MedTech Breakthrough commends Promex and Realeve for their innovative approach in pain management solutions
In the ever-evolving world of neurostimulation, a groundbreaking device has emerged as a beacon of hope for patients suffering from various central nervous system (CNS) disorders. This device, known as Pulsante, developed by Realeve, is making waves in the medical community for its innovative approach to treating conditions like chronic migraine, neuropathic pain, and even sleep disorders.
Pulsante is a minimally invasive, battery-free, wireless compact microstimulation implant that offers patients greater independence and improves their quality of life by improving healthcare delivery. The device is externally powered by the RC-200 handheld device, allowing for treatment at home without the need for frequent hospital visits.
The Pulsante system has been clinically proven in over 700 patients and has received the FDA's Breakthrough Device designation. In studies of chronic cluster headaches, 75% of participants reported a significant reduction in headache frequency and intensity using the system over a four-week period. This remarkable success has earned Pulsante the MedTech Breakthrough Award for Best New Pain Management Technology Solution in 2025.
Dr. Peter Bonutti, the founder and CEO of Realeve, has over 30 years of experience in the medical field and has more than 500 patents. His dedication to innovation is evident in the development of Pulsante, which redefines chronic pain management across various neurological conditions.
The AI-based features of Pulsante aim to offer more precise treatment and improve patient outcomes. Future iterations of the device may incorporate AI-based pain tracking and predictive analytics, further enhancing its capabilities.
Realeve is not a newcomer to the medtech industry. They are a medical device company focused on developing treatments for CNS disorders via micro-neurostimulation. Their partnership with Promex, a leader in microelectronic component assembly, process design, and packaging of medtech and biotech devices, ensures the high-quality production of their innovative devices.
Recent advancements in micro-neurostimulation technology for treating CNS disorders focus on improved precision, safety, and novel approaches like brain-computer interfaces and non-invasive methods. While specific detailed recent information about Pulsante was not found in the search results, the device represents the type of micro-neurostimulation technology that provides targeted, adjustable stimulation, aiming to treat complex disorders mediated by CNS circuits, such as neurogenic bladder dysfunction.
As more specific, recent data on Pulsante's clinical trial outcomes, technological upgrades, or regulatory status becomes available, it will deepen our understanding of its advancement relative to CNS disorder treatments. With Dr. Bonutti's expectations of the technology treating conditions linked to nerve dysfunction, such as sleep disorders and anxiety, the future of Pulsante and its impact on the medical community looks promising.
- The Pulsante system, a groundbreaking device in digital health, has been clinically proven effective in managing various medical-conditions such as chronic cluster headaches, neuropathic pain, and sleep disorders, contributing to the health-and-wellness of patients.
- The AI-based features of Pulsante, a revolutionary microstimulation implant in the realm of medical-conditions treatment, aim to offer more precise therapies-and-treatments and improve patient outcomes, paving the way for advancements in science and neurostimulation technology.
