Sanford Health Now Implanting Axonics® Sacral Neuromodulation Systems

Business Wire

Among Largest Rural Health Systems in the U.S.

IRVINE, Calif. & SIOUX FALLS, S.D.--(BUSINESS WIRE)-- Axonics Modulation Technologies, Inc. (NASDAQ:AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today announced that surgeons have begun implanting commercial patients with the Axonics r-SNM^® System at Sanford Health facilities (“Sanford”).

Sanford Health, headquartered in Sioux Falls, South Dakota, is one of the largest rural health systems in the United States, with 44 hospitals and 1,400 physicians in 26 states and nine countries. Axonics and Sanford have a formal agreement permitting commercial sale of the Axonics r-SNM System into Sanford facilities. Sanford Health in Sioux Falls was one of the sites for the Axonics ARTISAN-SNM pivotal clinical study.

“I appreciate the commitment Axonics has made to innovate in this space,” said Kevin Benson, M.D., a urogynecologist at Sanford Health who also served as an investigator in the Axonics pivotal clinical study. “I’ve already treated several commercial patients since the FDA approval in early September and I’ve noted excellent and consistent results. This device represents an exciting alternative in sacral neuromodulation.”

The implantable, long-lived, rechargeable, full-body MRI compatible Axonics r-SNM System was recently approved by the U.S. Food & Drug Administration (“FDA”) for patients suffering from overactive bladder, urinary retention and fecal incontinence.

Raymond W. Cohen, CEO of Axonics, commented, “Sanford Health is one of a growing number of regional and national IDNs (integrated hospital delivery networks) and ambulatory surgery centers that have entered into agreements with Axonics since we received the first FDA approval in September. The pace at which we are signing agreements is quickening given the second FDA approval this November for all urinary indications. We are grateful for the opportunity to work with Sanford and could not be more pleased with the response to our product offering from the SNM implanting community.”

About Sanford Health

Sanford Health, one of the largest rural health systems in the United States, is dedicated to the integrated delivery of health care, genomic medicine, senior care and services, global clinics, research and affordable insurance. Headquartered in Sioux Falls, South Dakota, the organization includes 44 hospitals, 1,400 physicians and more than 200 Good Samaritan Society senior care locations in 26 states and nine countries. Nearly $1 billion in gifts from philanthropist Denny Sanford have transformed how Sanford Health improves the human condition. For information, visit sanfordhealth.org.

About Axonics Modulation Technologies, Inc. and Sacral Neuromodulation

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. SNM therapy has been employed to reduce symptoms and restore pelvic floor function for the past two decades. Reimbursement coverage is well established in the U.S. and Europe. The Axonics System is the first rechargeable SNM system approved for sale in the U.S., Canada and Europe, and the first to gain full-body MRI conditional labeling. For more information, visit the Company’s website at www.axonics.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.