[Edaily Reporter YU JIN-HEE ] Innovative biomedicine company #NEXTBIOMEDICAL CO., LTD. is accelerating its entry into the U.S. market with “Nexsphere-F™,” a rapidly degradable embolization therapy for arthritis pain that it developed in-house. The company plans to use the establishment of a U.S. partnership as a turning point for global commercialization to achieve a quantum leap in sales.

50% of Patients Recruited for U.S. Approval Trial... Concerns Over Dropouts from Steroid Control Group

According to the pharmaceutical and biotech industry on the 14th, NEXTBIOMEDICAL CO., LTD. is accelerating discussions with local companies and clinical trials to bring Nexsphere-F™ to the U.S. market.

The key strategies involve entering the U.S. outpatient-based procedure (OBL) market and building a physician adoption base centered on a network of key opinion leaders (KOLs). In addition, the company is simultaneously pursuing a strategy to secure U.S. insurance reimbursement approval, which is considered a critical factor for actual market penetration and commercial expansion.

The clinical trial for NexSphere-F’s U.S. Food and Drug Administration (FDA) approval has enrolled approximately 80 patients—half of the target enrollment—since the first patient was enrolled. More than 15 major clinical institutions across the U.S. are participating.

The response from participants observed in the clinical setting has been positive. There is a growing trend of patients assigned to the control group—which receives steroid injections—hesitating to continue their participation in the study. This is because patients with knee osteoarthritis who have not achieved sufficient symptom relief with conventional steroid therapy are participating in the clinical trial with high expectations for treatment using NexSphere-F in knee osteoarthritis embolization (GAE) procedures. This demonstrates that awareness of and preference for GAE procedures are spreading within the U.S. healthcare sector.

The U.S. market is experiencing rapid growth in the minimally invasive musculoskeletal (MSK) embolization sector, driven by a combination of an aging population, an increase in patients with chronic arthritis, and a trend toward avoiding surgery. In particular, as the market for OBL-based interventional procedures expands, NexSphere-F—which allows procedures to be performed on an outpatient basis—has been highly regarded for its suitability for the U.S. market. NexSphere-F is systematically securing the regulatory and clinical milestones necessary for entry into the U.S. market. It was selected for the FDA’s Targeted Advisory Program (TAP), validating its technological differentiation and market need. It has also obtained “Category B” approval from the U.S. Centers for Medicare & Medicaid Services (CMS), allowing clinical costs to be reimbursed by local health insurance.

NexSphere-F’s core competitive advantage lies in its “resorbable” mechanism, which allows it to safely dissolve within the body. It temporarily blocks abnormal new blood vessels formed in areas affected by chronic arthritis or inflammation using microspheres to reduce pain, and then completely dissolves within the body after a certain period. It has garnered attention in the medical community for overcoming side effects—such as necrosis of normal tissue or skin discoloration—that previously occurred due to permanent occlusion.

According to the results of a 12-month long-term follow-up study conducted at Charité Berlin Hospital in Germany on patients with hip osteoarthritis, the success rate of NexSphere-F embolization therapy was 97.5%. No severe side effects, such as avascular necrosis of the femoral head, occurred. The rate of conversion to total hip arthroplasty (THA) remained at 4.9%, demonstrating the therapy’s effectiveness in delaying the need for surgery.

Market Growing Rapidly... Aiming to Expand Market Share in the U.S.

Although the musculoskeletal embolization market is still in its early stages, it is expanding in line with the growing demand for non-surgical treatments. According to a global market research firm, the degenerative arthritis market grew from $7.3 billion (approximately 10 trillion won) in 2020 to $11 billion (approximately 16 trillion won) in 2025. Within this, the potential market for embolization treatments for osteoarthritis is projected to grow to 5 trillion won this year. NEXTBIOMEDICAL CO., LTD. aims to quickly secure a foothold in the U.S. market by keeping pace with this growing trend.

If this comes to fruition, NEXTBIOMEDICAL CO., LTD. is expected to grow rapidly by securing a solid source of cash flow following its endoscopic hemostatic agent, “Nexpowder™.” Nexpowder is Next Biomedical’s core product, generating over 90% of its global revenue overseas in U.S. dollars through Medtronic, the world’s leading medical device company.

In fact, NEXTBIOMEDICAL CO., LTD.’s growth trajectory is steep. This year’s annual revenue is projected to surpass the 20 billion won mark for the first time in the company’s history. NEXTBIOMEDICAL CO., LTD. plans to use the establishment of its U.S. OBL partnership as a turning point for global commercialization to significantly boost its performance.

NEXTBIOMEDICAL CO., LTD. emphasized, “We will establish our position as a global leader in the degradable embolization platform, starting with the U.S. market, by seamlessly executing clinical trials for FDA approval and insurance reimbursement strategies,” adding, “We will increase our corporate value based on validated clinical data and global commercialization agreements.”