Company Profile
Prodeon Medical is a US-based manufacturer of minimally invasive urological devices, headquartered in Sunnyvale, California, USA. Founded in 2016, the company operates as an independent, privately-held entity backed by Medeon Biodesign, serving urologists and outpatient clinics in the benign prostatic hyperplasia treatment market.
Core Products ＆ Technologies
Urocross Expander System
• Urocross Expander System: FDA 510(k) cleared temporary nitinol implant (K253525, March 2026) for relieving lower urinary tract symptoms attributed to BPH in men ≥ 45 years old; available in small (20 mm × 18 mm) and large (30 mm × 25 mm) sizes
• Urocross Retrieval Sheath: Dedicated retrieval system designed for removal of the Urocross Expander Implant during the in-dwell period of up to 6 months
• Prodeon Urethral Sheath System: FDA 510(k) cleared endoscopic access overtube (K252572, October 2025) for use with flexible cystoscopes during implant delivery and retrieval
Prostatic Urethral REshaping (PURE) Procedure
• PURE Procedure: Office-based, minimally invasive therapy deploying the Urocross Expander Implant through the instrument channel of a commercially available flexible cystoscope; the implant applies constant gentle pressure to push obstructive prostatic lobes aside, increasing urethral lumen opening
• Key Design Goals: Rapid symptom relief, minimal post-procedural catheterization, preservation of sexual function, bladder neck preservation to avoid retrograde ejaculation, and no permanent foreign body left in situ
Market Position ＆ Certifications
Prodeon Medical holds a specialized position in the global minimally invasive surgical therapy for BPH market, competing with Olympus (iTind) and Teleflex (UroLift) in temporary and permanent prostatic implants. Key strengths include:
• 10+ years of development heritage in prostatic urethral reshaping
• Retrievable implant design: Nitinol tissue expander with quadrant strut-like architecture, allowing up to 6 months in-dwell with full retrieval capability
• Regulatory compliance: FDA 510(k) cleared (Urocross Expander System and Prodeon Urethral Sheath System); predicate device iTind System (DEN190020)
• Clinical evidence: Expander-2 pivotal trial (NCT05400980) demonstrated 48.1% mean IPSS improvement at 12 months and 74.5% procedural responder rate across 23 US and Canadian sites; no device- or procedure-related serious adverse events; sexual function preserved with no de novo sustained erectile or ejaculatory dysfunction
Corporate Timeline
2016 — Founded in Sunnyvale, CA to develop minimally invasive BPH treatments
2019 — Medeon Biodesign led investment; XFLO Expander System completed first clinical use in Australia and the Republic of Georgia
2021 — Expander-1 feasibility study completed; Urocross Expander System introduced in peer-reviewed literature
2025 — Expander-2 pivotal trial enrollment completed (240 patients, 23 sites); Prodeon Urethral Sheath System received FDA 510(k) clearance
2026 — FDA 510(k) clearance granted for the Urocross Expander System (K253525, March 16); AUA 2026 presentation of Expander-2 30-month interim safety and durability data, sexual function preservation data, and retrieval outcomes; controlled US commercial release planned for later this year
Target Markets ＆ Applications
• Benign prostatic hyperplasia: Temporary urethral expansion for men ≥ 45 years with moderate to severe LUTS and prostate volumes of 30 to 80 cc
• Office-based urology: Outpatient procedure under local anesthesia via flexible cystoscopy, avoiding operating room utilization
• Preservation-focused patients: Therapy designed for sexually active men seeking to maintain antegrade ejaculation and avoid permanent implants or tissue ablation
Contact Information
Global Headquarters
Address: 452 Oakmead Parkway, Sunnyvale, CA 94085, USA
Phone: 1.669.467.1100
Parent Company
Prodeon Medical operates as an independent, privately-held entity backed by
Medeon Biodesign, with no publicly traded stock.
Website: prodeonmedical.com
Investor Relations: Private company; contact info@prodeonmedical.com
