NEXT BIOMEDICAL secures key US CMS approval for investigational arthritis treatment device
NEXT BIOMEDICAL, a Korean innovator in advanced interventional therapies, announced Wednesday that its resorbable embolic microsphere product, Nexsphere-F, has received Investigational Device Exemption (IDE) Category B approval from the U.S. Centers for Medicare & Medicaid Services (CMS), a major federal agency under the Department of Health and Human Services.
Nexsphere-F is designed to offer minimally invasive, localized therapy that avoids the long-term complications associated with permanent embolic agents.
The approval marks a critical milestone for the company’s ongoing U.S. clinical trial titled RESORB (Resorbable Embolization MicroSpheres for OsteoARthritis Benefit), which is investigating the use of Nexsphere-F in treating osteoarthritis.
The IDE Category B designation signifies that the U.S. federal government has officially recognized both the scientific rationale and the ethical framework of the study as meeting national insurance coverage standards and clinical research principles.
Notably, the CMS IDE approval enables hospitals participating in the Nexsphere-F trial to receive Medicare reimbursement not only for the device itself, but also for all routine and ancillary medical services associated with treatment.
This includes imaging procedures, clinical visits, hospitalizations, and follow-up care. Furthermore, the decision grants immediate clearance for trial expansion across all U.S. states and territories without the need for additional local review by Medicare Administrative Contractors (MACs), significantly accelerating nationwide trial deployment.
The company expects that the CMS endorsement will reduce clinical trial costs significantly per site and dramatically lower the barriers to participation for hospitals and research institutions across the U.S., paving the way for faster patient enrollment and broader clinical adoption.
“This CMS IDE approval is a strong validation by the U.S. federal government of the clinical design and therapeutic value of Nexsphere-F,” NEXT BIOMEDICAL CMO Ziv Haskal said. “It represents a pivotal inflection point that significantly enhances the device’s prospects for future insurance reimbursement and commercial entry in the U.S. market.”
The company added that the improved access for hospitals and patients in the U.S. will likely accelerate the trial timeline and positively influence broader market strategies.