Cresilon has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for Traumagel for temporary external use to control moderate to severe bleeding.

Cresilon已获得美国食品和药物管理局（FDA）510（k）的Traumagel许可，可暂时外用以控制中度至重度出血。

The Brooklyn-based biotech company’s plant-based hemostatic gel stops and controls life-threatening bleeding in seconds when applied to a wound. Traumagel uses Cresilon’s proprietary hydrogel tech and is a first-of-its kind hemostatic medical device with its indicated FDA clearance.

这家总部位于布鲁克林的生物技术公司的植物止血凝胶在几秒钟内就能止血并控制危及生命的出血。Traumagel使用Cresilon专有的水凝胶技术，是同类止血医疗器械中第一款获得FDA批准的产品。

The gel is supplied in a prefilled syringe and requires no preparation. Traumagel is Cresilon’s second FDA clearance for human use—the first was awarded in June 2023 for Cresilon Hemostatic Gel (CHG) to locally manage bleeding wounds such as minor cuts, lacerations, and abrasions.

凝胶在预填充注射器中提供，不需要准备。Traumagel是Cresilon第二次获得FDA批准供人类使用。第一次于2023年6月获得Cresilon止血凝胶（CHG）的批准，用于局部治疗出血性伤口，如轻微伤口，撕裂伤和擦伤。

Cresilon plans to develop and manufacture Traumagel for the needs of the U.S. military, government health agencies, emergency medical services systems, and clinicians who routinely encounter traumatic wounds and need a solution to quickly stop and control severe bleeding.

Cresilon计划开发和制造Traumagel，以满足美国军方、政府卫生机构、紧急医疗服务系统以及经常遇到创伤性伤口并需要快速停止和控制严重出血的临床医生的需求。

The company expects to begin Traumagel’s strategic launch in late 2024. It also reported promising results from a cooperative R&D 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 after a penetrating traumatic brain injury (TBI)..

该公司预计在2024年末开始Traumagel的战略发布。它还报告说，与美国国防部沃尔特·里德陆军研究所（WRAIR）的合作研发协议取得了令人鼓舞的结果，该协议研究了Cresilon的凝胶技术，作为潜在的领域和院前治疗，以减轻危及生命的脑出血，并在穿透性创伤性脑损伤（TBI）后提供神经保护。。

'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.

Cresilon首席执行官兼联合创始人、该技术的发明者乔·兰多利纳（JoeLandolina）说，能够在护理时迅速止血并阻止危及生命的出血，可能是创伤患者生死的关键FDA对TRAUMAGEL的批准是Cresilon的一个里程碑，为我们拯救生命和改变伤口治疗护理标准的使命迈出了又一步。

Our proprietary hemostatic gel technology is a game-changer and unlike any other hemostatic agent currently being used.' .

我们专有的止血凝胶技术是一种改变游戏规则的技术，与目前使用的任何其他止血剂不同。”。