Realeve partnered with Promex for the development and manufacturing of its Pulsante™ Micro-Neurostimulator System
SANTA CLARA, Calif. (May 8, 2025)
— Promex, the leader in microelectronic component assembly, process design, and packaging of medtech and biotech devices, along with its customer, Realeve, a medical device company focused on developing novel treatments for diseases and conditions of the central nervous system by controlling the sphenopalatine ganglion (SPG) via micro-neurostimulation, have been recognized by MedTech Breakthrough with its 2025 Best New Pain Management Technology Solution for the Realeve’s Pulsante™.
Pulsante™ is the first externally powered implantable neuromodulation device system for treating central nervous system (CNS) disorders, including strokes and cluster headaches. The technology is clinically proven in 700+ patients and has FDA Breakthrough Device designation. Pulsante has the potential to overcome one of the critical remaining barriers to brain health — the ability to bypass the brain’s natural barrier and access the blood brain barrier to deliver therapeutics.
Pulsante features a minimally invasive battery-free wireless compact SPG microstimulation implant that is activated when a patient brings a Pulsante RC-200 handheld device to the implant area. The RC-200 powers the implant with the potential to treat a range of brain-related conditions and collect data for continuous monitoring of treatments and outcomes. Pulsante’s micro-neurostimulation provides relief for patients suffering from conditions such as chronic migraine and neuropathic pain. Unlike other approaches, Pulsante is a drug-free, safe, effective treatment option used at home, reducing the need for clinic visits and side effects associated with pharmaceuticals.
In Realeve studies of chronic cluster headaches, 75 percent of participants reported significant reduction in headache frequency and intensity using the system over a four-week period and noted improvements in daily function and overall wellbeing.
The annual MedTech Breakthrough Awards program is conducted by MedTech Breakthrough, an independent market intelligence organization, and recognizes the top companies, technologies, and products in the global health and medical technology market. After extensive analysis, the organization recognizes the innovation, hard work, and success across a range of health and medical technology categories with its award. In 2025, more than 4,500 nominations from throughout the world were considered.
“Together, we took a major leap forward in enabling this treatment for chronic pain. Pulsante is an alternative to traditional, more invasive therapies because it’s compact and wearable, delivering precise electrical pulses to the nervous system,” said Dave Fromm, chief operations officer at Promex, “We’re proud to support Relieve with the manufacturing of a critical part of the device, contributing to its success and recognition in the industry.”.
Promex worked with Realeve to translate the device’s design into working parts from the company’s assembly drawings and consigned materials. Promex built the heart of the device, which is the complex internal portion of its header assembly, which is sealed inside a ceramic/titanium encasement.
“Pulsante is redefining chronic pain management across various neurological conditions,” said Realeve founder and CEO, Dr. Peter Bonutti, who has more than 30 years of experience, 500+ patents, and has been involved in other groundbreaking medtech. Bonutti adds that future iterations of the technology may incorporate AI-based pain tracking and predictive analytics, offering even more precise treatment and improving patient outcomes. He expects the technology will treat other conditions linked to nerve dysfunction, such as sleep disorders and anxiety, where neurostimulation has shown promise.
“Pulsante changes the way chronic pain and neurological disorders are approached, offering patients greater independence and improving quality of life by improving healthcare delivery, reducing reliance on medications, and providing a more holistic treatment approach,” says Bonutti.
About Promex
Promex is the market leader in microelectronic component assembly, process design, and packaging for the medtech and biotechnology markets. It is uniquely positioned among contract manufacturers with the broadest set of capabilities under one roof: two full SMT lines; post-wafer processing technologies, including wafer dicing, grinding, die attach, and flip-chip; wire bonding; encapsulation; and more. With cutting-edge equipment, extensive material properties knowledge, and meticulous supply chain management, Promex partners with OEMs at all stages, from early and small prototypes to R&D development and high-volume production. Learn more about us at promex-ind.com.
About Realeve, LLC:
Realeve is a medical device company focused on developing novel treatments for diseases and conditions of the CNS by controlling the SPG via the Pulsante micro-neurostimulator system. Founded in 2019, Realeve builds on over a decade of safe and proven efficacy of the Pulsante system. For more information, visit realeve.net.