U.S. FDA grants Critical Innovations breakthrough device designation for its F.O.A.M.™ device
Updated: Jul 5, 2019
Critical Innovations announces today that the FDA has granted breakthrough device designation for its "Fast Onset Abdominal Management™ (F.O.A.M.™) device, which is designed to deliver a quickly-expanding foam to tamponade severe internal bleeding in trauma patients. F.O.A.M.™ research and development is supported by funding from U.S. Army Medical Materiel Development Activity (USAMMDA), through the Medical Technology Enterprise Consortium (MTEC), under a contract worth over one million dollars.
F.O.A.M.™ is designed to control severe intra-abdominal bleeding in critically ill trauma patients, when surgical intervention is not immediately available. Once delivered into the body via a specialized auto-stopping needle, its foaming agent expands and exerts pressure. Its main polymer component is unusual in that it exhibits reverse-phase-shift properties, meaning it becomes more solid at warmer temperatures (e.g. body temperature). If a subsequent surgical procedure is required, a surgeon can reverse the process and wash it away with cooled liquid. However, if no further procedure is required, the foaming agent should gradually dissolve to be removed by the body.
“The goal of the F.O.A.M.™ device is to provide a lifesaving bridge to surgical care for patients who might otherwise die from their injuries,” said Dr. Ross Donaldson, President & CEO of Critical Innovations and an emergency physician at one of Los Angeles’ main trauma centers. “In such patients, the probability of death increases approximately 1% for each 3-minute delay to surgery, meaning each minute counts.” Dr. Donaldson has been widely recognized for spearheading the development of emergency and trauma systems in Iraq and other countries in conflict, where he saw numerous such injuries.
“Military funding of F.O.A.M.™ device development has been key to our success so far,” stated Dr. Donaldson. To date, the company has developed a proof-of-concept device and performed initial animal testing. “We look forward to engaging with the FDA through the Breakthrough Devices Program.” The program helps speed up the development process through expedited regulatory assessment and review of medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
ABOUT CRITICAL INNOVATIONS
Critical Innovations LLC is a medical research and development company focused on creating cutting-edge solutions to health threats that the span pre-hospital, hospital, and military environments. It employs an iterative development methodology focused on human factors engineering to rapidly advance and commercialize products.
USAMMDA is a subordinate command of the U.S. Army Medical Research and Development Command, under the Army Futures Command. As the premier developer of world-class military medical capabilities, USAMMDA is responsible for developing and delivering critical products designed to protect and preserve the lives of Warfighters across the globe. These products include drugs, vaccines, biologics, devices and medical support equipment intended to maximize survival of casualties on the battlefield.