IRVINE, Calif.--(BUSINESS WIRE)--Jan. 2, 2019--
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 interim
clinical data from the ARTISAN-SNM pivotal clinical study to the U.S.
Food & Drug Administration (“FDA”).
The ARTISAN-SNM study is a 129-patient single-arm, prospective,
multi-center, unblinded pivotal clinical study, approved under an FDA
Investigational Device Exemption (“IDE”) to evaluate the safety and
efficacy of the Axonics r-SNM® System1 for urinary
dysfunction.
This interim clinical data was submitted as a supplement to the
Company’s previously filed “literature-based” premarket approval
application (“PMA”). The interim analysis was conducted in accordance
with a revised statistical analysis plan using an Intent to Treat
(“ITT”) analysis of a partial cohort of all implanted subjects that have
reached their six-month post-implant time point. The clinical study
report, filed with FDA, provides safety and efficacy results from an
early-look analysis in 60 implanted subjects, including 59 patients that
have reached the six-month primary endpoint and one explanted patient.
Enrollment for the ARTISAN-SNM study was completed in June 2018 and all
patients have now reached their six-month, post-implant primary endpoint.
Raymond W. Cohen, CEO of Axonics, commented, “On December 7, 2018, the
FDA authorized an interim analysis of a partial ITT cohort from our
ARTISAN-SNM pivotal study. Given that, we determined it was advantageous
to enrich our current literature-based PMA currently under review by the
FDA. We are in the process of analyzing the full ARTISAN-SNM cohort of
patients and maintain the option to submit a traditional PMA in Q1 2019.
Our strategy is intended to obtain PMA approval of our r-SNM System
through the most expeditious route.”
Axonics filed the literature-based PMA on December 3, 2018. 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
management responds to any questions that may arise, the FDA will then
have another 90 days to complete its review and issue a decision letter.
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 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.
1 The Axonics r-SNM® System is an investigational medical
device
View source version on businesswire.com: https://www.businesswire.com/news/home/20190102005023/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
