Collagen Matrix Inc has received CE Mark approval for its Collagen Bone Healing Patch. The Collagen Bone Healing Patch is a safe, resorbable, flexible, collagen-based membrane intended for maintaining the position of bony fragments and/or bone graft substitute materials and to assist in wound healing in guided/protected bone regeneration procedures.

The product is indicated for use at both the implant site and the autograft donor site in bone graft procedures, such as mandibular bone graft procedures, alveolar ridge repair, cranial bone graft procedures, maxillofacial bone graft procedures, and iliac crest autograft procedures. The Collagen Bone Healing Patch can be used in conjunction with rigid fixation devices.

The concept of guided bone regeneration, also referred to as protected bone regeneration, has long been accepted and practiced in the field of dentistry and oral surgery. The fundamental hypothesis, which has been demonstrated in animals and in humans, is that tissues, including bone, have the intrinsic ability to regenerate providing the environment is suitable for regeneration. As the guided bone regeneration concept gains popularity and use in many surgical applications, including cranial, maxillofacial and neurological surgery, Collagen Matrix has developed a collagen-based patch that possesses unique characteristics suitable to maintain bone graft material while assisting in wound healing of the bone defect. The Collagen Bone Healing Patch is biocompatible, resorbable, flexible, and semi-permeable. The unique orientation of the collagen fibers within the product provides a mechanical strength, which allows the product matrix to be sutured, tacked or screwed in place. The device is supplied sterile and non-pyrogenic.

"We are pleased that the clinical applications of our core collagen-based implant technology have expanded into the areas of cranial surgery, maxillofacial surgery and bone graft donor site surgeries with the approval of the Collagen Bone Healing Patch. The product's indication for cranial surgery is a nice compliment to our recently CE mark-approved DuraMatrix Collagen Dura Substitute Membrane," said Shu-Tung Li, Collagen Matrix's President and CEO. "The Company has developed a strong relationship with the European regulatory authorities and the U.S. FDA and plans to continue to aggressively expand its line of collagen-based medical devices in 2003." The Company is currently seeking a corporate partner to market the Collagen Bone Healing Patch.