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BSI OsteoCrete PowerPoint Overview, Mar 2008 (PPT)


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BSI OsteoCrete PowerPoint Overview, Mar 2008 (PPT)

  1. 1. OsteoCrete ® Next Generation Bone Void Filler
  2. 2. OsteoCrete ® <ul><ul><li>OsteoCrete ® is an award winning biomaterial containing a novel combination of potassium, tricalcium, and sodium phosphates . </li></ul></ul><ul><ul><li>OsteoCrete’s unique properties and multi-purpose capabilities provide the next generation in bio-materials. </li></ul></ul>
  3. 3. OsteoCrete ® properties <ul><li>Absorbed and replaced by new bone </li></ul><ul><li>Osteoproliferative </li></ul><ul><li>Slight expansion-increasing mechanical bond </li></ul><ul><li>Macro and micro pore structure </li></ul><ul><li>Excellent adhesive qualities </li></ul><ul><li>High compressive strength </li></ul><ul><li>Pore sizes cab be increased without loss of strength </li></ul><ul><li>Passes all FDA Guidance for Bio-Compatibility </li></ul><ul><li>Injectable or moldable </li></ul><ul><li>Initial set time 6-7 minutes, final set time 10-12 minutes </li></ul><ul><li>pH 7.2- 7-4 </li></ul>
  4. 4. OsteoCrete ® competition Calcium based products: Most other products as bone void filler, putty, or cement are calcium based Calcium based products do not have OsteoCrete’s unique combination of properties such as: being osteoconductive, osteogenic, resorbable, biocompatible, moldable and injectable, adhesive, and providing high compressive strengths.
  5. 5. OsteoCrete ® comparison * initial tests revealed osteogenic properties √ √ Biocompatible √ √ Provides effective bone growth scaffold √ √ Osteoconductive √ High compressive strengths √ Excellent adhesive properties √ Multipurpose bio-material √ Osteogenic OsteoCrete ® Ca based bone fillers
  6. 6. <ul><li>Orthopedic </li></ul><ul><li>Maxillofacial /Craniofacial </li></ul><ul><li>Plastic Surgery </li></ul><ul><li>Podiatry </li></ul><ul><li>Neurosurgery </li></ul>OsteoCrete ® medical applications
  7. 7. OsteoCrete ® medical applications <ul><li>Replacement for allografts without pathogen concerns </li></ul><ul><li>Alternative to BMP2 </li></ul><ul><li>Bio-adhesive for attachment of ligaments to bone </li></ul><ul><li>Maxillofacial- adhesive for replacing screws and plates </li></ul><ul><li>Augmentation of plates and screws </li></ul><ul><li>Neurosurgery </li></ul><ul><li>Plastic Surgery - building up facial skeleton </li></ul><ul><li>Hemostat </li></ul><ul><li>Cartilage Repair </li></ul><ul><li>Delivery System </li></ul><ul><li>Dental - securing implants same day after extraction, ridge augmentation and buildup, filler replacing allograft </li></ul>
  8. 8. <ul><li>Oral Surgery </li></ul><ul><li>Periodontal </li></ul><ul><li>Implantation </li></ul><ul><li>General Dentistry </li></ul>OsteoCrete ® dental applications
  9. 9. OsteoCrete ® Biocompatibility Tests Cytotoxicity Passed Sensitization Passed Intracutaneous Reactivity Passed System Toxicity Passed Implantation Passed Hemocompatiblity Passed
  10. 10. OsteoCrete ® Studies <ul><li>Critical size defeat in femur </li></ul><ul><li>ACL repair attaching ligament to bone </li></ul><ul><li>Augmentation screws and plates </li></ul><ul><li>Dental Implants </li></ul><ul><li>Critical size hole in cranium </li></ul>
  11. 11. OsteoCrete ® Future 510K FDA Filings <ul><li>Maxillofacial </li></ul><ul><li>Dental </li></ul><ul><li>Bone Cement </li></ul><ul><li>Anchor </li></ul>
  12. 12. OsteoCrete ® Future FDA Filings <ul><li>Adhesive </li></ul><ul><li>Delivery Stem Cells </li></ul>
  13. 13. OsteoCrete ® Investigators/ Researchers Alicia L. Bertone, Ph.D. Ohio State University David Cochran, D.D.S. Department of Periodontics at the University of Texas Health Science Center at San Antonio Scott A. Rodeo, M.D. Orthopedics Hospital for Special Surgery John Russo, M.D., D.D.S. International Congress of Oral Implantologists Stephen A. Schendel, M.D., D.D.S. Stanford University Medical Center
  14. 14. OsteoCrete ® Scientific Advisor Board Alicia L. Bertone, Ph.D. (Chair) Ohio State University Edward Mills, D.D.S. Center for Restorative Dentistry James Montgomery, M.D. Orthopedic Specialists of Dallas Michael A. Pikos, M.D., D.D.S. MAP Implant Institute John Russo, M.D., D.D.S. International Congress of Oral Implantologists Thomas G. Wilson, Jr., D.D.S. U. of Texas Dental School; Baylor College of Dentistry
  15. 15. OsteoCrete ® Phosphate Biohesive Markets <ul><li>Market Potential of $3B </li></ul><ul><li>Top 5 initial segments </li></ul><ul><ul><li>Bone Grafting </li></ul></ul><ul><ul><li>Maxillofacial/Craniofacial </li></ul></ul><ul><ul><li>Dental Implant/Oral-Periodontal Surgery </li></ul></ul><ul><ul><li>Bone Void Filler-Augmentation </li></ul></ul><ul><ul><li>Anchor </li></ul></ul>
  16. 16. OsteoCrete ® Intellectual Property <ul><li>BSI technology is protected by U.S. Patents </li></ul><ul><li>Additional U.S. and International Patent Applications are pending </li></ul><ul><li>OsteoCrete ® is a Registered U.S. Trademark </li></ul>
  17. 17. OsteoCrete ® Summary <ul><li>Unique low cost solution for major orthopedic market segments </li></ul><ul><li>Patented and proven technology </li></ul><ul><li>Next Generation biomaterial with unique properties </li></ul><ul><li>Additional applications under research </li></ul><ul><li>First FDA clearance pending </li></ul>
  18. 18. <ul><li>Founded 2003 </li></ul><ul><li>Based in Dallas, TX </li></ul><ul><li>Patented product – biocompatible magnesium phosphate compound </li></ul><ul><li>Company partners </li></ul><ul><ul><li>Boston Biomedical Associates – FDA </li></ul></ul><ul><ul><li>Tesca – FDA & CE </li></ul></ul><ul><ul><li>BCTech – manufacturing </li></ul></ul><ul><ul><li>McDonnell Boehnen Hulbert & Berghoff LLP – IP Counsel </li></ul></ul><ul><ul><li>Wilson Sonsini Goodrich and Rosati – Corporate Counsel </li></ul></ul><ul><ul><li> </li></ul></ul>Bone Solutions, Inc. Company Profile