Industry Press Releases

Axonics ® issued extended CE mark; First and only sacral neuromodulation system approved for use with whole-body MRI scans

Monday, Feb 25, 2019

Axonics Modulation Technologies, Inc., a medical device company focused on the development and commercialization of novel implantable sacral neuromodulation ("SNM") devices for the treatment of urinary and neurological disorders  Concentrated intestinal dysfunction , today announced that it has received CE Mark approval for conditional identification of the Axonics r-SNM® system with 1.5T and 3T whole-body magnetic resonance imaging ("MRI").

The Axonics r-SNM system is the only implantable SNM system that has received conditional full-body MRI labeling for sale in Europe 1 .

Raymond W. Cohen, Axonics' Chief Executive Officer, said: "Without this tag, any patient who needs an MRI scan of a part of the body below the head will have their neurostimulator and lead surgically removed before the MRI scan. As a result, effective treatment is not possible, patients will have to undergo another operation and additional costs will be incurred for the patient and the healthcare system. This approval of whole-body MRI scans in Europe is another important milestone for Axonics, as it distinguishes our technology from the competitive system and the foresight of our engineers, as well as our commitment to invest time and capital in patients, To continue to provide clinicians and the healthcare system with the best possible SNM solution. As announced on February 12, Axonics has provided the FDA with complete test data for the acquisition of conditional magnetic resonance imaging in the United States. "

Whole-body MRI marking is an important complement to the many distinguishing features that the Axonics r-SNM product already offers: a miniaturized and long-lasting implantable neurostimulator that is one-third the size of its competitor and with a lifespan of at least 15 Years in the body is suitable. Among other things, the Axonics r-SNM system has a fast and safe charging capability with a rare charging interval and a patient-friendly radio remote control.

"This is a turning point," said Dr. Karen L. Noblett, Chief Medical Officer of Axonics. "Whole-body MRI tagging is critical for patients who need or expect magnetic resonance imaging. This new extended label eliminates a major problem for both groups of patients and will allow more patients to choose SNM to treat their urinary and bowel function without compromising their quality of life. "

What is the conditional marking of MRI
MRI is the abbreviation for magnetic resonance imaging. There are MRI scanners with different magnetic field strengths, which are measured in Tesla or "T" and are usually between 0.5 T and 3.0 T. The scanners are also available in different sizes, including open or generously sized scanners. In simple terms, an MRI scanner is a very large, strong magnet in which a patient lies. A radio wave sends signals to the patient's body. The returned signals are received by a computer connected to the MRI scanner and converted into images. The image quality of an MRI depends on the signal and the field strength. A conditional MRI tag means that a product has been tested and proven to be safe for the patient under certain conditions of use in a given MRI environment, and that the test results are sufficient to assess how the product behaves in the MRI environment. The testing of devices that are allowed to be in an MRI environment should include subjects such as the magnetically induced displacement force and torque, as well as inadvertent stimulation and temperature damage. Other possible safety issues include image artifacts, device vibration, device interaction, safe device operation, and safe operation of the MRI system. Every parameter,

About bladder hyperactivity and sacral neuromodulation
In the US and Europe, an estimated 85 million adults are affected by bladder hyperactivity, which includes urinary incontinence and frequent urination. Bladder hyperactivity is caused by defective bladder and brain signal transmission and significantly affects quality of life. SNM therapy is a proven treatment widely used to relieve symptoms and restore bladder function. It is also used to treat urinary retention and fecal incontinence. The reimbursement of SNM is quite common in the US and is also covered by health insurance in Europe, Canada and Australia.

About Axonics Modulation Technologies Inc.
Axonics, headquartered in Irvine, CA, is focused on the 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 external one-way test system, a miniaturized and rechargeable long-lasting stimulator that is suitable for a functional life of at least 15 years. Also included are a tinned lead and patient-friendly accessories such as a charging system optimized for minimal charging time without overheating, a small, easy-to-use patient remote and an intuitive clinic programmer that facilitates placement and programming of leads. For more information, visit the company website atwww.axonicsmodulation.com .

Forward-looking statements
Statements in this press release that relate to future plans, events, projections or results are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "planned," "expects," "believes," "assumes "," Designed "and similar expressions are intended to identify such forward-looking statements. While these forward-looking statements are based on management's current expectations and beliefs, they are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from those expressed in this news release, including risks and rewards uncertaintieswww.sec.gov are available. Readers are cautioned not to place undue reliance on these forward-looking statements, as they are only valid at this time. Unless required by law, Axonics assumes no obligation to update or revise any forward-looking statements as a result of new information, changed circumstances or unforeseen events.

1 Axonics r-SNM system is approved for sale in Europe, Canada and Australia. It is currently referred to in the US as a medical device in the approval process.

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Contacts
Contact Axonics

Axonics Modulation Technologies, Inc.
Dan Dearen, 1-949-396-6320
President and Chief Financial Officer
ir@axonics.com

Investor and Media
Relations W2Opure
Matt Clawson, 1-949-370-8500
mclawson@w2ogroup.com

 

Source: businesswire.com

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