Adr120S Secures Key Milestone for Male Urinary Incontinence Device

TOKYO, Aug 07 (Pulse News Wire) – ADR120S,Inc. (3750.T) announced that its subsidiary, ADR Therapeutics Co., Ltd., received preliminary approval from the Central Social Insurance Medical Council's specialized organization (Shohizai Zenbu) for the medical device "Cellation Cell Therapy Kit SUI," used to treat male urinary incontinence resulting from prostate surgery.

The device falls under category C2 (new function/new technology) with a proposed reimbursement price of ¥860,000. Further formal approval procedures with the Ministry of Health, Labour and Welfare are pending. The Cellation Cell Therapy Kit SUI is designed for patients suffering from mild to moderate male urinary incontinence post-prostate surgery who have failed or shown insufficient response to behavioral therapy or medication. It uses a single-use kit to process fat tissue harvested from the patient to prepare specific cells or tissues for treatment, supporting therapies involving adipose-derived regenerative (stem) cells (ADRCs). According to the National Cancer Center’s cancer registry, approximately 102,094 cases of prostate cancer were newly diagnosed in 2023, making it a significant cancer type in Japan. With high long-term survival rates, maintaining quality of life post-treatment is crucial, creating a substantial need for innovative treatments like the Cellation Cell Therapy Kit SUI.

Following the progress update on July 06, 2026, which detailed the advancement through the insurance committee review, this latest development represents a significant step forward. The estimated peak number of potential patients eligible for the treatment is 2,118. Looking ahead, ADR120S,Inc. plans to complete necessary procedures for final insurance approval while establishing systems for manufacturing, supply, and training healthcare providers. Collaborating with related medical societies, institutions, and specialists, the company aims to promote safe and appropriate use of the product and offer new treatment options to those affected by male urinary incontinence. The impact on fiscal year 2027 results remains under assessment based on factors such as the timing of formal approval, post-market surveillance implementation, and supply capabilities.

Any further developments will be disclosed promptly.