URO-1

Executive Summary

URO-1 is a privately held medical device company based in San Diego, founded in 2018, focused on developing innovative instruments for prostate biopsy. The company aims to address the limitations of current biopsy techniques by providing larger, higher-quality tissue cores, which are critical for accurate diagnosis of prostate cancer. URO-1’s portfolio is designed to enhance the diagnostic accuracy in urologic oncology, potentially reducing false negatives and improving patient outcomes. As an emerging player in the diagnostics space, URO-1 is still in the development stage and has not yet commercialized any products, but its technology addresses a clear unmet need in prostate cancer detection. The global prostate biopsy market is growing, driven by rising prostate cancer incidence and demand for more precise diagnostics. URO-1’s competitive edge lies in its core-size innovation, which could differentiate it from established players. Near-term progress depends on successful product development, regulatory clearance, and securing funding. While the company has not disclosed specific milestones, its focus on improving biopsy core quality positions it for potential partnerships or acquisition interest. The company’s success will hinge on achieving regulatory approvals and demonstrating clinical utility in upcoming studies.

Upcoming Catalysts (preview)

• Q3 2026FDA 510(k) clearance for next-generation prostate biopsy device60% success
• 2026Series A funding round to support clinical development70% success
• Q4 2026First clinical study results demonstrating diagnostic accuracy improvement50% success