Entegrion Inc., a biomedical group based in North Carolina's Research Triangle Park, has received clearance from the Food and Drug Administration for over-the-counter sales of its fabric, Stasilon.

The product accelerates the clotting of blood in external wounds through the use of bamboo and glass fibers in a woven fabric. The company is trying for FDA clearance on surgical pads.

"This is a remarkable technology," said Stan Eskridge, the president and chief executive of Entegrion. "It's so powerful in controlling problem bleeding that it was approved by the FDA for use by medical professionals, yet so easy to use that it's also approved for Dr. Mom.

"You simply open the package, apply the dressing to the wound and maintain firm pressure."

One potential hurdle for Entegrion attracting mainstream consumers is the current price of the product, versus lower-cost gauze products already on the market.

A box of 10 4-inch bandages retails for $90, while a box of 10 2-inch bandages retails for $70. Entegrion said it is negotiating with distributors and hopes to have its bandages on retail shelves by the end of the year.

Joe Dacorta, the chief technical officer for Entegrion, said that the FDA market clearance for over-the-counter sales "will greatly expand the addressable market for the Stasilon textile family of products, particularly in the consumer retail, industrial health and sports-medicine markets."

Eskridge acknowledges that Entegrion has a major branding challenge regarding Stasilon.

"We're trying to get our product into the hands of as many doctors as we can," Eskridge said. "We know they want evidence that the product is doing what we say it does, and is not causing harm."

Scientists have known for years that blood begins to clot when put in contact with glass. Stasilon serves as a low-cost dressing for wounds that performs better than gauze. The fabric also has a better chance of keeping the clot intact when the dressing is removed.

Entegrion said it invented Stasilon in consultation with the U.S. Office of Naval Research.

"The technology addresses the military's critical need for effective, but low-cost, hemostatic wound dressings, as severe blood loss accounts for 50 percent of all battlefield deaths," the company said. "Severe blood loss is also a contributing factor in 50,000 civilian deaths each year."

Stasilon has been tested on the battlefields in Iraq for several months.

In recent weeks, the product has been made available to emergency workers through a distribution agreement with Southeastern Emergency Equipment Distributors of Wake Forest.

Stasilon also is being tested at the N.C. Jaycee Burn Center at UNC Hospitals in Chapel Hill.

"We're studying the bandage to see if it is a better product than cotton gauze for reducing blood loss," said Dr. Bruce Cairns, the director of the burn center and an associated professor of surgery/microbiology and immunology at UNC School of Medicine.

"When you remove a burn dressing to put down a skin graft, there will be blood loss, sometimes considerable blood loss," Cairns said. "Because the bandage is designed not to stick to the blood clot, it lessens the chance of reopening the wound.

"The product is not a magical solution for stopping bleeding immediately, but it has the potential to stop it quicker and longer than cotton gauze. Whether you are a ballplayer, a mother or emergency personnel, anything that can get that accomplished quicker is going to be well received."

Entegrion's reputation in the state's biotech sector is rising.

Industry officials said that Entegrion could collaborate eventually with the Institute of Regenerative Medicine at Wake Forest University Baptist Medical Center.

The institute was named April 17 as a recipient of a five-year, $42.5 million grant from the U.S. Defense Department that focuses on the use of regenerative treatment for lost limbs or severe burns - the signature injuries of the wars in Iraq and Afghanistan. Regenerative therapies use the body's natural healing powers to restore or replace damaged tissue and organs.

Institute officials said last week that there are no current plans to collaborate with Entegrion, but Eskridge said that "since there is much overlap in our product and their research, we feel there is the potential to assist in regenerative tissue development."

E-mail Richard Craver at rcraver(at)wsjournal.com. For more stories visit scrippsnews.com

— Winston-Salem Journal

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