Vascular Solutions, Inc., has entered into a cooperative research and development agreement with the U.S. Army Medical Materiel Development Activity (USAMMDA) to develop a freeze-dried plasma product for use in battlefield treatment of severe hemorrhage. Vascular Solutions will be responsible for completing development of the product and establishing manufacturing operations, including chemistry, manufacturing, and controls information to support the Investigational New Drug application to the U.S. Food and Drug Administration. The Army will sponsor, manage, and fund all pre-clinical and clinical studies required by the FDA for regulatory approval, and sponsor and fund a post-approval clinical study to broaden the approved indication if required by the FDA.
Following regulatory approval, Vascular Solutions will be responsible for post-licensure production, regulatory and commercial marketing, and distribution of the freeze-dried plasma product, and the U.S. Army will purchase quantities of the freeze-dried plasma product from Vascular Solutions for military use. Vascular Solutions will be entitled to market the product to other government agencies and for civilian use, subject to regulatory authorization.
“We believe that a freeze-dried plasma product will offer important benefits for both the U.S. military and the general public,” comments Howard Root, Vascular Solutions CEO. “Freeze-dried plasma will have wide applicability in emergency situations where plasma is not currently available or when time constraints limit the use of fresh frozen plasma. In addition to the military and other government agencies, freeze-dried plasma would be a natural option for rural treatment facilities and private first-responder organizations with advanced life support capabilities.”
Vascular Solutions expects its freeze-dried plasma product to be regulated by the FDA as a blood product and to require a Biologics License Application (BLA). Vascular Solutions is currently targeting submission of the BLA in 2018-2019, following completion of the required clinical studies. Learn more about Vascular Solutions.Read more