Pain management solution offered by Promex and Realeve honored by MedTech Breakthrough Awards

Pain management solution offered by Promex and Realeve honored by MedTech Breakthrough Awards

In a groundbreaking development, Realeve's Pulsante micro-neurostimulation device is redefining the way chronic pain and neurological disorders are approached, offering patients greater independence and improving quality of life.

This innovative device, recognised as the 2025 Best New Pain Management Technology Solution, provides on-demand stimulation therapy targeting the sphenopalatine ganglion (SPG) to manage pain, particularly for cluster headaches. The micro-neurostimulator system allows targeted, adjustable neurostimulation, offering a novel, minimally invasive approach to pain relief by directly modulating the neural pathways involved in pain signaling.

The Pulsante device, which includes an RC-200 handheld device to power the implant, has the potential to treat a range of brain-related conditions and collect data for continuous monitoring of treatments and outcomes. The device's compact and wearable design makes it an alternative to traditional, more invasive therapies.

Dr. Peter Bonutti, founder and CEO of Realeve, has stated that Pulsante is redefining chronic pain management across various neurological conditions. The technology is clinically proven in over 700 patients and has FDA Breakthrough Device designation, reflecting its significant advancement over traditional pain therapies.

The key points of innovation include:

• A microimplantable design enabling precise neurostimulation at the SPG.
• On-demand activation allowing patients to control stimulation when pain occurs.
• Targeted therapy focused on a neural ganglion critically involved in certain types of severe headache pain.
• A minimally invasive approach reducing side effects compared to pharmacological treatments or more invasive interventions.

In studies conducted by Realeve on chronic cluster headaches, 75% of participants reported significant reduction in headache frequency and intensity using the system over a four-week period.

Looking ahead, future iterations of the Pulsante technology may incorporate AI-based pain tracking and predictive analytics, offering even more precise treatment and improving patient outcomes. The technology is also expected to treat other conditions linked to nerve dysfunction, such as sleep disorders and anxiety.

Promex, a key partner in the development of Pulsante, worked with Realeve to manufacture a critical part of the device, specifically the complex internal portion of its header assembly. Dave Fromm, chief operations officer at Promex, stated that Pulsante is a game-changer, delivering precise electrical pulses to the nervous system in a compact and wearable form.

Neurostimulation has shown promise in treating conditions like sleep disorders and anxiety, according to Dr. Bonutti. As Pulsante continues to evolve, it 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.

With its revolutionary approach to pain management, Pulsante is not just a device, but a beacon of hope for those suffering from chronic pain and neurological disorders.

[1] Realeve. (n.d.). Pulsante: The Future of Neuromodulation. Retrieved from https://www.realeve.com/pulsante

[2] TENS Units Explained. (n.d.). Retrieved from https://www.healthline.com/health/tens-units-explained

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2. Science and technology are merging to offer innovative solutions, such as the Pulsante device, which targets the sphenopalatine ganglion (SPG) to manage chronic pain.
3. This new technology, recognized as the 2025 Best New Pain Management Technology Solution, is revolutionizing the approach to pain relief for various medical conditions.
4. The Pulsante device, equipped with an RC-200 handheld device, enables targeted, adjustable neurostimulation, offering a minimally invasive solution to chronic pain compared to traditional therapies.
5. The miniaturized device, a beacon of hope for sufferers of chronic pain and neurological disorders, is redefining the quality of life for many patients.
6. The technology behind Pulsante has received FDA Breakthrough Device designation, highlighting its significant advancement over traditional pain therapies.
7. Studies conducted by Realeve on chronic cluster headaches have shown that 75% of participants experienced a significant reduction in headache frequency and intensity using the system over a four-week period.
8. The microimplantable design of Pulsante allows for precise neurostimulation at the SPG, a neural ganglion critically involved in certain types of severe headache pain.
9. The on-demand activation feature allows patients to control stimulation when pain occurs, providing greater independence and autonomy.
10. The Pulsante device, through its targeted therapy, may reduce side effects compared to pharmacological treatments or more invasive interventions.
11. The healthcare and wellness industry is showing increased interest in advancements in neurological conditions, including sleep disorders and anxiety, which may benefit from neurostimulation technology like Pulsante.
12. Pulsante technology has proven clinically effective in over 700 patients, according to the founder and CEO of Realeve, Dr. Peter Bonutti.
13. Future iterations of the Pulsante technology may incorporate AI-based pain tracking and predictive analytics, potentially improving patient outcomes.
14. Neurostimulation, as demonstrated by Pulsante, shows promise in treating various medical conditions beyond chronic pain, such as sleep disorders and anxiety.
15. Promex, a key partner in the development of Pulsante, played a crucial role in manufacturing a critical part of the device, specifically the complex internal portion of its header assembly.
16. Dave Fromm, chief operations officer at Promex, described Pulsante as a game-changer, delivering precise electrical pulses to the nervous system in a compact and wearable form.
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