FDA Clears Innovative Bandage to Stop Severe Bleeding on the Battlefield and in Hospitals

January 7, 2003

PORTLAND, Ore. -- A revolutionary new medical tool, a bandage that actually stops bleeding, has just received clearance by the Food and Drug Administration. Intended for civilian and military use, the HemCon bandage's first customers will be U.S. army soldiers.

Made from chitosan, a shrimp-based product, the bandage halts severe bleeding and is being manufactured by Portland, Oregon-based, HemCon, Inc. The HemCon Bandage was invented at the Oregon Medical Laser Center (OMLC) based at Providence St. Vincent Medical Center through a research grant from the U.S. Army Medical Research and Materiel Command. Congress provided funding for the advanced research, development and procurement of the bandage with the support of several members of the Oregon and Washington congressional delegations.

"Historically, hemorrhaging is the single major cause of death among those killed in action -- as many as 25 percent of battle casualties that result in early death could benefit from rapid hemorrhage control," said Jim Hensel, president and CEO of HemCon, Inc., the Oregon company that will produce and distribute the bandage. "In addition, trauma is the leading cause of death for persons aged 1 to 44. We believe that the HemCon Bandage will save the lives of a significant number of both combat soldiers and civilians in need of emergency medical care."

HemCon has already secured three government contracts to immediately supply over 6,000 bandages. An injured soldier, combat medic or untrained first responder can easily apply the HemCon Bandage, which is designed for immediate hemorrhage control.

"Test results on the bandage have conclusively demonstrated excellent results in stopping bleeding for trauma injuries like those experienced in battlefield conditions," said Kenton W. Gregory, MD, director of OMLC, an interventional cardiologist at Providence St. Vincent Medical Center, and HemCon board member. "With advanced hemorrhage control methods and devices, we estimate that 20-30 percent of all combat deaths can be prevented."

The HemCon Bandage addresses the U.S. Army's guidelines for rapid control of severe, life-threatening bleeding. The bandage allows the wound to quickly form a strong, adherent clot, enabling a patient to be transported, and offers rapid, strong adhesion to the injury site to seal the wound -- specific criteria mandated by the military.

The HemCon Bandage is portable and can be self-administered in combat or easily used by a medic, generally the first responder to an injured soldier. The device is durable enough to withstand blunt force as well as extreme field conditions, including inclement weather, temperature and rugged terrain.

The bandage repeatedly demonstrated success in carotid artery stab wounds, in aortic perforations and in severe liver injuries in multiple pre-clinical studies. Data indicates the HemCon Bandage should seal a severely bleeding external wound within 1-5 minutes. The bandage, whose developers just received an award for excellence from the U.S. Army at the Advanced Technology Applications for Combat Casualty Care Conference (ATACCC), is currently under patent application.

The device comes in an array of sizes and configurations to provide hemorrhage control to a wide variety of traumatic wounds. A 4"x 4" version with plastic backing that is easily removable offers quick adhesion and clotting abilities for external wounds.

Incorporated in Oregon in 2001, HemCon, Inc. develops, manufactures and markets innovative technologies to control bleeding from traumatic injuries. HemCon specializes in the development of hemostatic control dressings for use in emergency medical, pre-hospital and other out-of-hospital environments where rapid control of bleeding is of paramount importance.

Source: PRNewswire