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, announced today the publication of a Medtech Innovation Briefing by The National Institute for Health and Care Excellence (“NICE”) following a careful review of the innovations offered by the Axonics System.
The NICE Medtech Innovation Briefing entitled: “Axonics rechargeable sacral neuromodulation system for overactive bladder and faecal incontinence,” describes published clinical evidence on the Axonics r-SNM System®, confirming efficacy as well as the potential positive economic impact that is possible by the use of the Axonics system in the United Kingdom.
The Axonics r-SNM System is the first rechargeable Sacral Neuromodulation system approved for sale in Europe and commercially available to all hospitals and clinics in the U.K. for patients suffering from urinary and fecal dysfunction. It is estimated that approximately 1,200 patients receive a Sacral Neuromodulation implant in the U.K. every year.
Raymond W. Cohen, CEO of Axonics, commented, “NICE is a highly rigorous and respected institution, and we are proud that the Axonics system is recognized as an innovative technology deserving attention from the U.K. physician community. This publication is a testimony to the ingenuity of our engineering, regulatory and quality teams, as well as our focus on providing a solid foundation of clinical evidence.”
The NICE Briefing can be found here: https://www.nice.org.uk/advice/mib164
About The National Institute for Health and Care Excellence (NICE)
NICE
provides guidance and advice to improve health and social care primarily
in England. NICE is accountable to the UK’s Department of Health and
Social Care, however, is operationally independent of government.
Guidance and other recommendations are made by independent committees.
NICE was originally set up in 1999 as the National Institute for
Clinical Excellence, a special health authority, to reduce variation in
the availability and quality of NHS treatments and care. In 2005, after
merging with the Health Development Agency, NICE began developing public
health guidance to help prevent ill health and promote healthier
lifestyles and the name changed to the National Institute for Health and
Clinical Excellence. In April 2013 we were established in primary
legislation as set out in the Health and Social Care Act 2012 and became
a Non-Departmental Public Body (NDPB) taking on responsibility for
developing guidance and quality standards in social care, and our name
changed once more to reflect these new responsibilities.
About Axonics Modulation Technologies, Inc.
Axonics, based
in Irvine, CA, is focused on development and commercialization of novel
implantable Sacral Neuromodulation devices for patients with urinary and
bowel dysfunction. Overactive bladder 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. 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 designed and 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.
