,000 Americans experience a TIA.

For more information about NMT Medical, please visit 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 those relating to the timing and outcome of statistical analysis relating to CLOSURE I and the filing of a PMA, 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 might cause such a difference include, but are not limited to, those discussed under the heading “Risk Factors” included in the 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, 2008, Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, and subsequent filings with the U.S. Securities and Exchange Commission.

NMT Medical, Inc.
Richard E. Davis, 617-737-0930
Chief Operating Officer
red@nmtmedical.com