Levee Medical® to Accelerate Development of its Voro® Urologic Scaffold, Designed to Improve Post-Prostatectomy Recovery Outcomes

Additionally, Company Reaches Significant Enrollment Milestones in Feasibility and Observational Studies

Durham, NC – June 10, 2024 – Levee Medical®, a medical device company designing solutions to improve surgical outcomes following prostate cancer, announced today it has received significant funding commitments to support ongoing regulatory and clinical activities. The funds raised will be instrumental in advancing the development of the Voro® Urologic Scaffold and supporting broader clinical studies to further establish its safety and efficacy.

Additionally, the first U.S patient has been enrolled in ALTO, an observational study evaluating urinary function and quality of life following radical prostatectomy. Dr. Naveen Kella, founder of The Urology Place in San Antonio, TX, enrolled the first patient. “We are truly excited about the progress Levee Medical is making with the Voro Urologic Scaffold,” he said. “Their clinically robust approach to developing this innovative solution is a testament to their commitment to improving patient outcomes. The preliminary results are encouraging, and I am confident their efforts will lead to significant advancements in the treatment of post-prostatectomy urinary incontinence.”

In parallel to the ALTO study, Levee has also made substantial progress in ARID, its feasibility study of the Voro Urologic Scaffold, a novel device for the mitigation of post-prostatectomy stress urinary incontinence. The study, aimed at evaluating the safety and performance of Voro, has successfully enrolled 25 patients with the participation of five surgeons, showing promising preliminary results.

The Voro Urologic Scaffold is designed to be placed during the prostatectomy procedure to manage the geometry of the bladder neck and maintain urethral length, which are critical factors in preventing post-operative incontinence. This innovative, absorbable device aims to significantly reduce the incidence of stress urinary incontinence, providing a much-needed solution for patients undergoing radical prostatectomy.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended (“Securities Act”).

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 not FDA cleared or approved and is currently in the research and development phase and is not available for sale in any country.

For more information, please visit leveemedical.com