Replies to post #25598 on Biotech Values

[DewDiligence]

NMTI settles with long-standing
competitor, but they don’t get
much for their trouble.

http://biz.yahoo.com/prnews/060328/netu014.html?.v=51

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NMT Medical Announces Settlement of Patent Infringement Lawsuit Against AGA Medical

Tuesday March 28, 7:48 am ET

Agreement includes $30 million payment to NMT that will be shared with inventor

BOSTON, March 28 /PRNewswire-FirstCall/ -- NMT Medical, Inc. (Nasdaq: NMTI ), an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat cardiac sources of migraine headaches, stroke and other potential brain attacks, announced today that the Company, along with Lloyd A. Marks, MD ("Dr. Marks"), has settled its outstanding patent litigation with AGA Medical Corporation ("AGA").

In the suit originally filed in March 1999, NMT claimed that AGA manufactured and distributed a septal occlusion device that violated U.S. patent No. 5,108,420. NMT is the exclusive licensee of this patent, which was issued to Dr. Marks in 1992.

In exchange for a cash payment of $30 million to NMT, AGA has been granted a nonexclusive sublicense to the patent involved in the litigation. The cash payment will be shared equally, after NMT's legal fees and expenses, by NMT and Dr. Marks. All parties agreed to have the case dismissed with prejudice and also agreed to a general release of any and all claims.

"We are pleased to reach a favorable settlement and to have the long-running patent litigation concluded," said NMT Medical President and Chief Executive Officer John E. Ahern. "Management is now in a better position to focus its energies on expanding its leadership in the emerging PFO (patent foramen ovale) closure market opportunity. The settlement will also provide us with additional flexibility to accelerate investments in our ongoing PFO closure clinical trials, new technology initiatives, and future sales and marketing programs."
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[DewDiligence]

NMTI Modifies PFO Study

[This has the appearance of being a sensible change, but the change is actually based on the weakness of the results in NMTI’s prior PFO trial (#msg-10141757), which this PR attempts to tap-dance around. I bought this stock in the mid single digits last year (#msg-5041574), but I’m now bearish (as noted in the aforementioned post). PFO-closure results for treating migraine must be *superb* for such an invasive procedure to be warranted, IMO, but the results in the prior study were not. I think the current PFO trial that was just modified may be an example of Zebra’s Law in which a small biotech company plows ahead with a bad study because it has no choice.]

http://biz.yahoo.com/prnews/060831/neth001.html?.v=70

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NMT Medical Receives FDA Approval to Modify MIST II PFO Migraine Study in the United States

Thursday August 31, 7:00 am ET

Changes Include Adjusted Primary Endpoint and Incorporates New BioSTAR(R) Bioabsorbable Implant

BOSTON, Aug. 31 /PRNewswire-FirstCall/ -- NMT Medical, Inc. (Nasdaq: NMTI ) announced today that it has received conditional approval from the U.S. Food and Drug Administration (FDA) for modifications the Company requested to its current investigational device exemption (IDE) for its pivotal PFO (patent foramen ovale)/migraine clinical study, MIST II. The changes are supported by the Company's previous trials -- MIST and BEST (BioSTAR® Evaluation STudy). The FDA granted approval to adjust the primary endpoint for the study from resolution to reduction of migraine headaches and to upgrade the implant used in the study from STARFlex to NMT's new bioabsorbable implant, BioSTAR. MIST II's modified design will evaluate the safety and effectiveness of NMT's proprietary catheter-based implant technology for the treatment of migraine headaches in patients with a PFO.

A PFO is a common heart defect that may be a potential risk factor for migraine headaches in some patients. The PFO allows venous blood, unfiltered and unmanaged by the lungs, to enter the arterial blood circulation. The unfiltered venous blood may contain elements that can trigger migraines in some patients.

John E. Ahern, NMT's President and Chief Executive Officer, said, "The approved clinical trial changes represent an important milestone for NMT and will benefit patients and our clinical partners in several ways. First, we believe patients participating in the MIST II study will benefit from the advantages of our latest PFO closure technology, BioSTAR®, including faster healing and more complete closure.

"Second, the MIST II clinical research team and the patients they enroll will participate in the only PFO/migraine clinical trial designed to reflect clinical evidence from a predicate PFO/migraine study, MIST. Completed earlier this year, NMT's MIST trial in the United Kingdom is the only prospective study that showed a PFO/migraine connection and a positive treatment effect [however, the trial failed to meet its pre-specified primary endpoint].

