Pioneering a Paradigm Shift in Pain Treatment, Accelerating Global Market Expansion
SEOUL, South Korea, March 6, 2025 /PRNewswire/ -- NEXTBIOMEDICAL CO., LTD, a leading developer of cutting-edge Devices, announced that its groundbreaking product 'Nexsphere-F,' a resorbable microsphere for musculoskeletal pain embolization, has received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
The FDA's Breakthrough Device Designation is granted to medical devices that demonstrate substantial improvement over existing treatments and address high unmet clinical needs. This designation enables Nexsphere-F to benefit from close collaboration with the FDA, allowing for prioritized review and expedited regulatory processes. Additionally, the designation offers greater flexibility in clinical trial design, significantly accelerating the product's market entry.
Nexsphere-F's proposed indication is "for use in the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and/or analgesics by temporarily occluding blood flow in the genicular arteries". The product utilizes innovative 'resorbable microsphere technology' to deliver fast-acting microspheres into abnormal blood vessels responsible for arthritis pain. These microspheres dissolve within 2 to 6 hours, leading to the necrosis of pain-inducing nerve cells and providing rapid and effective pain relief.
Having already received FDA approval for its Investigational Device Exemption (IDE), Nexsphere-F will launch its pivotal clinical trial at major U.S. university hospitals this year, targeting approximately 120 patients. It is the only product approved under the European CE-MDD for musculoskeletal pain embolization and has recently launched in key European markets. "Nexsphere-F has already been effectively used in thousands of MSK embolization patients worldwide, " said Dr. Ziv Haskal, National Principal Investigator of the RESORB Trial. "W e expect to echo these outstanding results in the US trial." The company is also in active discussions with global medical device companies for commercialization partnerships.
At a recent Global Embolization Symposium and Technologies Musculoskeletal (GEST MSK) conference in Europe, Nexsphere-F's clinical results captured the attention of international medical professionals and experts, highlighting its innovation and clinical value.
A spokesperson for NEXTBIOMEDICAL stated that they are thrilled that Nexsphere-F's innovative technology and critical clinical need have been recognized through the FDA Breakthrough Device Designation. This will not only expedite the FDA approval process but also positively influence collaborations with global medical device companies and business expa nsion.
With this designation, NEXTBIOMEDICAL aims to leverage its vanguard pain treatment solution to strengthen its competitive edge in both the U.S. and global markets, setting a new paradigm in the medical device industry.
SOURCE NEXTBIOMEDICAL CO., LTD.
