NMT Medical Halts PFO/migraine Trial To Concentrate On PFO/stroke Opportunity

(RTTNews) - Wednesday, medical technology company NMT Medical Inc. (NMTI | news | PowerRating | PR Charts ) revealed that it is closing down its patent foramen ovale, or PFO/migraine trial, MIST II, to focus its resources on its PFO/Stroke opportunity.

MIST II was approved by the FDA in September 2005 and redesigned in August 2006, had a rigorous patient screening process. Despite frequent discussions with the FDA and substantial enrollment initiatives designed to accelerate that process, the resulting patient randomization progressed more slowly than anticipated.

NMT Medical said that MIST II has become an expensive endeavor with little likelihood of being completed in a reasonable timeframe, mainly due to the strict enrollment requirements. It has become clear that an acceptable enrollment dynamic was not possible and completing the study would require more time and financial resources than the company is willing to commit at this time. Hence the company decided to close the study.

The company has ceased patient enrollment in MIST II, which was being conducted at 20 centers in the US. A portion of the savings would be used to further finance CLOSURE I, which is the company's pivotal PFO/stroke and transient ischemic attack, or TIA, clinical trial nearing enrollment completion in the US.

NMT Medical said that it is on track to be the first to complete enrollment and submit the data for US regulatory approval for a PFO/stroke indication. The company also said that positive data from the study would help assure its continued leadership in addressing the PFO/stroke and TIA market.

John Ahern, Chief Executive Officer of NMT Medical commented, "The CLOSURE I stroke/TIA trial includes a migraine sub-study which, when combined with the data from our MIST I and ongoing MIST III studies, will help with our efforts to design a scientifically sound PFO/migraine study that can succeed with patient enrollment."

NMTI is currently trading at $4.47, down $1.78 or 28.45% from its previous closing of $6.25.

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