If you are a device manufacturer dealing with high rates of skin erosion and lead migration in cranial implants — this project developed a paper-thin implant with a 0.1 mm lead that mitigates these risks.
Minimally-Invasive Implant for Drug-Resistant Chronic Cluster Headache and Migraine Treatment
Imagine a tiny, paper-thin electronic patch placed under the skin of the head. Instead of using heavy drugs that often don't work, it sends gentle electrical pulses to calm the nerves causing severe headaches. It's like a precise dimmer switch for pain that doesn't require a bulky battery.
What needed solving
Millions of chronic headache sufferers are drug-refractory, and existing neuromodulation devices are unsuitable for the head's anatomy, causing skin erosion and lead breakage.
What was built
The PRIMUS system, a paper-thin peripheral nerve modulator with a 0.1 mm lead and no large implanted battery.
Who needs this
Who can put this to work
If you are a clinic dealing with the 48-64% of chronic headache patients who are drug-refractory — this project developed the PRIMUS system which showed a 98.5% effectiveness in reducing attack frequency.
If you are an investor dealing with the untapped potential of the 109B chronic migraine market — this project developed a disruptive dual-site stimulation technology aiming for a 2027 IPO.
Quick answers
What is the estimated cost or pricing of the device?
Based on available project data, specific unit costs or pricing models are not disclosed.
How will the technology be scaled for industrial production?
The project focuses on funding the clinical pivotal trial and regulatory approval to enable a market launch in Europe and the USA by 2026.
What is the IP or licensing status of the PRIMUS system?
Based on available project data, the technology is developed by Salvia BioElectronics BV, but specific patent or licensing terms are not listed.
What is the timeline for market entry?
The company aims for market launch in Europe and the USA in 2026, followed by an IPO in 2027.
What regulatory hurdles must be overcome?
The project will use EIC support to fund the clinical pivotal trial and obtain regulatory approval for refractory chronic cluster headache.
Who built it
The project is led by a single SME, Salvia BioElectronics BV from the Netherlands. With a 100% industry ratio and no university or research partners, the consortium is lean and focused entirely on commercialization and regulatory approval rather than basic research.
Contact Salvia BioElectronics BV in the Netherlands
Talk to the team behind this work.
Contact us to explore licensing or partnership opportunities with Salvia BioElectronics.