Latest news with #PaulMolloy
Yahoo
3 days ago
- Business
- Yahoo
Avvio Medical Proudly Announces ISO 13485 Certification, Marking a Major Milestone in Global MedTech Readiness
SAN FRANCISCO, June 26, 2025--(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. View source version on Contacts Media Contact: Paul MolloyChief Executive OfficerAvvio Medical, Tel: (415) 887-2037
Business Wire
3 days ago
- 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.
Yahoo
25-04-2025
- Health
- Yahoo
Avvio Medical to Present Clinical Trial Results at the 2025 American Urological Association Annual Meeting
Moderated Interactive Poster Session to Feature AEROLITH RCT Data on Acoustic Enhancer Microbubble Cavitation with Ureteroscopic Laser Lithotripsy SAN FRANCISCO, April 25, 2025--(BUSINESS WIRE)--Avvio Medical Inc. (formerly Applaud Medical, Inc.) today announced that results from its AEROLITH randomized clinical trial will be presented at the upcoming 2025 American Urological Association (AUA) Annual Meeting, taking place April 26-29 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. Moderated Interactive Poster PresentationPresenter: Wesley Mayer, MDTitle: A Prospective, Multi-Center, Randomized, Placebo-Controlled Clinical Trial Evaluating the Safety and Efficacy of Ureteroscopic Laser Lithotripsy With and Without Acoustic Enhancer Microbubble Cavitation for the Treatment of UrolithiasisSession: IP08-22Date/Time: April 26, 3:30–5:30 PMLocation: Room Marco Polo 701 This clinical presentation adds to the growing body of evidence supporting Avvio's proprietary technology. Avvio Medical is also looking to initiate its forthcoming pivotal clinical trial evaluating the safety and effectiveness of Acoustic Enhancer Microbubbles delivered with its breakthrough Enhanced Lithotripsy System (ELS). "There is a clear need for improved and novel strategies in stone management," said Paul Molloy, President and Chief Executive Officer of Avvio Medical. "We are thrilled to advance our clinical research with our patented microbubbles and the Enhanced Lithotripsy System—a revolutionary approach to treating urinary stones." For more information, go to or visit Suite 115 at AUA and schedule a demo of the technology. 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. View source version on Contacts Media Contact: Paul MolloyChief Executive OfficerAvvio Medical, Tel: (415) 887-2037 Sign in to access your portfolio
Associated Press
25-04-2025
- Health
- Associated Press
Avvio Medical to Present Clinical Trial Results at the 2025 American Urological Association Annual Meeting
SAN FRANCISCO--(BUSINESS WIRE)--Apr 25, 2025-- Avvio Medical Inc. (formerly Applaud Medical, Inc.) today announced that results from its AEROLITH randomized clinical trial will be presented at the upcoming 2025 American Urological Association (AUA) Annual Meeting, taking place April 26-29 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. Moderated Interactive Poster Presentation Presenter: Wesley Mayer, MD Date/Time: April 26, 3:30–5:30 PM Location: Room Marco Polo 701 This clinical presentation adds to the growing body of evidence supporting Avvio's proprietary technology. Avvio Medical is also looking to initiate its forthcoming pivotal clinical trial evaluating the safety and effectiveness of Acoustic Enhancer Microbubbles delivered with its breakthrough Enhanced Lithotripsy System (ELS). 'There is a clear need for improved and novel strategies in stone management,' said Paul Molloy, President and Chief Executive Officer of Avvio Medical. 'We are thrilled to advance our clinical research with our patented microbubbles and the Enhanced Lithotripsy System—a revolutionary approach to treating urinary stones.' For more information, go to or visit Suite 115 at AUA and schedule a demo of the technology. 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. View source version on CONTACT: Media Contact: Paul Molloy Chief Executive Officer Avvio Medical, Inc. Email:[email protected] Tel: (415) 887-2037 KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: HEALTH TECHNOLOGY HEALTH SURGERY CLINICAL TRIALS SOURCE: Avvio Medical Inc. Copyright Business Wire 2025. PUB: 04/25/2025 12:45 PM/DISC: 04/25/2025 12:46 PM
Business Wire
25-04-2025
- Health
- Business Wire
Avvio Medical to Present Clinical Trial Results at the 2025 American Urological Association Annual Meeting
SAN FRANCISCO--(BUSINESS WIRE)-- Avvio Medical Inc. (formerly Applaud Medical, Inc.) today announced that results from its AEROLITH randomized clinical trial will be presented at the upcoming 2025 American Urological Association (AUA) Annual Meeting, taking place April 26-29 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. Moderated Interactive Poster Presentation Presenter: Wesley Mayer, MD Title: A Prospective, Multi-Center, Randomized, Placebo-Controlled Clinical Trial Evaluating the Safety and Efficacy of Ureteroscopic Laser Lithotripsy With and Without Acoustic Enhancer Microbubble Cavitation for the Treatment of Urolithiasis Session: IP08-22 Date/Time: April 26, 3:30–5:30 PM Location: Room Marco Polo 701 This clinical presentation adds to the growing body of evidence supporting Avvio's proprietary technology. Avvio Medical is also looking to initiate its forthcoming pivotal clinical trial evaluating the safety and effectiveness of Acoustic Enhancer Microbubbles delivered with its breakthrough Enhanced Lithotripsy System (ELS). 'There is a clear need for improved and novel strategies in stone management,' said Paul Molloy, President and Chief Executive Officer of Avvio Medical. 'We are thrilled to advance our clinical research with our patented microbubbles and the Enhanced Lithotripsy System—a revolutionary approach to treating urinary stones.' For more information, go to or visit Suite 115 at AUA and schedule a demo of the technology. 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.
