#South Korea #Seoul #NEXTBIOMEDICAL #Nexsphere-F™ #Breakthrough Device

NEXTBIOMEDICAL's Nexsphere-F™ Receives FDA Breakthrough Designation

In an exciting development for pain management therapies, SOUTH KOREA based NEXTBIOMEDICAL CO., LTD has secured the prestigious Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its innovative product, Nexsphere-F™. This groundbreaking resorbable microsphere is designed specifically for managing musculoskeletal pain associated with osteoarthritis.

What is the Breakthrough Device Designation?

The FDA's Breakthrough Device Designation could not be more crucial. It is granted to medical devices that show substantial improvements over existing therapies and target significant clinical needs. By receiving this designation, Nexsphere-F™ will benefit from expedited review processes and enhanced collaboration with the FDA, allowing for flexibility in clinical trial designs and quicker paths to market.

How Does Nexsphere-F™ Work?

Nexsphere-F™ is designed to provide rapid pain relief for patients with osteoarthritis of the knee who have not responded well to conservative treatments or analgesics. The innovative microsphere technology targets the genicular arteries and occludes blood flow temporarily, which helps alleviate pain. Within just 2 to 6 hours, these microspheres dissolve, and the necrosis of pain-inducing nerve cells occurs, facilitating effective relief from discomfort.

The product has undergone further clinical exploration after gaining FDA approval for its Investigational Device Exemption (IDE) and is set to undertake its pivotal clinical trial at leading U.S. universities, engaging about 120 patients. Notably, it stands as the only device currently approved under the European CE-MDD for similar pain treatments.

Global Expansion and Future Prospects

Beyond its impressive FDA milestones, Nexsphere-F™ has already achieved significant utilization in numerous cases worldwide, which adds to its credibility among medical professionals. Dr. Ziv Haskal, the National Principal Investigator of the RESORB Trial, expressed optimism, indicating that the expected outcomes from the U.S. trial should echo those successful results achieved in other global trials.

The significance of Nexsphere-F™ was underscored at a recent Global Embolization Symposium and Technologies Musculoskeletal conference in Europe, where it garnered interest from medical experts and professionals, illuminating its clinical value and innovative edge.

NEXTBIOMEDICAL views the FDA's recognition as a stepping stone toward greater partnerships and commercial opportunities in the medical device industry. The company envisions expanding Nexsphere-F™ strategically across U.S. and global markets, allowing it to redefine treatment options for patients suffering from osteoarthritis-related pain.

With the Breakthrough Device Designation, NEXTBIOMEDICAL aims not only to enhance their competitive position in the evolving medical landscape but also to pave the way for future technologies that can transform pain management practices. As they leverage this unique advantage, the company remains committed to addressing the pressing needs of patients and healthcare providers around the world.

In conclusion, Nexsphere-F™ symbolizes an important step forward in medical technology aimed at improving the quality of life for individuals affected by chronic pain, and NEXTBIOMEDICAL's continued innovation promises to contribute significantly to the healthcare industry's trajectory.