Finding a new way to treat wounds

Local woman's firm has crafted 'WoundStat' to stop bleeding

Seconds count when someone suffers a big, gaping wound gushing arterial blood.

If help is far away, death is a possibility.

This situation can happen in combat - or it can happen in the wilderness.

Bandages and tourniquets work, but could be better, especially with extremely serious wounds.

Last month, the federal Food and Drug Administration approved a new way to stop severe bleeding in the field.

A part-time Flathead resident is president of the Maryland company that nurtured the technology from a Virginia lab through the FDA and hopes to have mass production under way next month.

Rhonda Friedman, who has a Ph.D. in epidemiology, is president and chief operating officer of TraumaCure, an 18-month-old firm that is seeking its first military contract for "WoundStat," which in less than 30 seconds can form a seal similar to Silly Putty over heavily bleeding wounds.

"It can help immediately on the battlefield with no side effects," Friedman said.

Friedman, 57, and her husband, Jim Rafferty, live part-time in Smith Valley, and the rest of the time in Potomac, Md. TraumaCure is located in Bethseda.

WoundStat works like this.

Its large sandy particles are created by proprietary means; its chemical makeup and creation technology are secret. The particles are stuffed in an easy-to-tear package.

In a battle, a soldier tears the package and pours the particles on a buddy's bleeding wound, and applies pressure to pack it in.

The particles form a sticky substance that adheres to the wound and absorbs the blood. They also cause the blood to coagulate, creating a clot where an artery is cut.

Later, WoundStat can be pulled off wound and the wound can be washed out with saline solution, allowing blood to flow again.

Researchers at Virginia Commonwealth University had been working on WoundStat for three years, specifically for the U.S. Army's Special Forces, which usually operate far from medical help.

But developing a product in a lab is just the first step, Friedman said.

"Universities are about discovery," she said. "This is about engineering."

The product had to go through tests to get FDA approval and has to meet military specifications for withstanding heat and stress. WoundStat had to be proven nontoxic with a shelf life of one to three years. Then there's the marketing, mass production and financing.

That's where Friedman and her partners came in with TraumaCure.

A Brooklyn native, Friedman became interested in epidemiology as a teen when she read a 1953 book called "Eleven Blue Men" by Berton Rouech/, which told stories about medical detective work involving diseases.

That book hooked her on becoming an epidemiologist with a fascination with health issues on a large scale.

Friedman eventually ended up on Capitol Hill, getting health-care legislation through Congress. Then she joined the Pharmaceutical Manufacturers Association to lead its science and public health policy efforts.

She eventually became a biotechnology entrepreneur and then a consultant before teaming with some colleagues to form TraumaCure in early 2006.

TraumaCure's first and only current venture is moving WoundStat from the academic world to the real world.

It zipped through the FDA process - it's not classified as a drug which takes years to approve, but in a wider-open "unclassified" category - in a few months.

Meanwhile, WoundStat was tested against four other bandages, wound-plugging and clotting materials for battlefield use.

The competition tested the five blood-stoppage devices on 25 anesthetized pigs, each of which had a leg artery slit. After 45 seconds of bleeding, the five wound-stoppage devices were applied to the pigs. All five WoundStat pigs and one bandaged pig survived three hours, while the rest died, according to the August issue of The Journal of Trauma. Plus no side effects, such as burned skin, showed up.

"The data was very compelling," Friedman said.

The military is currently doing additional testing of WoundStat.

TraumaCure expects to manufacture 200,000 WoundStat packages by the end of November for military, boating and wilderness uses.

TraumaCure does not yet have a military contract, but hopes to have one within a year.

Friedman cited backcountry accidents she has heard about in Northwest Montana as a reason to believe it would make a good lightweight addition to medical supplies taken on hikes and other wilderness trips.

She said: "We think any place where immediate medical care is not available is where this product will work out well."

Reporter John Stang may be reached at 758-4429 or by e-mail at jstang@dailyinterlake.com