Neuromodulation Vendors Target Diabetes Pain

by Jeremy Koff, senior consulting editor

June 2024 issue

To date, the worldwide neuromodulation market has been largely driven by sales of spinal cord stimulation systems to treat various forms of chronic pain. One of the newest pain indications to be approved for neuromodulation therapies is pain related to diabetes.

The recent meeting of the American Diabetes Association, which concluded its 84th Scientific Sessions, featured three notable exhibitors with approved products for the treatment of painful diabetic neuropathy: Abbott, Medtronic, and Nevro, alongside two insightful poster sessions.

Diabetic neuropathy is a type of nerve damage that is common with individuals suffering from diabetes. It primarily affects the legs and feet, leading to pain, numbness, loss of sensation, falls and sometimes serious complications such as ulcers and amputations. The incidence of diabetic neuropathy increases with the duration of diabetes, affecting up to 50% of individuals with diabetes after 10 years (Type II). Key risk factors include poor blood sugar control, high blood pressure, high cholesterol levels, and obesity. This condition not only impacts physical health but also significantly affects mental well-being and quality of life. Typically, only about one-third of patients achieve clinically significant pain relief with conventional therapies. As a result, neuromodulation interventions are increasingly being used as treatment modalities for PDN.

The first poster session, titled “Global Multicenter Registry of Prospectively-Enrolled Patients Utilizing SCS for Chronic Pain—Long-Term Outcomes from a Subcohort Diagnosed with Painful Diabetic Peripheral Neuropathy,” provided evidence supporting the use of SCS for PDN. The study assessed real-world outcomes from a global registry, revealing that patients experienced significant pain relief and improved quality of life. The results demonstrated high responder rates and minimal infection risks associated with the implant procedure.

The second session, “SCS for Painful DPN—Consistent Outcomes from Multiple RCTs and Real-World Data,” highlighted the effectiveness of SCS based on randomized controlled trials and real-world patient data. The findings showed that SCS significantly improved pain-related symptoms and functional outcomes in PDN patients, reinforcing its value as a treatment option.

The history of spinal cord stimulation for treating diabetic neuropathy dates back to at least 1996. One of the earliest references in the literature is the study by Kumar, Toth, and Nath, titled “Spinal cord stimulation for chronic pain in peripheral neuropathy,” published in Surgical Neurology. This pioneering work laid the groundwork for future advancements in neuromodulation therapies for diabetic neuropathy. To date, there are more than 60 publications in peer-reviewed journals on the use of neuromodulation to treat diabetic neuropathy.

In recent years, several companies have received FDA approval for their SCS systems to treat PDN. Nevro’s Senza SCS system, approved in July 2021, uses high-frequency stimulation to manage pain without causing the traditional tingling sensation. Abbott’s Proclaim XR was approved in January 2023, offering relief to PDN patients and featuring remote care capabilities through the NeuroSphere Virtual Clinic. Boston Scientific’s WaveWriter Alpha received an expanded indication for PDN treatment in October 2023, providing customizable therapy options. Medtronic’s Intellis and Vanta were approved in January 2022, targeting the significant patient population with unresolved PDN symptoms. Neuralace Medical’s Axon Therapy, a non-invasive magnetic peripheral nerve stimulation device, received FDA clearance in January 2024, marking a breakthrough in non-invasive treatment options for diabetic neuropathy pain.

Emerging companies, such as Sensars, are developing new approaches to treating PDN. In the case of Sensars, a clinical-stage company out of Switzerland, their PNS device uses an intra-nerve electrode array which is implanted in the peripheral nerve designed to restore sensory loss (which may improve balance and decrease foot ulcers) and provide greater coverage for pain reduction in the foot compared to conventional systems.

Sensars recently announced a pre-seed investment from HTH, a prominent VC investor dedicated to improving human health. The company also unveiled its latest Eurostars project, supported by a €500,000 grant. The project, titled SENSOLE, aims to develop the world’s first system capable of monitoring and treating gait disabilities and pain in patients afflicted with leg neuropathy-induced sensory loss. SENSOLE comprises wearable sensors, providing comprehensive data on leg movement and pressure points across various areas of the foot. When combined with a neurostimulator, SENSOLE works to mitigate neuropathy complications by restoring real-time sensory feedback. Leveraging AI-driven software, SENSOLE offers personalized treatment guidance based on individual patient data.

“We are thrilled to receive these investments and grants, which underscore the confidence in our innovative technologies and the potential impact they can have on patients’ lives,” said Francesco Petrini, CEO of Sensars. “With these resources, we are well positioned to accelerate our research and development efforts, bringing us closer to our goal of transforming the landscape of neuromodulation and offering hope to millions of individuals suffering from chronic pain and sensory loss.”

The advancements and FDA approvals in neuromodulation therapies offer new hope for patients with painful diabetic neuropathy. The ongoing research and development in this field continue to demonstrate the efficacy and safety of these treatments, providing significant improvements in pain management and quality of life for those affected by this debilitating condition. As neuromodulation technologies evolve, they promise to play an increasingly crucial role in managing diabetic neuropathy and other chronic pain conditions.