Levee Medical has closed an additional round of oversubscribed financing totaling more than $12 million, further extending its runway and supporting execution of the PMA process following completion of the ARID II study enrollment.

“We are grateful for the overwhelming investor support,” Levee Medical CEO Adam Irving stated. “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 progress in the ARID II pivotal trial continues. The Voro Urologic Scaffold is currently being evaluated in the multicenter, randomized study to further assess the device’s safety and effectiveness in men undergoing robotic-assisted radical prostatectomy.

“We hosted ARID II principal investigator, Dr. Scott Eggener, chair of Urology at UCLA, who is our 40th surgeon to participate,” said Ahmed Ghazi, M.D., professor of Urology at Johns Hopkins and director of the Surgical Learning and Innovation Center of Excellence. “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.”

“Stress urinary incontinence is one of the most feared outcomes after radical prostatectomy,” Scott Cheney, M.D., added. “I’m excited to help lead the ARID II study at Mayo Clinic, focused on minimizing early incontinence and accelerating recovery for our patients.”

The company remains focused on disciplined execution of its clinical and regulatory milestones as it advances toward PMA submission.

Levee Medical designs solutions that help reduce complications associated with prostate cancer surgical treatment. The Voro Urologic Scaffold is the first product Levee plans to market. The device is currently limited to investigational use and is not approved for commercial use in any country.