FDA Breakthrough-designated device under evaluation for treatment of life-threatening abdominal bleeding at leading U.S. trauma centers shows promising results in first patient
WALTHAM, Mass.–(BUSINESS WIRE)–Arsenal Medical, a clinical-stage company pioneering innovative biomaterials-based devices, today announced the first patient treated with a first-of-its-kind device, ResQFoam™, in the REVIVE clinical study at the University of Alabama at Birmingham (UAB).
ResQFoam is an investigational trauma intervention designed to function like a human “fix-a-flat.” When injected into the abdominal cavity, it rapidly expands to apply internal pressure helping slow bleeding in patients with life-threatening injuries. This buys critical time for transport to surgery, where the foam is removed, allowing surgeons to address the underlying injury. In extensive preclinical studies, ResQFoam demonstrated strong safety and rapid hemostasis across multiple injury types, laying the foundation for its clinical evaluation. The REVIVE trial (Reducing Exsanguination Via In-Vivo Expandable Foam) is assessing ResQFoam’s safety and effectiveness for treating life-threatening abdominal bleeding at Level 1 trauma centers under an investigational device exemption approved by the FDA.
“Critically injured patients with uncontrolled abdominal bleeding face a survival rate of just 50%, even if they rapidly reach surgery at level 1 trauma centers. Every minute counts,” said Preston Hewgley, M.D., Trauma Surgeon and Principal Investigator at UAB. “In this first REVIVE case, a 34-year-old involved in a motor vehicle crash arrived in severe shock, with no detectable blood pressure and a weak pulse. After ResQFoam was administered, the patient’s blood pressure and pulse improved. He survived surgery and was ultimately discharged.”
ResQFoam received initial funding from the Defense Advanced Research Projects Agency (DARPA) and subsequently the U.S. Army Medical Research and Development Command (formerly USAMRMC) to address battlefield trauma, where abdominal bleeding is the leading cause of potentially preventable death. “ResQFoam was born from battlefield necessity, but its potential extends far beyond combat, where trauma continues to be a leading cause of death in civilians and many of these cases are preventable,” said COL David King, M.D., US Army, Trauma and Acute Care Surgeon, at Massachusetts General Hospital Trauma Center and Medical Monitor for REVIVE. “This first case in the REVIVE study is consistent with our pre-clinical findings and represents an important first step toward bringing this potentially life-saving technology to patients with limited options.”
“This milestone reinforces our vision that biomaterials can overcome limitations of traditional medical devices and lead to potentially life-saving treatments,” said Upma Sharma, Ph.D., President and CEO of Arsenal Medical. “We are grateful to the clinical teams leading REVIVE and look forward to continued enrollment.”
About Arsenal Medical
Arsenal Medical is a clinical-stage company developing innovative biomaterials to address challenging and underserved medical problems. Its lead products target neurovascular and trauma conditions. The company was founded by academic luminaries Robert Langer and George Whitesides, together with entrepreneur-investor Carmichael Roberts, who shared a vision for how materials can transform medical devices. Learn more at www.arsenalmedical.com.
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