No thanks—NMTI ceased being a value stock a long time ago. Before today’s news, it was up 300% from where I bought it a year ago (#msg-5041574), thanks in part to Cramer’s pumping.
It’s down about 30% today after missing the primary endpoint in the MIST trial, although there was an efficacy signal.
[This is a case where the investment angle is about more than just hitting or missing clinical endpoints. In order for PFO closure—a non-trivial surgical procedure—to be an appealing option for a large enough number of migraine sufferers to make it a commercially successful proposition, the results must be superb, not just good. Unfortunately for the company, the results were only good.]
ATLANTA/CHICAGO, March 13 (Reuters) - NMT Medical Inc. < NMTI > said on Monday that its implant used for repairing a hole in the heart relieves migraine pain, but a trial of the procedure missed its goal, sending the company's shares tumbling nearly 33 percent.
The trial was to see whether repairing a hole in the wall between the two upper heart chambers that failed to close naturally after birth could relieve migraine headache pain. It was previously known that many migraine sufferers also have such an opening, called patent foramen ovale, or PFO.
NMT Medical said the 147-patient study of its implant found that it reduced migraine burden by about 37 percent, compared with 17 percent in patients undergoing a surgical sham -- or a procedure with no implant. The results were significant, but fell short of the trial's goal of a 40 percent improvement.
The study also missed its primary goal of eliminating migraine headaches. Three patients in the treatment group, and three who had the sham procedure reported their headaches had stopped.
The PFO, which is present in developing fetuses to allow blood to circulate without being diverted to the lungs, allows unfiltered venous blood to enter the arterial blood circulation. The unfiltered blood may contain elements that can trigger migraines in some patients. In a PFO closure procedure, a catheter is threaded through a femoral vein in the groin to deliver a pair of patches that form a tight seal on the hole in the wall separating the two upper chambers of the heart.
Researchers said at a meeting of the American College of Cardiology that further analysis of the data may indicate which patients are most likely to respond.
"It's not a totally negative study and it shouldn't be interpreted that way. Clearly there may be patients for whom this may be appropriate who are disabled by migraines," said Dr. David Williams, a cardiologist at Rhode Island Hospital.
Prudential Financial analyst Lawrence Biegelsen, in a note to clients Monday, said safety data in the PFO arm of the trial could be a cause for concern.
"Safety was given short shrift during the presentation in our view, and this may be a key obstacle to acceptance by neurologists," Biegelsen said.
But he also said the results should not dissuade other companies from enrolling patients in PFO closure studies. He said he expects St. Jude Medical Inc. < STJ > to complete enrollment in its own PFO-migraine study, called Escape, in late 2007.
NMT said it plans to conduct further trials of the procedure. The company's shares fell nearly 33 percent to close at a new four-month low of $14.04 on Nasdaq. <<
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