|Foam System for Acute Hemorrhage expanding in the abdominal cavity--Screenshot courtesy of Arsenal Medical|
Startup Arsenal Medical has pulled in a more than $14 million contract from the U.S. Army Medical Research and Materiel Command to complete the clinical and manufacturing development of and to submit an FDA application for its lead candidate ResQFoam. The biomaterial foam is used to temporarily stanch abdominal bleeding due to trauma.
The new Army contract brings the total U.S. military investment into Arsenal to more than $35 million from sources that also include the Defense Advanced Research Projects Agency (DARPA).
The U.S. military isn't the only high-profile funder of Arsenal Medical's medical foam. In June, Medtronic ($MDT) invested an undisclosed amount, in exchange for an option to acquire it, into Arsenal AAA, a subsidiary of Arsenal Medical that's focused on applying the foam specifically to filling the aneurysmal sac around an endograft.
An endograft is a hollow fabric-covered tube that surrounds a stent used to treat abdominal aortic aneurysm (AAA). The foam would be used to fix it in place. Medtronic, of course, markets stent and endograft products that could be used in conjunction with ResQFoam.
For its part, the U.S. military is more interested in the use of the biocompatible, self-expanding foam to halt massive blood loss in trauma patients with severe internal bleeding. The expectation is that ResQFoam could be used on the battlefield to stanch abdominal bleeding until surgery can be performed.
"ResQFoam is designed to be a life-saving intervention that will stabilize a traumatic injury victim with severe internal bleeding, buying valuable time to transport that victim to a qualified trauma center," said Dr. David King, an attending trauma surgeon in the Division of Trauma, Emergency Surgery and Surgical Critical Care at Massachusetts General Hospital, in a statement.
He added, "The majority of people with massive abdominal bleeding die before they reach the hospital. Many of these deaths could be prevented if we were able to temporarily stabilize a patient long enough to reach a trauma center. ResQFoam could enable first responders to slow internal bleeding in even the most severely injured patients, and substantially increase their chance of survival."
Earlier this week, the FDA cleared another traumatic wound dressing product for civilian use, the Xstat 30 from RevMedX. An earlier version of it had already been cleared for military use in 2014. But that's specifically indicated not for abdominal use.
Noted Upma Sharma, the senior director of R&D at Arsenal, in the statement, "The strong governmental support we have received for this program has allowed Arsenal to complete a comprehensive and carefully executed development program that was ideally tailored to create a novel, life-sustaining product of this kind. We look forward to working with the U.S. Food and Drug Administration (FDA) to ensure the timely review and availability of this critically important product for both civilian and military trauma care."
- here is the announcement