IRVINE, Calif.--(BUSINESS WIRE)--Nov. 7, 2018--
Axonics Modulation Technologies, Inc., (NASDAQ: AXNX), developer of the
first rechargeable Sacral
Neuromodulation (r-SNM™) system for the treatment of urinary
and bowel dysfunction, announced today that it has received Health
Canada approval (Homologation d'un instrument medical) to market its
External Trial System.
Axonics previously received Health Canada approval for its miniaturized
rechargeable implantable neurostimulator, tined lead, patient and
clinician programmers, charger and related accessories.
The External Trial System is an additional element of the Axonics r-SNM
system used to help identify responders to Sacral Neuromodulation
therapy prior to a permanent implant. It is composed of a temporary,
single-use disposable external stimulator that is connected to either a
Tined Lead or a temporary Peripheral Nerve Evaluation (PNE) Lead,
depending on the preferred trial method.
Raymond W. Cohen, Chief Executive Officer, said, “This approval comes at
the right time, as we begin commercial activities in Canada. Whilst the
Canadian SNM market has been limited historically, we believe that our
small rechargeable neurostimulator, which features an expected in-body
life of 15 years or more, will potentially spur market growth by
bringing tangible benefits to patients and significant cost savings to
the national health care system by eliminating the need to replace our
competitor’s non-rechargeable device every three to five years.”
Axonics is currently conducting a 129-patient pivotal clinical study for
urinary incontinence patients under a U.S. FDA Investigational Device
Exemption. The enrollment and implant phase was completed in late June
2018. The Company anticipates filing a pre-market approval (PMA)
application for FDA approval in the United States after the six-month
post-implant endpoint has been reached.
On November 2, 2018, Axonics completed an IPO raising $120 million in
gross proceeds from the offering. Common stock is now trading on The
Nasdaq Global Select Market under the ticker symbol “AXNX”.
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 an effective and durable
treatment that has been widely used and reimbursed in Europe and the
U.S. for the past two decades. It is estimated that well over 300,000
patients have benefited from the therapy to date. SNM is the only OAB
treatment with proven clinical superiority to standard medical therapy
and OAB patients who receive SNM report significantly higher quality of
life than patients undergoing drug treatment.
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 and disrupting the SNM market that is
currently dominated by one large provider. The Axonics r-SNM system
offers a temporary disposable external trial system, a minituarized and
rechargeable long-lived stimulator that is qualified to function for at
least 15 years and 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/20181107005238/en/
Source: Axonics Modulation Technologies, Inc.
Company Contact
Axonics Modulation Technologies, Inc.
Dan
Dearen, +1 949-396-6320
President & Chief Financial Officer
ir@axonics.com
or
Investor
& Media Contact
W2Opure
Matt Clawson, +1 949-370-8500
mclawson@W2Ogroup.com