FlowStop Hemostatic Spray Achieves Milestone Sales, Pursues FDA Approval

FlowStop Hemostatic Spray Achieves Milestone Sales



In an inspiring development in emergency medical technology, INNOPHARMA Co., Ltd. announces that its revolutionary hemostatic spray, FlowStop, has reached an impressive sales milestone of 18,000 units in South Korea. This innovative product allows individuals without formal medical training to effectively manage bleeding without relying on traditional methods such as gauze packing or sustained pressure. With the increasing focus on immediate care before professional medical help arrives, this spray presents a significant advancement in first aid responses.

Addressing Critical Needs
One of the standout features of FlowStop is its capability to be utilized by bystanders, including firefighters and military personnel, who may be the first responders in emergencies. According to a study published in JAMA Surgery, U.S. emergency medical services take an average of 7 minutes to reach a patient after a 911 call, with rural areas facing even longer response times. In situations of mass casualty, where numerous injuries occur, traditional methods of bleeding control can be insufficient. This is where FlowStop steps in, promising to be a game-changer.

Emergency situations have a high risk of hemorrhage, a major cause of preventable deaths, especially on battlefields. A report from the Journal of Trauma and Acute Care Surgery indicated that between 2001 and 2011, hemorrhage accounted for 90.9% of potentially survivable deaths among U.S. troops pre-treatment. The Tactical Combat Casualty Care guidelines recommend applying direct pressure to a wound for at least 3 minutes, which can hinder a responder's ability to assist others in chaotic environments. FlowStop alleviates this issue considerably; a user can just shake the spray for 30 seconds and then apply it directly to the wound, eliminating the need for packing or sustained pressure.

Innovative Composition
FlowStop's formula features kaolin, a clay mineral that activates the body's natural clotting processes, along with carboxymethylcellulose that creates a gel-like seal over the wound to prevent rebleeding. The absence of animal-derived ingredients increases its safety profile and broadens its applicability, making it a suitable choice for various emergency settings.

In preclinical testing conducted at the Daegu-Gyeongbuk Medical Innovation Foundation, FlowStop showcased its effectiveness by stopping bleeding in an average of 2.29 minutes – impressively, within 2 minutes for around 70% of test subjects. Notably, there were no adverse reactions or inflammation noted during follow-up evaluations extending to 28 days.

Regulatory Approvals and Market Impact
Achieving certification as a Class II medical device from South Korea's Ministry of Food and Drug Safety in 2025, FlowStop is now recognized for its efficacy in managing local bleeding from sources such as stab wounds and abrasions. The Ministry of the Interior and Safety also acknowledged its potential in disaster safety. Since its launch in October 2025, FlowStop has been a trusted tool for public agencies, emergency services, and even private companies that utilize it in industrial safety contexts.

As INNOPHARMA seeks FDA clearance for over-the-counter sales in the United States, the company submitted a pre-submission package to the FDA, with a follow-up meeting scheduled for early 2027. Company CEO Seong Hwan Kim will be representing FlowStop at an upcoming outbound program in Washington and Fairfax County, Virginia, from November 9 to 12, engaging in discussions with entities in emergency response and military medicine sectors.

INNOPHARMA's achievements mark the start of a promising journey for FlowStop, which is already available for sale in South Korea but is eagerly awaiting FDA approval to assist a broader audience. The intent to share test data and further explore partnerships underscores INNOPHARMA's commitment to ensuring safer outcomes in emergency medicine.

About INNOPHARMA
Founded in 2023, INNOPHARMA Co., Ltd. specializes in developing innovative spray-type hemostatic products for emergency, dental, and veterinary applications. The company's commitment to excellence is reflected in its production facility, which adheres to Korean Good Manufacturing Practices and ISO 13485 standards. With multiple patents under its belt and recognition from South Korea's Minister's Award for outstanding achievements in innovation, INNOPHARMA is well-positioned to make significant strides in the medical supplies market.

For more information and inquiries, visit www.innophm.com.

Topics Health)

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