Pain management solution by Promex and Realeve gains recognition from MedTech Breakthrough Awards
In the ever-evolving field of medical technology, advancements in micro-neurostimulation are making significant strides, particularly in the treatment of central nervous system (CNS) disorders. One such innovation is the Pulsante system, developed by Realeve, a medical device company specializing in novel treatments for CNS disorders using micro-neurostimulation.
Dr. Peter Bonutti, the founder and CEO of Realeve, brings over 30 years of experience and more than 500 patents in the medtech field to this groundbreaking project. Pulsante is the first externally powered implantable neuromodulation device system for treating CNS disorders, designed to offer patients greater independence and improve their quality of life.
The Pulsante system, which received the FDA's Breakthrough Device designation, has been clinically proven in over 700 patients. In studies of chronic cluster headaches, 75% of participants reported significant reduction in headache frequency and intensity using the Pulsante system over a four-week period. This drug-free, safe, and effective treatment option provides relief for patients suffering from conditions such as chronic migraine and neuropathic pain.
Pulsante features a minimally invasive, battery-free, wireless compact SPG microstimulation implant. 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, further enhancing its capabilities.
The Pulsante technology is expected to treat other conditions linked to nerve dysfunction, such as sleep disorders and anxiety. In 2025, Promex and Realeve's Pulsante received the MedTech Breakthrough Award for the Best New Pain Management Technology Solution, recognising the technology's potential to transform healthcare delivery by reducing reliance on medications.
The annual MedTech Breakthrough Awards program, conducted by MedTech Breakthrough, honours the top companies, technologies, and products in the global health and medical technology market. Pulsante provides a more holistic treatment approach for chronic pain and neurological disorders, offering a promising future for patients suffering from these debilitating conditions.
While the latest technical details or clinical results from 2025 are not directly available in the current search results, contacting Realeve or consulting their latest publications would be necessary for detailed information on Pulsante's latest protocols. The field of micro-neurostimulation is rapidly evolving, with integration of brain-implantable high-density electrode arrays, advanced signal processing, surgical microrobots, and expanded indications beyond traditional use, including Parkinson’s, stroke, addiction, and pelvic disorders.
In conclusion, Pulsante by Realeve represents a significant leap forward in the treatment of CNS disorders, offering a drug-free, safe, and effective solution for patients suffering from chronic pain and neurological disorders. As the field of micro-neurostimulation continues to advance, we can expect to see more innovative technologies like Pulsante being developed and implemented in clinical practice.
- In the domain of digital health and health-and-wellness, advancements in micro-neurostimulation, particularly in the treatment of neurological disorders, areshowcasingpromising progress.
- The Pulsante system, a groundbreaking medical device developed by Realeve, utilizes micro-neurostimulation for treating a wide range of medical-conditions, including chronic migraine, neuropathic pain, sleep disorders, and anxiety.
- Pulsante's innovative therapies-and-treatments, such as its drug-free, wireless compact SPG microstimulation implant, received the FDA's Breakthrough Device designation and was honored with the MedTech Breakthrough Award for the Best New Pain Management Technology Solution.
- The field of micro-neurostimulation is experiencing rapid growth, with emerging technologies involving brain-implantable high-density electrode arrays, advanced signal processing, surgical microrobots, and expanded indications for conditions such as Parkinson’s, stroke, addiction, and pelvic disorders.
