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Westaim Biomedical receives FDA clearance for 7-day chronic wound dressing

10/17/2000


Case studies conclude that Acticoat® dressings are effective for chronic wounds, which affect millions annually

CALGARY, ALBERTA, CANADA - The Westaim Corporation’s subsidiary, Westaim Biomedical Corp., today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) and Canada’s Health Protection Branch for Acticoat® 7 dressing, a new product that delivers a sustained seven-day release of antimicrobial silver nanocrystals, for acute and chronic wounds.

Chronic wounds are severe, persistent, painful wounds such as diabetic foot ulcers, pressure ulcers and venous insufficiency leg ulcers. They are prone to infection, which can lead to dire consequences such as severe pain, an inability to stand, and in the case of foot and leg ulcers, amputation of limbs. Chronic wounds affect more than four million people in North America every year.

Westaim Biomedical also released three new case studies from independent wound care professionals in the United States and Canada describing clinical results using Acticoat® Burn Dressings on various chronic wounds.

Acticoat® dressings were first used to treat burn wounds, graft sites and donor sites and are now used in more than 100 burn centers in North America. In its first full year on the market, Acticoat® Burn Dressing generated sales of US$3.2 million. The new Acticoat® 7 dressing can be left on wounds for a longer period of time, seven days, which is beneficial for the chronic wound market.

“Westaim Biomedical is translating the success of Acticoat dressings in managing burn wounds to the much larger chronic wound market,” said Scott H. Gillis, President of Westaim Biomedical. “This success puts us in an excellent position to introduce our technology more widely into the chronic wound market and quickly establish the Acticoat brand with chronic wound caregivers.”

Westaim Biomedical’s Acticoat® barrier dressings use a proprietary nanocrystalline coating of pure silver. Laboratory tests have shown that this unique delivery system has lowered proteolytic enzymes in chronic wounds. Many physicians believe that the reduction in proteolytic enzymes is a key factor in moving non-healing wounds into a progressing healing state.

Acticoat® dressings also deliver antimicrobial activity considerably faster than other forms of silver, providing the optimal healing environment. Acticoat® dressings have demonstrated effectiveness against more than 150 pathogens, including antibiotic-resistant superbugs such as Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant Enterococcus (VRE).

Clinical results
Anecdotal case studies conducted by independent wound care professionals in Toronto and London, Ontario, and Baltimore, Maryland examined the use of Acticoat® dressings for the treatment of a variety of chronic wounds including a venous insufficiency ulcer, an infected surgical wound and TENS, a disease which causes blistering of most of the body’s skin.

“The wound we treated did not respond to other treatments,” said Louanne Rich-vanderBij, a Clinical Nurse Specialist at Sunnybrook and Women’s College Health Sciences Centre in Toronto. “The Acticoat dressings appear to have ‘kick started’ the wound healing process. The Acticoat dressing we used was effective in reducing infection in the wound with a concurrent reduction in the amount and type of wound fluid. Once the wound bio-burden was reduced we observed a proliferation of healthy tissue growth.”

Strong customer demand
Westaim Biomedical’s strategy is to establish strategic partnerships with medical product companies that have specialized sales forces and marketing expertise in the chronic wound market.

However, strong demand for Acticoat® brand products among chronic wound care professionals has led the company to begin distributing Acticoat® 7 dressings in North America using its existing sales force. Acticoat® 7 dressings will be distributed along with Westaim Biomedical’s other FDA-cleared wound products.

In focus groups of nurse practitioners and doctors at the 15th Annual Clinical Symposium on Advances in Skin & Wound Care held in Nashville, Tennessee in early October, several chronic wound professionals revealed that they were already using Acticoat® antimicrobial dressings to treat chronic wounds despite the fact that Westaim Biomedical had not yet marketed a product specifically designed for the chronic wound market.

The nurse practitioners and doctors who took part in the focus groups identified ease of use, fewer dressing changes, the need for a broad spectrum of antimicrobial activity and the need for a dressing to help move chronic wounds into a progressive healing state as key attributes of a superior chronic wound dressing.

“We are encouraged that so many chronic wound professionals are already aware of Acticoat dressings,” said Gillis. “The new Acticoat 7 dressings are even better suited for chronic wounds, because they only need to be changed every seven days.”

About Westaim Biomedical Corp.
Westaim Biomedical Corp. develops medical devices based on its Acticoat® antimicrobial technology, a patented method of applying a thin layer of antimicrobial silver to base materials. The first commercial product based on this technology is the Acticoat® Burn Dressing, launched into the burn wound market in 1998. Future applications based on Acticoat® antimicrobial technology include additional specialized wound dressings, catheters, orthopaedic implants and other surgical devices.

About The Westaim Corporation
The Westaim Corporation is a technology accelerator that launches exceptional technologies into the marketplace. In addition to its investment in Westaim Biomedical, Westaim’s technology investments include iFire Technology Inc., which has developed a revolutionary low-cost flat panel display and Savvion, a leader in e-business management software. Westaim’s common shares are listed on Nasdaq under the symbol WEDX and on the Toronto Stock Exchange under the trading symbol WED.


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For more information contact:
Tony Johnston, Senior Vice President, Corporate Affairs
The Westaim Corporation
(403) 234-3103
info@westaim.com
www.westaim.com
www.westaimbiomedical.com

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This news release may contain forward-looking statements. These statements are based on current expectations that are subject to risks and uncertainties, and the Company can give no assurance that these expectations are correct. Various factors could cause actual results to differ materially from those projected in such statements, including financial considerations and those predicting the timing and market acceptance of future products. The Company disclaims any intention or obligations to revise forward-looking statements whether as a result of new information, future developments or otherwise. All forward-looking statements are expressly qualified in their entirety by this Cautionary Statement.