#South Korea #Seoul #NEXTBIOMEDICAL #Nexsphere-F™ #GAE

NEXTBIOMEDICAL's Major Breakthrough in Pain Management

South Korea's NEXTBIOMEDICAL CO., LTD has reached a significant milestone with the receipt of Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for its innovative product, Nexsphere-F™. This approval allows the company to commence the RESORB trial in the United States, focusing on Genicular Artery Embolization (GAE) as a new treatment method for knee osteoarthritis.

Knee osteoarthritis (OA) is a prevalent and crippling condition that affects over 654 million individuals aged 40 and above worldwide. It is a major contributor to pain and disability among older adults. Traditional pain relief options, such as non-steroidal anti-inflammatory drugs (NSAIDs) and hyaluronic acid injections, often present short-term relief but fall short on efficacy over extended use while carrying notable side effects. By aiming to address these limitations, the RESORB trial seeks to offer knee OA patients a more effective and sustainable solution via Nexsphere-F™.

The RESORB trial will be conducted at multiple leading healthcare institutions across the United States and is designed as a randomized, open-label study. Its main objective will be to evaluate the effectiveness of Nexsphere-F™ in alleviating pain and enhancing mobility for patients suffering from OA.

Dr. Ziv J Haskal, a recognized authority in Interventional Radiology and the national Principal Investigator for the RESORB trial, noted that Nexsphere-F™ has already been granted CE-MDD approval. It has demonstrated substantial safety and efficacy in numerous musculoskeletal embolization cases across Asia and Europe. Currently, NEXTBIOMEDICAL is in the process of securing clinical trial sites for this pivotal study.

The company’s CEO, Dr. Don Haeng Lee, emphasized that this FDA approval represents a critical turning point for NEXTBIOMEDICAL. He expressed his pride in achieving this essential IDE approval and shared his optimism for the upcoming clinical trial’s progress, which could ultimately lead to widespread FDA authorization. Dr. Lee envisions that Nexsphere-F™ will be accessible globally, significantly improving the quality of life for arthritis patients.

About Nexsphere-F™

Nexsphere-F™ is a fast-resorbable microsphere designed for use during endovascular embolization procedures. It is composed of a hydrophilic material and is utilized in conjunction with a contrast medium. The microspheres are injected via a microcatheter and swell to effectively block targeted blood vessels, temporarily stopping blood flow to tissues. Over time, the microspheres maintain their embolization effect to support therapeutic objectives before being fully resorbed by the body. This unique characteristic ensures safety, reduces complications, and provides an effective treatment option for OA patients.

About NEXTBIOMEDICAL

NEXTBIOMEDICAL specializes in creating cutting-edge therapeutic materials that leverage advanced drug delivery systems. The company prioritizes research, development, and manufacturing of drug-device combination products that address significant clinical needs. One of its notable innovations includes Nexpowder®, which has acquired FDA approval for its effectiveness in rapid bleeding control, showcasing the company’s commitment to advancing healthcare solutions.

Through ongoing investments in research and development aimed at major medical challenges, NEXTBIOMEDICAL aspires to become a global leader in innovative, life-saving solutions that reshape patient care standards.