Axonics® Announces Comprehensive Launch of the Axonics F15™ Recharge-Free Sacral Neuromodulation System

Rhea-AI Summary

Axonics, Inc. has launched the Axonics F15, a recharge-free sacral neuromodulation (SNM) system, across the United States. This device, which received FDA approval in March, boasts a longevity of over 15 years at typical settings and potential for more than 20 years at lower energy. The F15 is 20% smaller than competitors and features constant current stimulation. Physician responses have been positive, indicating strong clinical outcomes. The launch aims to address the needs of millions suffering from bladder and bowel dysfunction, supported by established reimbursement coverage.

Positive

• The Axonics F15 system has received positive feedback from physicians, indicating strong clinical outcomes.
• The device offers a longevity of over 15 years at typical stimulation and over 20 years at lower energy settings.
• The launch is expected to meet the needs of millions suffering from bladder and bowel dysfunction.

Negative

• None.

IRVINE, Calif.--(BUSINESS WIRE)-- Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced the comprehensive launch of the Axonics F15 across the United States. The newly developed, long-lived, fully recharge-free sacral neuromodulation (SNM) system received FDA approval in March.

“The Axonics recharge-free system is a welcome advancement for patients suffering from bladder and bowel dysfunction,” said Taylor Moore, M.D., board-certified urologist at Arkansas Urology. “My initial implants of the new device have gone well, with low amplitudes achieved at the time of implant suggesting longevity in the body of around 20 years. Clinical outcomes with the Axonics rechargeable SNM system have exceeded our expectations and we anticipate similar results with the Axonics F15. We are pleased to now offer patients a non-rechargeable option that provides significant longevity in the body, constant current stimulation, and a remote control that is recharge-free and easy for patients to use.”

About Axonics F15

• INS type: primary cell battery
• INS longevity: functional life has been validated for over 15 years at typical stimulation parameters and over 20 years at lower energy settings
• INS volume: 10 cubic centimeters (20% smaller than the market’s other non-rechargeable SNM device)
• Stimulation: constant current automatically adjusts stimulation output
• Tined lead: universal tined lead compatible with both recharge-free and rechargeable Axonics systems
• MRI compatibility: full body with 1.5T and 3.0T whole-body scanners
• Patient remote control: intuitive, recharge-free key fob featuring SmartMRI^™ technology
• Programming: proprietary algorithm recommends optimal stimulation parameters based on intraoperative responses

Raymond W. Cohen, CEO of Axonics, said, “Physician response to the Axonics F15 has been overwhelmingly positive. Our sales team is now armed with a complete portfolio of SNM products that, along with our national DTC campaign, will contribute to Axonics achieving its mission of treating more adults suffering from incontinence. We remain confident that our commitment to innovation, quality, and providing physicians and patients strong support will continue to drive SNM market expansion and advance Axonics on its path to market leadership.”

About Axonics

Based in Irvine, Calif., Axonics is a global medical technology company that is developing and commercializing novel products for adults with bladder and bowel dysfunction. Axonics recently ranked No. 1 on the 2021 Deloitte Technology Fast 500™ and the 2022 Financial Times ranking of the 500 fastest growing companies in the Americas.

Axonics’ sacral neuromodulation (SNM) systems provide patients suffering from overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, the company’s best-in-class urethral bulking hydrogel, Bulkamid^®, provides safe and durable symptom relief to women with stress urinary incontinence (SUI). Overactive bladder affects an estimated 87 million adults in the U.S. and Europe, with an additional 40 million adults estimated to suffer from fecal incontinence. SUI affects an estimated 29 million women in the U.S. alone. Axonics’ clinically proven products are offered at hundreds of medical centers across the U.S. and abroad. Reimbursement coverage is well established in the U.S. and is a covered service in most European countries. For more information, visit www.axonics.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220419005467/en/

Neil Bhalodkar

Investor Relations

949-336-5293

ir@axonics.com

Source: Axonics, Inc.

FAQ

What is the Axonics F15 system and its benefits?

The Axonics F15 is a recharge-free sacral neuromodulation system that offers longevity of over 15 years, is 20% smaller than competitors, and features constant current stimulation.

When was the Axonics F15 system approved by the FDA?

The Axonics F15 received FDA approval in March.

What conditions does the Axonics F15 aim to treat?

The Axonics F15 is designed for adults suffering from bladder and bowel dysfunction.

How does the Axonics F15 compare in size to competitor devices?

The Axonics F15 is 20% smaller than other non-rechargeable sacral neuromodulation devices.

What has been the response from physicians regarding the Axonics F15?

Physician responses have been overwhelmingly positive, with strong clinical outcomes reported.