NEXT BIOMEDICAL seeks to expands FDA indication for Nexpowder to lower gastrointestinal tract

NEXT BIOMEDICAL, a local medical solution company, has submitted documentation to the U.S. FDA to expand the indication for its endoscopic hemostatic agent, Nexpowder, to include preventive use for lower gastrointestinal (GI) tract bleeding.

The company announced the submission on Tuesday, noting its aim to extend the product’s current indication from upper to lower GI tract applications.

The submission focuses on assessing the clinical efficacy and safety of Nexpowder in preventing lower GI tract bleeding. If granted approval, the indication for Nexpowder will cover both upper and lower GI tract bleeding, significantly broadening its clinical utility.

Nexpowder, a powder-type hemostatic agent, allows rapid and straightforward hemorrhage control during endoscopic procedures, making it valuable in emergency bleeding cases. The product is currently approved by the Ministry of Food and Drug Safety (MFDS), the FDA for upper GI tract bleeding, and holds CE-MDR certification for use in Europe.

The company anticipates that the expanded indication will enhance Nexpowder’s applications in both local and international markets.

In addition to the FDA approval for the lower GI indication, NEXT BIOMEDICAL is also seeking regulatory approvals for Nexpowder in Latin America, the Middle East, and Japan. The company projects that expanding into these new markets could provide access to a GI hemorrhage prevention market estimated at approximately 4 trillion won ($2.8 billion).

The preventive market, which seeks products that can preemptively manage bleeding risks and reduce rebleeding, is particularly well-suited to Nexpowder’s performance and ease of use.

“If this expanded indication is approved, we anticipate that Nexpowder could see increased use in various GI bleeding prevention areas,” a company official said. “Our goal is to establish it as a trusted product in the global market, driving growth in sales and brand recognition.”