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Friday, June 18, 2010

NMT Medical heart device fails to hit trial goal

By Michelle Lang

NMT Medical Inc., a developer of medical implant technologies, reported today that its device to treat structural heart disease has failed to meet its target endpoint.

NMT develops implant technologies that treat structural heart disease using minimally invasive, catheter-based procedures. The company had a goal for its Closure I trial to provide better results for its device closure with STARFlex technology, a septal repair implant, than current therapies to treat a heart defect called patent foramen ovale (PFO) and mini-strokes called transient ischemic attacks (TIA). A news release from NMT Medical officials today noted, “the preliminary results indicate that closure with STARFlex provided a small, but not statistically significant, benefit over current best medical therapy.”

Despite the performance results, the trial showed that the STARFlex technology’s safety profile was on par with current treatments and showed a low risk of complications.

NMT Medical (Nasdaq: NMT) said that it is following the trial with talks with the U.S. Food and Drug Administration regarding next steps for its device, as well as with full trial data analysis to review with the company’s trial committee, contract research organizations, clinical researchers and shareholders.

The Boston-based company filed a shelf registration in April with the U.S. Securities and Exchange Commission enabling it to sell up to $30 million in equity and debt.




 

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