Business Wire

NICE Recommends Axonics® r-SNM System for Treating Overactive Bladder

8.9.2020 15:30:00 EEST | Business Wire | Press release

Share

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, today announced the publication of medical technologies guidance for the Axonics r-SNM System by the National Institute for Health and Care Excellence (NICE).

NICE provides evidence-based guidance to improve health and social care in the United Kingdom. The guidance report, entitled “Axonics sacral neuromodulation system for treating refractory overactive bladder,” was developed by NICE over the past twelve months with the support of independent external assessment centers, expert clinicians and patients. It is based on the analysis of Axonics’ clinical results, a detailed cost model, and a complete body of evidence related to its technology.

In its evaluation, NICE concluded that the 15+ year battery life of the Axonics rechargeable implantable neurostimulator is likely to reduce the number of avoidable replacement procedures a patient may need to undergo as compared to non-rechargeable InterStim™ II. The clinical benefit to patients and cost savings to the health system from a longer-lived device resulted in NICE recommending the Axonics System for treating overactive bladder patients in the National Health System.

"The NICE guidance reinforces the importance of longevity in the body for devices treating overactive bladder," said Dr. Neil Harris, a urological surgeon practicing in Leeds, England. "The reduction in replacement procedures and identified cost savings provide significant benefits to both patients and the healthcare system."

Axonics is the only available rechargeable SNM system with published clinical data on therapy efficacy, patient satisfaction, quality of life improvement, charging experience, and safety. It is estimated that approximately 800 patients receive an SNM implant in England every year, with a few hundred more in the balance of the United Kingdom.

Raymond W. Cohen, CEO of Axonics, commented, “We have been impressed with the level of detail, fairness and transparency of the NICE evaluation. The conclusions acknowledging the Axonics System as safe, effective, and cost saving are in-line with our goal of offering best-in-class SNM technology to patients, physicians and healthcare systems. The international recognition and influence of NICE will undoubtedly carry this message beyond the borders of the United Kingdom.”

The NICE guidance can be accessed at https://www.nice.org.uk/guidance/mtg50.

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. The 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 the Company’s website at www.axonics.com.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Axonics contact:
Neil Bhalodkar
Investor Relations
949-336-5293
IR@axonics.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Incyte Announces Positive CHMP Opinion for Opzelura ® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis26.6.2026 14:30:00 EEST | Press release

Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate. “AD is a chronic skin condition that can have a significant impact on daily life. The positive CHMP opinion for Opzelura marks meaningful progress toward bringing the first non-steroidal topical JAK treatment option to adults in Europe with moderate AD for whom standard topical therapies have failed,” said Lee Heeson, Executive Vice President and Head of Incyte International. “If approved by the European Commission, Opzelura could help address an important gap for patients who have limited treatment options when TCSs and TCIs are inadequate or inappropriate.” The positive CHMP o

Datroway ® Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy26.6.2026 14:00:00 EEST | Press release

Datroway® (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the TROPION-Breast02phase 3 trial, which werepresented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU. In TROPION-Breast02, Datroway demonstrated a

DAYBU ® (trofinetide) Recommended for Approval in the European Union by CHMP26.6.2026 13:49:00 EEST | Press release

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion following a re-examination procedure, recommending the granting of a marketing authorization for DAYBU® (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If granted marketing authorization by the European Commission, DAYBU® would be the first therapy approved for this indication in the European Union (EU). “The CHMP’s positive opinion for DAYBU® is an important milestone in our mission to bring this innovative therapy to the EU, where there are no therapies specifically approved for the neurobehavioral symptoms of this devastating condition," said Catherine Owen Adams, Acadia’s Chief Executive Officer. “Our commitment is to make a meaningful difference in the lives of patients, caregivers, and the wider Rett com

HTEC Showcases Lakebase Branching at Databricks’ Data & AI Summit26.6.2026 12:18:00 EEST | Press release

HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. The Solution was developed in collaboration with a leading risk and compliance technology provider who serves financial institutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260626875859/en/ HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. Solving Critical Development Bottlenecks in Regulated Environments At the core of the collaboration was a shared challenge: how to enable modern data workflows in an envi

Stallergenes Greer Named One of Switzerland’s Best Managed Companies for 202626.6.2026 11:28:00 EEST | Press release

Stallergenes Greer, a global leader in allergy care, has been recognised for its overall business performance, company culture, and sustained growth by receiving the prestigious 2026 Switzerland’s Best Managed Companies award. The 2026 Best Managed Companies programme award winners are among Switzerland’s best private companies. The awards are derived from Deloitte’s global Best Managed Companies awards programme, an internationally recognised programme that evaluates businesses based on their leadership in the areas of strategy, culture and commitment, capabilities, innovation, governance and financial performance. Applicants are evaluated by an independent jury of experts. The evaluation of the Switzerland awards is based on more than 30 years of observed practice from the global awards programme that has been rolled out in 50+ countries worldwide. This recognition reflects Stallergenes Greer's consistent ability to deliver on its strategic vision while maintaining the operational di

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