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BioMimetic Therapeutics Successfully Completes Enrollment in Three Orthopedic Pilot Clinical Trials for GEM OS1(TM) Bone Graft; Canadian Study Expanded to 60 Patients

11 Jul 2006

Announced today that the Company has successfully completed enrollment in its Canadian pilot clinical study with its lead orthopedic product candidate GEM OS1 Bone Graft

FRANKLIN, TN, USA | Jul 11, 2006 | BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced today that the Company has

successfully completed enrollment in its Canadian pilot clinical study with its lead orthopedic product candidate GEM OS1 Bone Graft. As a result of the preliminary data obtained, the Company has received authorization from the Canadian government to expand the study from the original 20 patients up to 60 patients. Subject to the results of the expanded study, the Company intends to file for Canadian product registration for orthopedic indications in 2007.

The Company also has successfully completed enrollment in its U.S. pilot clinical study for foot and ankle fusions and its Swedish pilot clinical study to evaluate the treatment of distal radius (wrist) fractures. To date, there have been no product related serious adverse events (SAEs) attributed to GEM OS1 in any of the three studies.

"We are pleased with the progress of our clinical trials to date and hope to present top line data for these studies by year end. With the completion of enrollment in these three pilot clinical studies, the Company remains on target to meet its current orthopedic product development timelines," stated Dr. Samuel E. Lynch, president and CEO of BioMimetic Therapeutics. "Due to the broad spectrum of activity of PDGF, we believe that our multiple GEM product candidates will address a variety of musculoskeletal indications. With the FDA approval of GEM 21S(R) for treatment of periodontally related bone defects and our clinical progress in orthopedics, we are well on our way to executing on this strategy."

BioMimetic is developing GEM OS1 for use in open surgical treatment of fractures and bone fusions where the use of bone graft, a material used to augment bone healing, is indicated. GEM OS1 is designed to be placed directly into an open surgical site to stimulate bone regeneration. The combination of the two GEM OS1 components, recombinant human platelet-derived growth factor (rhPDGF) and Beta-tricalcium phosphate ((beta)-TCP), is key to the product's overall effectiveness. rhPDGF is intended to provide the biological stimulus for tissue regeneration by stimulating the in-growth and proliferation of osteoblasts, cells responsible for the formation of bone, while (beta)-TCP provides a framework or scaffold for new bone growth to occur. According to securities research analyst reports, U.S. sales of bone grafting products and orthobiologics reached $1.3 billion in 2005, a 27% increase over 2004 sales.

Dr. Christopher DiGiovanni, chief of foot and ankle in the department of orthopaedic surgery at Rhode Island Hospital and associate professor at Brown Medical School in Providence, will present an overview of the Company's U.S. study and the biology of PDGF on July 15, 2006 at the Orthobiologics Symposia during the American Orthopaedic Foot and Ankle Society's (AOFAS) 22nd Annual Summer Meeting in San Diego.

"Based on the established biology of rhPDGF as a wound healing factor and the demonstrated clinical benefit of the combination of rhPDGF and B-TCP to stimulate new bone formation, as shown in the Company's clinical studies with their product GEM 21S(R), I am optimistic about the potential for GEM OS1 to accelerate healing in foot and ankle applications," said Christopher W. DiGiovanni, MD.

Foot and Ankle Procedures

There are approximately 70,000 foot and ankle fusions performed annually in the United States. Foot and ankle fusion procedures are primarily performed in patients with severe osteoarthritis, who do not respond to more conservative treatments. In a fusion procedure, the joint space between adjacent bones is surgically prepared and treated with a graft material to stimulate a fusion, or permanent connection of the two bone ends. This connection eliminates the pain associated with the movement of the joint. Typically, foot and ankle fusions are performed with bone material harvested from the patient, which is obtained as the result of a second surgical procedure. Harvesting bone graft material has significant drawbacks, which include requiring of a second surgery to harvest the graft material, pain and morbidity associated with the second surgery and inconsistent volume and quality of the bone material harvested. GEM OS1, which is being developed as a fully synthetic bone graft substitute for harvested bone graft, eliminates the need for this second surgery.

About BioMimetic Therapeutics

BioMimetic Therapeutics, Inc. is developing and commercializing bio-active drug-device combination products for the healing of musculoskeletal injuries and disease, including periodontal, orthopedic, spine and sports injury applications. BioMimetic received marketing approval from the FDA for its first product, GEM 21S(R), as a grafting material for bone and periodontal regeneration following completion of human clinical trials, which demonstrated the safety and efficacy of its platform technology in this indication. The Company's product and product candidates all combine recombinant protein therapeutics with tissue specific scaffolds to actively stimulate tissue healing and regeneration.

Forward-looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of BioMimetic Therapeutics. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. BioMimetic's actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with our unproven preclinical and clinical development activities, regulatory oversight, intellectual property claims, litigation and other risks detailed in the company's filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its registration statement on Form S-1. Except as required by law, BioMimetic undertakes no responsibility for updating the information contained in this press release beyond the published date, whether as a result of new information, future events or otherwise, or for changes made to this document by wire services or Internet services.

For further information, visit www.biomimetics.com or contact Kearstin Patterson, manager corporate communications, at 615-236-4419.

SOURCE: BioMimetic Therapeutics, Inc.

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