Replies to post #6545 on Biotech Values

[DewDiligence]

drbio: I noticed that you dallied in NMTI about four years ago. I saw your posts on the BSX board; your thoughts were on target but you were probably too early. Perhaps you ought to give it another look.

[DewDiligence]

While no one noticed… NMTI has quietly gone up 20% since I bought it exactly two weeks ago (#msg-5041574). Caution: the stock is highly volatile.

[DewDiligence]

Closing a hole in the heart to possibly prevent migraines

[This story from Tuesday’s WSJ features the heart device from NMTI that I’ve previously mentioned (#msg-5041574, #msg-5183962). Although the article contains no info beyond what the company itself has disclosed, it nevertheless caused a substantial spike in the price of NMTI’s shares. (I took advantage of the spike to sell.)]

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A Breakthrough for Migraine Sufferers?
Patient Test Targets Minor Heart Defect

By RHONDA L. RUNDLE
February 15, 2005

Severe migraine headaches are a painful and stubborn curse for those who suffer them. Now researchers are exploring whether a 45-minute outpatient procedure used to treat a heart problem in stroke victims may point the way to relief for millions of migraine patients.

The debilitating headaches have unexpectedly disappeared in some stroke patients who have undergone a new cardiac procedure intended to prevent another stroke. Researchers think some types of strokes and some migraines may be linked to a minor heart defect that affects as much as a quarter of the human population.

Tests are under way in the United Kingdom and are on the drawing board in the U.S. to find out if repairing the defect eliminates or reduces migraines that have an "aura" -- those where the pain is accompanied by flashing lights, vision loss and other temporary neurologic changes.

If the studies are successful, it "means that there could be, within the next couple of years, a very effective treatment for migraine headache sufferers," says Jonathan Tobis, director of interventional cardiology research at the University of California at Los Angeles. As many as 28 million people in the U.S. are estimated to suffer from migraine headaches, of which perhaps 15% are the kind with aura. These migraines can be so disabling that patients are unable to work.

Some physicians are skeptical about the procedure. "I've been doing headache work for almost 45 years and I've seen a lot of ideas that didn't work," says Seymour Diamond, director of the Diamond Headache Clinic in Chicago. Dr. Diamond says he is eager to see the studies, but in the meantime, "I don't think people should flock to get the [defect] corrected."

The defect is a small hole called a patent foramen ovale, or PFO, that allows blood to travel from the right upper chamber of the heart to the upper left side. Inside a mother's womb, this pathway permits oxygenated blood to pass through the fetus. It closes in most people within a year after birth. When it remains open, researchers speculate, it may allow tiny blood clots or chemicals to bypass the natural filter of the lungs and enter the brain, triggering strokes or migraines.

The closure procedure, which involves placing a tiny device in the heart to seal the opening, has been performed on a small number of U.S. stroke patients during the past several years under an unusual Food and Drug Administration authorization, called a Humanitarian Device Exemption. In outpatient surgery, at a total cost of about $20,000, the device is inserted through a catheter threaded through the femoral vein. Complications are rare but potentially life-threatening.

Dr. Tobis at UCLA is organizing a clinical trial to use a closure device made by closely held AGA Medical Corp. of Minneapolis to seal the hole in migraine patients. In the U.K., some migraine patients already have been treated, using a similar device made by NMT Medical Inc. of Boston. Preliminary results from the U.K. trial could be known as early as the end of this year, says Rick Davis, NMT's chief financial officer.

The first patients in the U.K. were recruited shortly before Christmas and "we've had a massive response from the public," says Andrew Dowson, the study's chief investigator and director of the headache service at King's College Hospital in London. "It has been portrayed in the British press as some kind of Holy Grail, but we have to wait until the results are in," cautions Anita Few of the Migraine Action Association, an independent British advocacy group, which helped alert patients to the test.

The study has a highly unusual feature. British regulatory authorities, including medical ethicists, approved inclusion of a "sham" procedure. While all of the subjects undergo the same preparations, including pretreatment anesthesia and a small incision in the groin, some will have the procedure to seal their PFOs and others won't. If the procedure proves to work, untreated patients will be brought back later.

This "double-blind" feature means that neither the patient nor the patient's neurologist knows whether the patient's heart defect has been closed. Investigators lobbied hard for this approach because they must rely on patients to report any headaches, which can't be independently verified. Some tests of migraine medicines have been inconclusive because a high percentage of subjects who received a placebo rather than the drug have reported improvement.

Proponents of the U.K. trial argued the need for a clinical trial because a very small number of cardiologists there and in the U.S. already have begun deploying PFO closure devices, based on growing anecdotal evidence of a link between PFOs and migraines. Two observational reports by researchers at UCLA and at the Swedish Heart Institute in Seattle are published in today's issue of the Journal of the American College of Cardiology.

Such reports fall short of the rigorous scientific tests needed to prove a link between the heart defect and migraines but could spur the FDA to consider allowing human trials to move forward in the U.S. this year. "It's quite a leap of faith to think about putting a device into someone's heart to relieve their migraines," says Mark Reisman, director of cardiovascular research for the Swedish Heart Institute.

One of Dr. Reisman's patients says she never dreamed her migraines would vanish when she had the hole in her heart sealed in 2002 to prevent another stroke. "I haven't had any migraine headaches since then," says Lorraine Hummel, a 52-year-old homecare giver in Renton, Wash.
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[DewDiligence]

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

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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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