FRANKLIN, Tenn.–(BUSINESS WIRE)–BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced it has submitted both the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its Premarket Approval (PMA) application for marketing of Augment Bone Graft in the U.S. These are two of the three parts, or modules, required for a complete PMA application to the FDA. The Company intends to file the third and final module, containing the clinical data, in the fourth quarter of 2009.
A modular submission breaks the PMA document into three sections or “modules” filed at different times that together become a complete application. The modular approach allows the applicant to potentially resolve any concerns noted by FDA earlier than would occur with a traditional PMA application, and may ultimately shorten the review and approval timeline.
“The submission of the first two PMA modules is a significant accomplishment for BioMimetic,” commented Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. “These submissions allow FDA to begin their review of these modules well in advance of receiving the final clinical data later this year. We believe this modular strategy will facilitate the most efficient and timely review and ultimate FDA approval of Augment Bone Graft for orthopedic applications.”
The Company also announced today it has achieved a new ISO 9001:2008 certification and ISO 13485:2003 recertification. These certifications are maintained by the International Organization of Standardization, which is the world’s largest developer and publisher of international industrial and commercial standards for business. Companies that achieve these certifications are recognized within the medical device industry and by international regulatory bodies as operating at the highest standards of quality. This certification provides external objective evidence and recognition of leading management systems, achievement of continual high quality standards and customer satisfaction.
“BioMimetic achieved certification to the new 2008 version of ISO 9001, as opposed to the prior 2000 version, six months ahead of schedule,” indicated John McKay, vice president of quality and environmental, health and safety for BioMimetic Therapeutics. “The Company is one of the first in the United States to achieve the new ISO 9001:2008 certification.”
Additionally, the Company received ISO 13485:2003 recertification, which represents the requirements that medical device manufacturers must incorporate into their management systems. The certification emphasizes meeting regulatory as well as customer requirements, risk management and maintaining effective processes specific to the safe design, manufacture and distribution of medical devices.