15 Oct Axonics® Provides Update on U.S. Launch Activities
Approximately 300 Physicians Registered to Attend Axonics-sponsored Seminars Showcasing Recently FDA-Approved1 Axonics r-SNM® System
First Commercial Implants in the U.S. Planned for the Week of October 28
IRVINE, Calif.–(BUSINESS WIRE)–Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable Sacral Neuromodulation (“SNM”) devices, today provided an update on the status of U.S. launch activities following Food & Drug Administration (“FDA”) approval of the Axonics r-SNM® System for bowel dysfunction in September 2019.
On Saturday, October 12, in Orlando, Fla., Axonics completed the first of four physician seminars scheduled in the United States in October and November. More than 60 experienced SNM implanters attended the one-day seminar in Orlando with an additional 250 physicians registered for the remaining fully booked programs in Dallas, Irvine and Boston. The seminar content included background on Axonics, a detailed overview of the Axonics r-SNM System and its approach to developing the fuss-free system, best SNM implant practices, a review of clinical experience and a panel discussion with physicians experienced in implanting the Axonics device. In addition, attendees were provided hands-on product demonstrations of the system. Additional programs in the fourth quarter are being contemplated based on demand.
Meena Jain, M.D., F.A.C.O.G., of St. Petersburg, Fla., a practicing gynecologist who has been implanting SNM devices for over seven years and is one of the highest volume implanters on the west coast of Florida, said, “I’m excited to get started and to be one of the first physicians to offer the Axonics device in my local area. The seminar I attended this past weekend was very professional and the Company provided information that was fact based. After reviewing the clinical data published in the Journal of Urology and listening to the physician panel in Orlando, I believe Axonics has a very attractive product that addresses the need for improvement over the existing neurostimulator and focuses specifically on a long-lived device that is MRI compatible with easy to use accessories. Moreover, it is equally clear that Axonics is committed to supporting physicians and helping them to expand awareness for SNM therapy.”
“Between in-office and in-hospital visits by our 145-person U.S. sales and clinical field team, wide-ranging clinical and commercial activities at the recent AUGS/IUGA conference and the early and positive response to our physician seminar series, we are well on our way toward accomplishing our objective of establishing broad exposure to the Axonics brand and generating significant interest for our product among top SNM implanters,” said Raymond W. Cohen, Chief Executive Officer. “We are ahead of schedule in terms of complying with post-approval FDA requirements and will soon begin shipping to U.S. customers with the first commercial implants in the U.S. planned for the week of October 28.“
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 world, and the first to gain full-body MRI conditional labeling. For more information, visit the Company’s website at www.axonicsmodulation.com
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.
1The Axonics r-SNM System received FDA approval for the treatment of fecal incontinence on September 6, 2019. Clinical indications for urinary dysfunction are currently under Premarket Approval (PMA) review with the FDA.
Axonics’ ContactAxonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
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Matt Clawson, +1-949-370-8500