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https://www.fastcompany.com/91173438/traumagel-cresilon-fda-approval
08-15-2024
NEWS
The FDA just cleared a new device that stops bleeding from gunshot wounds in seconds
Cresilon’s Traumagel, which can stop bleeding from wounds in seconds, is already being looked at for future uses by the Department of Defense.
The FDA just cleared a new device that stops bleeding from gunshot wounds in seconds
[Photo: Courtesy Cresilon]
BY David Salazar
3 minute read
As advanced as medicine is 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 by packing wounds with gauze. Traumagel, which earned the Food and Drug Administration’s medical device clearance on Wednesday, could change how first responders address severe bleeding.
Traumagel, which will launch later this year, is a 30-ml syringe of an algae- and fungi-based hemostatic gel that’s the color and texture of hummus. It can be applied directly into a wound, helping stanch bleeding within 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 “flowable” properties can improve the safety of treating something like a gunshot wound.
“If you have a roll of gauze, you have to pack that into a bullet wound inch by inch, and you have to ensure it’s making contact with whatever’s bleeding,” he says. “It’s painful for the patient and it’s dangerous because it can expose an EMT or emergency physician to shrapnel or shards of bone. [Traumagel] finds its way to where it needs to go.”
The first patients
Traumagel’s clearance by the FDA follows last year’s approval of Cresilon Hemostatic Gel, a 5-ml version of the same product that was allowed to be used on minor cuts. But even before that, the company’s product was proving its capabilities at more than 10,000 veterinarian clinics as Vetigel. In animal medicine, Vetigel was used for everything from spinal surgeries to teeth cleanings.
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“All of the work we’ve done to this point has not only allowed us to save lives in the pet space,” Landolina says. “It’s also allowed us to build up the business functions that we need as we launch Traumagel.”
Building out a solid base of veterinarian customers allowed the company to scale 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 Traumagel demand once the product launches later this year. The company has also built out a national sales team and forges partnerships with the animal health arms of major healthcare distributors.
Exploring future applications
Landolina says the original impetus behind Traumagel was making it so victims of bullet wounds would have a quick, effective way to stop bleeding and get them to a medical facility. He knows that while that’s a broad application, soldiers in the field are a big potential use case.
“Ninety-one percent of battlefield mortality is due to preventable hemorrhage,” he says. “Which means if there were only a better product to stop bleeding, lives could be saved.”
The Department of Defense has taken notice of even broader applications of Cresilon’s technology. Since 2022, the company has been working with the Walter Reed Army Institute of Research under a cooperative research and development agreement to help stabilize traumatic brain injuries among soldiers. In July, Cresilon shared positive results from a preclinical study evaluating its gel’s impact on intracranial pressure and hemoglobin content in small animals.
“Anything done in small animals like this may or may not translate to results in humans,” Landolina says, adding that the application Walter Reed is investigating is still a ways off, if it’s found to be viable.
For now, Cresilon is focused on Traumagel’s launch, and getting EMTs and physicians trained to use it. Landolina says that it’ll be easier to teach physicians to Traumagel in humans than it was to train vets to use Vetigel. Animals, after all, take many different shapes and sizes, and Vetigel was used more broadly than Traumagel will be.
“The learning curve is much easier than what we saw with Vetigel,” he says. “It’s not quite as simple as ‘point and shoot’ but it’s about as close as you can get.”
08-15-2024
NEWS
The FDA just cleared a new device that stops bleeding from gunshot wounds in seconds
Cresilon’s Traumagel, which can stop bleeding from wounds in seconds, is already being looked at for future uses by the Department of Defense.
The FDA just cleared a new device that stops bleeding from gunshot wounds in seconds
[Photo: Courtesy Cresilon]
BY David Salazar
3 minute read
As advanced as medicine is 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 by packing wounds with gauze. Traumagel, which earned the Food and Drug Administration’s medical device clearance on Wednesday, could change how first responders address severe bleeding.
Traumagel, which will launch later this year, is a 30-ml syringe of an algae- and fungi-based hemostatic gel that’s the color and texture of hummus. It can be applied directly into a wound, helping stanch bleeding within 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 “flowable” properties can improve the safety of treating something like a gunshot wound.
“If you have a roll of gauze, you have to pack that into a bullet wound inch by inch, and you have to ensure it’s making contact with whatever’s bleeding,” he says. “It’s painful for the patient and it’s dangerous because it can expose an EMT or emergency physician to shrapnel or shards of bone. [Traumagel] finds its way to where it needs to go.”
The first patients
Traumagel’s clearance by the FDA follows last year’s approval of Cresilon Hemostatic Gel, a 5-ml version of the same product that was allowed to be used on minor cuts. But even before that, the company’s product was proving its capabilities at more than 10,000 veterinarian clinics as Vetigel. In animal medicine, Vetigel was used for everything from spinal surgeries to teeth cleanings.
Fast Company Newsletters
“All of the work we’ve done to this point has not only allowed us to save lives in the pet space,” Landolina says. “It’s also allowed us to build up the business functions that we need as we launch Traumagel.”
Building out a solid base of veterinarian customers allowed the company to scale 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 Traumagel demand once the product launches later this year. The company has also built out a national sales team and forges partnerships with the animal health arms of major healthcare distributors.
Exploring future applications
Landolina says the original impetus behind Traumagel was making it so victims of bullet wounds would have a quick, effective way to stop bleeding and get them to a medical facility. He knows that while that’s a broad application, soldiers in the field are a big potential use case.
“Ninety-one percent of battlefield mortality is due to preventable hemorrhage,” he says. “Which means if there were only a better product to stop bleeding, lives could be saved.”
The Department of Defense has taken notice of even broader applications of Cresilon’s technology. Since 2022, the company has been working with the Walter Reed Army Institute of Research under a cooperative research and development agreement to help stabilize traumatic brain injuries among soldiers. In July, Cresilon shared positive results from a preclinical study evaluating its gel’s impact on intracranial pressure and hemoglobin content in small animals.
“Anything done in small animals like this may or may not translate to results in humans,” Landolina says, adding that the application Walter Reed is investigating is still a ways off, if it’s found to be viable.
For now, Cresilon is focused on Traumagel’s launch, and getting EMTs and physicians trained to use it. Landolina says that it’ll be easier to teach physicians to Traumagel in humans than it was to train vets to use Vetigel. Animals, after all, take many different shapes and sizes, and Vetigel was used more broadly than Traumagel will be.
“The learning curve is much easier than what we saw with Vetigel,” he says. “It’s not quite as simple as ‘point and shoot’ but it’s about as close as you can get.”
