IRVINE, Calif.–(BUSINESS WIRE)–Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical
technology company focused on the development and commercialization of
novel implantable sacral neuromodulation (“SNM”) devices for the
treatment of urinary
and bowel dysfunction, today announced the U.S. Food & Drug
Administration (“FDA”) approved the use of full-body magnetic resonance
imaging (“MRI”) using 1.5 Tesla MRI scanners for clinical study patients
implanted with the Axonics System.
The approval was a result of a supplement filed by Axonics with the FDA
under the Investigational Device Exemption (“IDE”) regarding the
Company’s ARTISAN-SNM 129-patient pivotal clinical study. The FDA
concluded that Axonics provided sufficient data to support full-body
Raymond W. Cohen, CEO of Axonics, commented, “Allowing full-body MRI
scans for our clinical study patients means that none will have to
undergo an explant of their neurostimulator device should they require
an MRI. We view this as a very positive step by the FDA that underscores
the quality of data that Axonics has submitted to the agency. Given this
approval, we are confident that this capability will be included as part
of the Axonics SNM System premarket approval (“PMA”) approval, which is
anticipated in the second half of 2019.”
The Axonics System1 is the first rechargeable SNM system
approved for sale in Europe, Canada and Australia and is currently under
PMA review by the FDA. Axonics offers a long-lived miniaturized
neurostimulator that is approximately the size of a USB stick and is
qualified to last at least 15 years in the body, as compared to the only
competitive device on the market from Medtronic, which requires
replacement every 3 to 5 years. The Axonics System also features many
other differentiating attributes, including a patented tined lead, a
wireless charging system optimized for infrequent charging, a key fob
size easy-to-use patient remote control and an intuitive clinician
programmer that facilitates lead placement and stimulation programming.
About Overactive Bladder and Sacral Neuromodulation
Overactive bladder (OAB) includes urinary urge incontinence and urinary
frequency and affects an estimated 85 million adults in the U.S. and
Europe. OAB is caused by a miscommunication between the bladder and the
brain and significantly impacts quality of life. SNM therapy is a
well-established treatment that has been widely employed to reduce
symptoms and restore bladder function and is also employed to treat
urinary retention and fecal incontinence. Reimbursement for SNM is well
established in the United States and is a covered service in Europe,
Canada and Australia.
About Axonics Modulation Technologies, Inc.
Axonics, based in Irvine, CA, is focused on the development and
commercialization of a novel implantable SNM system for patients with
urinary and bowel dysfunction. The Axonics System is the first
rechargeable sacral neuromodulation system approved for sale in Europe,
Canada and Australia and the first SNM system to gain full-body MRI
conditional labeling in Europe. 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.
1 The Axonics r-SNM System is currently under PMA review and
is designated as an investigational medical device
Axonics Modulation Technologies, Inc.
President & Chief Financial Officer
Investor & Media Contact
Zack Kubow +