In a world where gun violence is a grim reality, particularly in crime-ridden areas like South Africa, a new innovation promises to offer a lifeline to victims of gunshot wounds.
TraumaGel, a revolutionary hemostatic gel developed by Brooklyn-based company Cresilon, has just received medical device clearance from the Food and Drug Administration (FDA). This groundbreaking technology could drastically improve the chances of survival for those suffering from severe bleeding caused by gunshot wounds.
TraumaGel, a 30-ml syringe filled with a unique algae- and fungi-based gel, works by rapidly stopping bleeding when applied directly to a wound. The gel, which resembles hummus in texture and colour, has been shown to be effective in stanching bleeding within seconds, offering a much-needed advantage in emergency situations.
The FDA has cleared its use for moderate to severe bleeding, making it a potential game-changer for first responders and medical professionals treating gunshot wounds.
"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. 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," explains Joe Landolina, founder of Cresilon.
Landolina highlights the potential of TraumaGel to improve the safety of treating gunshot wounds, where traditional methods can be both painful and risky for both the patient and medical personnel.
The gel's "flowable" properties allow it to reach the source of bleeding efficiently and effectively, making it a more reliable and safer option than traditional gauze packing.
This is not the first time Cresilon's hemostatic gel technology has proven its worth. A 5-ml version of the product, Cresilon Hemostatic Gel, was approved for use on minor cuts last year.
Even before that, the company's product, marketed as Vetigel, was successfully used in over 10,000 veterinary clinics for a range of applications, from spinal surgeries to teeth cleanings.
"All of the work we’ve done to this point has not only allowed us to save lives in the pet space," says Landolina.
"It’s also allowed us to build up the business functions that we need as we launch Traumagel."
The success of Vetigel in the veterinary market has allowed Cresilon to scale its operations in preparation for the launch of TraumaGel. The company now operates a 33,000-square-foot biomanufacturing facility in Brooklyn's Industry City, capable of meeting the anticipated demand for TraumaGel.
Cresilon has also assembled a national sales team and forged partnerships with major healthcare distributors, ensuring that the product will be readily available when it launches later this year.
Landolina's initial vision for TraumaGel was to develop a quick and effective solution for stopping bleeding in victims of gunshot wounds, particularly soldiers in the field.
"Ninety-one percent of battlefield mortality is due to preventable hemorrhage. Which means if there were only a better product to stop bleeding, lives could be saved," he says.
The Department of Defense has taken notice of the potential of Cresilon's technology, recognizing its broader applications. Since 2022, the company has been collaborating with the Walter Reed Army Institute of Research under a cooperative research and development agreement to explore the use of Cresilon's gel in stabilizing traumatic brain injuries among soldiers.
In July, Cresilon shared positive results from a preclinical study evaluating the 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 acknowledges, emphasizing that the application Walter Reed is investigating is still in its early stages.
For now, Cresilon is focused on the launch of TraumaGel and ensuring that EMTs and physicians are properly trained to use it. Landolina believes that training medical professionals will be easier than training veterinarians, as TraumaGel will have a more specific application in human medicine compared to Vetigel's broader use in veterinary care.
"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."
