Levee Medical Advances Voro Scaffold With ARID II Trial Milestone and Peer-Reviewed Data

New updates have been reported about Levee Medical.

Levee Medical has reported two significant milestones for its Voro Urologic Scaffold, underscoring clinical and reimbursement momentum for its lead prostate surgery recovery device. The company announced that its ARID II pivotal trial, a multicenter randomized controlled study in men undergoing robotic-assisted radical prostatectomy, has reached its halfway enrollment point, signaling strong trial execution and growing clinician confidence. In parallel, interim data from the earlier ARID feasibility study have been published in the World Journal of Urology, providing peer-reviewed validation of the scaffold’s safety profile and early efficacy in accelerating continence recovery, with no device-related adverse events observed. Results from ARID showed more than half of patients were continent by six weeks and over 70% by six months, with nearly all patients achieving continence by six months when the device was optimally deployed, based on rigorous 24-hour pad weight testing.

Clinicians involved in the research highlighted the potential of the Voro Scaffold to meaningfully improve post-prostatectomy quality of life by expediting continence recovery, an outcome that has direct implications for patient adoption and surgeon interest if ultimately approved. Strategically, the World Journal of Urology publication is an important step toward upgrading Levee Medical’s Category III CPT code to a permanent Category I code, a shift that would enable broader reimbursement from CMS and private payers and materially affect the company’s commercial trajectory. ARID II enrollment remains ongoing and is designed to confirm safety and effectiveness in a larger randomized population with longer follow-up, data that will be critical for regulatory and payer discussions. While the Voro Urologic Scaffold remains investigational and is not yet approved for commercial use in any market, these developments strengthen Levee Medical’s clinical evidence base and position the company for future commercialization and expanded patient access if pivotal results are positive.