FRANKLIN LAKES, N.J., Oct. 31 /PRNewswire/ -- Collagen Matrix, Inc. is pleased to announce that it has received FDA’s 510(k) clearance of its Collagen Bone Healing Protective Sheet intended for use in orthopedic applications involving bone repair. The Collagen Bone Healing Protective Sheet is used to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The product is also indicated for cement restriction in total joint arthroplasty procedures.
The Collagen Bone Healing Protective Sheet is a white, nonfriable, conformable, resorbable sheet engineered from highly purified type I collagen. The product can be cut with scissors to the desired shape and size. It is fully conformable when hydrated and can conform three dimensionally to most any anatomical orientation. The Collagen Bone Healing Protective Sheet can be rolled into a tube or used as a flat sheet. It can be used either alone or in conjunction with internal bone fixation devices such as plates and screws, which also can serve to further stabilize the anatomical region.
The concept of “protected bone regeneration” in orthopedics is a concept whereby three prerequisites for bone healing are desired: (i) adequate blood supply, (ii) abundant bone forming cells, and (iii) protected healing space. The Collagen Bone Healing Protective Sheet provides the third factor of protected healing space by containing the bone fragments or bone graft material within the defect site while not hindering/impeding the blood supply or accessibility of bone forming cells to the site. We believe that this product has tremendous opportunity in the orthopedic market, particularly in the areas of tumor resections, trauma, and iliac crest harvests.
“The FDA clearance of the Collagen Bone Healing Protective Sheet along with the existing CE mark for this device represents the first of a pipeline of products intended for the orthopedic market. We continue to expand on our core technology in the repair of both soft and hard tissues,” said Shu-Tung Li, Ph.D., Founder and CEO of Collagen Matrix.
Collagen Matrix, Inc. is a leader in the design and engineer of collagen- based extracellular matrices for tissue and organ repair and regeneration. The Company currently manufactures collagen-based finished medical devices in areas of oral surgery, neurosurgery, orthopedic surgery, and wound care. For more information, see www.collagenmatrix.com.
Contact: Shu-Tung Li, Ph.D., 201-405-1477
Collagen Matrix, Inc.
CONTACT: Shu-Tung Li, Ph.D., +1-201-405-1477, for Collagen Matrix, Inc.
Web site: http://www.collagenmatrix.com/
