Key Step Towards Entering Consumer Healthcare Market
WALTHAM, Mass.--(BUSINESS WIRE)--
NeuroMetrix, Inc. (Nasdaq: NURO) today announced that its wearable
technology for treatment of chronic pain received 510(k) clearance
(K140333) from the U.S. Food and Drug Administration (FDA) for
over-the-counter use.
The Company is in late stage development of a consumer oriented chronic
pain treatment product. The device is based on wearable technology,
presently deployed in the Company's SENSUS® Pain Management
System, that utilizes comfortable, non-invasive electrical stimulation
of sensory nerves to induce safe and effective pain relief. It is
lightweight and can be worn during the day while active, and at night
while sleeping. This 510(k) clearance allows the Company to market the
over-the-counter device through retail distribution channels without a
prescription requirement.
"Patient response to SENSUS, our prescription wearable device for
treatment of chronic pain, has been very positive since it was launched
in early 2013. We believe that there is a substantial consumer market
for an over-the-counter version of this technology," said Shai N.
Gozani, M.D., Ph.D., President and Chief Executive Officer of
NeuroMetrix. "The ability to offer both prescription and
over-the-counter products will give us maximal market exposure and allow
us to reach more people with chronic pain. We anticipate a commercial
launch in 2015."
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.SENSUSRx.com
or http://www.NeuroMetrix.com.
NeuroMetrix, Inc.
Thomas T. Higgins, 781-314-2761
Chief
Financial Officer
neurometrix.ir@neurometrix.com
Source: NeuroMetrix, Inc.
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