BioMimetic Therapeutics, Inc. Receives Approval To Commercialize Augment® Bone Graft In Australia
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced that 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, in hindfoot and ankle fusion procedures.
“Approval of Augment Bone Graft by another major regulatory agency, such as the TGA, marks a significant achievement in BioMimetic’s global product development program and further validates our technology, clinical data and ability to gain regulatory approvals,” said Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. “Given that obtaining autograft often requires a second surgical procedure, increasing the pain and potential for complications for the patient, and that Augment will be the first alternative approved in foot and ankle fusion surgery with large, randomized controlled clinical data, we are optimistic that Augment will find broad support from Australian hospitals, surgeons and patients alike. We are completing the final steps for pricing and reimbursement and expect a full launch of the product in the first quarter of 2012.”
Augment Bone Graft
Augment was approved in Canada in November 2009 as an alternative to the use of autograft in midfoot, hindfoot and ankle fusion indications and approvability decisions are currently pending in the United States and European Union. Augment is a completely synthetic two-component grafting system for bone regeneration and is composed of a purified bone and tissue growth factor, recombinant human platelet derived growth factor (rhPDGF-BB), and a synthetic calcium phosphate matrix, beta-tricalcium phosphate (β-TCP). When combined the rhPDGF-BB provides the biological stimulus for tissue repair by stimulating the recruitment and proliferation of new bone forming and wound healing cells and blood vessels, while the β-TCP provides the framework or scaffold for new bone growth to occur. Clinicians are referred to the Augment package insert for additional information on the use of this product.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV