Healthcare Industry News:  Wound Dressing 

Devices Wound Care Regulatory

 News Release - September 20, 2007

Keraplast Technologies Announces Breakthrough Approval of Functional Keratin Wound Dressings

SAN ANTONIO--(HSMN NewsFeed)--In a unique joint global announcement, Keraplast Technologies, Ltd., a long-standing San Antonio-based medical technology company founded in 1996, and its New Zealand-based partner, Keratec Limited, have confirmed approval of the first keratin-containing medical devices by the European Union Medical Regulatory Body.

Through the CE Marking process, a process similar to the FDA approval process in the United States, the EU Regulatory Body has approved, for immediate manufacture and sales, three Wound Dressings developed in a joint collaboration by the two companies.

"The Keraderm, Kerafoam, and Keragel dressings are designed to target chronic wounds in a wide range of clinical settings," according to Tim Herring, Chairman/CEO of Keraplast Technologies, Ltd.

Herring added, "While these dressings will be of significant interest to consumers in the worldwide markets that recognize the CE Mark, we also envision sizeable application of these products ultimately in the global theaters of war and human suffering. This approval fulfills years of research and development plus an unyielding commitment by everyone involved to confirm Keraplast and Keratec as the world leaders in the field of highly functional keratin products." These Wound Dressings have been independently confirmed as being designed and manufactured to the stringent ISO 13485:2003 Medical Device Quality Management Systems Standard.

Keraplast Board member, practicing plastic surgeon and inventor Dr. Robert Allen Smith of Jackson, Mississippi, echoes the sentiments of the other members of the Keraplast Board of Directors when he says, "This is a revolutionary medical platform technology that further encompasses not only the field of wound healing, but also has vast relevance in orthopedics, tissue engineering, drug delivery, medical device coatings and endosurgery. These three products will be directed toward full thickness and partial thickness injuries. Full thickness injuries include surgically created wounds as well as the chronic ulcerations of bed sores, venous stasis ulcers and diabetic ulcerations of all types. Partial thickness injuries include such wounds as burns, abrasions and donor sites for skin grafts."

In addition to Tim Herring and Dr. Robert Allen Smith, others serving on the Keraplast Board of Directors include Dr. Charles A. LeMaistre of Houston, TX, Greg A. Kozmetsky of Austin, TX, and William Shea of Hartford, CT.

Source: Keraplast Technologies

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