NeuroMetrix develops and commercializes health care products that utilize non-invasive neurostimulation and digital medicine. Our core expertise in biomedical engineering has been refined over two decades of designing, building and marketing medical devices that stimulate nerves and analyze nerve response for diagnostic and therapeutic purposes. We created the market for point-of-care nerve testing and were first to market with sophisticated wearable technology for symptomatic relief of chronic pain. Our business is fully integrated with in-house capabilities spanning research and development, manufacturing, regulatory affairs and compliance, sales and marketing, product fulfillment and customer support. We derive revenues from the sale of proprietary medical devices and after-market consumable products and accessories. Our products are sold in the United States and select overseas markets. They are cleared by the U.S. Food and Drug Administration (FDA) and regulators in foreign jurisdictions where appropriate. We have two principal product lines:

• Point-of-care diagnostic tests for peripheral neuropathies
• Wearable neurostimulation devices for chronic pain

Peripheral Neuropathy
Peripheral neuropathy refers to the conditions that involve damage to the peripheral nervous system, the communication network that sends signals between the central nervous system (the brain and spinal cord) and all other parts of the body. Peripheral nerves deliver sensory information to the central nervous system (CNS) and carry motor signals from the CNS to the rest of the body, including signals that control movement. In addition, there are signals that help control everything from heart and blood vessels, digestion, urination, sexual function, to the bones and immune system.

Symptoms of peripheral neuropathy can range from mild to disabling. The symptoms depend on the type of nerve fibers affected and the type and severity of damage. Neuropathic pain and other systems may develop over days, weeks, or years. In some cases, the symptoms improve on their own and may not require advanced care. Damage to motor nerves is most commonly associated with muscle weakness. Damage to sensory nerve causes a wide range of symptoms, including inability to feel vibrations and touch, especially in the hands and feet, and inability to feel pain or changes in temperature. Neuropathic pain is sometimes worse at night, disrupting sleep.

More than 20 million people in the United States are estimated to have some form of peripheral neuropathy, but this figure may be significantly higher—not all people with symptoms of neuropathy are tested for the disease and tests currently don’t look for all forms of neuropathy. Neuropathy is often misdiagnosed due to its complex array of symptoms. About three-fourths of polyneuropathies are “length-dependent,” meaning the farthest nerve endings in the feet are where symptoms develop first or are worse. In severe cases, such neuropathies can spread upwards toward the central parts of the body. In non-length dependent polyneuropathies, the symptoms can start more toward the torso, or are patchy.

There are multiple causes of acquired peripheral neuropathy. These include physical injury (trauma) which is the most common cause of nerve injury. Diabetes is another significant cause. About 60 - 70 percent of people with diabetes have mild to severe forms of nerve damage. Other causes include vascular problems, systemic (body-wide) or targeted autoimmune diseases, hormonal imbalances, kidney and liver disorders, nutritional imbalances, alcoholism, certain cancers, chemotherapy drugs, and infections (i.e. shingles, West Nile virus, Lyme disease, HIV).

Diabetes
Diabetes is a worldwide epidemic with an estimated affected population of over 400 million people. Within the United States, there are over 30 million people with diabetes and another 80 million people with pre-diabetes. The annual direct cost of treating diabetes in the United States exceeds $100 billion. Although there are dangerous acute manifestations of diabetes, the primary burden of the disease is in its long-term complications, which include cardiovascular disease, nerve disease and resulting conditions such as foot ulcers which may require amputation, eye disease leading to blindness, and kidney failure.

The most common long-term complication of diabetes is neuropathy. Diabetic peripheral neuropathy (DPN) is the primary trigger for diabetic foot ulcers which may progress to the point of requiring amputation. People with diabetes have a 15-25% lifetime risk of foot ulcers and approximately 15% of foot ulcers lead to amputation. Foot ulcers are the most expensive complication of diabetes with a typical cost of $5,000 to $50,000 per episode. In addition, between 16% and 26% of people with diabetes suffer from chronic pain in the feet and lower legs.

Early detection of DPN is important because there are no treatment options once the nerves have degenerated. Today’s diagnostic methods for DPN range from a simple monofilament test for lack of sensory perception in the feet to a nerve conduction study performed by a specialist. Our DPNCheck® technology provides a rapid, low cost, quantitative test for peripheral nerve disease, including DPN. It addresses an important medical need and is particularly effective in screening large populations. DPNCheck has been validated in numerous clinical studies.

Chronic Pain
Chronic pain is a significant public health problem. It is defined by the National Institutes of Health (NIH) as pain lasting more than 12 weeks. This contrasts with acute pain which is a normal bodily response to injury or trauma. Chronic pain conditions include low back pain, arthritis, fibromyalgia, neuropathic pain, cancer pain and many others. Chronic pain may be triggered by an injury or there may be an ongoing cause such as disease or illness. There may also be no clear cause. Pain signals continue to be transmitted in the nervous system over extended periods of time often leading to other health problems. These can include fatigue, sleep disturbance, decreased appetite, and mood changes which cause difficulty in carrying out important activities and can contribute to disability and despair. In general, chronic pain cannot be cured. Treatment of chronic pain is focused on reducing pain and improving function. The goal is effective pain management.

