DURHAM, N.C., Jan. 20, 2026 /PRNewswire/ -- Levee Medical®, a medical device company focused on improving outcomes for prostate cancer surgery patients, today announced continued progress in the clinical and commercial advancement of its Voro® Urologic Scaffold, highlighted by the ARID II pivotal clinical trial reaching its halfway enrollment milestone and the publication of interim ARID clinical results in the World Journal of Urology.
ARID II is a multicenter, randomized, controlled pivotal study evaluating the safety and effectiveness of the Voro Urologic Scaffold in men undergoing robotic-assisted radical prostatectomy. This midpoint enrollment milestone reflects strong momentum and growing clinical validation, bringing the field closer to the potential for a new, evidence-backed option supported by comprehensive reimbursement.
"It's encouraging to see ARID II enrolling so efficiently—our collective focus remains on exploring this exciting approach that may improve recovery for men after prostate cancer surgery," said Lee Richstone, MD, Chair of Northwell Urology at Lenox Hill Hospital. "Expediting continence following surgery matters to my patients and is a truly important goal."
Levee Medical also announced the publication of interim results from the ARID Study in the World Journal of Urology. The peer-reviewed article reports findings from a first-in-human, prospective early feasibility study evaluating the safety and performance of an absorbable urologic scaffold placed at the time of robot-assisted radical prostatectomy. The study demonstrated a favorable safety profile with no device-related adverse events and used objective 24-hour pad weight testing to assess continence recovery. Results showed encouraging early continence outcomes, with more than half of patients achieving continence by six weeks and over 70 percent by six months. Patients with optimal device deployment experienced substantially higher continence rates, with nearly all achieving continence by six months.
"This recent publication in the World Journal of Urology marks a key step in the dissemination of data showing that a novel urologic scaffold at the time of prostatectomy can enhance continence recovery", said Jeff Gahan, MD, Duke University, Department of Urology. "The data were generated using one of the most rigorous definitions of continence to date, strengthening the publication's conclusions and informing the design of the ongoing randomized trial."
"The World Journal of Urology publication represents meaningful progress toward generating the peer-reviewed clinical evidence required to support the transition of Levee's Category III CPT code to Category I status," said Jeffrey Dann, MD, previous Chairman of the AUA Coding and Reimbursement Committee and former AMA CPT Editorial Panel Adviser for the AUA. "This type of high-quality clinical data is essential to enabling broader reimbursement by CMS and private payers."
Enrollment in ARID II is ongoing, with the study designed to further validate safety and effectiveness across a larger randomized population and extended follow-up. Together, the ARID II enrollment milestone and World Journal of Urology publication underscore Levee Medical's mission and continued progress toward improving post-prostatectomy recovery and expanding patient access to innovative solutions.
About Levee Medical
Levee Medical is committed to designing solutions that aim to reduce complications associated with surgical treatment for prostate cancer. The Voro Urologic Scaffold is the first product Levee plans to bring to market. This device is limited to investigational use and is not approved for commercial use in the U.S. or in any country.
For more information, please visit www.leveemedical.com.
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SOURCE Levee Medical
