Friday, April 11, 2008

Battlefield kits stop the bleeding

TraumaCure of Bethesda awaiting decision from Pentagon on buying its WoundStat product

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Laurie DeWitt⁄The Gazette
Jack McDonnell says he and other TraumaCure founders were ‘‘wowed” when they first saw a demonstration of WoundStat, used to stop bleeding wounds.
Two years ago, the founders of startup TraumaCure of Bethesda drove to Richmond, Va., to see a new wound-healing technique. They liked what they saw.

Today the company says it is prepared to equip every U.S. soldier in Iraq and Afghanistan with WoundStat, a product that’s 100 percent effective at stopping high-pressure bleeding in severe wounds, according to military experts.

Last month the Army Institute of Surgical Research announced that WoundStat was the most effective wound treatment available to stop severe bleeding. The product is a granular mix that comes in a lightweight pouch.

So far, TraumaCure has only a small sales order for WoundStat for special operations units — frontline fighting forces — in the U.S. military.

But the company has raised $5 million in private equity and has already spent most of it developing WoundStat, getting federal approval for it and manufacturing the 200,000 units now in its warehouse, said Chairman Jack McDonnell. ‘‘We could put one unit in the hands of every soldier in Iraq and Afghanistan right now if they want to buy it.”

TraumaCure executives expect the company to finish producing another 200,000 units within three months.

McDonnell said Pentagon officials are currently deciding whether to place a large order.

‘‘They are in the procurement cycle right now,” he said. ‘‘They are studying the results of the report and other data. ”

Retired Lt. Gen. Ronald Blanck, a former surgeon general of the Army, has only praise for the product.

‘‘WoundStat’s value goes beyond the battlefield,” Blanck said in a statement. ‘‘It will provide a life-saving tool in everyday civilian emergency situations as well as where advanced medical care is not immediately available, such as accidents in remote terrain and on the high seas, or in unexpected disasters such as earthquakes or explosions.”

McDonnell, a lawyer and banker, has helped launch several companies, including biopharma GenVec Inc. and Yurie Systems Inc., a telecommunications-electronics company founded by Jeong H. Kim of Potomac and later sold to Lucent Technologies for $1 billion in 1998.

TraumaCure, though, is the most fascinating of all of his enterprises, McDonnell said. Protecting soldiers in the battlefield is emotionally uplifting. ‘‘It is terrifically gratifying,” he said. ‘‘We and our investors will do very well by doing good.”

Wow factor at VCU

Two years ago, Devinder S. Bawa, now CEO of TraumaCure, asked McDonnell and McDonnell’s business partner, Ronda Friedman, to check out a wound bandage product developed and patented by Virginia Commonwealth University in Richmond.

McDonnell and Friedman — now president and COO of TraumaCure — watched a video of the product stopping the bleeding on a lab animal whose femoral artery had been severed.

‘‘We were wowed,” he said.

The VCU technology transfer office challenged the visitors to put together an investment team for licensing the product.

The company incorporated in March 2006 as TraumaCure, raised $1 million to start, then signed a licensing agreement with VCU in May of that year. The U.S. Food and Drug Administration approved WoundStat within 40 days after TraumaCure submitted its new product application last July.

McDonnell said he didn’t know if the wars in Iraq and Afghanistan were factors in the speedy federal approval, but ‘‘you have to think that’s so without being told it is so and historically it is so, that they saw a need, an ability to save lives quickly.”

‘‘The FDA’s speedy approval of WoundStat means that we can get it more quickly into the hands of those who need it most today — our war fighters in harm’s way around the world,” Bawa said. ‘‘The product’s effectiveness is particularly important with core body wounds that a tourniquet can’t reach. We believe that WoundStat has the potential to provide the military with another important tool to minimize battlefield deaths caused by hemorrhaging.”

The FDA deemed the core ingredients of WoundStat to be safe. The company, which says the ingredients are a trade secret, is also developing gauze versions of WoundStat that it hopes to finish this year. Whereas the granular mix works on large, gaping wounds, the gauze versions are designed for lighter cuts. They can later be adapted to other surgical applications, McDonnell said.

Biotech entrepreneur John Holaday, who once asked McDonnell to be a director of HarVest Bank of Maryland in Rockville, where Holaday is a director and former chairman, said his former colleague is most excited about the new company.

‘‘TraumaCure has a bandage that instantly stops bleeding, with great applications in battlefield wound care, and they have put up the capital (without government assistance) to develop the product for saving lives on the battlefield and in EMS situations,” Holaday wrote in an e-mail. Holaday said he has not invested in TraumaCure.

McDonnell said the company shunned government grants ‘‘because, frankly, that would have taken too long.”

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