September 20, 2004
- Waltham, MA
NeuroMetrix, Inc. (NASDAQ:NURO), a medical device company focused on the design, development and sale of proprietary products used to diagnose neuropathies, today noted an important advance in the management of diabetic peripheral neuropathy.
The American Diabetes Association estimates that more than 18 million Americans have diabetes. Over half of these individuals are believed to have diabetic peripheral neuropathy (DPN) or nerve damage. However, as many as three-quarters of people with DPN are unaware of the nerve degeneration until they begin to experience the distressing symptoms, which include pain, unusual sensations and numbness. The recent FDA priority approval of Cymbalta® (duloxetine HCl), which is directed towards the management of pain caused by diabetic nerve damage, underscores a direct connection between the diagnosis and treatment of patients with DPN.
Nerve conduction studies (NCS) are considered to be the most accurate and objective way to diagnose and stage DPN. The NEUROMetrix NC-stat System allows all physicians to perform nerve conduction studies in their practice. Prior to this technology, patients were typically assessed by a highly subjective clinical examination and occasionally required a referral to a specialist for further diagnosis. This indirect patient care model could lead to late diagnosis, patient inconvenience and significant costs to the healthcare system. The NC-stat System addresses these issues and allows all physicians to advance their practice on a clinical, patient care and practice building level. The NC-stat System is present in over 1,900 physician practices, allowing thousands of physicians to rapidly and accurately diagnose the presence and severity of DPN.
“We are excited by this important advance for treating the patients who have pain caused by DPN and the opportunity it represents for increased use of the NC-stat System by physicians,” said Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix. He continued, “We are particularly proud of the role of the NC-stat System in the clinical trials which lead to FDA approval. The NC-stat System was used to demonstrate that duloxetine (Cymbalta) did not damage peripheral nerves, thus demonstrating that its mode of action was both safe and efficacious. These findings were noted in a joint publication between Lilly Research Laboratories and NeuroMetrix presented at the 2004 American Diabetes Association Meeting this past June. The approval of this drug now delivers even greater therapeutic options for our physician customers and their patients.”