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Hemostatic gel receives FDA approval for use in US soldiers

A biotechnology company in the USA has received approval from the American Food and Drug Administration (FDA) for its new innovation – a hemostatic gel that is intended to stop moderate to heavy bleeding within seconds.

Brooklyn-based Cresilon says the plant-based hemostatic gel is designed to temporarily control blood flow when applied topically to a wound.

The company’s Trauma Gel is the first FDA-approved hemostatic medical device for temporary topical use.

The company aims to develop and manufacture trauma gel to meet the needs of the U.S. military, government health agencies, emergency services and medical professionals.

It is intended for anyone who regularly deals with traumatic wounds and needs a solution to stop and control heavy bleeding quickly and effectively.

The company plans to begin launching Traumagel in the U.S. in late 2024.

Benefits of Traumagel

There are numerous hemostatic agents as well as simpler bandages and gauze available on the market that can stop bleeding to some extent in accidents, wounds and times of conflict.

However, most of these drugs require either lengthy preparation or a longer application time. In addition, they can be difficult to use or require technical expertise to ensure that they are effective at stopping blood flow in all possible situations.

Severe blood loss can cause death within minutes, especially in accidents and war-like situations where it is not possible to reach a hospital within minutes. Effective and simple temporary interruption of blood flow can ensure that the injured survive for another day.

According to Cresilon, their herbal hemostatic gel is unique because it comes in a pre-filled syringe, is very easy to use, requires no preparation and is designed to quickly stop bleeding in all types of hemorrhages.

Technology behind herbal hemostatic gel and FDA approval

“The ability to stop bleeding on site and terminate life-threatening bleeding can mean 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.

“FDA approval for TRAUMAGEL is an important milestone for Cresilon and takes us another step forward in our mission to save lives and change the standard of care in emergency medicine. Our proprietary hemostatic gel technology is groundbreaking and unlike any other hemostatic agent currently in use.”

Interestingly, this is not the first time Cresilon has received FDA approval for products for human use.

The company’s first FDA approval for hemostatic gel was intended for the topical treatment of bleeding wounds such as minor cuts, lacerations and abrasions.

The company also produces Vetigel – a product for animals that stops bleeding when it comes into contact with the affected area. The product can be used both internally and externally, is biocompatible and does not require any preparation.

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ABOUT THE PUBLISHER

Abhishek Bhardwaj Abhishek brings a wealth of experience in reporting on diverse topics across multiple domains. He has worked for reputed news agencies and Indian media outlets like ANI and NDTV and has particular interest in covering technology, business and defence.

By Jasper

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