Business Wire

CA-AXONICS-MODULATION

Share
Axonics® Reports 2-Year Clinical Results from ARTISAN-SNM Pivotal Study

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has reported full 2-year clinical results from its ARTISAN-SNM pivotal study.

Key clinical results at 2-years include:

  • Responder rate: 88% of all implanted participants (n=129) were therapy responders at 2-years, defined as a ≥50% reduction in urgency incontinence episodes compared to their baseline.
    • Results are consistent with the 89% therapy responder rate reported at 1-year post implant.
    • Completers analysis (n=121) demonstrated 93% therapy responder rate at 2-years post implant.
  • Urinary Urge Incontinence (UUI) episodes: declined from an average of 5.6 per day at baseline to 1.0 per day at 2-years.
    • 80% of therapy responders had ≥75% reduction in their UUI episodes.
    • 37% of therapy responders were dry, having experienced a 100% reduction in their UUI episodes.
  • Quality of life: participants experienced a clinically meaningful improvement in quality of life as indicated by a 36-point improvement in their ICIQ-OABqol score.
    • 93% of participants reported being “satisfied” with their r-SNM therapy.
    • 93% of participants responded that they would undergo the procedure again to gain the benefit of the therapy.
  • Recharging experience: all participants reported successful device recharging throughout the 2-year study.
    • 94% of participants reported charging frequency and duration as “acceptable.”
    • 91% of participants reported charging as “easy.”
  • Safety: there were no serious device-related adverse events.

Detailed study results were presented via webinar by principal investigators Felicia Lane, M.D., FPMRS of University of California, Irvine and Andrea Pezzella, M.D., FPMRS, FACOG of Southern Urogynecology in West Columbia, South Carolina. Interested parties may access the webinar by visiting axonicswebinars.com .

Karen Noblett, M.D., FPMRS, chief medical officer of Axonics, said, “The 2-year responder rate from the ARTISAN-SNM pivotal study is the highest ever reported in SNM clinical literature. The clinically significant and durable symptom relief, ease of recharging, and high degree of satisfaction reported by study participants is being replicated every day in the real world, with over 4,000 patients having been treated with the Axonics System since its introduction into the U.S. market in November 2019. We remain committed to partnering with physicians to increase the awareness and adoption of sacral neuromodulation, which has the potential to significantly improve quality of life for millions of patients suffering from bladder and bowel dysfunction.”

The completion of 2-year follow-ups concludes the ARTISAN-SNM study.

Axonics will continue to add to its growing body of clinical data with the fourth quarter 2020 launch of a multi-center registry study in the United States. The registry will collect additional real-world clinical evidence on performance, safety and patient experience with the Axonics System across all approved clinical indications to advance physician knowledge and patient access to rechargeable sacral neuromodulation therapy.

ARTISAN-SNM study

The ARTISAN-SNM study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study to evaluate the safety and efficacy of the Axonics r-SNM System. The study was conducted in 14 centers in the U.S. and five centers in Western Europe. All patients diagnosed with urinary urge incontinence were implanted with a tined lead and the Axonics miniaturized rechargeable neurostimulator in a non-staged (no external trials) procedure. Pre- and post-implant efficacy data was collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a satisfaction questionnaire. Therapy responders at follow-up were identified as patients with at least a 50% reduction in urinary urgency incontinence episodes compared to baseline. Any patient that did not meet the reduction criteria or who dropped out of the study were counted as non-responders. A total of 121 participants completed the 2-year follow-up visit, which concludes the ARTISAN-SNM study.

About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, Calif., has developed and is commercializing novel implantable SNM devices for patients with urinary and bowel dysfunction. These conditions are caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. Overactive bladder affects an estimated 87 million adults in the U.S. and Europe. Another estimated 40 million adults are reported to suffer from fecal incontinence/accidental bowel leakage. Axonics SNM therapy, which has been clinically proven to reduce symptoms and restore pelvic floor function, is now being offered at hundreds of medical centers across the U.S. and in dozens of select hospitals in Western Europe. Reimbursement coverage is well established in the U.S. and is a covered service in most European countries. The Axonics System is the first long-lived rechargeable SNM system approved for sale in the world, and the first to gain full-body MRI conditional labeling. For more information, visit www.axonics.com .

