DURHAM, N.C., July 14, 2026
Levee Medical has reached a significant clinical development milestone with the successful completion of patient enrollment in the ARID II pivotal clinical trial, a multicenter, randomized study evaluating the safety and effectiveness of the investigational Voro® Urologic Scaffold in men undergoing robotic-assisted radical prostatectomy for prostate cancer. The achievement marks an important step toward the company’s planned Premarket Approval (PMA) submission and future commercialization of a medical device designed to improve one of the most challenging postoperative complications—urinary incontinence. Following prostatectomy, many patients experience varying degrees of continence loss that can significantly affect quality of life, making the development of innovative technologies that accelerate continence recovery a major priority in modern urologic surgery. The completion of patient accrual across multiple leading academic and community urology centers throughout the United States demonstrates strong physician confidence and patient participation in evaluating this next-generation surgical innovation. As Levee Medical advances toward the next phase of clinical evaluation, the ARID II study represents an important contribution to evidence-based innovation in urologic medical devices and prostate cancer surgery.
ARID II Trial Advances Innovation in Post-Prostatectomy Recovery
The ARID II pivotal trial was specifically designed to evaluate whether the Voro Urologic Scaffold can support an earlier return to urinary continence following robotic-assisted radical prostatectomy, one of the most common surgical treatments for localized prostate cancer. Although robotic surgery has significantly improved surgical precision and recovery outcomes, postoperative urinary incontinence remains a persistent concern affecting many patients during recovery. The investigational scaffold has been engineered to provide structural support following surgery with the goal of improving continence restoration while integrating seamlessly into existing robotic surgical workflows. According to Dr. Arvin George, Associate Professor of Urology and Director of Robotic Surgery at Johns Hopkins Medicine and National Principal Investigator for the ARID II study, the rapid pace of enrollment reflects growing enthusiasm among surgeons and patients for technologies capable of meaningfully improving recovery after prostate cancer treatment. He emphasized that reducing post-prostatectomy incontinence remains one of the most important unmet clinical needs in urology, making continued evaluation of the Voro scaffold particularly significant.
Clinical Momentum Supports Future Regulatory Submission
With patient enrollment now complete, Levee Medical will continue comprehensive patient follow-up, clinical monitoring, and data collection to generate robust evidence supporting the safety and effectiveness of the Voro Urologic Scaffold before submitting its PMA application to the U.S. Food and Drug Administration. Investigators participating in the trial have expressed strong confidence in both the device’s surgical usability and its potential clinical benefits. Dr. Adam Stewart of the Conrad Pearson Clinic, one of the study’s highest-enrolling investigators, noted that the device integrates efficiently into robotic prostatectomy procedures while representing one of the most promising innovations he has encountered throughout years of participation in both pharmaceutical and medical device clinical studies. Karen Cornett, Vice President of Clinical Affairs at Levee Medical, highlighted that the successful completion of enrollment demonstrates the importance clinicians place on improving postoperative continence recovery through rigorous scientific evaluation. She also acknowledged the dedication of participating patients, surgeons, research coordinators, and clinical teams whose contributions made this milestone possible. While the Voro Urologic Scaffold remains an investigational device and has not yet received regulatory approval for commercial use, the completion of ARID II enrollment marks a major advancement toward generating high-quality clinical evidence that could reshape postoperative care for men undergoing prostate cancer surgery. If future clinical outcomes confirm improved continence recovery, the technology has the potential to become an important addition to modern robotic urologic surgery, helping physicians improve patient quality of life while reinforcing the growing role of innovative medical devices in advancing surgical outcomes for prostate cancer treatment.
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Source: Levee Medical press release
