Medeon Biodesign announced on the evening of October 8 that its urological medical device, Urocross Retrieval Sheath (Prodeon Urethral Sheath System), has received U.S. FDA 510(k) clearance. This marks the first FDA-approved accessory in the company’s Urocross Expander System product line, signifying another major step forward in the field of innovative treatments for benign prostatic hyperplasia (BPH).

According to Medeon, the Urocross Retrieval Sheath is a dedicated retrieval device designed for use with the Urocross Expander System. It is compatible with standard flexible cystoscopes and primarily intended for the safe removal of implants six months after placement. In addition, the system can serve as an endoscopic access sheath to facilitate urological procedures, such as those for urinary tract stones and other related conditions.

The Urocross Expander System is a temporary implantable system designed to relieve lower urinary tract symptoms (LUTS) caused by BPH. It can be implanted under minimal anesthesia in the prostatic urethra and removed six months later using the Retrieval Sheath, thereby reducing the risk of long-term foreign-body retention while maintaining both therapeutic efficacy and safety.

Medeon stated that the FDA clearance of the retrieval device paves the way for the market approval of the main system. The company plans to submit the Urocross Expander System for FDA clearance in the fourth quarter of 2025, with overall development progressing according to schedule and no delays reported.

According to Grand View Research, the global BPH treatment device market reached USD 1.42 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 8.9% from 2023 to 2030. In the U.S. alone, an estimated 40 million men are affected by BPH, and demand is expected to rise in line with population aging.

Medeon emphasized that to preserve flexibility for future international licensing negotiations, it will not disclose details regarding cumulative R&D expenditures at this stage. The company highlighted that this FDA clearance represents a key milestone in the overall Urocross system’s development, and it will continue to advance regulatory submissions and commercialization plans in compliance with relevant regulations, while disclosing updates in due course.

Resource: 益安泌尿醫材再傳捷報 Urocross取出裝置獲美FDA核准