Military team having a first aid training course stock photo.
A biotechnology firm in the United States has received the Food and Drug Administration (FDA) clearance for its new innovation – a hemostatic gel that is designed to control moderate to severe bleeding in seconds.
The Brooklyn-based company, Cresilon, says the plant-based hemostatic gel is designed to temporarily control the flow of blood when applied externally to a wound.
The company’s Traumagel is the first hemostatic medical device with FDA clearance for temporary external use.
The company wants to develop and manufacture Traumagel to address the needs of the United States military, government health agencies, emergency medical services (EMS) systems, and medical professionals.
It is intended for anyone who routinely encounters traumatic wounds and need a solution to quickly and effectively stop and control severe bleeding.
The company is planning to initiate a launch of Traumagel in the US in late 2024.
There are multiple hemostatic agents and simpler bandages and gauze bandages available in the market which can stop bleeding to some extent in case of accidents, wounds, and for those which are inflicted during times of conflict.
However, most of them either require lengthy preparations or have extended application time. Moreover, they can also be difficult to apply or require technical expertise to ensure they are effective in stopping the flow of blood in all kinds of situations.
Severe blood loss can lead to the loss of lives in a matter of minutes, especially in cases such as accidents and in war-like situations where getting to a hospital within minutes is not possible. Stopping the flow of blood temporarily in an effective and easy way can ensure that the wounded get to live another day.
According to Cresilon, their plant-based hemostatic gel is unique because it is supplied in a pre-filled syringe, is quite easy to apply, requires no preparation, and is designed to stop bleeding quickly across all types of bleeds.
“The ability to rapidly stop bleeding at the point of care and halt a life-threatening hemorrhage can be the difference between life and death for people with traumatic injuries,” said Joe Landolina, CEO and co-founder of Cresilon and inventor of the technology.
“The FDA clearance for TRAUMAGEL is a monumental milestone for Cresilon and brings us another step forward in our mission to save lives and transform the standard of care in emergency medicine. Our proprietary hemostatic gel technology is a game-changer and unlike any other hemostatic agent currently being used.”
Interestingly, this is not the first time that Cresilon has received the FDA clearance for products intended for human use.
The company’s first FDA clearance for Hemostatic Gel was intended for the local management of bleeding wounds, such as minor cuts, lacerations, and abrasions.
The firm also makes Vetigel – a product intended for animals, which stops the bleeding upon coming in contact with the affected part. The product can be used both internally and externally, and it is biocompatible and requires no preparation.
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Abhishek Bhardwaj Abhishek brings a wealth of experience in covering diverse stories across different beats. Having contributed to renowned wire agencies and Indian media outlets like ANI and NDTV, he is keenly interested in Tech, Business and Defense coverage.
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