NextBio, "Nexphere Surpasses FDA Approval Standards"... Published in Prestigious International Journal

Clinical Results of Uterine Fibroid Embolization
Comparable Effectiveness and Safety to Existing Embolic Agents
Body-Absorbable Material Gains Attention in US and Europe

Uterine fibroid embolization using Nexsphere by Nextbiomedical has secured clinical evidence.

Nextbiomedical, an innovative therapeutic development and export company, announced on the 11th that the clinical trial results of the vascular embolization microsphere Nexsphere™ have been published in 'Radiology' (Impact factor: 19.7), the most prestigious international journal in the field of radiology.

The title of the paper is "Resorbable Microsphere (NexsphereTM) versus Tris-Acryl Gelatin Microspheres (Embosphere®) for Uterine Artery Embolization."

The principal investigator is Professor Man-Deuk Kim from Yonsei University Severance Interventional Radiology, a global authority on uterine fibroid embolization. The paper compares the efficacy and safety of Nexsphere and Embosphere® embolic agents. Embosphere®, used as the control group, is currently the most widely used embolic material worldwide.

Clinical study results showed that both products had an equal procedural success rate of 97%. There were no differences in post-procedural pain or safety. This indicates that Nexsphere is a product with competitiveness comparable to Embosphere®, the most widely used embolic agent globally.

Unlike Embosphere®, which is a plastic-like embolic material that remains permanently in the body, Nexsphere is composed of absorbable components, which can reduce patient anxiety.

Professor James B. Spies, MD, MPH, a leading expert in uterine fibroid embolization at Georgetown University in Washington, USA, commented on this study, saying, "This research offers an alternative to patients who have long sought an ideal embolic agent," and praised it as "a rare occurrence for a robust study to be completed at the early stage of embolic agent evaluation." He also emphasized that this study already exceeds the minimum evaluation standards required for approval by the U.S. Food and Drug Administration (FDA).

A representative from Nextbiomedical stated, "The Nexsphere product showed very successful clinical results, demonstrating equivalence in efficacy and safety compared to Embosphere®, the global leader in embolic materials," adding, "Its absorbable nature is attracting high interest in both the U.S. and Europe."

Nextbiomedical possesses core technology that can control the degradation time in the body depending on the disease. Along with Nexsphere-F, which has been approved for clinical trials in the U.S. as a treatment for arthritis, and Nexpowder, an endoscopic hemostatic agent, Nexsphere is expected to become one of Nextbiomedical's flagship products.

Nextbiomedical CEO Don-Haeng Lee explained, "It is very meaningful that this study, conducted by the research team led by Professor Man-Deuk Kim of Yonsei University Severance Hospital, a world-renowned expert in uterine fibroid embolization, was published in Radiology, the most authoritative journal in radiology." He added, "Based on clinical evidence, we plan to strengthen global sales of Nexsphere."