An Oregon company is ramping up to produce an Army-backed sponge that could save lives by slowing bleeding from some battlefield wounds in seconds.
RevMedx received approval in April from the Food and Drug Administration to produce XStat, a compressed sponge looks like an antacid tablet but expands many times its size when exposed to fluids, such as blood. The material is also treated with a hemostatic agent, which quickly coagulates the blood flow.
A large syringe is used to inject dozens of the sponges deep into a wound, and its inventors say blood flow can be staunched as quickly as 20 seconds.
The Army has invested heavily in the production and development of XStat, providing RevMedx with about $5 million during the past five years, said John Steinbaugh, a vice president at the company.
A recent study of roughly 4,600 casualties from the Iraq and Afghanistan wars in 2001-11 found that a quarter of the deaths were potentially preventable, with uncontrolled bleeding a major cause.
Hemostatic gauzes have long been used by medics and civilian emergency personnel to stop bleeding but have only been approved by the FDA for dressing external wounds. However, they are routinely inserted into wounds to stem blood flow, Steinbaugh said.
“Our product is actually approved to be inserted into the body to control bleeding,” he said. And unlike makeshift gauze, XStat expands and puts pressure on the point of bleeding.
The device “doesn’t solve all of our bleeding problems,” according to Dr. Anthony Pusateri, with the Combat Casualty Care Research Program of the Army Medical Research and Materiel Command at Fort Detrick, Md., which oversaw its development and testing.
But XStat is intended to work specifically on “one of our most challenging forms of hemorrhage” — wounds in the areas where the legs and arms meet the torso, Pusateri said in an article posted on the command’s web site.
XStat is useful in spots where a tourniquet can’t be easily applied or when the wound is so deep that applied pressure from the outside won’t stop the bleeding.
It’s not intended to be used for wounds on most of the torso, neck and head, where expanding sponges could do more harm than good on critical organs and primary blood vessels.
Each sponge also has a radioactive marker that can be detected by X-ray so none is inadvertently left in the body after hospital treatment.
Steinbaugh said it will take about six months to reach full production, and XStat is only approved for military use for now.
Steinbaugh, a former Army medic, spent extensive time in Iraq and Afghanistan and remains in contact with many active-duty and former medics — many who provide feedback on RevMedx’s prototypes.
Medics are often frustrated with using “off-the-shelf” medical items that haven’t been modified for the battlefield, he said.
“So medics were forced for years to just use something that was designed for an ambulance or an emergency room, and a medic on the battlefield would literally tear it out of the packaging and rip out the parts he wants and throw the rest away,” Steinbaugh said. “No one was making anything specific for pre-hospital combat trauma.”
RevMedx has made that a niche focus, and it has other life-saving medical devices in the pipeline. The military is testing the company’s inflatable bandage that keeps pressure on a wound to stop bleeding, similar to the way a medic presses with his hands.
Once a medic sends a wounded fighter to the hospital, there’s often no one to keep that pressure on, and bleeding can continue.
“When the air bladder is inflated, it puts pressure downward, which is basically the same as the medic putting his weight down on the bandage,” Steinbaugh said.