Shares of BioMimetic Therapeutics Inc. (NSDQ:BMTI) continued their slide today after plummeting 35.3 percent yesterday to close at $8.66 on news of the FDA’s dim view of its Augment bone graft product.
BMTI shares today recovered some of those losses to close at $9.20, up more than 6 percent for the day, but the stock was trading at $13.39 as of the market’s close on May 9 — the day before the release of the Food & Drug Administration’s summary of the company’s pre-market approval application for Augment.
The federal watchdog agency said a clinical study of the product, which is used to stimulate bone growth in foot and ankle fusion procedures, showed that it was not as successful as grafts taken from patients’ own bones. The agency’s Orthopedic and Rehabilitation Devices panel is set to meet tomorrow for a public hearing, after which it will vote whether to recommend that the FDA approve the device.
Augment is a drug/device combination that uses a recombinant human platelet-derived growth factor called B homodimer (rhPDGF-BB) and a bioresorbable synthetic bone matrix called beta-tricalcium phosphate or β-TCP. Surgeons mixequal 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.
The company posted its first-quarter results this week, reporting a revenue increase of 13.2 percent, to $399,000, for the three months ended March 31. BioMimetic also shaved its net loss 6.7 percent, from $8.5 million during Q2 2010 to $8.0 million during the just-ended quarter.
MassDevice keeps a close eye on public medical device companies, tracking their quarterly sales and earnings reports. For the most recent filings, check out our Earnings Roundup, where we collect each quarter’s reports.
Here’s a quick rundown of a few releases over the past couple days:
Bioject losses ease after sales bump
Bioject Medical Technologies Inc. (OTC:BJCT) posted a loss of $182,000, or 1 cent per diluted share, on sales of $1.7 million during the three months ended March 31. That compares with a loss of $568,000, or 3 cents per diluted share, on sales of $1.2 million during the same period last year.
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Derma Sciences earnings stagnant despite increased sales
Derma Sciences Inc. (NSDQ:DSCI) posted a loss of $547,032, or 8 cents per diluted share, on revenue of $14.4 million during the three months ended March 31. That compares with a loss of $578,689, or 10 cents per diluted share, on revenue of $12.8 million during the same period last year.
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DJO Global losses ease by more than a third
DJO Global Inc. reported a loss of $20.9 million on sales of $249.7 million during the three months ended April 2. That compares with a loss of $33.3 million on sales of $240.1 million during the same period last year.
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pSivida losses remain unchanged
pSivida Corp. (NSDQ:PSDV) reported a loss of $2.7 million, or 13 cents per diluted share, on revenue of $360,000 during the three months ended March 31. That compares with a loss of $2.7 million, or 15 cents per diluted share, on revenue of $515,000 during the same period last year.
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Cardica losses widen as sales remain unchanged
Cardica Inc. (NSDQ:CRDC) posted a loss of $3.6 million, or 14 cents per diluted share, on sales of $954,000 during the three months ended March 31. That compares with a loss of $3.0 million, or 12 cents per diluted share, on sales of $979,000 during the same period last year.
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Misonix reports mixed Q1
Misonix Inc. (NSDQ:MSON) posted losses of $531,478, or 8 cents per diluted share, on revenue of $3.6 million during the three months ended March 31. That compares a loss of $281,492, or 4 cents per diluted share, on revenue of $3.3 million during the same period last year.
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American Shared Hospital Services sales see small bump
American Shared Hospital Services (NSDQ:AMS) reported profits of $21,000, or 0 cents per diluted share, on sales of $4.4 million during the three months ended March 31. That compares with profits of $8,000, or 0 cents per diluted share, on sales of $4.1 million during the same period last year.
Tornier losses widen dramatically despite increased sales
Tornier N.V. (NSDQ:TRNX) posted a loss of $24.0 million, or 68 cents per diluted share, on sales of $69.4 million during the three months ended April 3. That compares with a loss of $10.0 million, or 41 cents per diluted share, on sales of $61.8 million during the same period last year.
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Mindray sales rise 24 percent
Mindray Medical International Ltd. (NYSE:MR) posted profits of $37.7 million, or 32 cents per diluted share, on revenue of $180.9 million during the three months ended March 31. That compares with profits of $36.2 million, or 31 cents per diluted share, on revenue of $145.8 million during the same period last year.
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Allied Healthcare Products sales slacken slightly
Allied Healthcare Products (NSDQ:AHPI) reported profits of $60,324, or 1 cent per share, on revenue of $11.3 million during the three months ended March 31. That compares with profits of $37,530, or 0 cents per share, on revenue of $11.6 million during the same period last year.
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Luminex sales increase 30 percent
Luminex Corp. (NSDQ:LMNX) posted a profit of $4.5 million, or 11 cents per diluted share, on sales of $43.3 million during the three months ended March 31. That compares with a profit of $1.9 million, or 5 cents per diluted share, on sales of $33.3 million during the same period last year.
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