Cresilon Receives FDA Clearance for TRAUMAGEL

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Hemostatic gel designed to control moderate to severe bleeding in seconds and save lives

NEW YORK, Aug. 15, 2024 /PRNewswire/ -- Cresilon Inc. ("Cresilon"), a Brooklyn-based biotechnology company focused on hemostatic medical device technologies, today announced it has received U.S. Food and Drug Administration ("FDA") 510(k) clearance for TRAUMAGEL^® ("TRAUMAGEL") for temporary external use for controlling moderate to severe bleeding.

Cresilon's revolutionary plant-based hemostatic gel technology is designed to stop and control life-threatening bleeding in a matter of seconds when applied to a wound at the point of care. TRAUMAGEL, which utilizes Cresilon's proprietary hydrogel technology, is a first-of-its-kind hemostatic medical device with FDA clearance for temporary external use in moderate to severe bleeding.

Cresilon intends to develop and manufacture TRAUMAGEL to address the needs of the U.S. military, government health agencies, emergency medical services ("EMS") systems, and medical professionals who routinely encounter traumatic wounds and need a solution to quickly and effectively stop and control severe bleeding. The company plans to initiate a strategic launch of TRAUMAGEL in the U.S. late 2024.

"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 wounds," 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 wound treatment. Our proprietary hemostatic gel technology is a game-changer and unlike any other hemostatic agent currently being used."

Severe blood loss can kill in a matter of minutes, whether from a gunshot wound or a massive injury-related hemorrhage. A person dies from injury nearly every 3 minutes, and 40% of these deaths are due to major hemorrhage or its consequences.¹ Death from hemorrhage is early, with up to 60% of deaths occurring within the first 3 hours of injury.²

While several hemostatic agents and gauze bandages are currently available for applications such as trauma and surgery, many products require preparation and lengthy application time, can be difficult to apply, or are not suited to work across all types of bleeds. Cresilon's plant-based hemostatic gel is supplied in a pre-filled syringe, easy-to-apply, requires no preparation, and designed to stop bleeding quickly across all types of bleeds.

TRAUMAGEL marks Cresilon's second FDA clearance for human use. The first was granted in June 2023 for Cresilon Hemostatic Gel^® ("CHG"), which is indicated for use in the local management of bleeding wounds such as minor cuts, lacerations, and abrasions. The recent FDA clearances follow several major advancements for the company which operates out of a state-of-the-art 33,000-square-foot biomanufacturing facility in Brooklyn's Industry City.

Additionally, the company recently reported promising results from its cooperative research and development agreement with the U.S. Defense Department's Walter Reed Army Institute of Research (WRAIR) from a study of Cresilon's gel technology as a potential field and prehospital treatment to mitigate life-threatening brain hemorrhage and provide neuroprotection following a penetrating traumatic brain injury ("TBI").

For more information about Cresilon and TRAUMAGEL, visit www.cresilon.com.

About Cresilon
Cresilon^® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company's proprietary hydrogel technology. The company's plant-based technology has revolutionized the current standard by stopping bleeding in seconds. The company's current and future product lines target trauma care, biosurgery, and animal health. Cresilon's mission is to save lives. For more information about Cresilon, which was named to Fast Company's annual list of the World's Most Innovative Companies of 2024, ranking No. 1 in the medical devices category, visit www.cresilon.com.

References

¹Curry NS, Davenport R. Transfusion strategies for major haemorrhage in trauma. Br J Haematol. 2019 Feb;184(4):508-523. doi: 10.1111/bjh.15737. Epub 2018 Dec 27. PMID: 30592036.

²Holcomb JB, del Junco DJ, Fox EE, et al. The prospective, observational, multicenter, major trauma transfusion (PROMMTT) study: comparative effectiveness of a time‐varying treatment with competing risks. Journal of the American Medical Association Surgery 2013; 148: 127–36.

SOURCE Cresilon