NextBioMedical Selected for National R&D Projects in Hemostatic and Embolic Agents

NextBioMedical announced on April 15 that it has been selected for national research and development (R&D) projects in the fields of hemostatic agents and embolic materials.

NextBioMedical is a medical device company that develops therapeutics and exports finished products based on polymer and drug delivery system (DDS) technologies.

The project led by the Ministry of SMEs and Startups aims to develop a converged medical product by advancing the existing hemostatic agent, ‘Nexpowder.’ NextBioMedical will participate as the lead institution and will work on the development of ‘Nexpowder™-T,’ which contains additional blood coagulation substances.

The core of the project is to enhance hemostatic performance by combining the existing physical adhesion-based hemostasis mechanism with a chemical blood coagulation mechanism. After securing safety and efficacy data through clinical trials in Korea, the company plans to seek approval of an Investigational Device Exemption (IDE) for clinical trials from the U.S. Food and Drug Administration (FDA).

The company has also been selected for the ‘Support Project for Clinical Evaluation of Domestic Medical Device Users,’ organized by the Korea Health Industry Development Institute. The goal of this project is to verify the clinical efficacy and safety of domestically produced medical devices in medical settings.

NextBioMedical plans to evaluate the efficacy and safety of its vascular embolization prosthesis, Nexphere-H, in real-world clinical settings targeting abnormal blood vessels related to musculoskeletal disorders. In particular, the company aims to confirm the applicability of the product to various patient groups, including those experiencing persistent pain after surgery, and to establish clinical evidence for expanding the indications of the product in the future.

A representative from NextBioMedical commented, “With the selection for these projects, we are now able to pursue both strengthening our product competitiveness and securing clinical data,” adding, “We will use this as a foundation for entering the global market.”

This content was produced with the assistance of AI translation services.