An injectable foam that snakes through the abdomen is drawing big interest from the Pentagon, which hopes to use it to control bleeding from internal injuries on the battlefield.
Arsenal Medical, a medical device firm based in Watertown, Mass., on Wednesday announced it had received $14 million from the US Army Medical Research and Materiel Command. That’s on top of $22 million it received from the Pentagon research arm known as DARPA, or the Defense Advanced Research Projects Agency, for development.
The new funding will pay for the company’s first study in patients — a necessary step if it is to receive approval from the Food and Drug Administration.
Arsenal’s foam, which is injected through the belly button, expands into the abdomen, filling into the nooks and crannies of the cavity and exerting pressure on wounds as it hardens. It’s engineered so surgeons can easily pull it out from patients during an operation, often in one piece.
The device could eventually be used by first responders and on battlefields. For the clinical trial, which Arsenal hopes to launch in 2017, the foam will be administered to patients at participating hospitals when they first arrive in the emergency room. Researchers will track if the foam slows blood loss or improves patient condition before they undergo surgery.
Other scientists are also racing to develop devices that could treat trauma patients.
The FDA on Monday approved a wound dressing called XStat, which had been used by the military, for the general population. The device, made by the Oregon company RevMedX, contains sponges that expand to fill a wound and can be used in areas like the groin or armpit, where a tourniquet can’t be applied.
Researchers at the University of Washington, meanwhile, are testing a synthetic polymer called PolyStat that can be injected into the bloodstream. It seeks out clots and binds to them, making them stronger and longer lasting. Results from a study in rats published this year suggested it helped the animals survive otherwise fatal femoral artery injuries.
“The advantage that we see with our approach is that you don’t need to know where the wound is,” said Dr. Nathan White, an assistant professor of emergency medicine at the University of Washington.
In yet another approach, Remedium Technologies, a company spun out from research conducted at the University of Maryland, is developing a foam that causes blood cells to clump and become immobilized. It will be studied first as a technique to reduce external hemorrhaging.
Matt Dowling, Remedium’s chief executive, said bleeding amounts to a major medical problem. And right now, he said, there are few solutions. “That’s what motivates us,” he said.
But developing the new products can be a challenge.
Researchers can’t recruit patients in advance to test out devices that, by their nature, are used only in emergencies. Instead, the companies have to get what’s known as community consent: After selecting hospitals to partner with them on the study, they must describe the study at local meetings, in ads, and on social media, allowing residents to opt out of the trial.
“It’s a way to do emergency medicine research in a population that can’t provide consent,” said Upma Sharma, Arsenal’s senior director of research and development.
Arsenal’s device resembles a caulking gun when fully assembled. The foam forms when two liquids are combined, along with air, as they are injected through the belly button.
In a demo in the Arsenal lab, a balloon hanging in a clear container served as the abdominal cavity. At first, the combination of liquids seemed to just sit in the balloon, but within a few seconds, the foam took off and the balloon swelled. The foam expands to fill a volume 35 times greater than the volume of the two liquids, according to Arsenal.
The foam is not designed to stop bleeding from major external trauma. But in some cases, those types of wounds can be addressed before a patient makes it to the operating room, while internal wounds cannot, said Dr. David King, a trauma surgeon at Massachusetts General Hospital who has run Arsenal’s studies in pigs and cadavers.
“After the Boston [Marathon] bombing, we had patients come with traumatic amputations who also had internal bleeding,” said King, who ran the 2013 marathon and then treated patients. “It was hard to distinguish which they were dying from. Once you put the tourniquet on … and they were still dying, then you can assume it’s from the internal bleeding and make an intervention.”
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