A spray for untrained hands
INNOPHARMA Co., Ltd. of Daegu, South Korea, makes FlowStop, a liquid spray the company says lets people without medical training control bleeding without packing a wound with gauze or holding sustained pressure. A user shakes the container for about 30 seconds and sprays the injury, and the spray reaches areas gauze cannot easily press, such as the face, according to the company.
INNOPHARMA describes the product as intended for bystanders, firefighters and soldiers who reach injured people before medical care. It points to a 2017 JAMA Surgery study that put the median time for U.S. emergency medical services to reach patients after a 911 call at 7 minutes, and 13 minutes in rural areas, and to a 2012 Journal of Trauma and Acute Care Surgery study that found hemorrhage accounted for 90.9% of potentially survivable deaths among U.S. troops who died before reaching treatment from 2001 to 2011.
18,000 units sold in South Korea
INNOPHARMA said it sold 18,000 human-use units of FlowStop between its launch in October 2025 and October 2026, with fire stations among repeat buyers. South Korea's Ministry of Food and Drug Safety certified it in 2025 as a Class II medical device for managing bleeding at local sites such as stab wounds, lacerations and abrasions, and the Ministry of the Interior and Safety awarded disaster safety product certification the same year.
Public agencies and emergency services use the spray, and private companies use it as industrial safety equipment, according to the company. It said the gamma-sterilized container stores at room temperature and sprays in any direction.
Preclinical results
In a liver-resection animal model study at the Daegu-Gyeongbuk Medical Innovation Foundation's preclinical center, bleeding stopped without compression in an average of 2.29 minutes, within two minutes in about 70% of test subjects and within three minutes in all of them, the company said. Follow-up over 28 days found no inflammation or foreign-body reaction.
The company said kaolin in the liquid activates the blood's clotting pathway and carboxymethylcellulose forms a gel barrier over the wound that resists rebleeding, and that the formula uses no animal-derived ingredients such as shellfish-derived chitosan. It said it assessed performance and safety through preclinical work and ISO biological safety tests.
FDA filing and U.S. meetings
INNOPHARMA has submitted an FDA Pre-Submission and expects to meet the agency by March 2027 before filing for 510(k) clearance to sell FlowStop over the counter in the United States, the company said in its announcement. Chief executive Seong Hwan Kim will join the G-Round x Fairfax County Economic Development Authority outbound program in Washington and Fairfax County, Virginia, from Nov. 9 to 12, seeking talks with U.S. emergency response, military medicine and medical supply organizations.
