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Collagen Matrix, Inc. Receives FDA 510(k) Clearance for New Collagen Dental Membrane Based on New Collagen Platform Technology


10/22/2009 9:26:21 AM

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FRANKLIN LAKES, N.J., Oct. 22 /PRNewswire/ -- Collagen Matrix, Inc., the leader in collagen- and mineral- based matrix engineering, announced today that it has received FDA's 510(k) clearance of its new Collagen Dental Membrane indicated for use in oral surgical procedures involving guided tissue and bone regeneration.

This new Collagen Dental Membrane is a nonfriable, conformable, resorbable, membrane matrix consisting of highly purified type I and III collagen derived from bovine dermis. The purified intact collagen tissue membrane offers differences in handling as compared to the Company's already marketed and highly successful collagen dental membranes. As the area of regenerative medicine in the dental market continues to expand, the demand for collagen membranes has increased worldwide. Each of Collagen Matrix's five distinct Collagen Dental Membranes has features that distinguish one from the other. These distinguishing features have been driven by the needs and input from the clinicians. Design requirements such as handling, in vivo stability, shape, conformability or rigidity, have been optimized and adjusted for each dental membrane based on clinical feedback and specific treatment needs.

The significance of the new technology is the use of tissue rich in collagen, whereby the proprietary treatment eliminates most, if not all, of the non-collagenous materials resulting in a highly purified intact collagen matrix. This treatment maintains the intact collagen framework while eliminating associated non-collagenous materials. The purity of the Company's intact collagen tissue matrix surpasses most tissue-based products currently on the market.

"We are pleased to add another important product to our expanding portfolio of solutions for periodontal and oral surgical procedures. The new purified intact collagen tissue matrix technology complements the existing reconstituted type I collagen technology and adds another dimension to the breadth of collagen expertise in the Company's intellectual property. This is another platform on which we plan to build and innovate for future products in key areas of growth," said Shu-Tung Li, Ph.D., Founder and CEO of Collagen Matrix.

Collagen Matrix, Inc. is a leader in the design and engineering of collagen- and mineral-based extracellular matrices for tissue and organ repair and regeneration. Since its inception in 1997, the Company has received many government grants for the development of collagen-based matrix products in the areas of neurological, vascular, urological, and orthopedic tissue regeneration applications. The Company currently manufactures collagen- and mineral-based finished medical devices in the areas of neurosurgery, oral surgery, orthopedic-spine surgery, and wound care. More information about the Company can be found at www.collagenmatrix.com.

Contact: Peggy Hansen, RAC, Vice President, Clinical, Regulatory, Quality Assurance, and Marketing


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