NMT Medical Completes Enrollment In Landmark PFO/Stroke Clinical Trial

Main Category: Stroke
Also Included In: Neurology / Neuroscience;  Clinical Trials / Drug Trials
Article Date: 09 Oct 2008 - 9:00 PDT

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NMT Medical, Inc. (NASDAQ: NMTI) announced today that the Company has completed patient enrollment in its pivotal patent foramen ovale (PFO) /stroke clinical trial, CLOSURE I. NMT believes it is the first company to complete enrollment of a prospective, multi-center, randomized, controlled study that examines the potential relationship between PFO and stroke and transient ischemic attacks (TIA). The Company also believes it will be first to submit a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the PFO/stroke and TIA indication.

CLOSURE I is designed to compare the effectiveness of the STARFlex ® septal repair implant technology against drug therapy in reducing the risk of recurrent stroke and TIA in patients with a PFO. The PFO is a common heart defect that allows a right to left shunt or flow of venous blood directly into the arterial circulation while bypassing processing and filtering by the lungs. Of the 900 stroke and TIA patients enrolled in the study, half received PFO closure in a catheter-based procedure with NMT's STARFlex® implant and half will be treated with drugs alone.

More than 190 leading stroke neurologists and interventional cardiologists at approximately 95 centers in the United States, Canada and the United Kingdom are participating in the CLOSURE I study. 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.

"The obstacles to completing this first ever randomized controlled trial of medical versus interventional therapy for stroke risk reduction in patients with PFO have been many including patient and physician treatment biases," said Dr. Furlan. "The world neurological and cardiology communities therefore eagerly await the results of this landmark trial since the best way to reduce stroke risk in our patients with PFO is currently unknown."

Dr. Reisman added, "It is important to commend the investigators and NMT for having the resolve to see this study through despite these challenges. We expect the results of this trial will deliver guidance and clarity to the management of PFO/stroke and TIA."

"Completing patient enrollment in our CLOSURE I clinical trial is an important milestone for NMT Medical and our investigator partners," said President and Chief Executive Officer John E. Ahern. "I would like to acknowledge the commitment and valiant effort by our investigators, their research teams and our internal clinical team to attain the 900 patient enrollment goal. We knew this would be a challenge, but a challenge worth taking on together. We believe that data from CLOSURE I will help the clinical community and stroke and TIA patients diagnosed with a PFO shunt make informed decisions as to the best course of therapy."

"The next two significant CLOSURE I milestones will be 1) data analysis and publication in a peer reviewed journal; and 2) PMA submission to the FDA for commercial approval in the United States," said Ahern. "The Executive Committee is working with independent statistical experts and the FDA to determine the optimal timeframe in which to perform the follow up data analysis. An endpoint driven adaptive trial design is currently undergoing this independent statistical review. We currently expect to have that guidance by the end of the year."

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 28,000 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. 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.

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 CLOSURE I trial, regulatory approvals for the Company's products in the United States, Europe and elsewhere abroad, and the Company's investment in product development - 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, as well as risk factors discussed under the heading "Risk Factors" included in the Company's Annual Report on Form 10-K for the year ended December 31, 2007, Quarterly Report on Form 10-Q for the period ended June 30, 2008 and subsequent filings with the U.S. Securities and Exchange Commission.

NMT Medical, Inc.