“Currently, there are no effective pre-hospital treatments available for intra-abdominal bleeding on the battlefield. Our ultimate goal is to find innovative ways to improve treatment and save lives of those who are serving their country, as well as those who experience serious injury through trauma.”
David King, MD, Department of Trauma Surgery, Massachusetts General Hospital and Lieutenant Colonel in the U.S. Army
Foam System for Acute Hemorrhage
Clinical Problem: Non-Compressible Hemorrhage
Injuries in modern warfare are often caused by explosion and related high-velocity penetrating shrapnel leading to non-compressible bleeding.[1-3] Non-compressible bleeding accounts for approximately 85% of preventable deaths on the battlefield [3-6], 80% of which include acute hemorrhage within the abdomen/torso.  Abdominal hemorrhage involves injury to the spleen, liver, or retroperitoneal vasculature, and is typically non-compressible, meaning that it cannot be treated by external compression or the application of tourniquets or topical dressings.
Emergency surgical intervention is currently the only available method for treating abdominal hemorrhage. However, battlefield trauma generally occurs in an austere, resource constrained environment, often with extended evacuation time due to persisting tactical threats. Transport time to reach a hospital where surgery can take place varies, but is estimated to average one hour. The majority of preventable deaths due to abdominal hemorrhage is nearly 50% and can be attributed to delays in hemorrhage control during transportation, highlighting the need for rapid, far-forward hemorrhage treatments.
Arsenal Foam System
Arsenal Medical’s in-situ forming polymeric foam 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, facilitating battlefield use. Results of pre-clinical studies evaluating the Arsenal foam technology in non-compressible abdominal hemorrhage were presented at the 2012 American Association for the Surgery of Trauma (AAST) Annual Meeting and published in the Journal of Trauma.
The Arsenal team is also developing its novel foam technology platform for acute hemorrhage in the civilian population and other clinical scenarios.
The Arsenal Foam Technology is currently not available for sale or distribution and is limited to clinical investigational use only.
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 binding preferentially to the wounded tissue. In the context of this program, Arsenal Medical’s novel foam-based system for non-compressible abdominal hemorrhage has emerged as a highly promising point-of injury solution.
DARPA recently awarded a $15.5 million Phase II contract to Arsenal Medical, bringing the total DARPA funding for the Arsenal foam technology to $22.5 million. The Phase II award will support continued product and clinical development through the US FDA regulatory process.