A Medical Device Daily

The U.S. Army has selected HemCon Medical Technologies (Portland, Oregon) as the sole source to develop, test and secure FDA approval for a lyophilized (freeze-dried) human plasma (LHP) product and delivery system. The $15.4 million multi-year cooperative agreement will support the research and development of the new process. The project is expected to be complete in 2010.

The use of plasma as a resuscitation fluid, according to early U.S. Army studies, has shown to significantly reduce battlefield mortality. In many situations, use of fresh frozen human plasma is limited by storage requirements and the short shelf-life for thawed plasma. As a life-saving measure for coagulopathy, the US Army Medical Research and Materiel Command has identified the LHP initiative as a high priority.

The new LHP product and delivery system will offer individual units of single source donor plasma that are safe and easy to carry reconstitute and administer, the company said.

HemCon previously partnered with the U.S. Army to develop the HemCon Bandage. Since 2003, HemCon has produced and distributed the HemCon Bandage and ChitoFlex dressings for the U.S. Army and other military and civilian medical professionals.

The chitosan-based hemostatic dressings, manufactured using a proprietary process, are currently included in every U.S. soldier's battlefield first-aid kit. The success of the HemCon Bandage led to improved civilian patient care when the bandage moved to acute care facilities in 2007.

HemCon develops, technologies to control bleeding and infection resulting from trauma or surgery.