The FDA recently cleared a new device that stops bleeding from gunshot wounds in seconds

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As medicine has advanced in some areas, when it comes to stopping bleeding, most solutions are decidedly old-school: applying pressure and trying to absorb blood with powder or packing wounds with gauze. Traumagel, which received medical device approval from the Food and Drug Administration on Wednesday, could change the way first responders deal with severe bleeding.

Traumagel, to be launched later this year, is a 30-ml syringe of algae- and fungus-based hemostatic gel with the color and texture of hummus. It can be applied directly to the wound, helping the bleeding in seconds. The FDA cleared its use for moderate to severe bleeding. Joe Landolina, founder of Brooklyn-based Cresilon, which makes Traumagel, says that in addition to stopping bleeding quickly, the product’s “flow” properties can improve the safety of treating something like a gunshot wound.

“If you have a gauze strip, you have to pack it in an inch by inch area, and you have to make sure you’re in contact with anything that comes out,” he said. “It is painful for the patient and dangerous because it can expose the EMT or paramedic to the bone fragments. [Traumagel] it finds its way to where it needs to go.”

First patients

Traumagel’s approval by the FDA follows last year’s approval of Cresilon Hemostatic Gel, a 5-ml version of the same product that was approved for use in minor cuts. But even before that, the company’s product was proving its strength in more than 10,000 veterinary clinics like Vetigel. In veterinary medicine, Vetigel was used for everything from spinal surgery to cleaning teeth.

“All the work we’ve done so far has not only allowed us to save lives in the animal shelter,” said Landolina. “It also allowed us to build the business operations we needed as we launched Traumagel.”

Building a strong veterinary customer base has allowed the company to grow in anticipation of Traumagel’s approval for use in humans. The company now operates a 33,000-square-foot biomanufacturing facility in Brooklyn’s Industry City, which Landolina says will be able to meet demand for Traumagel when the product launches later this year. The company also built a national sales force and built relationships with the animal health arms of major healthcare distributors.

Tests future applications

Landolina says the original impetus for Traumagel was to give gunshot wound victims a quick and effective way to stop the bleeding and get them to a medical facility. You know that even though that’s a broad plan, the military in the field is a big use case.

“Ninety-one percent of battlefield deaths are due to preventable bleeding,” he said. “Which means that if there was a better product to stop bleeding, lives could be saved.”

The Department of Defense has recognized an even broader use of Cresilon technology. Since 2022, the company has been working with the Walter Reed Army Institute of Research under a collaborative research and development agreement to help stop traumatic brain injuries among soldiers. In July, Cresilon shared positive results from a preclinical study testing the effect of its gel on intracranial pressure and hemoglobin content in small animals.

“Anything that’s done in small animals like this may or may not translate to humans,” Landolina said, adding that the application Walter Reed is investigating is still an avenue to avoid, if found to be effective.

For now, Cresilon is focused on introducing Traumagel, and getting EMTs and doctors trained to use it. Landolina says it will be easier for doctors to teach Traumagel to humans than to train vets to use Vetigel. Animals, after all, take different shapes and sizes, and Vetigel was used more widely than Traumagel.

“The learning curve is much easier than what we saw with Vetigel,” he said. “It’s not as simple as ‘point and shoot’ but it’s as close as you can get.”

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