[Special Stock] NextBioMedical Reaches Decisive Turning Point for Nexphere-F's U.S. Entry... Clinical Trial Costs to Be Covered by Medicare

Shares of NextBioMedical, an innovative therapeutic developer, are showing strong performance. The company's stock appears to be influenced by news that its next-generation embolic microsphere product, Nexphere-F, has received 'IDE Category B' approval from the Centers for Medicare & Medicaid Services (CMS), the agency overseeing the Medicare program under the U.S. Department of Health and Human Services.

As of 9:29 a.m. on May 22, shares of NextBioMedical were trading at 45,050 won, up 6.88% from the previous day.

This approval signifies that the research objectives and methods of the ongoing RESORB clinical trial (NCT06872567) in the U.S., which is investigating bioabsorbable embolic microspheres for osteoarthritis treatment, have been recognized at the federal level as meeting U.S. insurance reimbursement standards and medical ethics principles. This is expected to serve as a decisive turning point for the expansion of clinical trials and insurance coverage in the U.S. going forward.

With CMS IDE approval, hospitals participating in the Nexphere-F clinical trial can now receive Medicare reimbursement not only for device costs related to the procedure, but also for all associated and routine medical service costs, including imaging studies, medical consultations, hospitalization, and follow-up care. Hospitals across all U.S. states have been granted the authority to begin clinical trials immediately, without the need for separate local review by Medicare Administrative Contractors (MACs).

Clinical trial costs in the U.S. are expected to be reduced by tens of millions of won, and the barriers to participation for hospitals and research institutions are also anticipated to be significantly lowered.

A NextBioMedical representative stated, "This CMS IDE approval means that the U.S. federal government has recognized and placed trust and value in the clinical design and therapeutic concept of Nexphere-F," adding, "It is a significant milestone that dramatically increases the potential for U.S. insurance coverage and commercial entry."

The representative further commented, "As hospital and patient access improves in the U.S., the pace of clinical trials will also accelerate," and added, "This will have a positive impact on our overall market strategy."

The representative also emphasized, "NextBioMedical will continue to expand Nexphere-F as a new interventional treatment option for patients with musculoskeletal disorders who face limitations with existing surgical or drug therapies," and stated, "We plan to further develop it for a range of indications in the future, including tendinitis, plantar fasciitis, and post-surgical pain."

Ha Taegi, a researcher at SangSangin Securities, analyzed, "NextBioMedical is currently in discussions with global medical device distributors regarding U.S. licensing agreements for Nexphere-F," and added, "The long-term growth prospects for Nexphere-F look promising." He estimated the clinical trial costs for Nexphere-F and related products over the next two years at 15 billion won. He also noted that profitability is likely to improve as a result of the IDE Category B approval.

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