Numerous presentations were made today during the Regenerative Strategies Forum at the 2012 American Orthopaedic Foot and Ankle Society (AOFAS) annual meeting in San Diego, CA which supported the safety, effectiveness, clinical need, biologic rationale and cost effectiveness of Augment™ Bone Graft from BioMimetic Therapeutics, Inc. (NASDAQ: BMTI). Regenerative Strategies and Emerging Technologies Pre-meeting Presentations The forum included lectures by numerous leading foot and ankle surgeons covering regenerative strategies related to foot and ankle surgery. The following presentations highlighted the clinical and pharmaco-economic need and biologic rationale for Augment Bone Graft as an alternative to autograft.
- Augment Bone Graft: Worldwide Clinical Evidence was presented by Timothy Daniels, MD and focused on the compelling evidence, generated from multiple clinical studies involving over 600 patients, supporting the safety and effectiveness of Augment Bone Graft in promoting bone healing. Dr. Daniels reviewed Augment Bone Graft’s clinical trials conducted throughout the United States, Canada and Europe and recognized the product as the first orthobiologic with compelling level 1-5 evidence in foot and ankle fusions, concluding that in his opinion it had been demonstrated to be a safe and effective alternative to autograft
- Pain after Bone Graft Harvest: Are All Sites the Same? was presented by Judy Baumhauer, MD, president of the AOFAS. Dr. Baumhauer reviewed results of patient reported outcomes of acute and chronic pain from bone grafts harvested from different anatomical sites in the body to determine if harvest site location influenced levels of pain experienced by patients. The results presented demonstrated that harvesting autogenous bone graft causes clinically significant acute pain in 35 percent of patients and clinically significant chronic pain in up to 20 percent of patients, regardless of the anatomic harvest site. Because Augment Bone Graft does not require harvesting autogenous bone graft, the patient is spared the pain associated with this procedure. Christopher DiGiovanni, MD will also elaborate on the findings in this study and their implications for foot and ankle surgeons later in the conference.
- Establishing the Relationship between Clinical Outcome and Extent of Osseous Bridging by CAT Scan Assessment in Isolated Hindfoot and Ankle Fusions was presented by Mark Glazebrook, MD and analyzed data from the Augment Bone Graft pivotal trial correlating clinical outcomes assessed by the patient and surgeon with the radiologic outcomes (osseous bridging on CT scans) assessed by a blinded musculoskeletal radiologist. The data presented demonstrated a strong correlation between the degree of osseous bridging on CT scans and improvement in clinical outcome scores. This analysis also substantiated the use of CT scans to assess the primary endpoint of bone fusion in BioMimetic’s pivotal clinical trial.
- Concept of Relative Deficiency of Growth Factors in Hindfoot Fusions was presented by Sheldon Lin, MD and reported clinical results demonstrating that diabetic patients with poor bone healing have deficiencies in growth factors, specifically platelet-derived growth factor (PDGF) and vascular endothelial growth factor (VEGF). These patients are therefore more prone to complications, including non-unions, in hindfoot fusion surgery. The study suggests a correlation between lower levels of PDGF and poorer bone healing. This finding supports the biologic rationale for use of Augment to increase local PDGF levels in patients, such as diabetics, who may be at increased risk for delayed healing or non-union.
- Does Bone Graft Work in Foot and Ankle Surgery? was presented by Christopher DiGiovanni, MD. Dr. DiGiovanni reviewed results from a meta analysis of published, peer-reviewed literature assessing the effectiveness, and necessity, of bone grafting in foot and ankle fusions. The odds of successful union for patients treated with autograft were one-and-a-half- to three-times higher than for patients treated without graft. This observation supports the use of autograft as the positive control in Augment Bone Graft’s pivotal trial, which demonstrated that the two products have equivalent efficacy. Further analyses of the data are ongoing.
