URO-1, Inc. has achieved significant clinical validation milestones for its SUREcore biopsy system, demonstrating substantial improvements in prostate cancer diagnostic accuracy that could transform current standard of care practices. The Greensboro-based medical device company recently presented compelling data showing its novel biopsy needle achieved 92% targeting accuracy compared to just 36% for conventional needles meeting current standards of care.
Clinical Validation Demonstrates Superior Performance
A study involving the SUREcore needle and coreCARE specimen retrieval system validated that the biopsy platform produces larger tissue specimens with significantly less fragmentation and tortuosity compared to traditional methods. The technology addresses a critical gap in prostate cancer diagnostics, where traditional transrectal ultrasound-guided techniques contribute to a staggering 25% false negative rate.
Most significantly, the use of URO-1's platform was associated with a substantial decrease in diagnoses of Atypical Small Acinar Proliferation (ASAP), a diagnostic category used when pathologists cannot definitively determine whether cells are malignant. Under current standard of care guidelines, men diagnosed with ASAP must return for a second biopsy 3-5 months after the initial procedure.
Dr. Daniel Wiener, a pathologist from Acworth, Georgia, who presented findings at the recent U.S. and Canadian Academy of Pathology conference, explained that the improved tissue quality translates into slides that are "not only easier and faster for the pathologist to read but also reduce the need for making additional slides." He noted that time is saved and more tissue is preserved for important molecular diagnostic studies.
Expert Recognition and Clinical Impact
The technology has garnered attention from leading urologic oncologists, with presentations at the American Urological Association's annual conference highlighting its clinical significance. Dr. James Wysock of NYU Langone Health emphasized that the improved needle design could play a vital role in prostate diagnosis accuracy, addressing a critical need in a field where biopsy tools have not seen innovation in decades.
Dr. Eric Gwynn of New River Urology in Bluffton, South Carolina, presented data at the Engineering and Urology Society meeting during the AUA conference, demonstrating the stark difference in targeting accuracy between conventional and SUREcore needles.
Expanding Commercial Operations
URO-1 has secured new equity financing led by GenHenn Capital, a single-family office investor in life sciences companies, adding to the $8 million Series A round announced in early 2024. The company has also established manufacturing capabilities with a 300-square-foot ISO-certified cleanroom at its Greensboro facility, where the SUREcore needle will be manufactured.
According to company President and CEO Ted Belleza, the current manufacturing setup can fulfill forecasted demand through 2026, with discussions already underway with a North Carolina contract manufacturer for additional capacity planning. Belleza, himself a prostate cancer survivor, was inspired to develop the SUREcore platform after experiencing the limitations of traditional biopsy methods firsthand.
Future Clinical Development
URO-1 is preparing to launch a multi-center, prospective, randomized controlled study of the SUREcore and coreCARE systems, with patient enrollment beginning this month. The study will be conducted at comprehensive cancer centers designated by the National Cancer Institute, representing a significant step toward broader clinical validation.
The company is currently focused on the B2B market, offering its platform to hospitals, urology centers, and military hospitals, including VA Medical Centers across the country. While initially concentrated on prostate biopsy applications, URO-1 plans to expand its technology to other cancer types, including liver, lung, kidney, and breast cancer diagnostics.
The SUREcore and coreCARE systems are FDA-cleared for all soft tissue biopsies, positioning the technology to potentially become the new standard for targeted biopsy procedures aimed at achieving earlier diagnoses and more appropriate treatment decisions.
