Axonics® Submits Full Body MRI Data to U.S. Food & Drug Administration for its Sacral Neuromodulation System

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 submission of complete
test data to the U.S. Food & Drug Administration (“FDA”) for the purpose
of gaining Conditional Full Body Magnetic Resonance Imaging (“MRI”)
labeling approval for the Axonics r-SNM® System1 for urinary
and bowel dysfunction. This data was submitted as an amendment to the
Company’s previously filed premarket approval application (“PMA”).

Raymond W. Cohen, CEO of Axonics, commented, “Without this Full Body
labeling, any patient requiring an MRI scan on any body part below the
head must have their neurostimulator and lead surgically explanted prior
to the MRI scan, resulting in loss of an effective treatment, another
surgery for the patient and additional cost to the patient and
healthcare system. Our robust testing and analyses conclude that Full
Body MRI scans can be safely performed on patients with an implanted
Axonics r-SNM system.”

The Axonics r-SNM System is already approved for head and neck MR scans
in Europe, Canada and Australia. CE Mark approval of Full Body MRI
conditional labeling for the Axonics r-SNM System is currently pending.

Cohen continued, “We met with the FDA in January 2019 and determined it
was advantageous to file an amendment to the current literature-based
PMA. The FDA now has all of our MRI test data for both head and full
body and we believe that, once PMA approved, our r-SNM System will
include conditional labeling for 1.5T MRI scans.”

Axonics has performed all the required tests to support Full Body
conditional labeling on 1.5T MR scanners for the implantable components
of its r-SNM System.

What is MRI Conditional Labeling

MRI is short for Magnetic Resonance Imaging. MR scanners come in
different magnet field strengths measured in Tesla or “T”, usually
between 0.5T and 3.0T. They also come in varying sizes including open
and wide-bore. Simplistically, an MR scanner is a very large, strong
magnet into which a patient lies. A radio wave is used to send signals
to the body of the patient. The returning signals are received and
converted into images by a computer attached to the MR scanner. The
image quality of an MRI depends on signal and field strength. MRI
Conditional Labeling means a product has been tested and demonstrated to
pose no known hazards to the patient in a specified MRI environment with
specified conditions of use and the results of testing are sufficient to
characterize the behavior of the product in the MRI environment. Testing
for devices that may be placed in the MRI environment should address
magnetically induced displacement force and torque, unintended
stimulation, and thermal injury. Other possible safety issues include
but are not limited to, image artifact, device vibration, interaction
among devices, the safe functioning of the device and the safe operation
of the MRI system. Any parameter that affects the safety of the device
should be listed and any condition that is known to produce an unsafe
consequence must be described.

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 a proven therapy to
treat urinary retention and fecal incontinence. Reimbursement for SNM is
well established and available in the United States, Europe, Canada and

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. The Axonics r-SNM System is the first
rechargeable Sacral Neuromodulation system approved for sale in Europe,
Canada and Australia. The r-SNM System offers a temporary disposable
external trial system, a miniaturized and rechargeable long-lived
stimulator that is qualified to function for at least 15 years. Also
included is 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

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
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 an investigational medical


Axonics’ Contact
Axonics Modulation Technologies, Inc.
Dearen, +1-949-396-6320
President & Chief Financial Officer
& Media Contact

Matt Clawson, +1-949-370-8500