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

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 .

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