MASSDEVICE ON CALL — BioMimetic Therapeutics (NSDQ:BMTI) cut 25% of its workers in hopes of saving some cash in focusing on getting FDA pre-market approval for its Augment bone graft.
The federal watchdog agency’s advisory panel recommended approving the treatment in May 2011, after releasing a dim summary of the pre-market approval application that sunk BMTI shares by more than 35%.
Earlier this month the Nashville, Tenn.-based company was dealt a harsh blow when the FDA announced that it needed more clinical information from BioMimetic before approving the Augment device.
BioMimetic had been aiming for clearance by the end of 2011, the Nashville Business Journal reported.
Now the company is preparing to cut a quarter of its 75 employees, which it expects will result in $2.5 million of savings in salaries and benefits.
BioMimetic is also planning on scaling back its clinical programs in order to devote more resources to addressing the FDA’s concerns, according to SEC filings.
Augment is a drug/device combination that uses a recombinant human platelet-derived growth factor and a bioresorbable synthetic bone matrix. Surgeons mix equal amounts of the substances in a surgical bowl and pack the mixture into a bone void.
BioMimetic won Health Canada approval from Health Canada in November 2009 for midfoot, hindfoot and ankle fusion indications. Augment has only been used in IDE studies in the U.S.
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