Link:

ClickThru

Social Media:

https://www.facebook.com/axonics

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

SCENTMATIC's AI "KAORIUM" Debuts at THAMEEN Fragrance Launch in London's Selfridges4.7.2025 11:13:00 CEST | Press release

SCENTMATIC Inc., a leader in scent digitalization, introduced its AI-powered scent-to-language system, KAORIUM, at the THAMEEN Fragrance new product launch event. This pivotal event took place from June 5 to 11, 2025, at Selfridges department store in London, UK. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250703662207/en/ State of exhibition Global Expansion: KAORIUM Establishes UK Presence Europe leads the global fragrance market, with the UK projected to reach US$2.82 billion by 2033. Recognizing this, SCENTMATIC is rapidly expanding its international footprint. In May 2024, SCENTMATIC established its overseas subsidiary, KAORIUM, in London, appointing industry expert Ben Yanoushek as CEO. Official UK operations commenced on February 1, 2025, with the launch of its dedicated website: www.kaorium.com. KAORIUM Trialed at "Florentine Diamond" Launch Event The "Florentine Diamond" launch event for luxury brand THAMEEN Frag

Andersen Consulting samarbejder med Mercurial Minds om at forbedre mulighederne inden for digital transformation4.7.2025 01:10:00 CEST | Pressemeddelelse

Andersen Consulting udvider sit udbud af teknologidrevne løsninger med tilføjelsen af samarbejdsfirmaet Mercurial Minds (M.M.), et konsulentfirma inden for digital transformation, AI og IT med base i Pakistan. M.M. blev grundlagt i 2013 og tilbyder en række tjenester, der er designet til at hjælpe organisationer med at udvikle sig og skalere, herunder i forbindelse med deres digitale transformationsstrategi, AI-tjenester, it-rådgivning og udvikling af robuste mobil- og webbrugeroplevelser. Firmaet leverer end-to-end-løsninger – udformning af datadrevne køreplaner, udvikling af intelligent automatisering og levering af sikre mobil- og weboplevelser, der kan skaleres – skræddersyet til virksomheder, der ønsker at forbedre sine forbindelsesmulighederne og opnå indsigter i realtid. M.M. betjener en bred vifte af brancher med fokus på finans, telekommunikation og andre dataintensive sektorer. "Dette samarbejde er en katalysator," siger Nabeel Saiyer, administrerende direktør for M.M. "Vores

Global Tourism Surging Ahead of Economic Growth, With Visits to Hit 30 Billion by 20344.7.2025 01:00:00 CEST | Press release

The World Economic Forum report, in collaboration with Kearney and the Ministry of Tourism Saudi Arabia, predicts a significant uptick in tourist trips across the globeThe tourism sector will contribute $16 trillion to global GDP (more than 11% of the global economy) by 2034, according to World Travel & Tourism Council estimates (WTTC)India and China will be responsible for more than 25% of all outbound travel by 2030 The World Economic Forum has today published a new report forecasting that the travel and tourism industry is projected to serve 30 billion tourist trips by 2034. Travel and Tourism at a Turning Point: Principles for Transformative Growth, produced in collaboration with Kearney and the Ministry of Tourism Saudi Arabia, reveals a projected $16 trillion contribution to global GDP by the same year—representing more than 11% of the total world economy, according to World Travel & Tourism Council estimates. The report also found that the sector is expanding 1.5 times faster th

The 2025-2026 World Branding Awards Animalis Edition Honouring Leading Pet and Animal Brands Globally3.7.2025 21:00:00 CEST | Press release

The 2025-2026 World Branding Awards Animalis Edition marked its fifth instalment, bringing together leading pet and animal brands from all around the world. These brands were celebrated for their outstanding achievements, earning recognition as National, Regional, and Global Winners. The awards ceremony, held at Vienna's prestigious Hofburg Palace, welcomed winners across diverse categories, including pet food, retail, wellness, pet exhibitions, and aquatic products. Mounia Berrada-Gouzi expertly hosted the evening, which culminated in a grand celebration of brand excellence. “The Animalis Edition of the World Branding Awards recognises brands that have achieved the highest distinction—genuine recognition in the hearts and minds of consumers. Tonight, we honour those whose names resonate globally, whose values inspire loyalty, and whose presence defines excellence in the pet and animal industry,” said Richard Rowles, Chairman of the World Branding Forum. Out of over 950 brands nominate

Venture Global Announces 20-Year Sales and Purchase Agreement with PETRONAS3.7.2025 14:59:00 CEST | Press release

Today, Venture Global, Inc. (NYSE: VG) announced the execution of a new 20-year Sales and Purchase Agreement (SPA) with PETRONAS LNG Ltd. (PLL), a subsidiary of the Malaysian state-owned oil and gas company, PETRONAS. Under the terms of the SPA, PETRONAS will purchase 1 million tonnes per annum (MTPA) of liquefied natural gas (LNG) from Venture Global’s third facility, CP2 LNG, for 20 years. This builds upon Venture Global’s existing agreement with PETRONAS for 1 MTPA of LNG supply from Plaquemines LNG. PETRONAS, a world-class partner in the LNG industry, joins other CP2 LNG customers in Europe, Asia and the rest of the world in a strategically important project to global energy supply and security. To date, approximately 10.75 MTPA of the 14.4 MTPA nameplate capacity for CP2 Phase One has been sold. About Venture Global Venture Global is a long-term, low-cost provider of U.S. LNG sourced from resource rich North American natural gas basins. Venture Global’s business includes assets ac

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye