New Scaffold Offers Hope for Faster Recovery After Prostate Surgery

DURHAM, NC – January 20, 2026 – For the hundreds of thousands of men who undergo surgery for prostate cancer each year, the treatment can be life-saving. However, the recovery often brings a challenging and distressing side effect: urinary incontinence. A North Carolina-based medical device company, Levee Medical®, is pioneering a potential solution that aims to address this problem from the outset, and recent clinical milestones suggest it is gaining significant momentum.

Levee Medical has announced that its pivotal clinical trial, known as ARID II, has reached the halfway point for patient enrollment. This trial is evaluating the Voro® Urologic Scaffold, an absorbable implant designed to be placed during robotic-assisted radical prostatectomy to help men regain urinary control more quickly. The news, coupled with the recent publication of promising early data in a peer-reviewed journal, signals a major step forward in potentially improving the quality of life for countless prostate cancer survivors.

A New Approach to a Persistent Problem

Post-prostatectomy incontinence (PPI) affects a wide range of patients, with some studies showing that nearly a quarter of men still experience frequent leakage six months after their surgery. This complication can profoundly impact a patient's emotional well-being, social life, and return to daily activities.

The current standard of care is largely reactive. Patients are typically advised to perform pelvic floor exercises (Kegels) and wait, often for six to twelve months, to see if continence returns naturally. For those with persistent, severe leakage, more invasive solutions are considered, such as implanting an artificial urinary sphincter (AUS) or a male sling—procedures that carry their own risks and are only performed long after the initial cancer surgery.

Levee Medical's Voro® Urologic Scaffold represents a paradigm shift toward a proactive approach. The small, mesh-like device is made from poly-p-dioxanone (PDO), a biocompatible material widely used in absorbable sutures. During the prostatectomy, after the cancerous prostate is removed, the surgeon places the scaffold over the newly reconnected bladder and urethra. It acts as a support structure, providing radial support to the bladder neck and maintaining crucial urethral length as the tissue heals. The device is designed to be fully absorbed by the body in about six to seven months, leaving behind supported, healed tissue.

By providing this temporary internal support, the Voro scaffold aims to mitigate the anatomical stress that leads to incontinence, giving patients a better chance at a faster, more complete recovery of urinary function from the very beginning.

Clinical Milestones Signal Growing Validation

The ARID II trial is a large-scale, multicenter, randomized, and controlled study—the gold standard for clinical evidence. It is designed to rigorously evaluate the safety and effectiveness of the Voro scaffold against the current standard of care in up to 266 men across the United States. Reaching the halfway enrollment mark is a critical milestone, indicating strong interest from urologists and patients alike and keeping the study on track to deliver definitive results.

"It's encouraging to see ARID II enrolling so efficiently—our collective focus remains on exploring this exciting approach that may improve recovery for men after prostate cancer surgery," said Dr. Lee Richstone, Chair of Northwell Urology at Lenox Hill Hospital, in the company's announcement. "Expediting continence following surgery matters to my patients and is a truly important goal."

This robust trial follows an earlier, smaller study that provided the foundational evidence for the device. The progress of ARID II is essential for demonstrating the scaffold's benefit to a broader, more diverse patient population and providing the high-quality data regulators require for potential approval.

Promising Early Data Published

Adding to the momentum, Levee Medical also announced the publication of interim results from its first-in-human feasibility study, ARID, in the World Journal of Urology. The peer-reviewed article reported on the first 24 patients who received the Voro scaffold.

The study demonstrated a favorable safety profile, with no adverse events related to the device itself. More importantly, the continence outcomes were highly encouraging. Using a rigorous definition of continence—a return to pre-surgery pad weight as measured by a 24-hour test—the study found that more than half of the patients achieved continence by six weeks, and over 70 percent were continent by the six-month mark.

A key finding from a sub-analysis was the importance of surgical technique. Patients who received optimal device placement experienced substantially higher continence rates, with nearly all of them achieving continence by six months. This insight has helped inform a standardized training program for surgeons in the larger ARID II trial, aiming to maximize the device's potential benefits.

"This recent publication in the World Journal of Urology marks a key step in the dissemination of data showing that a novel urologic scaffold at the time of prostatectomy can enhance continence recovery," stated Dr. Jeff Gahan of Duke University's Department of Urology. "The data were generated using one of the most rigorous definitions of continence to date, strengthening the publication's conclusions and informing the design of the ongoing randomized trial."

Paving the Path to Patient Access

Beyond clinical validation, generating robust data is critical for navigating the complex healthcare reimbursement landscape. The Voro scaffold currently has a Category III CPT code, a temporary designation for emerging technologies that often comes with uncertain and inconsistent reimbursement from insurers.

The ultimate goal is to achieve a Category I CPT code, which signifies a procedure is well-established, supported by strong clinical evidence, and has a corresponding established payment rate from payers like the Centers for Medicare & Medicaid Services (CMS) and private insurers. This transition is essential for ensuring widespread patient access and encouraging hospitals to adopt the technology.

"The World Journal of Urology publication represents meaningful progress toward generating the peer-reviewed clinical evidence required to support the transition of Levee's Category III CPT code to Category I status," explained Dr. Jeffrey Dann, a former adviser for the American Urological Association (AUA) on coding and reimbursement. "This type of high-quality clinical data is essential to enabling broader reimbursement by CMS and private payers."

With enrollment in the ARID II trial continuing, Levee Medical is systematically building the case needed to bring its innovation to the market. If the final results confirm the early promise, the Voro Urologic Scaffold could not only change the recovery trajectory for individual patients but also set a new standard of care in the surgical treatment of prostate cancer, turning a reactive waiting game into a proactive strategy for restoring quality of life.