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Axonics® Granted Seven U.S. Utility Patents Related to its Implantable Sacral Neuromodulation Technology

November 15, 2018

IRVINE, Calif.--(BUSINESS WIRE)--Nov 15, 2018--Axonics Modulation Technologies, Inc., (NASDAQ: AXNX) developer of the first rechargeable  Sacral Neuromodulation (r-SNM™) system  for the treatment of  urinary and bowel dysfunction, announced today that the United States Patent and Trademark Office has issued Axonics seven U.S. utility patents in 2018, along with numerous foreign counterparts relating to its implantable Sacral Neuromodulation technology.

The U.S. patents issued range in subject matter and include coverage of the Axonics clinician programmer, patient remote control, and internal system electronics. The issued U.S. patents are: 10,029,090; 9,855,436; 10,092,762; 9,855,423; 9,895,546; 10,105,542; 9,925,381.

“Axonics is committed to rapidly bringing innovative technology to market in order to serve the unmet needs of the millions of patients suffering from urinary and bowel dysfunction and the healthcare providers who serve them. We believe that the continued growth of our patent portfolio demonstrates how serious we are in our efforts,” said Raymond W. Cohen, Axonics Chief Executive Officer. “With these seven additional U.S. utility patents, we presently have 108 granted and 105 pending patent applications in our portfolio in various jurisdictions around the world.”

The Axonics patent portfolio represents technology internally developed by Axonics and technology developed under license from the Alfred Mann Foundation.

The Axonics r-SNM System has obtained European CE mark approval, Health Canada approval, and Australian Therapeutic Goods Administration approval for the treatment of overactive bladder, urinary retention, and fecal incontinence.

Currently, Axonics is in the follow-up phase of its 129-patient pivotal clinical study, ARTISAN-SNM, designed to gain U.S. Food & Drug Administration (FDA) approval in the United States for urinary urgency incontinence. All patients in the ARTISAN-SNM clinical study are scheduled to reach their six-month post-implant endpoint on or about, the end of 2018.

About Overactive Bladder, Fecal Incontinence and Sacral Neuromodulation

Overactive bladder affects an estimated 85 million adults in the U.S. and Europe. Another 40 million are reported to suffer from fecal incontinence. SNM therapy is an effective and durable treatment that has been widely used and reimbursed in Europe and the U.S. for the past two decades. SNM is the only treatment with proven clinical superiority to standard medical therapy and patients receiving SNM report significantly higher quality of life than patients undergoing drug treatment.

About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, CA, is focused on development and commercialization of a novel implantable SNM system for patients with urinary and bowel dysfunction, and disrupting the SNM market currently dominated by one large provider. The Axonics r-SNM system offers a temporary disposable external trial system, a miniaturized and rechargeable long-lived neurostimulator that is qualified to function for at least 15 years, a tined lead as well as patient-friendly accessories such as a charging system optimized for minimal charge time without overheating, a small, easy to use patient remote control and an intuitive clinician programmer that facilitates lead placement and programming. For more information, visit the Company’s website at  www.axonicsmodulation.com.

Forward Looking Statements

Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

View source version on businesswire.com:https://www.businesswire.com/news/home/20181115005296/en/

CONTACT: Company Contact

Dan Dearen, President & Chief Financial Officer

Axonics Modulation Technologies, Inc.

+1-949-396-6320

ir@axonics.com

Investor & Media Contact

W2Opure

Matt Clawson

+1-949-370-8500

mclawson@W2Ogroup.com

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: TECHNOLOGY HARDWARE HEALTH BIOTECHNOLOGY CLINICAL TRIALS MEDICAL DEVICES FDA

SOURCE: Axonics Modulation Technologies, Inc.

Copyright Business Wire 2018.

PUB: 11/15/2018 09:00 AM/DISC: 11/15/2018 09:00 AM

http://www.businesswire.com/news/home/20181115005296/en

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