"Lastly, we believe that the MIST II changes extend the Company's leadership position in PFO clinical research and technology. We provided the FDA with real-time data from our recently completed BEST study and clinical evidence from our randomized, double-blinded MIST study. As a result, we have transformed MIST II into a stronger, U.S.-based PFO/migraine study with a clinically relevant primary endpoint."

MIST II is a prospective, randomized, multi-center, controlled study. The double-blinded trial is designed to randomize approximately 600 migraine patients with a PFO to either PFO closure with NMT's implant technology or a control arm. More than 40 leading migraine headache specialists and interventional cardiologists have committed to participate in MIST II.

MIST II will employ the bioabsorbable BioSTAR® implant. As reported in NMT's recently completed BEST study, BioSTAR® achieved a post implant complete closure rate of 92% at 30 days and 96% at six months. Over time, 90% to 95% of the BioSTAR® implant is absorbed and replaced with the patient's native tissue providing a more natural, biological closure of their PFO.

Stewart Tepper, MD and Mark Reisman, MD are the co-principal investigators of the MIST II clinical trial. Dr. Tepper is Director of The New England Center for Headache in Stamford, Connecticut. Dr. Reisman is Director of Cardiovascular Research at Swedish Medical Center, Seattle, Washington.

Ahern concluded, "The MIST II modifications are a considerable achievement and reflect a tremendous amount of collaborative work from our strong clinical and regulatory partnerships and our dedicated employees."

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 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 21,000 PFOs have been closed globally with NMT's minimally invasive, catheter-based implant technology.
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[DewDiligence]

NMT Medical Sues Whistleblower Clinician

[I haven’t paid much attention to NMTI since its PFO-closure-for-migraine trial failed in 2006 (#msg-10141757).]

http://www.nytimes.com/2009/01/14/health/research/14heartside.html

›Device Maker Sues a Doctor Who Called Its Product Flawed

January 14, 2009
By BARRY MEIER

A scientific dispute has become a slander suit, in a legal case involving NMT Medical and its device for closing congenital holes in the heart.

The lawsuit, pending in London, was filed in 2007 by NMT Medical after a clinical trial failed to show that its device could eliminate migraine headaches in people with the congenital heart opening, known as a patent foramen ovale, or P.F.O.

NMT Medical contends that one of the British researchers in the study slandered and libeled it when he was quoted in an online publication as saying the trial may have failed because the product did not work well. The researcher, Dr. Peter Wilmshurst, was also quoted as saying the company had withheld trial data because it feared that it might undercut sales of the device for other uses, like stroke treatment.

“I’m not as concerned about the companies as I am about the fact that the patients who are in the studies will suffer,” Dr. Wilmshurst was quoted by the publication, theheart.org, which covers cardiology.

NMT Medical executives and another researcher involved in the trial dispute Dr. Wilmshurst’s suggestions. They say that Dr. Wilmshurst turned on them because the trial’s failure undermined his theory of a link between P.F.O. and migraine. “Everything was being completely torn to shreds by his attacks,” said John E. Ahern, the company’s chief executive. “We felt it was appropriate to protect the good name of this company and the work it does.”

Dr. Wilmshurst, a cardiologist in Shrewsbury, England, is known among his British colleagues as a whistle-blower. Among other things, he has helped expose research fraud and corporate conflicts of interest.

Dr. Wilmshurst responded through his lawyer to written questions. But in those responses, published interviews and court papers, he has said that the medical study may have been compromised because the NMT Medical device frequently failed to seal off blood flow within the heart. He has also claimed that the company failed to share all diagnostic tests with him, findings that might prove his contention.

For their part, NMT Medical officials said Dr. Wilmshurst became more irrational and demanding as the trial evolved and eventually proved impossible to deal with. They added that both American and British regulators had looked into his complaints and told the company it had done nothing wrong.

“All the other people involved in the study have been happy to accept the results,” said Dr. Andrew Dowson, a headache specialist in London, who also directed the study. Dr. Wilmshurst has said he continued to believe that there was an association between P.F.O. and migraine.

A trial date for the lawsuit has yet to be set. As for Dr. Wilmshurst, he said that he rejected an earlier offer from NMT Medical to settle the case by apologizing for his statements.

“I saw this as a bully’s attempt,” he stated. “To bow to such bullying would be a dangerous precedent which might prevent other doctors and researchers blowing the whistle.”‹