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IsoTis OrthoBiologics Receives Two FDA 510k Clearances in Dental Indications |
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04 Apr 2006 |
LAUSANNE, Switzerland, IRVINE, CA, USA | Apr 04, 2006 | IsoTis S.A. (SWX/Euronext: ISON) (TSX: ISO) today announced it received 510(k) clearances from the US Food and Drug Administration (FDA) for the use of Accell Connexus(TM) and OrthoBlast II(R) in dental indications.
Pieter Wolters, President and CEO of IsoTis OrthoBiologics said: "We are very pleased with our ability to now offer a complete product range for bone graft substitution in dental indications in the United States. Earlier we had obtained FDA 510(k) clearance for DynaGraft II (TM) and OsSatura BCP (TM) in dental indications. While our focus as a company will remain on spinal and orthopaedic indications, our differentiated portfolio of products for dental indications should enable us to benefit from opportunities in the dental field as well."
Accell Connexus is a highly osteoinductive bone graft substitute that provides exceptional handling and graft containment. It is part of the Company's proprietary Accell(R) technology product line. Accell Connexus is a putty with an array of growth factors, including TGF- Beta-1 and various natural human bone morphogenetic proteins (nhBMPs™). Compared to 1st generation DBM products, the AccellRx process on which Accell Connexus is based yields a higher level of TGF- Beta-1 and nhBMPs, including BMP-2, BMP-4 and BMP-7, which act synergistically to stimulate new bone formation. Employing a state-of-the-art reverse phase medium ("RPM"), Accell Connexus thickens at body temperature and resists irrigation so the nhBMPs are delivered at the surgical site where they are needed.
OrthoBlast II is a combination of demineralized bone matrix particles (DBM) with cancellous bone chips delivered in RPM. Therefore, the products it is malleable at operating room temperatures, but thickens when placed in the operative site. This allows the DBM particles and bone chips to be contained at the graft site with minimal loss through irrigation and suction.
IsoTis OrthoBiologics, the operating subsidiary of IsoTis S.A., has a product portfolio with several innovative and proprietary natural and synthetic bone graft substitutes on the market and others in development, an established North American independent distribution network, and an expanding international presence. The company's main commercial operations are based out of Irvine, CA; its international sales headquarters is based in Lausanne, Switzerland.
SOURCE: IsoTis S.A. |
