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Migraine Study Data from NMT Medical's MIST Study Presented at European Cardiology Conference
24 May 2005
NMT Medical, Inc. (Nasdaq: NMTI - News), a leader in designing, developing and marketing minimally invasive solutions for the treatment of cardiac sources of migraine headaches, stroke and other potential brain attacks, today announced that data from its MIST (Migraine Intervention with STARFlex® Technology) study was reported at the EuroPCR meeting in Paris, the largest interventional cardiology meeting in Europe.
Data on the incidence of PFO observed in the MIST study was presented by Peter Wilmshurst, MD, at the Late-Breaking Trials session. In today's presentation, Dr. Wilmshurst said, "In our evaluation of 370 migraine patients, we found that 50% of them had a PFO (patent foramen ovale), which allows a right to left shunt, or flow, of venous blood into the arterial circulation. This important finding is consistent with earlier observational data and is twice what one would expect to find in the general population. In addition to PFOs, we found other shunts, predominately pulmonary, in another 10% of the migraine patients studied, which again is greater than what one would expect. What is remarkable is that more than 40% of the migraine patients studied had a large shunt; this is six times greater than what would be expected in the general population. By far, the PFO was the most prevalent large shunt we saw in the migraine patients, accounting for over 85% of all large shunts detected."
Dr. Wilmshurst, Consultant Cardiologist at Royal Shrewsbury Hospital, Shrewsbury, England, is co-primary investigator on the MIST study with Andrew J. Dowson, MD, Director of the King's Headache Service, Kings College Hospital, London.
Commenting on the MIST data, Dr. Dowson said, "The initial data from MIST is intriguing. We are not certain what causes migraine headaches. If, however, shunts like the PFO allow venous blood to enter the cerebral circulation, unfiltered and unmanaged by the lungs, perhaps that venous blood contains materials that trigger migraines in some patients. The next question the MIST study is designed to answer is whether closing the PFO with NMT's STARFlex® implant technology reduces or eliminates migraine headaches. We should be able to provide an answer to that question by the end of this year or early next year."
John E. Ahern, President and Chief Executive Officer of NMT Medical, said, "The preliminary data from MIST is very encouraging. It validates an important part of the equation for us in that half the migraine patients prospectively studied had a PFO. The data also gives us confidence in the potential size of the opportunity and our ongoing investment in clinical trials and new PFO closure technologies."
MIST is the first prospective, randomized, controlled study to evaluate the potential relationship between PFO and certain migraine headaches. The MIST study is designed to evaluate the effectiveness of NMT's STARFlex® implant technology in the treatment of these headaches. MIST is a double- blinded study randomizing migraine patients with a PFO to either PFO closure with STARFlex® or a control arm. MIST was approved in the United Kingdom in November 2004 and enrollment was initiated in January 2005. As previously announced, patient enrollment in MIST is expected to be completed by the end of June -- well ahead of its original schedule. Patients will be followed for six months. NMT expects the full results of MIST to be available in late 2005/early 2006.
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. NMT Medical is investigating the potential connection between a common cardiac defect called a PFO and brain attacks such as migraine headaches, stroke and transient ischemic attacks (TIAs). 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 timing, cost, rate and amount of patient enrollment and outcome of the Company's MIST clinical trial -- 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 timing and outcome of our MIST study, 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, 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 & Chief Executive Officer
NMT Medical, Inc.
(617) 737-0930
jea@nmtmedical.com
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Source: NMT Medical, Inc.
Source: PR Newswire
All trademarks and copyrighted information contained herein are the property of their respective owners.
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