NeuroMetrix Announces Sleep Indication for SENSUS™ Pain Management System

  NeuroMetrix Announces Sleep Indication for SENSUS™ Pain Management System

             Key Step Towards Positioning SENSUS for Sleep Market

Business Wire

WALTHAM, Mass. -- July 8, 2013

NeuroMetrix, Inc. (NURO), a medical device company focused on the treatment of
the neurological complications of diabetes, reported that the SENSUS Pain
Management System became the first transcutaneous electrical nerve stimulator
to receive 510(k) clearance (K130919) from the U.S. Food and Drug
Administration (FDA) for use during sleep.

SENSUS is a convenient and wearable non-invasive device that offers physicians
and their patients a non-narcotic pain relief option as a complement to
medications. The device is lightweight and can be worn during the day while
remaining active. It is the only transcutaneous electrical nerve stimulator
designed specifically for people with diabetes and chronic pain. The most
common cause of such pain in people with diabetes is painful diabetic
neuropathy (PDN), which affects up to 5 million people in the US alone. About
half of patients with PDN suffer from sleep disturbances, which can aggravate
their diabetes. With this expanded regulatory indication, the device may now
be marketed for overnight use.

Under its draft guidance on transcutaneous electrical nerve stimulators for
pain relief, the FDA requires that these devices carry a warning against use
during sleep, primarily because of electrical hazards following dislodgement
of electrodes. SENSUS utilizes a proprietary electrode peeling detection
algorithm to address this risk.

“SENSUS is the first and only transcutaneous electrical nerve stimulator that
specifically includes use during sleep within its 510(k) indications,” said
Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer of
NeuroMetrix. “We believe that growing recognition of the inter-relationship
between chronic pain, such as painful diabetic neuropathy, and sleep
disturbances is clinically important and represents a unique market position
for SENSUS. We will build on this expanded indication by launching a series of
novel sleep enabling features for SENSUS over the next 12 months.”

About NeuroMetrix

NeuroMetrix is a medical device company that develops and markets home use and
point-of-care devices for the treatment of 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 and similar peripheral neuropathies. The
company also 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. For more information, please visit http://www.neurometrix.com.

Contact:

NeuroMetrix, Inc.
Thomas T. Higgins, 781-314-2761
SVP and Chief Financial Officer
neurometrix.ir@neurometrix.com
 
Press spacebar to pause and continue. Press esc to stop.