Traumagel is a new product to stop uncontrolled bleeding

Traumagel, a new medical product developed by the company Cresilon, has achieved FDA 510(k) clearance for controlling moderate to severe bleeding, including life-threatening injuries like gunshot wounds (Forbes, Fast Company). This gel-based treatment, harnesses the hemostatic (halting bleeding) properties of algae- and fungi-derived materials to rapidly form blood clots, eliminating the need for manual pressure or wound packing. Designed to act within seconds, Traumagel provides a critical solution for emergency situations. The FDA’s clearance was granted based on preclinical data that highlighted the product’s safety and effectiveness in comparison to existing treatments.

Uncontrolled bleeding is a major challenge in both civilian and military trauma care, with hemorrhage being the leading cause of preventable battlefield deaths, accounting for 91% of such fatalities. In the civilian context, uncontrolled bleeding contributes to 40% of trauma-related deaths globally, leading to approximately 1.5 million deaths annually.

Current methods for controlling bleeding depend on the injury's severity and location, often involving a combination of techniques. Basic approaches include direct pressure with sterile dressings, while tourniquets are used for severe limb injuries. Hemostatic dressings, such as QuikClot and Celox, promote clotting in emergency situations, while wound packing with gauze or hemostatic agents is effective for deep wounds. Surgical intervention is sometimes necessary when external methods fail.

Packaged in a 30-ml syringe (Figure 1), the Traumagel has a texture similar to hummus, making it easy to apply deep into wounds. Its algae- and fungi-based composition allows for more efficient bleeding control compared to traditional methods like gauze, which often require painful packing and pose risks due to exposure to shrapnel or bone fragments. Traumagel’s flowable nature enables it to conform to irregular wound shapes, creating a protective seal that minimizes blood loss without the need for external pressure, which  reduces the risk of contamination and injury for both the responder and the patient.

The gel’s chemical composition includes sodium alginate, a polymer derived from algae, and poly(N-acetyl-D-glucosamine), a polycationic polymer (found in cell wall of fungi). Upon contact with blood, sodium alginate forms a hydrogel, creating a scaffold that disperses poly(N-acetyl-D-glucosamine) particles. This interaction leads to rapid absorption of water and the formation of a gel-like matrix that acts as a physical barrier over the wound. The ionic interactions between the gel and blood components accelerate clotting, promoting platelet activation and fibrin formation to stabilize the wound and stop bleeding. The hemostatic agent Celox, mentioned above, also relies on a positively-charged polysaccharide to induce blood clotting. This dual-action, providing both a physical obstruction and enhancing biochemical clotting processes, makes Traumagel a powerful tool in emergency bleeding control.

The development of Traumagel is built on Cresilon’s earlier innovations in hemostatic technology, which began with the 2023 release of Cresilon Hemostatic Gel, a 5-ml product for minor human injuries. Before that, Cresilon’s technology was successfully used in veterinary medicine under the name Vetigel, which was deployed in over 10,000 clinics for animal surgeries and treatments. This extensive veterinary application provided a proof of concept, demonstrating the effectiveness of the gel in real-world scenarios. 

Set to launch by late 2024, Traumagel represents an important addition to trauma care. Cresilon plans to distribute the product to EMTs, military personnel, and healthcare providers. Time will tell whether Traumagel is safer and more effective than existing methods, but it has the potential to improve patient outcomes in both civilian and military trauma settings, ultimately saving lives.

Figure 1. Traumagel is a hemostatic gel administered by a syringe designed to stop bleeding at a wound. It combines a gel matrix to provide a physical barrier with chemical interactions that promote blood clotting. The product was recently cleared by the FDA is is set to launch at the end of 2024.