Correction: In earlier print and online versions, Style incorrectly reported that WoundStat had been tested in Iraqi battlefields. It's been lab-tested for use in Iraq.
Blood is spilling, and clotting, at VCU's Medical Center.
Perhaps the biggest breakthrough for the university's growing expertise in blood research appears to have come early last week. Sources say the U.S. Food & Drug Administration approved a claylike substance that when poured into open wounds prevents severe hemorrhaging -- the biggest killer of soldiers in combat. It was developed by Dr. Kevin Ward, director of research in the department of emergency medicine at VCU, and two colleagues who specialize in biochemistry.
Meanwhile, a bigger potential breakthrough is facing a severe cash crunch. It's a synthetic blood substitute developed by Dr. Bruce Spiess, vice chairman of VCU's anesthesiology department, that according to studies delivers oxygen to damaged tissue more effectively than recycled human blood greatly increasing the survival rate for victims of, say, severe head trauma.
It seems that Synthetic Blood International, the company that owns the rights to Spiess' compound called Oxycyte, is struggling financially. The company's stock was trading around 10 cents a share last week with investors cooling on biotech stocks, particularly those related to alternative blood treatments. (Other hemoglobin-based compounds have been Wall Street busts, turning up deadly side effects during clinical trials.)
"Investors are just not stepping up to the plate," Spiess says. "If they go bankrupt, I'm done."
Spiess holds out hope that the company's promised funding for the next phase of his clinical trials expected to span four cities and include up to 150 patients will come through by the end of September.
In an earlier nine-person clinical trial, seven patients suffering from severe head injuries recovered better than expected after receiving Spiess' synthetic blood a milky, Teflon-like substance that delivers five times more oxygen to damaged tissues than human blood. One patient, who died, was too far gone to be saved, Spiess says.
The biggest long-term concern with Oxycyte is over-oxygenating human tissue, which also can damage tissues and membranes, but the long-term effects are still largely unknown. (So far, no serious side effects have been reported, Spiess says.)
Spiess says he takes some solace in the success of his colleague Dr. Ward whose blood-clotting breakthrough has already been tested for use in the battlefields of Iraq. The compound, WoundStat, succeeded in stunting severe blood loss in aninal lab tests.
It's a "kitty litter"-like substance that's poured into the wound, and has proven more effective than the traditional tourniquet and gauze. Within seconds, or minutes, WoundStat clots wounds where blood loss is typically the primary cause of death.
It also has commercial applications. The company that financed the research and owns the right to WoundStat Bethesda, Md.-based TraumaCure Inc. also plans to someday sell it as an alternative to traditional Band-Aids.
Ward couldn't be reached for comment, but an official at TraumaCure confirmed that the company received notice from the FDA early last week that WoundStat had been approved for commercial sale. S