- FDA granted its second breakthrough device designation in as many weeks for an expandable foam to rapidly control severe internal bleeding in trauma patients. The breakthrough program expedites regulatory review of new medical technologies to treat and diagnose life-threatening conditions.
- The agency awarded the latest breakthrough designation to Critical Innovations, a medical research and development company focused on creating products to help military personnel injured in combat.
- Dubbed F.O.A.M., for Fast Onset Abdominal Management, the rapidly expanding foaming agent is delivered into the body via a specialized needle and exerts pressure to stop intra-abdominal hemorrhage.
The U.S. military has devoted significant resources over the past decade to pursue treatments for uncontrolled blood loss. In a large study published in 2012 that reviewed data on 10 years of battlefield fatalities, the U.S. Army Institute of Surgical Research found nearly 91% of potentially survivable deaths were due to hemorrhage. Of those deaths, 67% were from injuries to the trunk of the body.
Internal injuries of the abdominal cavity cannot be treated by combat medics through traditional methods to stop blood loss such as direct compression. The Defense Advanced Research Projects Agency (DARPA) launched the Wound Stasis System program in 2010 to study ways to stabilize the injured before transport to a medical treatment facility.
The program’s initial research led to a focus on foam material as the primary hemostatic agent to control bleeding in patients with non-compressible wounds. Supported by more than $35 million in funding from DARPA and other Defense Department agencies, privately held Arsenal Medical, in collaboration with Massachusetts General Hospital and Harvard Medical School, developed a self-expanding polyurethane foam designed to quickly stop abdominal bleeding from trauma at the point of care.
In 2017, FDA granted Arsenal Medical an investigational device exemption to conduct a clinical study for the injectable material, called ResQFoam. The treatment consists of an injection of two liquid polymers that react when combined to create foam that expands rapidly through flowing blood to compress the injury. The material is later removed by the surgeon. The agency last year gave the project’s researchers the green light to begin a 40-patient clinical trial through the agency’s Exception from Informed Consent policy covering research in emergency settings.
Critical Innovations’ foam works by a different mechanism. After the foaming agent is delivered via an auto-stopping needle, its main polymer solidifies at warmer temperatures in the body. The foam then expands and exerts pressure. A surgeon can reverse the process with cooled liquid to wash it away. If no further procedure is required, the foaming agent is designed to gradually dissolve in the body.
Development of the Critical Innovations foam is supported by a $1 million contract from the U.S. Army Medical Materiel Development Activity through the Medical Technology Enterprise Consortium.
The company has received Defense Health Agency funding to develop other medical devices for regulatory clearance: a portable system for treating intracranial pressure in traumatic brain injury, a decompression needle to treat tension pneumothorax from lung injury, and a thoracostomy system for thoracic trauma. It is also developing an antibiotic foam with private funding.
Another company working on a foam to stop abdominal bleeding in trauma and battlefield situations is Gel-e, which last month received an FDA breakthrough designation to accelerate development of its Life Foam treatment. The expanding, injectable foam previously received FDA clearance for topical and external applications. Gel-e raised $3.1 million in 2017 in private financing. Before that, the company was funded by grants from the National Science Foundation, U.S. Army Research Lab, Maryland Industrial Partnerships, and the Technology Development Corp.