BioMimetic Therapeutics, Inc. today announced it will introduce Augmatrix(TM) Biocomposite Bone Graft, a new bone graft substitute product line, to surgeons and distributors at its exhibit booth during the American Academy of Orthopedic Surgeons (AAOS) meeting this week in San Francisco, CA.
This Augmatrix product line is comprised of carbonate-apatite (calcium phosphate) and Type I collagen and is designed to be combined with bone marrow aspirate (BMA). The products are available in multiple forms to suit an array of bone grafting challenges, including fracture repair and general bone void filling procedures. The product line has been FDA cleared for use in orthopedic indications and is ready for sale in the United States. Aggregate sales of bone graft substitutes in the U.S. are estimated to reach $1.7B in 2012, according to Millennium Research.
In recent months, the company has suffered at the hands of the FDA, which delayed the launch of the company's Augment treatment by more than a year so that more information could be gathered. Last month, the company announced layoffs. In case you ever wondered, getting a drug/treatment to market is a royal pain.
Biotechnology outfit BioMimetic Therapeutics has turned in some preliminary results from clinical trials on 30 Canadian patients involving its Augment rotator cuff treatment. Investors dig it: The stock (Ticker: BMTI) is up 18 percent after the first hour of trading.
The product achieved its primary safety endpoint, which was evaluated by a comparison of adverse events between the two treatment groups, and no device-related serious adverse events (SAEs) were reported. The results also indicated improvement in the clinical outcome assessments on DASH (Disabilities of Arm, Shoulder and Hand) and WORC (Western Ontario Rotator Cuff) index scores. Additionally, Augment Rotator Cuff was found to be user-friendly for the surgeons and required no additional operating room or anesthesia time over the current standard of care.
In September, the fund bought more than 1 million BMTI shares, bringing its stake in the company to 5.3 percent. According to a recent filing with the SEC, that percentage has fallen to 4.
Shares of HCA Holdings and Community Health Systems may not be the best long-term bet for investors eyeing the hospital space, says analyst Ralph Giaccobe at Credit Suisse. But if you're looking for a quick pop — albeit with the volatility that could swing the other way quickly — the local companies are a better idea than his overall top pick, Universal Health Services.
Collins Stewart last week became the sixth firm to formally cover shares of Franklin-based BioMimetic Therapeutics. The firm's analysts have the local stock (Ticker: BMTI) rated a 'buy' and see it climbing to $7. That rise — which would reverse about half of the stock's 2011 losses — is likely to come at the hands of the Food and Drug Administration.
Over the next couple of months, BMTI should receive official comments from FDA regarding the regulatory pathway for Augment. We believe that any clarity on the next steps for Augment would be a catalyst for BMTI shares. We recently saw this with three companies whose share prices had fallen significantly only to rise later (by 75% on average) following FDA feedback that provided visibility on the regulatory pathway.
BioMimetic Therapeutics has recieved the regulatory go ahead to commercialize its Augment Bone Graft in Australia.
the Therapeutic Goods Administration (TGA) has approved the Company’s medical device application for Augment® Bone Graft clearing the way for commercialization of the product in Australia and its listing on the Australian Register of Therapeutic Goods (ARTG). Based on the clinical data from the North American pivotal trial and Canadian registration trial evaluating Augment Bone Graft, the product has been approved in Australia for use as an alternative to autograft, the current gold standard in bone grafting
The company's stock (Ticker: BMTI) has seen a big pop from the news rising 11 percent to $3.33 in early morning trading.
New York hedge fund Millennium Management has in recent weeks acquired more than 1 million shares of local medical device maker BioMimetic Therapeutics. Millennium, which is run by Izzy Englander, now controls 5.3 percent of BioMimetic, making it the fourth 5 percent owner of the Franklin-based company. The fund held about 1.2 percent of the company as of June 30.
SEE ALSO: A July Journal story about Englander's talks to sell a stake in Millennium
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