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NeuroMetrix Reports Publication of Study Demonstrating that DPNCheck is Effective at Detecting Diabetic Peripheral Neuropathy at all Stages of Severity

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NeuroMetrix, Inc. (Nasdaq: NURO), today reported publication of results from a DPNCheck(R) 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:

  • DPNCheck sural nerve amplitude and conduction velocity demonstrated high sensitivity and specificity of 0.7 – 0.9 at all stages of neuropathy.
  • 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(R) device for treating chronic pain, focusing on physicians managing patients with neuropathic pain such as painful diabetic neuropathy. The Company also markets DPNCheck(R), 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.

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