Avvio Medical Kicks Off Kidney Stone Therapy Study

Avvio Medical Inc. (formerly Applaud Medical Inc.) has treated the first patients with its investigational Enhanced Lithotripsy System (ELS), thereby officially launching its U.S. Food and Drug Administration Investigational Device Exemption-approved kidney stone therapy trial.

“Our team has developed a solution poised to redefine kidney stone treatment,” Avvio Medical President/CEO Paul Molloy said. “The AVVIO ELS is designed to dramatically improve patient outcomes and streamline current treatment protocols. We’re excited to begin this pivotal trial.”

The AVVIO Enhanced Lithotripsy System introduces a novel mechanism of action that enables kidney stone treatments to move out of the traditional operating room and into more accessible outpatient and office-based settings. The system provides a single, minimally invasive therapy for ambulatory surgery centers (ASCs) and cystoscopy suites, without the need for general anesthesia, fluoroscopy, or costly capital equipment. This approach offers meaningful clinical and economic advantages for both patients and providers.

“After years of research and development, we are excited to initiate our clinical trial to evaluate this new technology,” Avvio Medical Co-Founder Dr. Marshall Stoller stated. “Our goal is to explore its potential to improve kidney stone treatment and patient outcomes.”

The AVVIO ELS introduces microbubble enhanced acoustic cavitation lithotripsy to deliver a single, minimally invasive therapy that reduces procedural complexity and resource requirements. ELS supports wider patient access, improves care delivery efficiency, and offers meaningful clinical, economic, and health equity benefits, according to the company.

San Francisco-based Avvio Medical aims to expand access to safer, more effective urinary stone treatments. By developing minimally invasive solutions that lower costs, reduce reliance on hospital-based care, and remove barriers like general anesthesia and advanced imaging, Avvio aims to improve patient outcomes, drive health system efficiencies, and close gaps in care access across diverse healthcare settings.