Omron Healthcare Will Distribute in Japan
WALTHAM, Mass.--(BUSINESS WIRE)--
NeuroMetrix, Inc. (Nasdaq: NURO), an innovative health care company that
develops wearable medical technology and point-of-care tests to help
patients and physicians manage chronic pain, nerve diseases, and sleep
disorders, today reported the receipt of marketing certification from
Technischer Überwachungs-Verein SÜD Japan Ltd. (TÜV SÜD Japan) for
NC-stat DPNCheck as a Class II Designated Controlled Medical Device as
defined in the technical standards of the Japan Ministry of Health,
Labor, and Welfare.
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 regulatory process was managed by Omron Healthcare Co. Ltd. As the
Company's exclusive distributor for Japan, Omron initiated a DPNCheck
product awareness campaign at the recent Annual Meeting of the Japan
Diabetes Society. TÜV SÜD Japan approval will allow Omron to shift from
market education to direct sales promotion.
Diabetes is a major health issue in Japan affecting over 7 million
people or 7.6% of its adult population. Japan is also a unique market.
It has a combination of physician reimbursement for nerve conduction
testing and an approved pharmacological agent (Epalrestat) for treating
diabetic peripheral neuropathy. As the home market for Omron Healthcare,
Omron has a strong presence through complimentary products and broad,
established distribution.
"Omron skillfully guided DPNCheck through the Japan regulatory process,"
said Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer
of NeuroMetrix. "TÜV SÜD Japan approval allows us to finalize product
labeling and, within the next few weeks, initiate DPNCheck shipments to
Japan. Working closely with Omron over the past year has also helped us
develop a solid partnership foundation which should serve us well in
this and other large Asian markets."
Product information on DPNCheck is available at http://www.dpncheck.com/
About Omron
Omron Healthcare, headquartered in Kyoto, Japan, is a global leader in
health care monitoring. The company offers a wide range of devices and
services that help prevent and manage lifestyle diseases such as blood
pressure monitors, body composition monitors and activity counters as
well as medical devices such as vascular screening devices and visceral
fat monitors in more than 100 countries. For more information on Omron
Healthcare, visit www.healthcare.omron.co.jp/english/.
About NeuroMetrix
NeuroMetrix is an innovative health-care company that develops wearable
medical technology and point-of-care tests that help patients and
physicians better manage chronic pain, nerve diseases, and sleep
disorders. The Company has a major focus 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 device for treating chronic pain, focusing on physicians
managing patients with neuropathic pain such as painful diabetic
neuropathy. The company also markets DPNCheck, which is a rapid,
accurate, and quantitative point-of-care test for peripheral
neuropathies such as diabetic neuropathy. This product is used to detect
neuropathies at an early stage and to guide treatment. For more
information, please visit http://www.NeuroMetrix.com.
NeuroMetrix, Inc.
Thomas T. Higgins, 781-314-2761
Chief
Financial Officer
neurometrix.ir@neurometrix.com
Source: NeuroMetrix
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