MedTech Breakthrough recognizes Promex and Realeve for their exceptional pain management solution in the field of healthcare technology
In a groundbreaking development, Nalu Medical has unveiled a new innovation in micro-neurostimulation technology – a battery-free, miniaturized implantable pulse generator (micro-IPG) that is wirelessly powered and controlled via a smartphone app. This system, known as the Nalu Neurostimulation System, is FDA-cleared for spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS), providing a minimally invasive, drug-free option for chronic peripheral nerve pain and related conditions.
The Nalu Neurostimulation System offers advanced waveforms, extensive programming options, software upgradability, and an 18-year expected service life. This cutting-edge technology is the first externally powered implantable neuromodulation device system for treating central nervous system (CNS) disorders, including strokes and cluster headaches.
Dr. Peter Bonutti, founder and CEO of Realeve, a medical device company focused on developing novel treatments for diseases and conditions of the central nervous system, has praised neurostimulation as a promising avenue for treating conditions linked to nerve dysfunction. He has over 30 years of experience and more than 500 patents.
Realeve, in collaboration with Promex – a leader in microelectronic component assembly, process design, and packaging of medtech and biotech devices – has developed Pulsante, a system that aims to offer greater independence to patients and improve their quality of life by providing a more holistic treatment approach for chronic pain and neurological disorders. In 2025, Promex and Realeve were recognized by MedTech Breakthrough with the Best New Pain Management Technology Solution for Pulsante.
Pulsante has FDA Breakthrough Device designation and has been clinically proven in over 700 patients. In Realeve studies of chronic cluster headaches, 75% of participants reported significant reduction in headache frequency and intensity using the system over a four-week period. Pulsante provides relief for patients suffering from conditions such as chronic migraine and neuropathic pain, and is a drug-free, safe, and effective treatment option used at home.
The RC-200 handheld device powers the implant and has the potential to treat a range of brain-related conditions. Future iterations of Pulsante technology may incorporate AI-based pain tracking and predictive analytics.
Other notable recent advances in related neurostimulation therapies include transcutaneous vagus nerve stimulation (taVNS), repetitive transcranial magnetic stimulation (rTMS), deep brain stimulation (DBS), MySalvia Therapy, and SetPoint Medical’s FDA-approved neuroimmune modulation device for rheumatoid arthritis. These advancements demonstrate that implantable neuromodulation is expanding into autoimmune disorders and various neuromodulation techniques for psychiatric and neurological conditions.
In summary, Nalu Medical's miniaturized, wireless-powered neurostimulation system represents the forefront of micro-neurostimulation technology, targeting CNS disorders and chronic pain, while several companies are concurrently advancing distinct novel neurostimulation modalities and expanding the therapeutic indications. The future of neurostimulation technology looks promising in revolutionizing the treatment landscape for a wide range of neurological disorders and chronic pain conditions.
The digital health landscape is witnessing significant advancements with the advent of Pulsante, a drug-free treatment system for chronic pain and neurological disorders developed by Realeve in collaboration with Promex. This innovation, along with Nalu Medical's micro-neurostimulation system, is revolutionizing the health-and-wellness sector, particularly mental-health and therapies-and-treatments for neurological conditions like strokes and cluster headaches. These developments underscore the potential of science and technology to transform the treatment landscape for various chronic pain and neurological disorders.