Chronic pain affects over 100 million adults in the United States and more than 1.5 billion people worldwide. The estimated incremental impact of chronic pain on health care costs in the United States is over $250 billion per year and lost productivity is estimated to exceed $300 billion per year. The most common approach to chronic pain management is pain medication. This includes over-the-counter (OTC) internal and external analgesics as well as prescription pain medications, both non-opioid and opioid. The approach to treatment is individualized, drug combinations may be employed, and the results are often inadequate. Side effects, including the potential for addiction, are substantial. Increasingly, restrictions are being imposed on access to prescription opioids. Reflecting the complexity of chronic pain and the difficulty in treating it, we believe that inadequate relief leads 25% to 50% of pain sufferers to seek alternatives to prescription pain medications. These alternatives include nutraceuticals, acupuncture, chiropractic care, non-prescription analgesics, electrical stimulators, braces, sleeves, pads and other items. In total these pain relief products and services account for approximately $20 billion in annual out-of-pocket spending in the United States.

Nerve stimulation is a long-established category of treatment for chronic pain. This treatment approach is available through implantable spinal cord stimulation requiring surgery with its attendant risks. Non-invasive approaches involving transcutaneous electrical nerve stimulation (TENS) have achieved limited efficacy in practice due to device limitations, ineffective dosing and low patient adherence. Our app-enabled Quell® wearable technology for chronic pain is designed to address many of the limitations of traditional TENS.

Marketed Products:

DPNCheck^®
DPNCheck is a fast, accurate, and quantitative nerve conduction test that is used to evaluate peripheral neuropathies such as DPN. It is designed to be used by primary care physicians, endocrinologists, podiatrists and other clinicians at the point-of-care to objectively detect, stage, and monitor peripheral neuropathies. The device measures nerve conduction velocity and response amplitude of the sural nerve, a nerve in the lower leg and ankle. These parameters are widely recognized as sensitive and specific biomarkers of peripheral neuropathy. DPNCheck is comprised of: (1) an electronic hand-held device and (2) a single patient-use biosensor. In addition, we provide users with PC-based software that links to the device via a USB connection thereby allowing physicians to generate reports and manage their test data.

DPNCheck is a modified version of our previously marketed NC-stat nerve testing device that has the same clinical indications with respect to peripheral neuropathy. The modified device costs less than the original device but has the same functionality with respect to sural nerve testing. More than 3 million patient studies have been performed using our technology. Our technology has been the subject of over 20 peer-reviewed studies, including several studies specifically addressing the accuracy and clinical utility of the device in assessment of DPN. Cumulatively through 2019 approximately 5,500 DPNCheck devices have been shipped to customers.

Advance^®
The ADVANCE System is a comprehensive platform for the performance of traditional nerve conduction studies. The ADVANCE System is comprised of: (1) the ADVANCE device and related modules, (2) pre-configured electrodes, and (3) a communication hub that enables a physician’s office to network the device to their office computers and to our servers for data archiving, report generation, and other services. The ADVANCE System is used with proprietary nerve specific electrode arrays. These electrode arrays combine multiple individual electrodes and embedded microelectronic components into a single patient-use disposable unit.

The ADVANCE System was historically marketed to a broad range of physician specialties including neurologists, orthopedic surgeons, primary care physicians, and endocrinologists, and utilized for a variety of different clinical indications including assessment of carpal tunnel syndrome, or CTS, low back and leg pain, and DPN. Currently the Company supports the technology with sales of electrode arrays. The device itself is not actively marketed. As of December 31, 2019, we had an installed base of approximately 200 active customers for the ADVANCE System.

Quell^®
Quell incorporates a collection of proprietary approaches designed to optimize the effectiveness of nerve stimulation. These include high power electrical stimulation hardware with precise control, algorithms that automatically determine therapeutic stimulation intensity and compensate for nerve desensitization, and automated detection of user sleep and appropriate adjustment of stimulation level.

Quell is comprised of (1) an electronic device that is placed in a neoprene band worn on the upper calf, (2) an electrode that attaches to the device and is the interface between the device and the skin, and (3) a smartphone app to control the device and visualize, understand and optimize data. The app is integrated with the Quell Health Cloud for storage of user data, data analytics and scientific research. The device is lightweight and can be worn during the day while active, and at night while sleeping. It has been authorized by the FDA to help reduce the symptoms of fibromyalgia in adult patients with high pain sensitivity.

Research and Development
The Company has unique R&D capabilities with extensive experience in neurophysiology, biomedical instrumentation, signal processing, biomedical sensors, and information systems.