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Collagen Matrix, Inc. Receives FDA 510(k) Clearance for TenoMend(TM) Collagen Tendon Wrap for the Management and Protection of Tendon Injuries

Wednesday, May 28, 2008 General News J E 4
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FRANKLIN LAKES, N.J., May 27 Collagen Matrix, Inc.announced today that it has received the United States Food and DrugAdministration's 510(k) clearance of its TenoMend(TM) Collagen Tendon Wrapindicated for the management and protection of tendon injuries in which therehas been no substantial loss of tendon tissue.

TenoMend(TM) Collagen Tendon Wrap is a resorbable type 1 collagen matrixthat provides a non-constricting encasement for injured tendons. TenoMend(TM)Collagen Tendon Wrap is designed to be an interface between the tendon andtendon sheath or the surrounding tissue. When hydrated, TenoMend(TM) CollagenTendon Wrap is a conformable, nonfriable, self-curling collagen sheet designedfor easy placement under, around or over the injured tendon. The patentedself-curling wrap design offers the ability to implant with minimal suturing.The device provides a protected environment and gliding surface of the sheathfor tendon healing.

In trauma cases, fractures and injuries of bones in the extremitiestypically result in injury of the associated soft tissue such as tendon andperipheral nerves. Tendon scarring can often occur as a result of tendonrepair. When tendon scarring occurs, other structures such as joints may losenormal range of motion.

Collagen Matrix's portfolio of orthopaedic products now includes solutionsfor bone, tendon, and peripheral nerve repair. With Collagen Matrix'sOssiGuide(TM) Cancellous Granules, OssiMend(TM) and OssiMend(TM) PuttyMineral-Collagen Composites, OssiPatch(TM) Bone Healing Protective Sheet,NeuroMatrix(TM) Collagen Nerve Conduit, Neuroflex(TM) Flexible Collagen NerveConduit, NeuroMend(TM) Collagen Nerve Wrap and TenoMend(TM) Collagen TendonWrap, the surgeon is equipped with the products needed to repair a complexinjury.

The results of an animal flexor tendon repair study using TenoMend(TM)Collagen Tendon Wrap demonstrated the ease of implantation with the tendon'sreturn to full range of motion comparable to normal unsevered tendons. Thecontrols in which severed tendons were repaired but not wrapped, demonstratedstatistically significant reduction in range of motion. TenoMend(TM) CollagenTendon Wrap was successful in providing a protective environment for tendonrepair.

"We are committed to providing the surgical community with a full line ofproducts to address complicated orthopaedic injuries involving hard and softtissues. TenoMend(TM) Collagen Tendon Wrap is the first in a series of tendonrepair products under development," said Shu-Tung Li, Ph.D., Founder and CEOof Collagen Matrix. "We are currently exploring potential product marketingand distribution opportunities for worldwide distribution of TenoMend(TM)Collagen Tendon Wrap, which is available immediately," he added.

Collagen Matrix, Inc. is a leader in the design and engineering ofcollagen- and mineral-based extracellular matrices for tissue and organ repairand regeneration. Since its inception in 1997, the Company has received manygovernment grants for the development of collagen-based matrix products in theareas of neurological, vascular, urological, and orthopaedic tissueregeneration applications. The Company currently manufactures collagen- andmineral-based finished medical devices in the areas of neurosurgery, oralsurgery, orthopedic-spine surgery, and wound care. More information about theCompany can be found at www.collagenmatrix.com.CONTACT: Peggy Hansen, RAC Sr. Director, Clinical, Regulatory, and Quality Assurance Tel: 201-405-1477 Fax: 201-405-1355

SOURCE Collagen Matrix, Inc.
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