BOSTON--(BUSINESS WIRE)--NMT Medical, Inc. (NASDAQ: NMTI - News) today announced that in conjunction with the Executive Committee of the CLOSURE I trial, it has decided that data analysis for its landmark patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) clinical trial will remain scheduled for the fourth quarter of 2010. The Company would then expect 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) soon after the data analysis is completed.
With the approval of the Executive Committee, NMT recently received the findings of an independent statistical review committee regarding the timing of CLOSURE I data analysis. The independent statistical committee comprised of biostatisticians and trial design experts, whose charter had been previously approved by the FDA, determined that it was “highly likely” that sufficient primary outcome events (strokes and TIAs) would have occurred so that an analysis could be performed in October 2009 – one year earlier than originally planned. At that time, 93% of the trial data will be available and all patients will have completed at least one year of follow-up. However, while an early event driven analysis may be statistically valid, the CLOSURE I Executive Committee advised that the conservative pathway that offers the best statistical power to observe a significant difference in treatment alternatives would be to follow the original trial timeline. As a result, NMT has decided at this time to maintain the two-year timetable for data analysis.
NMT’s President and Chief Executive Officer Frank Martin said, “Our management team and CLOSURE I Executive Committee are mindful that an analysis in October 2009 might provide the clinical stroke community with an early answer to one of the most important and vexing problems in stroke neurology today – whether PFO closure prevents ongoing damage to the brain from recurrent strokes and TIAs. The answer to this question has assumed even greater importance with the recent data that TIAs may contribute to ongoing neurologic injury in certain instances.”
“At the same time, we carefully considered the current climate of increased scrutiny of clinical trials,” Martin continued. “We believe that the CLOSURE I trial, designed as a pivotal study, will serve as the single most important assessment of the link between PFO closure and the stroke/TIA indication. As a result, the quality and integrity of our landmark study takes on a more heightened level of significance.”
“There is a 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,” Martin said. “For this reason, NMT is currently maintaining the existing data analysis timing.”
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, “The results from CLOSURE I will provide valuable insight on how to best reduce recurrent stroke risk in patients with a PFO. The trial is designed to determine if PFO closure is a more effective treatment than medical therapy alone for patients with cryptogenic stroke and TIA. While the medical community eagerly awaits the results of this important trial, we applaud NMT’s current decision to maintain the original data analysis timetable, which will provide maximum statistical power. On the other hand, it is of some reassurance that the independent statistical committee indicated that we will likely have enough primary outcome events to detect a significant result as early as October 2009.”
Dr. Reisman added, “This landmark study and its anticipated results have generated a high level of interest within both the cardiology and neurology communities. However, there is no scientific advantage to changing the decision about the timing of the data analysis today.”
Martin concluded, “We all are eager to uncover the connection between PFO, stroke and TIA, but we decided not to accelerate the data analysis schedule at this time. We would like to acknowledge and thank the more than 190 leading stroke neurologist and interventional cardiologist investigators, their research teams, the enrolled patients, and our employees and shareholders for their continued commitment to the CLOSURE I trial.”
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 a 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 statements regarding the outcome of the Company’s CLOSURE I trial, expected timing for data analysis and PMA submission for the stroke and TIA indication, and regulatory approvals for the Company’s products in the United States and abroad – 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, 2008 and subsequent filings with the U.S. Securities and Exchange Commission.
Contact:
NMT Medical, Inc. Richard Davis, 617-737-0930 Chief Operating Officer red@nmtmedical.com
