FDA Approves Pivotal Trial of Novel Device for Post-Prostatectomy Incontinence Treatment
Key Insights
Levee Medical (search) receives FDA approval to initiate ARID II, a multicenter randomized controlled trial evaluating the Voro Urologic Scaffold (search) for treating stress urinary incontinence (search) after prostate surgery.
Johns Hopkins' Dr. Arvin K. George, a prominent prostate cancer (search) expert, will lead the pivotal study as national principal investigator to assess the device's safety and effectiveness.
The company recently secured over $14 million in Series B funding, demonstrating strong investor confidence in their innovative approach to addressing post-surgical complications.
Levee Medical (search) has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting approval for its ARID II pivotal study, investigating a novel device designed to address stress urinary incontinence (search) following radical prostatectomy procedures.
The ARID II (A Pivotal Study of VoRo UrologIc ScaffolD (search) for the Treatment of Post Prostatectomy Stress Urinary Incontinence (search)) trial will be conducted as a multicenter, single-blind, randomized controlled study. The trial aims to evaluate both the safety and effectiveness of the Voro Urologic Scaffold when used in adult men undergoing robotic-assisted radical prostatectomy, compared to standard care.
Leadership and Clinical Expertise
The study will be led by Dr. Arvin K. George, Director of Prostate Cancer (search) Programs at Johns Hopkins School of Medicine (search), who brings extensive experience in urologic oncology research. "Incontinence is a common, yet often under-addressed consequence of prostate cancer surgery," Dr. George explained. "The Voro Urologic Scaffold (search) represents a promising new approach that could redefine how we manage post-surgical incontinence, potentially enhancing the quality of life for many patients."
Innovation in Surgical Complications Management
Bruce Choi, Founder & CTO of Levee Medical (search), emphasized the significance of this development: "We are proud to reach this important milestone in our mission to minimize incontinence for patients of radical prostatectomy. This achievement reflects the dedication and hard work of our team and the invaluable support of our investors."
Financial Backing and Future Development
The company's innovative approach has garnered substantial financial support, with a recently closed Series B financing round exceeding $14 million, including note conversions. This funding, announced on February 11, 2025, will support the execution of ongoing clinical trials, including the ARID II study.
Clinical Impact and Market Potential
The Voro Urologic Scaffold (search) represents a novel intervention in the management of post-prostatectomy complications. While currently limited to investigational use and not yet approved for commercial use in any country, the device shows promise in addressing a significant quality-of-life issue for prostate cancer (search) survivors. The successful completion of this pivotal trial could potentially establish a new standard in post-surgical care for prostate cancer patients.