
Avvio Medical to Present Clinical Trial Results at the 2025 American Urological Association Annual Meeting
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 avviomed.com 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 businesswire.com:https://www.businesswire.com/news/home/20250425877347/en/
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
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Dr. Swanton is a fellow of the Royal Society, a fellow of the Royal College of Physicians and a fellow of the Academy of Medical Sciences. He completed his M.D. and Ph.D. training at the Imperial Cancer Research Fund Laboratories. Formed Research and Innovation Advisory Board (RAB) to support scientific advancement and strategic growth across preclinical programs. The RAB replaces Bicycle's Scientific Advisory Board. Inaugural RAB members include: Jose-Carlos Gutierrez-Ramos, Ph.D., is a director on the Bicycle Therapeutics Board of Directors. He also serves as the chief science officer at Danaher Corporation, leading the Danaher Innovation Centers and the Danaher Scientific Advisory Board. Previously, Dr. Gutierrez-Ramos was head of global drug discovery at AbbVie Inc., group senior vice president of biotherapeutics research and development (R&D) at Pfizer Inc., and senior vice president and CEDD head of immuno-inflammation at GlaxoSmithKline plc. 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Dr. Lewis is a laboratory head in Sloan-Kettering Institute's molecular pharmacology program and serves as a professor at the Gerstner Sloan-Kettering Graduate School of Biomedical Sciences and at Weill-Cornell Medical College. He earned a Ph.D. in biochemistry from the University of Kent and an M.S. and B.S. in chemistry from the University of Essex. Robert Lutz, Ph.D., is a consultant/advisor to biotech and pharma with more than 30 years of experience with a significant focus on the development of antibody-drug conjugates (ADCs). He currently serves as chief scientific officer of Iksuda Therapeutics and is a board member and chief development officer of Synthis Therapeutics. 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Participation in Upcoming Investor Conferences Bicycle Therapeutics management will participate in the following investor conferences in September: Cantor Global Healthcare Conference on Thursday, Sept. 4; fireside chat at 3:55 p.m. ET Morgan Stanley 23 rd Annual Global Healthcare Conference on Tuesday, Sept. 9; fireside chat at 7:45 a.m. ET Live webcasts of the fireside chats will be accessible in the Investor section of the company's website at Archived replays of the webcasts will be available following the fireside chat dates. Second Quarter 2025 Financial Results Cash and cash equivalents were $721.5 million as of June 30, 2025, compared to $879.5 million as of December 31, 2024. The decrease in cash and cash equivalents is primarily due to cash used in operations, including increased cash payments for clinical program activities. R&D expenses were $71.0 million for the three months ended June 30, 2025, compared to $40.1 million for the three months ended June 30, 2024. The increase in expense of $30.9 million was primarily due to increased clinical program expenses for zelenectide pevedotin development, increased discovery, platform and other expenses, and increased personnel-related costs, offset by decreased clinical program expenses for Bicycle Tumor-Targeted Immune Cell Agonist ® (Bicycle TICA ®) molecules as well as higher U.K. R&D tax credits period over period. General and administrative expenses were $18.5 million for the three months ended June 30, 2025, compared to $15.9 million for the three months ended June 30, 2024. The increase in expense of $2.6 million was primarily due to increased personnel-related costs, as well as increased professional and consulting fees. Net loss was $79.0 million, or $(1.14) basic and diluted net loss per share, for the three months ended June 30, 2025, compared to net loss of $39.8 million, or $(0.77) basic and diluted net loss per share, for three months ended June 30, 2024. In recognition of the evolving macroeconomic environment and the importance of preserving capital, Bicycle Therapeutics is implementing a workforce reduction and taking other steps to optimize its operations and extend the company's expected financial runway. These strategic cost realignment efforts are being implemented to prioritize potentially high-impact, value-generating programs, which include the advancement of zelenectide pevedotin, BT5528, next-generation Bicycle ® Drug Conjugates and the company's wholly owned pipeline of Bicycle ® Radioconjugates. Bicycle Therapeutics anticipates total operational savings of approximately 30% over the course of the financial runway period. These actions are expected to extend the financial runway into 2028 and strengthen the company's ability to weather continued market uncertainty as it advances clinical programs through key milestones. About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle ® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle ® Drug Conjugate (BDC ®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist ® (Bicycle TICA ®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle ® Radioconjugates (BRC ®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle ® technology to develop therapies for diseases beyond oncology. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'aims,' 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'forecasts,' 'goal,' 'intends,' 'may,' 'plans,' 'possible,' 'potential,' 'seeks,' 'will' and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the validation of MT1-MMP as a cancer target and BRC molecules having positive properties for radiopharmaceutical imaging; the initiation of new clinical trials, the progress of Bicycle's ongoing clinical trials and the timing of EphA2 human imaging data and updates on dose selection in the Duravelo-2 clinical trial and accelerated approval pathway; the outcome of Bicycle's strategic cost realignment efforts and Bicycle's expected financial runway; and the use of Bicycle Therapeutics' technology through various partnerships to develop therapies for diseases beyond oncology. Bicycle Therapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle Therapeutics' product candidates; the risk that Bicycle Therapeutics may not realize the intended benefits of its cost realignment efforts; the risk that Bicycle's projections regarding its expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Bicycle Therapeutics' actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled 'Risk Factors' in Bicycle Therapeutics' Annual Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 1, 2025, as well as in other filings Bicycle Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle Therapeutics expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Balance Sheets Data (In thousands) (Unaudited) June 30, December 31, 2025 2024 Cash and cash equivalents $ 721,451 $ 879,520 Working capital 726,840 861,375 Total assets 832,184 956,868 Total shareholders' equity 668,915 793,060 Expand