Patent issuance strengthens IP portfolio as ARID II pivotal trial advances with rapid site activation and patient enrollment
DURHAM, N.C., Sept. 8, 2025 /PRNewswire/ — Levee Medical®, a medical device company focused on improving outcomes for prostate cancer surgery patients, today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 12,324,586 on June 10, 2025, providing broad coverage for the company’s Voro® Urologic Scaffold and its technology and placement for Prostatic Urethra Restoration (PUR) to mitigate stress urinary incontinence.
This newly issued patent strengthens Levee’s growing intellectual property portfolio. The company now holds four issued patents with twelve additional patent applications pending across key global markets, including the United States, European Union, China, and Japan. In addition, trademark registrations for VORO® and LEVEE MEDICAL® extend across most major jurisdictions. This comprehensive IP foundation positions Levee for long-term strategic advantage in the urologic device market.
“The issuance of this primary patent is a defining moment for Levee,” said Bruce Choi, Founder, Director, CTO & Chairman of Levee Medical. “It provides strong protection for the unique technology and intraoperative placement of Voro, which is engineered to support the bladder neck and recreate urethral length—two anatomical factors associated with earlier return to continence following prostate surgery. This patent reinforces our leadership in PUR and accelerates our path to delivering a first-of-its-kind solution for patients.”
Levee highlighted continued momentum in ARID II, its landmark multicenter, randomized, controlled pivotal study evaluating the safety and effectiveness of the Voro Urologic Scaffold in men undergoing robotic-assisted radical prostatectomy. The company also expressed excitement about the recent addition of Johns Hopkins Medicine, with Dr. Arvin George serving as national Principal Investigator.
“We’re seeing strong enthusiasm from investigators and institutions to participate in this landmark IDE pivotal study,” said Arvin George, MD, Associate Professor of Clinical Urology and Director of Prostate Cancer Programs at Johns Hopkins Medicine. “Site activations have proceeded successfully, with more on the way, and early enrollment momentum underscores the clinical interest in strategies that may improve continence recovery after prostatectomy. The learnings from ARID II will unveil the potential of further reducing incontinence following radical prostatectomy, but also provide critical insights into the pathophysiology and recovery of urinary control after 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
