Latest news with #Avvio
Business Wire
22-07-2025
- Health
- Business Wire
Avvio Medical Announces New CPT Code for Its Breakthrough Kidney Stone Treatment Technology
SAN FRANCISCO--(BUSINESS WIRE)-- Avvio Medical, Inc., a company dedicated to revolutionizing the treatment of urinary stones, is excited to announce that the American Medical Association (AMA) has officially published the early release of a new Category III CPT code for Avvio's novel kidney stone treatment system. , CPT code 0991T will be used by healthcare providers and facilities nationwide to report procedures utilizing Avvio Medical's innovative technology. The new code, which reflects the final nomenclature approved by the AMA, marks a significant milestone in Avvio's journey to expand patient access, improve care, and streamline reimbursement for its groundbreaking approach. 'The introduction of a dedicated CPT code for our technology demonstrates the clinical importance of our ureteral stone solution,' said Paul Molloy, CEO, Avvio Medical. 'This achievement will help ensure that physicians and health systems can more easily offer our therapy to patients while benefiting from clear and accurate billing processes.' Avvio worked with expert reimbursement strategy consultants Jeffrey Dann, M.D., and PRIA Healthcare to support the code application process and overall market access planning. The announcement was made public as part of the AMA's official Category III CPT Code Early Release, available here. What This Means CPT 0991T will take effect January 1, 2026. The new code reflects important progress toward bringing Avvio's technology to patients and providers. This development highlights Avvio's commitment to advancing access and innovation in kidney stone care. About the Enhanced Lithotripsy System (ELS) The AVVIO ELS introduces microbubble enhanced acoustic cavitation lithotripsy 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 suitable for Ambulatory Surgery Centers (ASCs) and cystoscopy suites, without requiring general anesthesia, fluoroscopy, or costly capital equipment. This innovation offers compelling clinical and economic advantages for both patients and providers. About Avvio Medical Avvio Medical is a privately held company which aims to improve treatment methods, patient experiences and medical costs for all patients experiencing the effects of urinary stones. The company's initial technology is designed to offer patients and healthcare professionals a fast, minimally invasive solution for treating urinary stone disease in various clinical or outpatient settings, eliminating the routine need for anesthesia or X-ray imaging. For more information, visit
Business Wire
08-07-2025
- Health
- Business Wire
Avvio Medical's Microbubble Technology Reduces Complications and Shows Promise for Enhancing Laser Lithotripsy: AEROLITH Trial Results Published in
SAN FRANCISCO--(BUSINESS WIRE)-- 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: 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 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.
Business Wire
26-06-2025
- Business
- Business Wire
Avvio Medical Proudly Announces ISO 13485 Certification, Marking a Major Milestone in Global MedTech Readiness
SAN FRANCISCO--(BUSINESS WIRE)-- Avvio Medical, Inc., a clinical-stage medical device company focused on transforming the treatment of kidney stone disease, is proud to announce that it has successfully achieved ISO 13485:2016 certification following its initial audit conducted by BSI (British Standards Institution). This globally recognized certification demonstrates Avvio's compliance with international standards for medical device quality management systems and reflects the company's unwavering commitment to excellence, patient safety, and operational rigor. 'This milestone is more than a regulatory requirement—it represents the fulfillment of our promise to stand up a full-scale medical device company,' said Paul Molloy, CEO of Avvio Medical. 'Through disciplined execution, a culture of continuous improvement, and a mindset grounded in honor, behavioral integrity, and precision, we have built a foundation for scalable, global operations.' He added, 'The quality culture at Avvio is not just a box-checking exercise. We embed it through storytelling, structured messaging, and principles drawn from disciplines of Lean and KAIZEN and a culture Bushidō. As we shared with the BSI audit team, our internal motto is #ImproveEverything—and this certification illustrates that we live by it.' The ISO 13485 certification now enables Avvio to fully qualify its manufacturing and design processes for commercial scaling, pursue CE marking for international distribution, and reinforce confidence among global partners, investors, and regulators. The achievement is a major step toward the company's upcoming 2026 commercial launch in the U.S. market. With this certification, Avvio affirms that it is not only compliant—but built to lead. About the Enhanced Lithotripsy System (ELS) The AVVIO ELS introduces microbubble enhanced acoustic cavitation lithotripsy 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 suitable for Ambulatory Surgery Centers (ASCs) and cystoscopy suites, without requiring general anesthesia, fluoroscopy, or costly capital equipment. This innovation offers compelling clinical and economic advantages for both patients and providers. About Avvio Medical Avvio Medical is a privately held medical technology company based in San Francisco and dedicated to transforming the treatment of urinary stones. Its breakthrough platform is designed to improve patient experience, reduce healthcare costs, and expand access to care by offering a fast, minimally invasive solution suitable for a wide range of clinical settings. The company's system eliminates the routine need for general anesthesia or X-ray imaging, streamlining the treatment pathway for both patients and healthcare professionals.
