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NEXTBIOMEDICAL's Innovative Pain Relief Solution: Nexsphere-F

In a significant advancement for treating joint pain, NEXTBIOMEDICAL CO., LDT has revealed promising results from a clinical study of its resorbable embolic agent, Nexsphere-F™, published in the Journal of Vascular and Interventional Radiology (JVIR). This innovative treatment aims to alleviate discomfort associated with various joint disorders, showcasing exceptional safety and efficacy levels based on findings from 155 patients.

Clinical Study Overview

Under the leadership of Dr. Yuji Okuno, a distinguished expert in embolization treatments for joint pain, the study employed Nexsphere-F™ through transcatheter arterial embolization to address a range of conditions, including:

• - Knee osteoarthritis
• - Frozen shoulder
• - Symptomatic rotator cuff tears
• - Synovitis within the foot joints
• - Other refractory overuse injuries

The results found a noteworthy decline in pain levels, with a reported 67% reduction on the Numerical Rating Scale after just six months. Patients dealing with degenerative joint diseases and related injuries experienced sustained relief, emphasizing Nexsphere-F™'s strength as a reliable therapeutic option. Remarkably, no serious adverse events occurred across study participants, with only a 5.8% rate of post-embolization pain lasting beyond a week—substantially lower than alternative treatments.

Expert Insights

Eunhye Lee, Ph.D., Chief Technology Officer at NEXTBIOMEDICAL, expressed enthusiasm regarding the findings, stating, "The validation of safety and efficacy in Dr. Okuno's study is significant for our future endeavors. We intend to enhance our sales strategies in Europe and pursue additional clinical trials to expand Nexsphere-F™ indications to include a broader spectrum of joint disorders."

A Step Towards FDA Approval

In pursuit of broader market access, NEXTBIOMEDICAL has secured FDA Investigational Device Exemption (IDE) and WCG IRB approvals for the pivotal RESORB trial in the United States, currently in the recruitment phase across multiple clinical sites. This study aims to back the FDA approval for Nexsphere-F™ as a therapeutic modality for painful osteoarthritis, marking a crucial step toward bringing this innovative solution to American patients.

Financial Growth and Positive Outlook

Despite some uncertainties in the global healthcare market, NEXTBIOMEDICAL has reported impressive growth. The company has already exceeded its revenue for Q4 2024 within just the first two months of 2025. Projections indicate a 1.5-fold increase in revenue for Q1 2025 compared to the previous quarter. This consistent upward trend illustrates not only the market's confidence in their products but also the efficacy and demand for safety-first medical innovations.

Conclusion

With the release of Nexsphere-F™ and its promising clinical study results, NEXTBIOMEDICAL is setting a new standard in the management of joint pain, offering hope to many suffering from debilitating conditions. As the company advances its market strategies and clinical trials, the potential impact of Nexsphere-F™ could revolutionize pain management and enhance patient quality of life significantly.

It remains to be seen how Nexsphere-F™ will fare in the competitive landscape of medical devices, but the results thus far underscore a hopeful trajectory for this resorbable embolic agent. Stakeholders and patients alike will be eagerly awaiting further developments from NEXTBIOMEDICAL as they strive to redefine therapeutic approaches in joint pain treatment.