- Analysis of Cost for Autologous Bone Graft for Foot and Ankle Surgery was presented by Nicholas Abidi, MD and reported research findings from a study analyzing hospital budgetary impact costs for autogenous bone graft harvest and bone graft substitutes. Preliminary findings from the study demonstrated that actual incremental costs and budgetary impact associated with operating room time, graft harvesting supplies and complications are likely under-realized by hospitals. Dr. Abidi also presented a cost calculator by which hospitals may assess the true cost of autogenous bone graft in their institution relative to other orthobiologic alternatives.
- Bone Marrow Concentrate/Stem Cell for Fusion was presented by Michael Pinzur, MD and reported a new paradigm for bone healing stressing the importance of regulatory molecules such as rhPDGF-BB in combination with stem cells from bone marrow aspirate and tissue scaffolds. Dr. Pinzur noted that rhPDGF-BB and VEGF increase growth and recruitment of stem cells and new blood vessel formation leading to improved healing of bone defects and surrounding soft tissue injuries.
- Outcomes of Hindfoot Surgery Augmented with Injectable Bone Graft: Results of a Multi-centered Randomized Control Trial will be presented by Timothy Daniels, MD, the lead advisory investigator for this clinical trial. Dr. Daniels will review study results from the Company’s Canadian Augment™ Injectable Bone Graft trial. The Company plans to release the results provided during this presentation in a press release after market close on Thursday, June 21, 2012. Slides from the presentation will be filed as an 8K following the AOFAS meeting.
- Clinical Decision Making on the Need for Autologous Bone Graft: Results of a Nationwide Survey among Orthopaedic Foot and Ankle Surgeons will be presented by Judy Baumhauer, MD. This study reviews results from a survey which determined that both clinical and radiologic factors important to foot and ankle surgeons play a critical role in the decision to use bone graft or orthobiologics, such as Augment Bone Graft.
About BioMimetic TherapeuticsBioMimetic Therapeutics (NASDAQ: BMTI) is a biotechnology company specializing in the development and commercialization of clinically proven products to promote the healing of musculoskeletal injuries and diseases, including therapies for orthopedics, sports medicine and spine applications. All Augment ® branded products are based upon recombinant human platelet-derived growth factor (rhPDGF-BB), which is an engineered form of PDGF, one of the body's principal agents to stimulate and direct healing and regeneration. Through the commercialization of this patented technology, BioMimetic seeks to become the leading company in the field of regenerative medicine by providing new treatment options for the repair of bone, cartilage, tendons and ligaments. BioMimetic has received regulatory approvals to market Augment ® Bone Graft in Canada, Australia and New Zealand for use in hindfoot and ankle fusion indications. Augment is pending regulatory decisions in the U.S. and European Union for similar indications. The Company also markets a bone graft substitute line of products for orthopedic indications called Augmatrix TM Biocomposite Bone Graft. For further information contact Kearstin Patterson, senior director of corporate communications, at 615-236-4419. Forward-looking Statements This press release contains forward-looking statements about our future results of operations and financial position, product development programs, business strategy, budgets, projected costs, plans and objectives of management for future operations that are not historical facts. The words “may,” “continue,” “estimate,” “intend,” “plan,” “will,” “believe,” “project,” “expect,” “anticipate,” “optimistic” and similar expressions may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. There are many important factors that could cause actual results to differ materially from those indicated in the forward-looking statements, including factors related to: (i) the FDA may not be satisfied with the Company’s amendment to its PMA and may determine such PMA is not approvable or require additional clinical trials; (ii) despite the Company’s future marketing and commercialization efforts, Augment and Augmatrix may not achieve broad market acceptance; and (iii) the EU regulatory authorities may determine that the CE Mark for GEM 21S was improperly granted and may not approve the CE Mark for Augment as a medical device. Further, 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 detailed in BioMimetic’s recent annual and quarterly reports filed with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in the Company’s Annual Report on Form 10-K filed with the SEC on March 13, 2012, which are incorporated in this press release by this reference. 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, and has no policy of doing so.