Collagen Matrix, Inc. Receives FDA Clearance for Matrix Collagen Particles Wound Dressing

FRANKLIN LAKES, N.J. -- Collagen Matrix, Inc. has received the Food and Drug Administration (FDA)'s clearance of its 510(k) for Matrix Collagen Particles -- Wound Dressing. Matrix Collagen Particles is a safe, absorbent, microfibrillar particulate collagen matrix intended for the management of moderately to heavily exudating wounds and to control minor bleeding. These types of wounds include pressure ulcers, venous stasis ulcers, diabetic ulcers, acute wounds (trauma or surgical wounds), and partial-thickness burns.

Each year in the U.S., about 2.2 million patients are treated for diabetic ulcers, 3.1 million patients are treated for pressure ulcers, 650,000 patients are treated for venous stasis ulcers and 600,000 patients are treated for burns. In addition, there are about 135 million general and reconstructive procedures performed each year that may require the use of a wound dressing. Approximately $1 billion per year are spent on wound dressings.

The Matrix Collagen Particles product is the first of a line of wound-care products that the company is planning to develop. Its goal is to provide cost-effective solutions to the problem of treating topical wounds, particularly chronic wounds that are difficult to manage with currently available products on the market due to prohibitive cost structures or product ineffectiveness.

"The clinical applications of our proprietary collagen technology are immense in the health care industry. We hope to make an impact in the wound care market with an effective product that is also cost-effective," says Shu-Tung Li, PhD, Collagen Matrix's president and CEO.

Collagen Matrix, Inc. is a leader in the design and engineer of collagen-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 and vascular tissue regeneration applications. The company currently manufactures collagen-based finished medical devices in the areas of oral surgery, neurosurgery and wound care. Collagen Matrix works cooperatively with its clients in tissue engineering R&D, product development, and customized matrix development.

Source: Collagen Matrix, Inc.