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R & D
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The BioMimetic Advantage
BioMimetic Therapeutics believes it is uniquely positioned to develop a variety of enhanced medical devices through the combination of existing medical devices and a biologically active growth factor that will stimulate tissue regeneration and repair, thereby providing faster healing and a better functional outcome for the patient. Further, BioMimetic believes that this strategy positions the Company to open new musculoskeletal product segments that address underserved or unmet clinical needs, particularly in advancing the treatment of fractures and injuries of cartilage, ligaments, and tendons. In seeking to address these unmet medical needs, BioMimetic believes the orthopedic industry is in the early stages of a transition from the use of traditional, passive, highly invasive metallic devices to more advanced, bio-active devices.
BioMimetic's products and product candidates utilize recombinant human Platelet-Derived Growth Factor (rhPDGF-BB), one of the principal wound healing stimulators in the body. rhPDGF-BB is well suited for use in multiple product candidates due to its stimulation of a broad spectrum of cellular events critical for the initiation and progression of orthopedic tissue healing.
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BioMimetic Product Pipeline
Building on the successful approval of GEM 21S, BioMimetic has a pipeline of drug-device combination product candidates that the Company is developing for a broad range of orthopedic clinical indications. BioMimetic's product candidates, which also incorporate rhPDGF-BB in combination with a bone matrix, are targeted to be used in the open (surgical) treatment of fractures and fusions (GEM OS1), the closed (non-surgical) treatment of fractures (GEM OS2), and the stimulation of bone formation at sites of risk for fracture, such as the spine in individuals with osteoporosis (GEM OS2). The Company also plans to focus on product candidates targeting cartilage, ligament and tendon repair (GEM C and GEM LT). All of these product candidates are at various stages of preclinical or clinical development.
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Product Advantages
BioMimetic believes its product candidates have the opportunity to provide significant advantages compared to existing therapies. BioMimetic's product candidates, which are based on the FDA-approved components, rhPDGF-BB and synthetic and natural scaffold materials such as β–TCP, provide the following advantages:
- Broad application across orthopedic and musculoskeletal indications
- Stimulation of healing cascade
- Combined benefits of both the medical device and drug components
- Elimination of the requirement to harvest autologous tissue, therefore lessening pain, shortening surgical procedure time, and lowering potential adverse effects
- Proven safety profile
- Reliable, scalable manufacturing process
The strategy the Company is following leverages on its success of GEM 21S, which is now owned by Luitpold Pharmaceuticals, Inc., a group company of Daiichi Sankyo Co., Ltd. of Japan.
To view a brief animation describing the healing process of GEM technology, please click here. |
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Historical Product Development for Periodontal Disease
GEM 21S Growth-factor Enhanced Matrix
The Company's first product candidate, GEM 21S, was approved by the FDA and Health Canada for the treatment of bone loss associated with advanced periodontal disease. GEM 21S combines the tissue growth factor, recombinant human Platelet-Derived Growth Factor (rhPDGF-BB) with the synthetic bone matrix, Beta-tricalcium phosphate (β-TCP).
Osteohealth Company, a division of Luitpold Pharmaceuticals, Inc. which is a group company of Daiichi Sankyo Co., Ltd., Osteohealth is responsible for the worldwide marketing, sales, distribution, development and fill/finish of GEM 21S . Clinicians should contact Osteohealth directly for additional product information.
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Product Development for Orthopedic Indications
Development of "convergent devices" has revolutionized the way that cardiovascular disease is treated and has proven to be both a clinical and commercial success. BioMimetic 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. With GEM 21S approved for marketing and several product candidates in the research and development pipeline, the Company believes that it is well positioned to capitalize on this transformation.
BioMimetic has established strong clinical contacts, manufacturing facilities and a regulatory pathway to product development. These coupled with the well characterized biology and history of safe use of rhPDGF-BB and the clinically proven efficacy of the GEM technology, all position BioMimetic to become a leader in the development and commercialization of biologically-active devices that will capitalize on the growing market for these products in orthopedic, spine and sports injury applications.
The orthopedic, spine and sports injury markets have recently experienced increased demand towards adoption of biologically active treatments, which seek to stimulate the body's own capabilities for regeneration of tissue at the injury sites. The Company is developing a family of product candidates, for the treatment of specific orthopedic applications, including bone defects, fractures treated with open and closed surgical procedures, and spinal applications, including vertebral compression fractures. The GEM OS product candidates combine rhPDGF-BB with proprietary resorbable bone matrices.
| GEM OS1 components, rhPDGF
and β-TCP, mixed prior to surgery |
GEM OS1 Bone Graft
BioMimetic is developing GEM OS1 for use in open fracture reduction, or fractures requiring surgery. GEM OS1 is similar to GEM 21S in that it combines a particulate β-TCP with rhPDGF-BB. GEM OS1 is designed to be placed directly into an open surgical site for the stimulation of bone regeneration.
GEM OS2 Injectable Bone Graft
BioMimetic is developing an injectable product, GEM OS2, for the treatment of fractures not requiring surgery and for prophylactic bone augmentation. The GEM OS2 product combines rhPDGF-BB with an injectable bone matrix.
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Cartilage, Ligament and Tendon Product Candidates
BioMimetic is using its proprietary technology to develop products addressing unmet medical needs in sports injury, initially targeting cartilage, ligament and tendon repair and regeneration. |
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