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biodegradable injectable adhesive for orthopaedics

ORTHOPAEDIC NEEDS: RESORBABLE BIOADHESIVE ANCHOR. Synthetic hardening agents, PMMA and polymers, as well as Ca-based bone fillers/cements do not claim to be adhesiveIdeal Product would:adhere bone-to-bone; tendon and ligament-to-boneBe osteoconductive [Support bone formation]Serve as delivery device for osteoinductive substancesBe biocompatible and bioabsorbable within bone healing time frame (months).

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biodegradable injectable adhesive for orthopaedics

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    1. BIODEGRADABLE INJECTABLE ADHESIVE FOR ORTHOPAEDICS

    3. Current Bone Cement Limitations PMMA - Nonabsorbable, exothermic, nonadhesive Calcium [Ca] phosphate compounds Prolonged Resorption Profile (Norian® SRS®, Synthes) (Apelt et al. (2004) Biomaterials 25:1439) May not be Injectable (Bone Source®, Stryker) May be Associated with Lethal Embolization when Injected (Bernard et al. (2004) Trans ORS:254)

    4. BONE SOLUTIONS TECHNOLOGY Magnesium-based (87%) injectable formulation Global exclusive licensing rights with Bindan Corp, U.S. Patent 6533821, and all other refinements to this technology for human and vet applications 1 Patent awarded; 4 Patents filed including for adhesive qualities Key Components MgO2 MgKPO4 Small amts TCP (Tricalcium Phosphate) and other binders of H2O

    5. Magnesium Injectable Cement Adheres Bone and Tendon to Bone 16 Knee Joints, Femurs and Achilles from 8 mid-sized dogs Fracture Model Femur Anterior Cruciate Ligament Models Bone to Bone - Patellar bone-tendon in Femur Tendon to Bone - Achilles in Tibia Bone Tunnel

    6. Groups and Biomaterials Press-fit Control (n=16) Ca Injectable Cement - Ca Phosphate; (n=8; Norian® SRS®, Synthes, Paoli, PA) Mg Injectable Cement - Mg Phosphate; (n=8; Bone Solutions, Dallas, TX)

    7. RESULTS- ACL MODEL

    8. Magnesium Cement Adheres Screws to Bone Screw extraction torque greater than Ca product, PMMA, or Control (P<0.001)

    9. Mechanism of Bonding Phosphate bonding Expansion

    10. In Vivo Horse Study 3-piece Fracture Model 3 treatments Press fit Ca Phosphate cement (Bone Source, Stryker) Mag Cement (Osteokrete®, BSI)

    11. In Vivo Horse Study Computed Tomography confirmed more bone in Mag Cement group Histology at 7 weeks showed Mag cement still present in some specimens No inflammatory reaction Normal bone formation Good healing

    12. Current Strategy and Funding Needswww.bonesolutionsinc.com BSI is completing an initial angel round. An Offering Memorandum is available. Future funding, expected in 2006, after FDA 510 (k) submissions. Priority Use of Funds goes into science and completion of four FDA 510 (k)’s; bone void filler, bone cement, bone anchor, and dental cement. NAMSA, Toledo, OH, will complete initial 510 (k) animal testing. Veterinary launch 1Q 2006. Distributor selected. Market size potential covers over 100 CPT codes in initial targeted uses. BSI is also exploring CE Mark opportunities in Europe

    13. Technical Advisory Board Dr. Scott Rodeo, Orthopedics Hospital for Special Surgery, NY Dr. Joseph Iannotti, Chairman, Orthopedics Department, The Cleveland Clinic, Cleveland, OH Dr. Jim Montgomery, Head Orthopedic Specialists, Dallas, TX Dr. Tarek Souryal, Head, Sports Medicine Clinic of Dallas Dr. Richard Steadman, Steadman-Hawkins Clinic (pending) Dr. Michael A. Pikos, (DDS) MAP Implant Institute, a Diplomate of the American Board of Oral and Maxillofacial Surgery, Diplomate of the American Board of Oral Implantology/Implant Dentistry. Palm Harbor, FLA. Dr. Edward Mills, (DDS) Head, Center Restorative Dentistry. Dr. John Russo, (DDS, MHS), Fellow of the International Congress of Oral Implantologists, Sarasota, FL Dr. Alicia Bertone, Chair, BSI Technical Advisory Board, Professor, Ohio State University, Columbus, OH

    14. BSI Team John Albers, Chairman & CEO; Head of Fairfield Enterprises, Pharmaceutical Technologies Developer Tony Copp, COO & Director; 30 Years experience in Finance/EAC Ltd, focused on new technologies Tom Lally, President & Director, Inventor Jim McNamara, Treasurer; Director IBM Finance/Marketing Executive Drew Diaz, Director; Medical Device, International Sales Executive Wade B. Hampton, Director, Medical Device, National Sales Executive Leo Basta, Boston Biomedical Associates, Regulatory Consultant Dr. Alicia Bertone, Chair, Technical Advisory Board

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