Foam System for Acute Hemorrhage
Clinical Problem: Non-Compressible Hemorrhage
Currently, there are no widely available and effective pre-surgical hemorrhage control interventions for noncompressible abdominal hemorrhage. Patients with exsanguinating, noncompressible abdominal hemorrhage suffer suffers an extremely high mortality rate (greater than 40%) that has persisted unchanged for over 14 years utilizing the current standard of care. For both military and civilian patients, abdominal hemorrhage is a leading cause of preventable death. There is an emergent need for innovative technologies to temporize abdominal hemorrhage as an emergency bridge to trauma surgery.
Arsenal Medical’s in-situ forming polymeric foam, ResQFoamTM, is designed to control severe, intra-cavity hemorrhage by creating conformal contact and applying pressure to an actively bleeding site. Treatment consists of an injection of two liquid polymers that react upon combining to create a foam that expands rapidly through actively flowing blood to compress the injury and control bleeding. Once the patient reaches definitive surgical repair, the material can be removed by the surgeon. Arsenal’s foam system is durable, lightweight and low profile. ResQFoamTM may provide a life-saving bridge to surgical care for those who may otherwise die before reaching surgery. The clinical benefit and efficacy of ResQFoamTM will be evaulated in the upcoming multi-center REVIVE trial
In 2010, DARPA launched its Wound Stasis System program with the objective of finding a technology solution to address trauma-induced internal hemorrhage. The program sought to identify a biological mechanism capable of discriminating between injured and healthy tissue, and bind preferentially to the wounded tissue. In the context of this program, Arsenal Medical’s novel foam-based system for non-compressible abdominal hemorrhage emerged as a highly promising point-of injury solution.
In 2015, Arsenal was awarded a contract of more than $14 million from the U.S. Army to bring the total DOD funding to more than $35 million.