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Company Profile
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Company Profile
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Revolutionizing Regenerative Medicine
BioMimetic Therapeutics is developing and commercializing innovative drug-device combination products to promote the healing of musculoskeletal injuries and diseases, including orthopedic, spine and sports injury applications. BMTI's biologically-enhanced therapeutic devices provide new treatment options to improve the quality of life for millions of patients suffering injuries or deterioration of the bones, cartilage, ligaments and tendons.
Transforming the Orthopedics Industry
Development of drug-device combination products, or "convergent devices," has revolutionized the way that cardiovascular disease is treated and has proven to be both a clinical and commercial success generating over $5 billion in sales in 2005. BMTI believes the orthopedic industry will undergo a similar transformation from the use of traditional, passive, highly invasive metallic devices to more advanced, bio-active devices that stimulate tissue regeneration and repair. According to research analysts, U.S. sales of bone grafting products and orthobiologics reached $1.3B in 2005. Based on currently available therapies alone, the figure is expected to increase to $2.5B by 2010. With its first product approved for marketing by the FDA and several product candidates in the pipeline, BMTI believes it is well positioned to capitalize on this transformation.
| With the completed development and commercialization
of GEM 21S, the groundwork has been laid to rapidly
advance the Company's pipeline of products in
orthopedics and sports injuries. |
Investment Highlights - Large market opportunities in multiple markets – orthopedics, spine, sports medicine
- Deep product pipeline
- Clear development and commercialization pathway established - products seeking approval as medical devices (PMA)
- Exceptional management team with industry experience
GEM 21S Approved 2005
BioMimetic's first drug-device combination product, GEM 21S Growth-factor Enhanced Matrix, received FDA approval in November 2005 for the treatment of periodontal bone defects and gum tissue recession associated with periodontal disease. Since approval, the product has been marketed and distributed by Luitpold Pharmaceuticals, Inc.
GEM 21S is a fully synthetic regeneration system that combines the tissue growth factor rhPDGF-BB with a synthetic bone matrix, beta-tricalcium phosphate (β–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. In January 2008, BioMimetic sold its remaining dental business, including the downstream formulation, fill and finish manufacturing rights of GEM 21S to Luitpold. 
| Animal study combining rhPDGF with a
bone matrix to evaluate its ability to stimulate
bone repair in an osteoprotic model.
*(Significantly weaker than uninjured leg) |
The Augment™ Product
Advantage
BMTI believes its family of Augment™ product and product candidates will achieve widespread market acceptance and strong market penetration by providing significant advantages compared to existing therapies. The Company's Augment product and product candidates are based on the FDA-approved component rhPDGF-BB and synthetic and natural scaffold materials such as β–TCP, which have a history of demonstrated safety and efficacy in previous uses. Scientific studies in animal models have demonstrated that local administration of rhPDGF-BB can lead to enhancement of fracture repair while systemic administration can strengthen the skeleton throughout the body.
BioMimetic's Rapid Success
While on staff at Harvard, Dr. Samuel Lynch and colleagues begin developing the technology for the rhPDGF-BB protein, found to be one of the principal wound healing stimulators in the body.
2001 :: The Company closes its Series A funding and is officially incorporated. BioMimetic signs patent licensing agreements with Harvard Medical School and ZymoGenetics, Inc., and a supply agreement with Chiron Corporation.
2003 :: The Company completes pivotal clinical trials with GEM 21S in periodontal applications.
2005 :: The Company's first product, GEM 21S , is approved by the FDA for the treatment of periodontally-related bone defects.
2006 :: BioMimetic announces the initiation of orthopedic clinical trials with Augment™ Bone Graft in the United States, Canada and Sweden and releases clinical trial data showing Augment Bone Graft stimulates bone formation.
2007 :: BioMimetic announces positive results from its orthopedic pivotal trial with Augment Bone Graft in Canada. Company initiates pilot clinical trial with Augment™ Injectable Bone Graft in Sweden and Canada for use in closed fracture procedures.
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Stock Trading |
NASDAQ :: BMTI |
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IPO |
May 12, 2006 |
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Shares Outstanding |
18,336,746 [as of Jan. 2008] |
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Analysts |
Debjit Chattopadhyay [Boenning & Scattergood] |
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Tao Levy [Deutsche Bank Securities] |
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Michael S. Matson [Wachovia Capital Markets] |
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William Plovanic, CFA [Canaccord Adams] |
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Gregory Wade, Ph.D. [Pacific Growth Equities] |
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Jan Wald, Ph.D. [Stanford Group Company] |
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Christopher Warren [SunTrust Robinson Humphrey] |
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Executive Management
Samuel E. Lynch, D.M.D., D.M.Sc, President & CEO · Sankyo/Luitpold Pharmaceuticals
Steven N. Hirsch, COO · Pfizer, Smith & Nephew
Larry Bullock, CFO · RPI, La Jolla Pharmaceuticals
Charles E. Hart, Ph.D., CSO · Zymogenetics
Earl Douglas, General Counsel · Spinal Dynamics, Smith & Nephew
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Contact Information: 389 Nichol Mill Lane, Franklin, Tennessee 37067
Investor and Media Inquiries: Kearstin Patterson, Corporate Communications (615) 236-4419
Safe Harbor Statement
Certain statements in this Fact Sheet constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, all statements which set out our expectations, plans and other projections. These statements are based on management's current expectations and beliefs and actual events or results may differ materially. There are many important factors that could cause actual events or results to differ materially from those suggested by such forward-looking statements. BioMimetic encourages you to read the recent S-1 Prospectus for a more detailed discussion of risk factors which affect its business. BioMimetic does not assume an obligation to update forward-looking statements in respect of subsequent events except as required by law. |
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