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.
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