NMT Medical to Accelerate CLOSURE I Data Analysis Timing

Wed Sep 16, 2009 8:30am EDT
 
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Data Analysis to Now Commence in April 2010;

Potential PMA Submission for STARFlex in Third Quarter of 2010
BOSTON--(Business Wire)--
NMT Medical, Inc. (NASDAQ: NMTI) 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). 

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



Copyright Business Wire 2009

 

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