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Conversion of Sea-Shells to Synthetic Bone

Organization:University of California San Diego, 92093, US
I.P. Brief:A novel process for exploiting the natural structural strength of marine shells, converting them to hydroxyapaite for use as synthetic bone.
Summary of I.P.:This technology provides a ready inexpensive source for bone replacement materials which exhibit exceptional bio-compatibility and mechanical properties. Whereas Titanium has been the material of choice in the past, there exists considerable mechanical mis-match between native bone and the Ti alloy. The great differences in these two material\'s mechanical properties leads to eventual failure at the interface, where stresses are greatest. By introducing an implant material that exactly mimics bone, and is eventually integrated into the native bone, longer lasting (i.e. lifetime) implants are possible. This technology can be used in any number of implant prodecures, both cosmetic, dental and load bearing bone repairs (tibia/fibia, etc.).
Patent:PCT application filed. Not yet publicly available.
Keywords:synthetic bone, implants, orthpaedic surgery, cosmetic surgery, dental implant
Primary Industry:Pharma & Biotech
Specific Market:medical and dental implants
Market Size:the market size for this technology is in the billions of dollars world wide.
State of the Art:State of the art is Titanium based devices. While these work well, the significant mechancial property mis-match leads to fatigue in the union between native bone and the Ti materials. Also used are bone grafts from the patient and/or cadaver bones. Both increase risk of post-operative infection.
Competition:Other efforts to create synthetic bone do not exploit the native strength of marine shells. With competing approaches, an implant becomes load bearing after months of integration by the native bone. This adds months and thousands of dollars of cost to patient rehabilitation.
Figures of Merit:This technology maximizes the use of the marine shells inherent structural strength, yielding load bearing implants that are ready for full use the day after surgery. Currently the technology is being tested in animals at the UCSD School of Medicine.
Tech.  Obstacles:The marine shells, means of conversion to hydroxyapatite and milling techniques are all commercially available. The primary challenge will be ensuring bio-compatibility with human tissue; however, early animal studies are all positive in their findings.
Market Obstacles:To see this technology adopted in the broad orthopaedics market, we would need to overcome a strong market position held by Titanium implants, as well as the familiarity and comfort surgeons have using Ti alloy implants. The long term benefits however of a load bearing implant that is gradually integrated back into the native bone should be a compelling message which will allow this technology to gradually assume market share from the existing Ti technologies. Milestones include: - successful animal study and Phase 1 data - Phase II clinical trial with larger group - 510K submission to FDA - FDA approval for new medical implant device
Patent Landscape:6,302,913 6,527,810 6,022,509 various others related to methods of implantation
Publications:Xing Zhang and Kenneth S. Vecchio, Creation of dense hydroxyapatite (synthetic bone) by hydrothermal conversion of seashells, Materials Science and Engineering: C, In Press, Corrected Proof, , Available online 7 October 2005, . ( Keywords: Hydroxyapatite; Seashells; Hydrothermal
Research Team:Professor Kenneth Vecchio, PI in Materials Science (responsible for material development and process optimization) Professor Choll W. Kim, Co-PI in Orthopaedic Surgery (responsible for animal and future human trials) Various graduate students and post doctoral researchers. Combined experience 40 years.


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