Levee Medical Expands Horizons with FDA's Approval for ARID II Clinical Trial

DURHAM, N.C. — Levee Medical has recently achieved a significant milestone by receiving FDA approval to launch its ARID II clinical trial, a pivotal study focusing on post-radical prostatectomy stress urinary incontinence. This trial will implement the Voro Urologic Scaffold to evaluate its safety and effectiveness in patients undergoing robotic-assisted radical prostatectomy.

The ARID II study is designed as a multicenter, single-blind, randomized controlled trial. Its objective is to provide comprehensive insights into the potential benefits of the Voro Urologic Scaffold compared to existing treatment protocols. Bruce Choi, Founder and CTO of Levee Medical, expressed pride over this accomplishment: “This achievement showcases our commitment to addressing the challenges faced by patients who suffer from incontinence post-surgery. The Voro Urologic Scaffold is a leap towards reducing the frequency and severity of this prevalent issue, ultimately helping patients reclaim their quality of life.”

With Dr. Arvin K. George, a prominent figure at the Johns Hopkins School of Medicine and an expert in prostate cancer, appointed as the national principal investigator, the study is poised for thorough scientific scrutiny. Dr. George highlighted the urgent need for innovation in addressing post-surgical incontinence, stating, “Incontinence remains a major, yet often overlooked, issue after prostate cancer surgeries. The introduction of the Voro Urologic Scaffold represents a significant shift in how we approach this condition, with the potential to greatly enhance patients' lifestyles.”

Besides the trial approval, Levee Medical recently completed an impressive Series B financing round, amassing over $14 million, showcasing the confidence investors have in the company's innovative approach towards treating post-prostatectomy incontinence. This financial support will play a pivotal role in facilitating the ARID II clinical trial and ensuring that the groundbreaking research can be executed effectively.

Levee Medical's commitment goes beyond just innovation; it is about creating real-world solutions that mitigate the complications linked with surgical interventions for prostate cancer. The Voro Urologic Scaffold is expected to be a critical first step in this direction, although it is important to note that the device is currently restricted to investigational use only and has not yet received commercial clearance.

In summary, Levee Medical is on the brink of significant advancements in the realm of urological health, with the ARID II clinical trial representing a beacon of hope for countless men affected by the ramifications of prostate cancer surgery. The combination of cutting-edge technology, dedicated leadership, and robust financial backing positions the company for success in its mission to revolutionize treatment methodologies and improve the post-operative lives of patients.

For additional updates and information about Levee Medical and its pioneering work in urological health, visit www.leveemedical.com.