Collagen Matrix's new Collagen Dental Membrane granted FDA 510(k) clearance

Oct 1 2010

Collagen Matrix, Inc., the leader in collagen- and mineral-based matrix engineering, announced today that it has received FDA's 510(k) clearance of a new Collagen Dental Membrane derived from porcine dermis 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 porcine dermis.  The proprietary purification process results in a purified intact collagen tissue membrane with negligible non-collagenous materials. 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 six 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 porcine 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.      

"The introduction of porcine tissue to our technology coincides nicely with the facility expansion of Collagen Matrix occurring this year.  A space will be dedicated to the processing of porcine tissue.  The possible clinical uses of this new material are broad and add yet 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.