Significant Progress for Companies Developing Non-invasive Peripheral Nerve Stimulation Technologies

Electronics have entered every corner of our daily lives, and recent developments in the field of neuromodulation have shown that electronics have yet more to offer to human health and wellbeing. Also known as bioelectronic medicine, neuromodulation is the use of electrical signals to alter nerve activity and has been used for decades for therapeutic effect. Devices such as spinal cord stimulators and deep brain stimulations have been used to help people with conditions such as chronic pain and Parkinson’s disease respectively. 

IDTechEx have been following the field of bioelectronic medicine for the past 2 years and have reported on the opportunities that lie in peripheral nerve stimulation, a market forecasted (pre-COVID 19) to grow at 35% CAGR to the year 2029. For more information on bioelectronic medicine, including the opportunities in peripheral nerve stimulation, please refer to the IDTechEx report, «Bioelectronic Medicine 2019-2029«. 

Bioelectronic medicine is most attractive as a treatment option when it addresses conditions that are not served well by pharmaceutical or surgical interventions. Peripheral nerve stimulation is a relatively untapped area in bioelectronic medicine. The field is highly fragmented – only a couple of small companies compete against each other in over a dozen therapeutic areas. A rising trend in this field is the use of non-invasive devices (vs. implanted), as these allow the patient to avoid surgery, the risk of surgical complications, and future replacement surgeries down the line. 

Two notable companies that have developed non-invasive peripheral nerve stimulation technologies are Cala Health and Neuromod Devices. 

In August 2020, Cala Health published positive results from their PROSPECT trial, a study of 263 patients with essential tremor. By using the Cala Trio, a wrist-worn neuromodulation device, over 92% of patients saw a reduction in their tremors, with over 54% of patients experiencing more than 50% improvement. The non-invasive Cala Trio is a significant development for patients suffering from essential tremor, a condition that affects up to 5% of adults over the age of 60 years. Alternative treatments for patients who cannot be treated by pharmaceuticals include injection with botulinum toxin and surgical implantation of a deep brain stimulator. Implantation of a deep brain stimulator is an invasive procedure requiring extensive follow-up. A non-invasive, wrist-worn option will be life-changing for essential tremor patients. 

In October 2020, Neuromod Devices published positive results from their large-scale, 326-patient study on the use of the Lenire for the treatment of tinnitus. Patients using the Lenire, which provides a combination of sound stimulation to the ear and neuromodulation to the tongue, reported improvements to their symptoms – 81% of patients in the study reported improvements, and 77% could sustain the improvement for 12 months post-treatment. Tinnitus affects up to 10 – 15% of the population, and there is no clinically recommended drug or device to treat this condition. An easy-to-use and non-invasive device such as the Lenire will bring much-needed respite for these patients.