IRVINE, Calif.--(BUSINESS WIRE)--Dec. 4, 2018--
Axonics Modulation Technologies, Inc. (NASDAQ:AXNX), a medical
technology company focused on the design, development and
commercialization of rechargeable implantable Sacral Neuromodulation
(“SNM”) solutions for the treatment of urinary
and bowel dysfunction, today announced that on December 3, 2018, the
Company submitted a premarket approval application (“PMA”) to the U.S.
Food & Drug Administration (“FDA”) for the Axonics r-SNM® System, an
investigational medical device.
This PMA filing submitted by Axonics is referred to as a
“literature-based PMA”. While most PMAs are supported by original
clinical investigations, in rare cases, literature-based evidence may be
accepted as the sole basis for approval of a PMA to establish reasonable
assurance of safety and effectiveness when the literature is sufficient,
detailed, objective, and directly applicable to the subject device. In
this PMA filing, Axonics has submitted existing literature reporting on
InterStim II®, manufactured by Medtronic plc, the only currently
approved SNM device.
In addition to the technical specifications, testing data and published
literature, Axonics included one-year follow-up data from its 51-patient
RELAX-OAB European Post-Market Clinical Follow-up study to support the
PMA. This PMA filing incorporates all elements of the Axonics r-SNM
implantable system as well as the External Trial System and related
accessories.
As is the case with a traditional PMA, the FDA has at least 180 days to
review and decide whether or not to approve the PMA. Axonics anticipates
that the FDA will complete a substantive review by early March 2019.
Once the Company responds to any questions that may arise, the FDA will
then have another 90 days to complete its review and issue a decision
letter. Therefore, the earliest date a final determination is
anticipated is June 2019.
Axonics is currently conducting a 129-patient pivotal clinical study,
ARTISAN-SNM, under a U.S. Food & Drug Administration Investigational
Device Exemption, for urinary dysfunction. On June 27, 2018, Axonics
announced completion of the enrollment and implant phase. Axonics
anticipates that substantially all patients will reach their 6-month
post-implant endpoint on or about January 4, 2019.
Raymond W. Cohen, CEO of Axonics, commented, “This PMA filing gets
Axonics on the review clock with the FDA. We believe the filing is
robust and provides substantive responses to requests for additional
information made by the FDA in May of this year. This filing also
includes 1-year clinical follow up data from our European RELAX-OAB
study. Given the FDA authorized an interim analysis of a partial cohort
of 6-month post-implant safety and effectiveness data from our ongoing
ARTISAN-SNM pivotal study for the same device, we have the option to
submit this data to the FDA as part of this PMA. Moreover, we also
retain the option to submit a traditional PMA in Q1 2019 once our full
ARTISAN-SNM cohort reaches the 6-month primary endpoint. This strategy
of filing both a literature-based PMA and conducting a pivotal clinical
study in parallel provides Axonics with several pathways to ultimately
obtain PMA approval of our r-SNM System.”
Axonics originally filed the literature-based PMA in January 2018, which
underwent a substantive review by the FDA. On May 9, 2018, the FDA
responded and requested that the Company submit additional information.
In October of 2018, the Company withdrew the PMA in order to allow
sufficient time to prepare a thorough response to the questions. The
Company refiled the PMA on December 3, which included all of the
information previously submitted, as well as the additional information
addressing FDA’s questions in its May 9, 2018 correspondence. Axonics
already underwent a pre-PMA audit by the FDA during 2018 which was
completed without findings. Axonics continues to maintain a good working
relationship with the FDA and will work interactively and expeditiously
with the FDA during this process.
About Overactive Bladder and Sacral Neuromodulation
Overactive bladder (OAB) affects an estimated 85 million adults in the
U.S. and Europe. Another approximately 40 million adults are reported to
suffer from fecal incontinence. SNM therapy is well-established
treatment that has been widely used and reimbursed in Europe and the
U.S. for the past two decades.
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 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/20181204005264/en/
Source: Axonics Modulation Technologies, Inc.
Axonics’ Contact
Axonics Modulation Technologies, Inc.
Dan
Dearen, +1-949-396-6320
President & Chief Financial Officer
ir@axonics.com
Investor & Media Contact
W2Opure
Matt Clawson,
+1-949-370-8500
mclawson@w2ogroup.com