Close collaboration with Omron Healthcare in preparation of the Filing
WALTHAM, Mass.--(BUSINESS WIRE)--
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on
the treatment and management of the neurological complications of
diabetes, reported the regulatory submission for NC-stat DPNCheck® in
Japan. NC-stat DPNCheck is a rapid, accurate and quantitative
point-of-care test to detect diabetic peripheral neuropathy, or DPN, at
an early stage allowing physicians to select appropriate treatment. DPN
is the most common complication of diabetes, affecting over half of
people with diabetes. DPN causes significant morbidity including pain,
increased risk of falling in the elderly, and is the primary trigger for
diabetic foot ulcers which may require lower extremity amputations.
The submission was prepared in close collaboration with Omron Healthcare
Co., Ltd, NeuroMetrix' partner for NC-stat DPNCheck in Japan and other
Asia markets. The submission seeks marketing certification for a Class
II Designated Controlled Medical Device as defined in the technical
standards of the Japan Ministry of Health, Labor, and Welfare. Clearance
of the submission will allow NC-stat DPNCheck to be marketed within
Japan.
About NeuroMetrix
NeuroMetrix is a medical device company that develops and markets home
use and point-of-care devices for the treatment and management of
chronic pain, peripheral neuropathies, and associated neurological
disorders. The Company is presently focused on diabetic neuropathies,
which affect over 50% of people with diabetes. If left untreated,
diabetic neuropathies trigger foot ulcers that may require amputation
and cause disabling chronic pain. The annual cost of diabetic
neuropathies has been estimated at $14 billion in the United States. The
company markets the SENSUS™ Pain Management System for
treating chronic pain, focusing on physicians managing patients with
painful diabetic neuropathy. The company also markets the DPNCheck®
device, which is a rapid, accurate, and quantitative point-of-care test
for diabetic neuropathy. This product is used to detect diabetic
neuropathy at an early stage and to guide treatment. For more
information, please visit http://www.DPNCheck.com.
NeuroMetrix, Inc.
Thomas T. Higgins, 781-314-2761
SVP and
Chief Financial Officer
neurometrix.ir@neurometrix.com
Source: NeuroMetrix, Inc.
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