WATERTOWN, Mass.—Arsenal Medical, Inc. has announced the completion of a novel, multi-center translational research study of the company’s trauma foam technology, an intervention designed to slow traumatic internal bleeding in patients and allow them to survive long enough to reach a hospital and undergo surgery. This first-of-its kind study was conducted in recently deceased humans with different doses of foam, which creates a temporary, solid foam implant within the body. The study demonstrated an optimal foam dose in humans. Currently, there are no effective pre-hospital interventions for traumatic, internal abdominal bleeding. These findings were reported today at the 28th Eastern Association for the Surgery of Trauma (EAST) Annual Scientific Assembly.
“This investigation has allowed translation of a huge body of preclinical animal research, resulting in a dose identified as appropriate for humans,” said the study’s principal investigator David R. King, M.D. Dr. King is an attending trauma surgeon in the Division of Trauma, Emergency Surgery and Surgical Critical Care at Massachusetts General Hospital, an assistant professor of surgery at Harvard Medical School, and a lieutenant colonel in the U.S. Army with extensive combat experience. “To our knowledge, a study of this unique design in recently deceased humans has never been done before. When obtaining informed consent for participation in the study, patients and families became familiarized with the enormous problem of traumatic internal bleeding and the importance of this research. We are thankful for the tremendous gift of their participation.”
The study was conducted in 18 recently deceased humans at three leading trauma centers in the United States—Massachusetts General Hospital, Oregon Health and Sciences University and the University of Texas Health Science Center at Houston. To understand the performance of the foam in human anatomy with representative tissue properties, research teams injected the foam into the abdomen within three hours after the patients had passed away. The study assessed the foam’s performance by monitoring the pressure it generated and how it contacted the organs. This unique study design allowed researchers to compare findings in animal models to human anatomy without patient risk, a critical step toward future clinical use of foam in patients with traumatic internal injuries.
Severe torso bleeding results in a mortality rate of greater than 40 percent, and any delays in surgery increase mortality. In the military, up to 50 percent of preventable deaths are attributed to abdominal hemorrhage. For both military and civilian patients, the majority of deaths occurred before surgical care was available, underscoring the importance of rapid, effective therapies to treat these injuries immediately. Prior preclinical animal studies demonstrated that the optimal dose of foam treatment extended life by more than two hours.
“Utilizing advanced materials science, the team at Arsenal Medical has developed a breakthrough technology platform. We are encouraged by the results of this important study as we work to address one of the most significant gaps in trauma medicine,” said Upma Sharma, Ph.D., director of materials science and engineering at Arsenal. “We are looking forward to working with the U.S. Food and Drug Administration (FDA) to advance foam treatment toward potential use in military and civilian trauma care.”
The Defense Advanced Research Projects Agency (DARPA), Army Research Office (ARO), and U.S. Army Medical Research and Materiel Command (USAMRMC) have funded the development of Arsenal’s foam technology to address the critical unmet need in military and civilian trauma medicine. Arsenal anticipates filing a regulatory submission for its trauma foam technology with the FDA by mid-2015.
Terminal patients between 20 and 92 years old, their families and the participating hospitals provided informed consent to participate in the research study following each patient’s death. Within three hours of death, the abdomen was accessed and fluid was added to simulate hemorrhage. Foam was administered using a prototype delivery system at multiple doses (45, 55, 65, 75 and 100 mL). Intra-abdominal pressure was monitored for 15 minutes, after which the foam was removed to assess contact with abdominal tissues.
Arsenal Medical has developed in-situ forming foams to provide local therapy for acute hemorrhage and other critical clinical conditions including vascular injury and repair. Unique Arsenal foam properties include: Conformal contact with injured tissues in complex anatomies, even in the presence of severe bleeding; Ability to tamponade bleeding tissue in intricate spaces without direct visualization; minimally invasive delivery of liquid-state foam precursors through a compact, low-profile system; and Biocompatible, well characterized materials.
The trauma foam has the potential to radically change the standard of care by controlling severe hemorrhage whenever surgical intervention is delayed, both on the battlefield and in civilian medicine.
Arsenal Medical, a privately held company in Watertown, Mass., is focused on innovative application of advanced materials science to medicine. The company is advancing multiple programs based on both its two proprietary technology platforms: its therapeutic foam and AxioCore, a novel, high-throughput nanofiber technology. Arsenal Medical is supported by venture funding, as well as grants from the Department of Defense, the National Institute of Standards and Technology’s Technology Innovation Program (NIST-TIP) and the Bill & Melinda Gates Foundation. Its investors include Polaris Venture Partners, North Bridge Venture Partners and Intersouth Partners.
