Yesterday we reported news of NeuroMetrix, a Waltham, MA company, receiving FDA clearance for its SENSUS transcutaneous electrical nerve stimulator for diabetic pain management. We had a chance to speak with CEO and Director of Neurometrix, Shai Gozani, about the developments at the company and what are its goals for the future.
Shiv Gaglani, Medgadget: Can you describe the existing NeuroMetrix products (e.g. NC-stat and Sensus) & your pipeline? Are there any new problems you are looking to tackle?
Shai N. Gozani, M.D., Ph.D.: Thanks, Shiv. Let me first provide some background to the company and our products.
NeuroMetrix was founded in 1996 and has had FDA approved products on the market since 1999. Until recently, these products primarily consisted of medical devices used to perform nerve conduction tests at the point of care. Point of care nerve testing is a market that we created and one in which we had very good success until unfavorable changes in the reimbursement environment began to emerge around 2006.
After several years of working to address these market conditions, we changed the NeuroMetrix focus in mid-2010 from general purpose devices for nerve conduction tests (i.e. the ADVANCE System) to devices designed to specifically address diabetic peripheral neuropathy or DPN. This made strategic sense because the opportunity in the narrowly defined area of DPN was very large and attractive, we had extensive experience in this area, and the market for our general purpose products was contracting.
Nerve disease is the most common complication of diabetes and effects over 50% of people with diabetes. It can lead to problems with balance resulting in falls, and can lead to foot ulcers which can lead to amputation. These complications can be very costly to manage and adversely affect the quality of life of patients. The tools that are generally available to physicians to assess diabetes-related nerve disease are not sophisticated, rely on judgment for interpretation and do not provide quantitative information. They are only effective in detecting late stage disease when the foot has lost its protective sensation.
In late 2011, we launched our first diabetes product, NC-stat DPNCheck which is a rapid, accurate, quantitative device for assessing diabetic neuropathy at the point of care. This hand held device is used to detect diabetic neuropathy at an early stage and to guide treatment. Since launch we have seen encouraging market reception in endocrinology and podiatry (our launch market) and increasingly in managed care and in retail health
Beyond NC-stat DPNCheck, we have an active R&D pipeline and are planning our next product launch for later this year. The product is named SENSUS™. It is a pain management device designed to provide non-pharmacological relief to chronic pain in the lower legs and feet. In fact, about 10-20% of people with diabetes have pain. SENSUS is an easy to use, wearable device that provides on-demand pain relief at the push of a button. It also tracks patient usage which is important to the physician’s assessment of effectiveness. We recently received 510(k) clearance from the FDA for SENSUS we hope to launch it in the fourth quarter of this year.
As you may be aware, diabetic peripheral neuropathy is often accompanied by severe foot pain.
Medgadget: The “5 million nerves tested” description on your site is great. About how many clinicians/patients have benefited from your products?
Over the past decade our products have been used to perform nerve conduction tests on nearly two million patients with over five million tests performed. These have ranged from tests directed at low back pain, carpal tunnel syndrome, cubital tunnel, diabetic peripheral neuropathy and other nerve disorders. The technology is well established. Our long history and experience has positioned us well to address diagnostic and therapeutic challenges in DPN.
Medgadget: What differentiated your products from those of competitors?
The most common tool used today in assessing diabetes-related nerve disease is the monofilament, a simple piece of plastic line which is pushed against the bottom of the foot in multiple locations to determine whether the patient has feeling. The results are qualitative rather than quantitative, the examination relies on technique, and the test is only effective at determining late-stage neuropathy, after the foot has lost protective sensation. At this point nerve deterioration has usually advanced to the point where defensive foot care is the only available option. By contrast, the NeuroMetrix NC-stat DPNCheck provides immediate, quantitative data that allows early identification on neuropathy.
In terms of pain management, SENSUS offers an on-demand medical device alternative to pharmacological products. It is non-addictive, dosing is easily regulated, and it avoids side effects often associated with drugs. Further, the device has the capability to track patient usage for review and evaluation by his physician.
Medgadget: Are you excited by any particular trends in healthcare and med tech?
We are encouraged by the trend in Medicare away from fee for service and increasingly toward the funding of capitated managed care plans. Under these plans the risk of rising patient health care costs is shifted to the private sector in exchange for an annual premium payment. These plans, in turn, place a high value on early identification of disease complications such as diabetic peripheral neuropathy which allows for early intervention to avoid the expensive treatment costs of foot ulcers and amputation in the future. NC-stat DPNCheck is an attractive tool in this emerging healthcare model.
Medgadget: What is your background in medical technology? Is NeuroMetrix the first med tech company you’ve worked on?
Here is a brief biography:
Dr. Gozani founded NeuroMetrix in 1996 and currently serves as Chairman of the board of directors and as President and Chief Executive Officer. Prior to forming the company, Dr. Gozani completed a neurophysiology research fellowship in the laboratory of Dr. Gerald Fischbach at Harvard Medical School. Dr. Gozani holds a B.A. degree in Computer Science, an M.S. degree in Biomedical Engineering and a Ph.D. in Neurobiology, from the University of California, Berkeley. He also received an M.D. from Harvard Medical School and the Harvard-MIT Division of Health Sciences and Technology at M.I.T.
Flashbacks: NeuroMetrix Sensus Diabetic Pain Management System; The NC-stat System for Non-Invasive Nerve Conduction Testing