NeuroMetrix Completes 510(k) Clearance Process for SENSUS™ Pain Management System
WALTHAM, Mass.--(BUSINESS WIRE)--Nov. 29, 2012--
NeuroMetrix, Inc. (Nasdaq: NURO),
www.neurometrix.com,
a medical device company focused on the diagnosis and treatment of the
neurological complications of diabetes, reported that it has received
510(k) clearance from the
U.S. Food and Drug Administration (
FDA) for
the disposable electrode that is used in conjunction with its SENSUS
device. This regulatory determination by the
FDA gives
NeuroMetrix
clearance to market the SENSUS Pain Management System in the U.S. market.
The SENSUS device is a transcutaneous electrical nerve stimulator
intended for the symptomatic relief and management of chronic
intractable pain in the lower leg and foot. It is a light weight, low
profile device worn on the upper calf and activated by the press of a
single button. It can be placed in seconds and may be worn under
clothing.
“FDA clearance of the SENSUS electrode represents the last step in the
regulatory pathway for the SENSUS Pain Management System,” said Shai N.
Gozani M.D., Ph.D., President and Chief Executive Officer of
NeuroMetrix. “We believe that physicians treating patients with painful
diabetic neuropathy, a severe and debilitating form of chronic pain,
will find SENSUS to be a useful therapeutic option. We intend to
initiate the commercial launch for SENSUS before the end of the year, in
line with the goal that we set over a year ago.”
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 has also begun to market the SENSUS Pain
Management System for treating chronic pain, focusing on physicians
managing patients with painful diabetic neuropathy. 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
