Avvio Medical Inc. today announced the publication of its AEROLITH randomized clinical trial in The Journal of Urology. Study highlights were presented at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada. The AEROLITH study evaluated the safety and effectiveness of Acoustic Enhancer Microbubble Cavitation (AEMC) when used with ureteroscopic laser lithotripsy (URS-LL) to treat kidney and ureteral stones.

Study highlights include:

• Successful completion of a first-of-its-kind multi-center randomized controlled trial evaluating Avvio Medical’s Acoustic Enhancer Microbubble Cavitation (AEMC) technology in combination with URS-LL
• Statistically significant fewer adverse events observed in patients treated with AEMC compared to standard ureteroscopy
• Comparable stone-free rates, with early signs of improved stone free-rates, especially in ureteral stones when higher laser powers were used
• Potential tissue-protective effects suggested by the microbubble technology’s unique design
• New insights: Laser settings may be key to optimizing AEMC’s performance, possibly guiding future studies

The AEROLITH study demonstrated that in the ureteral stone subgroup, a key clinical population, efficacy was comparable between URS-LL with microbubbles and URS-LL alone. However, the use of microbubbles demonstrated a significant safety advantage, including a 42% relative reduction in adverse events. “This study demonstrates that conventional URS-LL, which currently is the most common surgical procedure to treat stones, yields disappointing results. More than 50% of patients will still have stones after the procedure, with residual fragments large enough to have a high chance for future problems,” stated Wesley Mayer, MD, lead author of the study. “It is also poorly tolerated, with > 40% of patients reporting adverse events. AEROLITH showed that patients undergoing URS-LL augmented with microbubbles had significantly fewer adverse events, suggesting improved safety and tolerability compared to conventional laser lithotripsy.”

These clinical findings further strengthen the growing body of evidence supporting Avvio’s proprietary technology. Avvio Medical is also currently evaluating, in a pivotal multi-center clinical trial, the safety and effectiveness of Acoustic Enhancer Microbubbles delivered with its breakthrough Enhanced Lithotripsy System (ELS) utilizing low-intensity therapeutic ultrasound.

For more information, visit www.avviomedical.com.

About the Enhanced Lithotripsy System (ELS)

The AVVIO ELS introduces microbubble enhanced acoustic cavitation lithotripsy, enabling kidney stone treatments outside the traditional operating room and into more accessible outpatient settings like ambulatory surgery centers (ASCs), office-based labs (OBLs), and cystoscopy suites. The system delivers a single, minimally invasive therapy without the need for general anesthesia, fluoroscopy, intra-operative imaging, or costly capital equipment. By reducing procedural complexity and resource requirements, ELS supports wider patient access, improves care delivery efficiency, and offers meaningful clinical, economic, and health equity benefits.

About Avvio Medical

Avvio Medical is a privately held medical technology company based in San Francisco committed to expanding 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.

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