Levee Medical Receives FDA Approval for its Landmark ARID II IDE Pivotal Study

Multicenter, randomized controlled pivotal study to investigate a novel device for post-radical prostatectomy stress urinary incontinence

DURHAM, N.C., March 4, 2025 /PRNewswire/ -- Levee Medical is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted approval to initiate the ARID II (A Pivotal Study of VoRo UrologIc ScaffolD for the Treatment of Post Prostatectomy Stress Urinary Incontinence) clinical trial under an Investigational Device Exemption (IDE). 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.

"We are proud to reach this important milestone in our mission to minimize incontinence for patients of radical prostatectomy," said Bruce Choi, Founder & CTO of Levee Medical. "This achievement reflects the dedication and hard work of our team and the invaluable support of our investors. We believe that the Voro Urologic Scaffold has the potential to significantly reduce the occurrence and severity of post-prostatectomy incontinence, and help patients quickly return to the quality of life they had before prostate cancer."

Levee Medical is also excited to announce that Arvin K. George, MD, Director of Prostate Cancer Programs at Johns Hopkins School of Medicine, will serve as the national principal investigator (PI) for the ARID II trial. Dr. George is a renowned expert in the field of prostate cancer and has led numerous pivotal studies in urologic oncology.

"Incontinence is a common, yet often under-addressed consequence of prostate cancer surgery," stated Dr. George. "The Voro Urologic Scaffold represents a promising new approach that could redefine how we manage post-surgical incontinence, potentially enhancing the quality of life for many patients."

The company also recently announced on February 11, 2025, the closing of its Series B financing totaling more than $14 million including note conversions. This fundraising round highlights strong investor confidence in the company's innovative solution for post prostatectomy incontinence and will support ongoing clinical trials, including ARID II.

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 not approved for commercial use in the U.S. or in any country.

For more information, please visit www.leveemedical.com.

SOURCE Levee Medical