Levee Medical Secures Over $12M to Advance PMA Plans for Voro Urologic Scaffold

Levee Medical has raised more than $12 million in an oversubscribed financing round to support its premarket approval process as the ARID II pivotal trial advances. The Durham, North Carolina–based company said the funding was completed ahead of schedule and will extend its operating runway through key regulatory milestones.

The capital will primarily support activities related to the planned PMA submission following completion of enrollment in the ARID II study. The trial is evaluating the company’s Voro Urologic Scaffold in men undergoing robotic-assisted radical prostatectomy. The multicenter, randomized study is designed to assess the device’s safety and effectiveness in reducing complications associated with prostate cancer surgery.

“We are grateful for the overwhelming investor support,” said Adam Irving, CEO of Levee Medical. “The extended runway strengthens our position during the PMA process following ARID II enrollment. We are laser focused on meaningful results for patients and stakeholders.”

Clinical participation in ARID II continues to expand. Ahmed Ghazi, MD, Professor of Urology at Johns Hopkins and Director of the Surgical Learning and Innovation Center of Excellence, said, “Yesterday we hosted ARID II principal investigator, Dr. Scott Eggener, Chair of Urology at UCLA, who is our 40th surgeon to participate. Our goal is to mobilize leadership among clinical research sites, standardizing an evidence-based, effective and reproducible implant technique for the scaffold during the IDE trial.”

Scott Cheney, MD, who is leading the study at Mayo Clinic, emphasized the clinical focus of the research. “Stress urinary incontinence is one of the most feared outcomes after radical prostatectomy,” he said. “I’m excited to help lead the ARID II study at Mayo Clinic, focused on minimizing early incontinence and accelerating recovery for our patients.”