NeuroMetrix Receives 510(k) Clearance for SENSUS™ Pain Management DeviceWALTHAM, Mass.--(BUSINESS WIRE)--Aug. 6, 2012--
NeuroMetrix, Inc. (Nasdaq: NURO),
www.neurometrix.com,
a medical device company focused on the diagnosis and treatment of the
neurological complications of diabetes, announced that it has received
510(k) clearance for its SENSUS Pain Management device from the
U.S.
Food and Drug Administration (
FDA). This regulatory determination by the
FDA gives
NeuroMetrix clearance to market the SENSUS device in the U.S.
market. The device is intended for use as a transcutaneous electrical
nerve stimulator for the symptomatic relief and management of chronic
intractable pain.
“This product has attracted attention among health care providers
because of its potential benefit to patients suffering from chronic
pain,” said Shai N. Gozani M.D., Ph.D., President and Chief Executive
Officer of NeuroMetrix. “FDA clearance keeps us on track to launch the
SENSUS Pain Management System in the fourth quarter of 2012. We are
particularly enthusiastic about adoption of the device by diabetes
focused clinicians because a number of recent systematic literature
reviews and meta-analyses have concluded that transcutaneous electrical
nerve stimulation may be an effective and safe treatment for painful
diabetic neuropathy.”
About NeuroMetrix
NeuroMetrix is an innovative medical device company that develops and
markets home use and point-of-care devices, associated consumables, and
support software for the treatment and management of diabetes and its
complications. The company is focused on nerve related complications of
diabetes, called diabetic neuropathies, which affect over 50% of people
with diabetes. If left untreated, diabetic neuropathies trigger foot
ulcers that may require amputation, cause disabling chronic pain, and
increase the risk of falling in the elderly. The annual cost of diabetic
neuropathies has been estimated at $14 billion in the United States. The
company’s products are used by physicians and other clinicians, in
retail health settings such as pharmacies, and by managed care
organizations to optimize patient care and reduce healthcare costs. The
company markets the NC-stat® 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. The company is in late stage
development of SENSUS™, a pain management device. The company
has additional therapeutic products in its pipeline. For more
information, please visit http://www.neurometrix.com.
Source: NeuroMetrix, Inc.
NeuroMetrix, Inc.
Thomas T. Higgins, 781-314-2761
SVP and
Chief Financial Officer
neurometrix.ir@neurometrix.com
