November 21 , 2005

BioMimetic Therapeutics Announces FDA Approval of GEM 21S® Growth-factor Enhanced Matrix for the Treatment of Periodontally-related Bone Defects

- First Recombinant Growth Factor Approved for Use in Periodontal Applications -

Franklin, Tenn. – November [xx], 2005 - BioMimetic Therapeutics, Inc. announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its lead product, GEM 21S®. The first BioMimetic product to be PMA approved by the FDA, GEM 21S is a fully synthetic regeneration system for the treatment of periodontal bone defects and associated gingival recession. GEM 21S is composed of the tissue growth factor, recombinant human Platelet-Derived Growth Factor (rhPDGF-BB), and a synthetic bone matrix, Beta-tricalcium phosphate (_-TCP). It is the first totally synthetic product combining a purified recombinant growth factor with a synthetic bone matrix to be approved by the FDA for human application.

“GEM 21S is an innovative new treatment and an important therapeutic advancement for patients who suffer from severe bone loss associated with periodontal disease,” commented Samuel E. Lynch, DMD, DMSc, president and chief executive officer of BioMimetic. “Approval of GEM 21S is the culmination of over a decade of scientific research by multiple investigational teams. These extensive studies have demonstrated the significant therapeutic potential of this technology to stimulate bone and periodontal regeneration leading to earlier resolution of periodontal lesions, and thereby offer a significant new option for clinicians and patients.”

“With this approval,” Dr. Lynch continued, “BioMimetic has taken another step forward in the development of the Company. We are in the position to immediately launch the product with our distribution partner Osteohealth, and have commercial supply ready for shipment. We hope to have the product in the hands of dentists, periodontists, and oral and maxillofacial surgeons within the coming two weeks. Additionally, this FDA approval, confirming the bone regenerative properties of the rhPDGF-BB technology, allows us to aggressively focus our efforts on the development of other product candidates for the treatment of orthopedic and sports injury conditions in bone, cartilage, ligaments and tendons.”

Under the exclusive agreement with Osteohealth Company, a division of Luitpold Pharmaceuticals, Inc. which is a group company of Sankyo Co., Ltd., Osteohealth is responsible for the worldwide marketing, sales, distribution, and post-approval development of GEM 21S for additional indications including the repair or reconstruction of cranio-maxillofacial osseous defect indications. As part of the agreement, BioMimetic will receive license fees, royalties, and marketing assistance and milestone payments, and will be the sole source manufacturer of GEM 21S.

The combination of the two components of GEM 21S are key to the overall effectiveness of the product. The rhPDGF-BB provides the biological stimulus for tissue repair by stimulating the proliferation and in-growth of osteoblasts, cells responsible for the formation of bone, while the _-TCP provides the framework or scaffold for new bone growth to occur. In recognition of the unique treatment modality provided by GEM 21S, the FDA has established it as a first-in-class compound in its treatment category.

Beyond GEM 21S, the Company has established a pipeline of orthopedic product candidates that are being developed to stimulate tissue healing/regeneration in bone, cartilage, ligaments and tendons.

GEM 21S Clinical Trial Results
GEM 21S approval was based on results from a pivotal 180 patient double-blind, randomized, controlled multicenter, pivotal clinical trial involving subjects who required surgical intervention to treat periodontal bone defects. Patients were studied for six months following implantation of the product.

The study assessed both soft-tissue attachment levels and bone regeneration, which was determined radiographically. The results of the study demonstrated that GEM 21S treatment led to statistically significant benefits in bone growth and accelerated tissue attachment level gain compared to the control group that received the _-TCP plus buffer, without the addition of the growth factor. Additionally, the study revealed no evidence of either local or systemic adverse effects resulting directly from placement of GEM 21S.

GEM 21S Information
GEM 21S is a prescription device. No specialized training is required for the use of the GEM 21S device beyond that required to perform periodontally-related grafting procedures. Clinicians are referred to the GEM 21S package insert for additional information, or to www.osteohealth.com.

Periodontal Disease
Currently there are over two million periodontal surgeries performed every year in the United States with nearly one-quarter of all adults over age 65 having severe periodontal disease. Periodontal disease results from infection and inflammation of the gum tissue adjacent to the tooth, and commonly leads to loss of bone and ligament structures supporting the tooth. A major goal of periodontal therapy continues to be regeneration of the attachment structures of teeth, including bone, periodontal ligament and cementum, which have been destroyed by periodontal diseases or trauma. Attempts to regenerate the bone and adjacent structures in periodontal defects have historically met with only modest and unpredictable success. Thus, clinicians have continued to seek more predictable regenerative therapies that are less technique sensitive, lead to faster tissue regeneration, and are applicable to the broad array of periodontal defects encountered daily by clinicians. Clinical studies conducted by BioMimetic demonstrated that GEM 21S stimulates healing of periodontally-related bony defect.

 

About BioMimetic Therapeutics
BioMimetic Therapeutics, Inc. is an emerging leader in the development and commercialization of recombinant protein-based products for the treatment of orthopedic and sports injury indications, including bone, cartilage, tendon and ligament. BioMimetic has established a multi-product pipeline based upon its core expertise in the development of convergent drug-device combinations for use in tissue engineering applications.

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. Except as required by law, BioMimetic undertakes no obligation to update any forward-looking or other statements in this press release, whether as a result of new information, future events or otherwise.

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