FlowStop Hemostatic Spray Hits 18,000 Units, Seeks FDA Clearance

South Korean maker INNOPHARMA designs the no-compression liquid spray for bystanders, firefighters and soldiers who reach injuries before medical care

DAEGU, South Korea, Nov. 6, 2026 — A liquid spray lets people without medical training control bleeding without gauze packing or sustained pressure. Maker INNOPHARMA Co., Ltd. has sold 18,000 human-use units of FlowStop in South Korea and seeks U.S. Food and Drug Administration clearance.

Direct Pressure Ties Up Hands Until EMS Arrives

U.S. emergency medical services took a median of 7 minutes to reach patients after a 911 call, and 13 minutes in rural areas, according to a 2017 JAMA Surgery study. Bystanders fill that gap, and INNOPHARMA says gauze and hand pressure can fall short at mass-casualty scenes.

On the battlefield, hemorrhage accounted for 90.9% of potentially survivable deaths among U.S. troops who died before reaching treatment from 2001 to 2011, according to a 2012 Journal of Trauma and Acute Care Surgery study. January 2024 Tactical Combat Casualty Care guidelines call for at least 3 minutes of direct pressure on a hemostatic dressing.

FlowStop may remove that step. A user with no medical training shakes the container for about 30 seconds, sprays the wound and does not need to pack it or hold sustained pressure. It also reaches areas gauze cannot easily press, such as the face. The company says freeing responders' hands could help them reach more patients at disaster scenes.

"In disaster response, what matters, ahead of specialized equipment, is a means for the people on the scene to act immediately," said Seong Hwan Kim, chief executive officer of INNOPHARMA.

Study Shows Kaolin Liquid Halts Rat Liver Bleeding in Minutes

Kaolin, a clay mineral in the liquid, activates the blood's clotting pathway, and carboxymethylcellulose forms a gel barrier over the wound that resists rebleeding. The formula uses no animal-derived ingredients such as shellfish-derived chitosan. Powder hemostats can require scraping at follow-up care, the company says, while FlowStop residue can stay on minor abrasions and lacerations and rinses from larger wounds with saline.

A liver-resection animal model study at the Daegu-Gyeongbuk Medical Innovation Foundation's preclinical center evaluated the spray's no-compression hemostatic performance. Bleeding stopped without compression in an average of 2.29 minutes, within 2 minutes in about 70% of test subjects and within 3 minutes in 100%. Follow-up over 28 days found no inflammation or foreign-body reaction. The company evaluated performance and safety through preclinical work and ISO biological safety tests.

FlowStop's gamma-sterilized container stores at room temperature and sprays in any direction, which suits home first-aid kits, vehicles, workplaces and public emergency kits.

South Korea's Ministry of Food and Drug Safety certified FlowStop as a Class II medical device in 2025 for managing bleeding at local sites such as stab wounds, lacerations and abrasions. The Ministry of the Interior and Safety awarded it disaster safety product certification the same year. The company says public agencies and emergency services use FlowStop and that private companies use it as industrial safety equipment. INNOPHARMA reports 18,000 human-use units sold from launch in October 2025 through October 2026, with fire stations among its repeat buyers.

INNOPHARMA has submitted an FDA Pre-Submission and expects to meet the agency by March 2027 before filing for 510(k) clearance for over-the-counter sale. Kim will join the G-Round x Fairfax County Economic Development Authority outbound program in Washington and Fairfax County, Virginia, Nov. 9-12, seeking talks with U.S. emergency response, military medicine and medical supply organizations.

FlowStop is on sale in South Korea, and INNOPHARMA is seeking FDA clearance for U.S. sale. Journalists and prospective partners can request test data and meetings through INNOPHARMA's website.

SOURCE INNOPHARMA Co., Ltd.