Collagen Matrix, Inc. Receives FDA 510(k) Clearance For SynOss(TM) Synthetic Mineral Bone Graft Material

Main Category: Bones / Orthopedics
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 06 Nov 2007 - 0:00 PDT

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Collagen Matrix, Inc. announces that it has received FDA's 510(k) clearance of its SynOss(TM) Synthetic Mineral bone graft material intended for use in oral surgical applications involving bone repair.

SynOss Synthetic Mineral is an osteoconductive calcium phosphate based bone graft material with an apatite structure similar to that of human bone. Unlike hydroxyapatite materials, SynOss' has a carbonate apatite structure which is comparable to the mineralized matrix structure of human bone. The similarity in structure between SynOss and natural bone mineral allows for SynOss' in vivo resorption and remodeling profile to mimic that of natural bone.

The synthetic mineral product is complementary to the Company's existing line of products intended for dental and oral surgery, which include Collagen Dental Membranes, Anorganic Bone Mineral, Anorganic Bone Mineral with Collagen, and Collagen Dental Wound Dressings in various forms (i.e., Foam, Tape, Plug, and Microfibrillar). These products are sold through partnerships with major companies in the dental market.

"Our goal is to provide the dental and oral surgical markets with a full line of innovative products for use in regenerative medicine. The addition of SynOss is another step in reaching that goal," said Shu-Tung Li, Ph.D., Founder and CEO of Collagen Matrix.

About Collagen Matrix

A Franklin Lakes, NJ based, privately-held, leading collagen- and mineral-based biomaterials company, Collagen Matrix, Inc. has applied its expertise in proprietary matrix engineering to develop and commercialize novel implants for tissue and organ repair and regeneration. The Company currently manufactures collagen- and mineral-based finished medical devices in areas of oral surgery, neurosurgery, orthopedic-spine surgery, and wound care. Over 20 products are currently being marketed directly or through partnerships with some of the world's major medical device companies. In addition to the products in the oral surgical area, Collagen Matrix's marketed products include: DuraMatrix(TM) for dural repair, Neuroflex(TM), NeuroMatrix(TM) for peripheral nerve repair, OssiMend(TM) for bone repair in orthopedics and spine, and the Matrix Collagen Family of Products for wound care. For more information, visit http://www.collagenmatrix.com.

Collagen Matrix, Inc
http://www.collagenmatrix.com

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