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Re: DewDiligence post# 6545

Monday, 07/11/2005 2:17:17 PM

Monday, July 11, 2005 2:17:17 PM

Post# of 252301
NMTI has been on fire… and now we know why:

[This is one of those very rare clinical trials that is proceeding *faster* than expected. The impressive biomarker data on the link between PFO and migraine are new, these data were presented at EuroPCR about six weeks ago (#msg-6488543).

I owned NMTI at lower prices but, in spite of the considerable commercial potential for the PFO-migraine link, I think the stock’s valuation has gotten a little ahead of itself. I might be completely off my head, of course.]


http://biz.yahoo.com/prnews/050711/nem032.html?.v=17

>>
NMT Medical Completes MIST Migraine Study Enrollment

Preliminary Data Reveals Strong Correlation Between PFO and Migraines; Study Results Expected First Quarter 2006

BOSTON, July 11 /PRNewswire-FirstCall/ -- NMT Medical, Inc. (Nasdaq: NMTI ) announced today that the Company recently completed patient enrollment in its MIST (Migraine Intervention with STARFlex® Technology) clinical study. The study, which is the first of its kind, enrolled 147 migraine headache patients at 16 participating centers in the United Kingdom. MIST is designed to evaluate the effectiveness of NMT's proprietary STARFlex® implant technology in the treatment of these patients. Patients were randomized to the STARFlex® implant or a control arm. NMT expects the results of MIST to be available in the first quarter of 2006.

John E. Ahern, NMT's President and Chief Executive Officer, said, "Completing patient enrollment in our MIST trial is a significant accomplishment for NMT, especially considering that we are ahead of our initial schedule by two full quarters. The overwhelming response we received since initiation of the trial suggests that current medical therapy is not working for many migraine sufferers, and alternative treatments are necessary."

"Encouraging preliminary data from our MIST trial recently was presented at EuroPCR, Europe's largest interventional cardiology meeting. The data revealed that 60 percent of migraine patients studied had a right to left shunt, the majority of which were a PFO (patent foramen ovale). The incidence of these shunts, which allow venous blood unfiltered and unmanaged by the lungs to enter the arterial blood circulation, is significantly greater than the general population. In addition, more than 40% of the migraine patients studied had a large shunt, six times greater than what would be expected in the general population. Again, PFO was the most prevalent shunt seen in these migraine patients, accounting for over 85% of all large shunts detected. This data indicates a strong correlation between PFO and migraine headaches. If MIST determines that PFO closure with NMT's STARFlex® implant is an effective treatment for certain migraine headaches, we believe that PFO closure for migraine will be a substantial revenue growth opportunity, and NMT will be the first to have the solution," concluded Ahern.

NMT received approval for MIST in the United Kingdom in November 2004 and enrollment was initiated in January 2005. The Company also recently announced it had received approval for and had initiated enrollment in another clinical trial in the United Kingdom. In that multi-center trial, named BEST (BioSTAR(TM) Evaluation STudy), NMT's new bioresorbable collagen matrix PFO closure technology will be evaluated.

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 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.
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