WALTHAM, Mass. — Arsenal Medical announced that the first patient has been treated with its investigational device ResQFoam in the REVIVE clinical study at the University of Alabama at Birmingham (UAB), marking an early milestone in the evaluation of the technology for life-threatening abdominal bleeding.
ResQFoam is designed as an emergency trauma intervention that acts like a “fix-a-flat” for severe internal bleeding. The device is injected into the abdominal cavity, where it rapidly expands to apply internal pressure and slow bleeding in critically injured patients. The temporary stabilization can provide valuable time to transport patients to surgery, where the foam is removed so surgeons can treat the underlying injuries. In preclinical studies, the device demonstrated strong safety and the ability to rapidly control bleeding across multiple injury types, supporting its move into human clinical evaluation.
The ongoing REVIVE clinical trial, short for Reducing Exsanguination Via In-Vivo Expandable Foam, is evaluating the safety and effectiveness of ResQFoam for treating life-threatening abdominal bleeding at Level 1 trauma centers. The study is being conducted under an investigational device exemption approved by the U.S. Food and Drug Administration.
“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 initially received funding from the Defense Advanced Research Projects Agency (DARPA) and later from the U.S. Army Medical Research and Development Command to address battlefield trauma, where abdominal bleeding remains a leading cause of potentially preventable deaths.
“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.”
Upma Sharma, Ph.D., President and CEO of Arsenal Medical, said the milestone highlights the potential for biomaterials-based medical technologies to address critical gaps in trauma care.
“This milestone reinforces our vision that biomaterials can overcome limitations of traditional medical devices and lead to potentially life-saving treatments,” Sharma said. “We are grateful to the clinical teams leading REVIVE and look forward to continued enrollment.”
