Levee Medical® Announces First Patient Enrolled in ARID II IDE Pivotal Trial

DURHAM, N.C., April 24, 2025 /PRNewswire/ -- Levee Medical^®, a medical device company focused on improving outcomes for prostate cancer surgery patients, today announced the enrollment of the first patient in its landmark ARID II pivotal trial. This marks a significant milestone in the company's mission to advance the treatment of post-prostatectomy stress urinary incontinence with the Voro^® Urologic Scaffold.

ARID II is a multicenter, single blind, randomized controlled study designed to demonstrate the safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control. The Voro Scaffold is an innovative, bioabsorbable device designed to support the bladder neck and preserve urethral length; two anatomical factors associated with earlier return to continence following prostate surgery.

The first site to enroll a patient in the ARID II pivotal study is Mississippi Baptist Medical Center where Dr. Patrick Daily, of Mississippi Urology Clinic, is the site's Principal Investigator.

"What is truly exciting is the potential for this device to meaningfully improve early and long-term continence rates, which can profoundly impact a patient's recovery and overall quality of life. We're excited to be the first site to enroll in the study and I look forward to seeing the outcomes once the study is complete," said Dr. Daily.

"Initiating the ARID II trial marks an important step as we build upon the promising results of our initial feasibility study," said Bruce Choi, Founder, Director, CTO, and Chairman of Levee Medical. "This next phase brings us closer to providing a new standard of care for men recovering from prostate cancer surgery."

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