[Edaily Reporter Yoo Jin-hee] #NextBioMedical is reshaping the medical device market landscape, centered on its knee osteoarthritis treatment, NexSphere F. This is because NexSphere F, which started as a treatment for knee osteoarthritis, is expanding its indications to the entire musculoskeletal system—including hip joints and sports injuries—thus proving its potential as a so-called “endlessly evolving” therapeutic platform.

Expanding ‘Platform’ Scope to Hip Joints and Sports Injuries

According to Next Biomedical’s publication status as of the 7th, the expansion of Nexsphere-F™ is evident. In the knee sector, five major studies have been published, including research on a precision approach to chronic gouty arthritis (2025), as well as studies on intractable pes anserinus tendinopathy (2025) and patellar tendinopathy (2025).

Recently, the platform has also demonstrated its potential in the hip joint field with the consecutive publication of a clinical study targeting elderly patients with hip osteoarthritis (2025) and a study on the treatment of symptomatic hip osteoarthritis (2026). In addition, clinical evidence is accumulating for various joint diseases and sports injuries caused by overuse, such as frozen shoulder, rotator cuff tears, and plantar fasciitis.

Good news also emerged in the field of hip osteoarthritis. According to a retrospective analysis conducted at Charité Berlin Hospital in Germany, a 12-month follow-up of 41 patients who had failed conservative treatment showed a success rate of 97.5% in the embolization group. No cases of severe adverse reactions or avascular necrosis of the femoral head were reported, confirming the overall safety of the procedure.

Improvements were also observed in clinical indicators. The pain score (NRS) decreased from an average of 7 before the procedure to 4 after the procedure. The Hip Function Score (HOOS) also improved across all domains. The fact that the conversion rate to total hip arthroplasty (THA) was only 4.9% at the 12-month mark suggests that embolization could serve as an alternative to delay the need for surgery.

Next Biomedical is currently accumulating clinical and real-world evidence based on data from approximately 1,500 patients both domestically and internationally. In the United States, a clinical trial for FDA approval is underway. In regions where the product is already in use, such as Europe, the company is concurrently securing additional clinical evidence through marketing-linked clinical trials that collect real-world experience, safety, and efficacy data in a post-marketing setting.

In South Korea, patient recruitment has been completed or is underway at Severance Hospital (knee) and Konkuk University Hospital (wrist and elbow). Clinical trials are also progressing steadily at Seoul National University Hospital and Chung-Ang University Hospital, with completion rates of approximately 70% and 30%, respectively.

The company is making even more dynamic strides in overseas markets. In Europe, the clinical trial for degenerative knee osteoarthritis is proceeding smoothly, with a patient enrollment rate of 65%. In the U.S., the world’s largest market, a regulatory clinical trial involving more than 15 medical institutions has gained momentum. The company’s achievement of obtaining Category B approval from the U.S. Centers for Medicare & Medicaid Services (CMS), which allows clinical costs to be reimbursed through insurance, marks a first for the domestic medical device industry. This enables both cost savings and accelerated commercialization.

Government Support and Global Partnerships Provide a Boost

Full-scale government support is

also

adding momentum to Next Biomedical’s pipeline. Next Biomedical was recently selected as a recipient of overseas clinical trial support from the Inter-Ministerial Medical Device R&D Project Group, securing a total of 2.2 billion won in funding for its U.S. Food and Drug Administration (FDA) approval-seeking clinical trial.

Next Biomedical has also laid the groundwork for entering the Japanese market. The company has signed an exclusive distribution agreement in Japan with Asahi Intecc, a global leader in medical devices. Asahi Intecc is a major corporation with annual sales of approximately 120 billion yen (about 1.07 trillion won) and boasts the world’s largest network in the guidewire and catheter sectors. Since this agreement involves the direct supply of finished products rather than a simple technology transfer, it enables the company to maximize profitability.

The evolution of Nexpowder™, the company’s existing cash cow—a hemostatic agent for endoscopy—is also underway. Through a project funded by the Ministry of SMEs and Startups, Next Biomedical has begun developing Nexpowder-T, a convergent product that combines physical adhesion with chemical blood coagulation mechanisms.

Nexpowder, which generates over 90% of its global revenue overseas through Medtronic, the world’s leading medical device company, is pursuing its inclusion as a global standard treatment. The potential for further growth resulting from this is drawing significant attention. According to industry sources, Next Biomedical is expected to surpass 25 billion won in revenue for the first time this year and return to profitability next year. Next Biomedical has set its sights on achieving 100 billion won in revenue within five years.

An industry insider stated, “Next Biomedical is continuing to expand indications and advance its polymer platform technology based on NexSphere,” adding, “Based on this, the company will enhance its competitiveness in the global medical device market.”