NeuroMetrix, Inc. (Nasdaq: NURO), today reported publication of results
from a DPNCheck® study conducted at the Diabetes Research
Unit of the Ipswich Hospital NHS Trust in the United Kingdom. The study
by Sharma and colleagues titled "Assessment of Diabetic Neuropathy Using
a Point-of-Care Nerve Conduction Device Shows Significant Associations
With the LDIFLARE Method and Clinical Neuropathy Scoring" was
published in the Journal of Diabetes Science and Technology and is
available at:
http://dst.sagepub.com/cgi/reprint/1932296814551044v1.pdf?ijkey=0NfrNfDIEsIlbcr&keytype=ref
DPNCheck is a fast, accurate and quantitative point-of-care test for
diabetic peripheral neuropathy, or DPN. The DPNCheck test addresses an
unmet medical need for better and more cost-effective screening,
diagnosing and monitoring of DPN. This complication affects over 50% of
people with diabetes and leads to foot ulcers and limb amputation, as
well as severe pain and an overall reduction in patient quality of life.
The study by Sharma and colleagues was a single site comparison of
DPNCheck with a standardized clinical definition of DPN (Neuropathy
Disability Score, NDS) and a validated measure of small fiber neuropathy
(Laser Doppler (LDI) Flare). The study enrolled a total of 242 subjects,
which included 162 subjects with diabetes (80 Type 1 and 82 Type 2) and
80 healthy controls. Key reported results include:
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DPNCheck sural nerve amplitude and conduction velocity demonstrated
high sensitivity and specificity of 0.7 – 0.9 at all stages of
neuropathy.
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DPNCheck sural nerve amplitude and conduction velocity were highly
correlated to LDIFLARE measurements of small fiber
neuropathy.
The study authors concluded that DPNCheck "… has good sensitivity and
specificity at the various stages of DPN and correlates well with the LDIFLARE
technique. These findings suggest that the device has considerable
potential for assessing DPN in diabetes clinics.”
"The impressive diagnostic performance of DPNCheck, as reported by
Sharma and colleagues, indicates that it is effective at detecting DPN
at all stages of the disease from mild to advanced neuropathy. There is
no other widely available diagnostic test for DPN with comparable
operating characteristics," said Shai N. Gozani, M.D., Ph.D., President
and Chief Executive Officer of NeuroMetrix. "By using a clinical
definition of DPN and also a comparison to a validated small fiber test,
this study adds to the growing base of evidence supporting the
effectiveness and utility of DPNCheck."
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.DPNCheck.com/
or http://www.NeuroMetrix.com.
Copyright Business Wire 2014