Levee Medical Announces Completion of Patient Accrual in ARID II Pivotal Trial Evaluating the Voro® Urologic Scaffold

Completion of enrollment marks major milestone in development of novel approach designed to improve continence recovery following prostatectomy

DURHAM, N.C., July 14, 2026 /PRNewswire/ -- Levee Medical, a medical device innovator focused on improving outcomes for men undergoing prostate cancer surgery, today announced the completion of patient accrual in ARID II,the company's multicenter, randomized pivotal trial evaluating the safety and effectiveness of the Voro® Urologic Scaffold in men undergoing robotic-assisted radical prostatectomy.

"The pace of enrollment in ARID II reflects the strong interest from surgeons and patients in innovations that may meaningfully improve recovery after prostate cancer surgery," said Arvin George, MD, Associate Professor of Urology and Director of Robotic Surgery at Johns Hopkins Medicine and National Principal Investigator of the ARID II study. "The opportunity to potentially reduce post-prostatectomy incontinence is incredibly important for patients, and we are encouraged by the momentum surrounding this technology."

The ARID II study enrolled patients across leading academic and community urology centers in the United States and underscores the company's continued progress toward regulatory approval and commercialization. The study is designed to further evaluate Voro's ability to support earlier return to continence following prostatectomy.

"We've participated in many drug and device studies over the years, but I've never been more excited about an innovation than this," said Adam Stewart, MD, of Conrad Pearson Clinic, one of the top enrolling investigators in ARID II. "The device is straightforward to implant, integrates well into robotic prostatectomy workflow, and I'm grateful to have been part of this experience and study."

"The level of participation in ARID II highlights the clinical importance of improving continence recovery and reinforces our confidence in the importance of advancing the Voro Urologic Scaffold through rigorous evaluation," said Karen Cornett, Vice President of Clinical Affairs at Levee Medical. "We are deeply grateful to the study participants and clinical teams whose commitment made this milestone possible. We look forward to generating high-quality clinical evidence in support of patients and providers."

With patient enrollment now complete, Levee Medical will continue patient follow-up and data collection as it advances toward PMA submission.

About Levee Medical

Levee Medical is dedicated to advancing solutions that aim to reduce complications associated with surgical treatment for prostate cancer. The Voro Urologic Scaffold is the first product Levee Medical 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.

SOURCE Levee Medical