A new life for people with severe disabling cluster headache: Neuromodulation therapy using safe, minimally-invasive simultaneous stimulation at the front and back of the head.

Introduction

Chronic cluster headache and chronic migraine pose a significant challenge for patients and neurologists worldwide. Approximately 48-64% of the patients experience only limited relief from drug-based treatments; they are drug-refractory.

Product Development

Salvia BioElectronics B.V. developed PRIMUS, an innovative peripheral nerve modulator to treat exactly these refractory chronic neurovascular headache patients. The ground-breaking dual-site stimulation targets both the front and back of the head.

Clinical Studies

In ongoing first-in-human studies, PRIMUS has demonstrated a 98.5% effectiveness in reducing the frequency of the debilitating headache attacks, with a 100% patient response rate.

Design and Safety

PRIMUS’ advanced design, with a lead of only 0.1 mm and no large implanted battery, significantly mitigates the risks of systemic side effects, with 0% device-related events reported. This is in contrast to existing and competitive neuromodulation devices that are incompatible with the intricate anatomy of the head, placing a heavy and stigmatizing burden on patients with severe device-related adverse events such as skin erosion and lead displacement.

Strategic Approach

Using EIC support, Salvia will fund the clinical pivotal trial, regulatory approval, and go-to-market for refractory chronic cluster headache. This strategic approach aims to prioritize the severe, yet comparatively rare, cluster headache indication while simultaneously maintaining a strong commitment to the much larger chronic migraine market worth €109B, which is heavily supported by our investors.

Market Access

By leveraging the positive outcomes for refractory chronic cluster headache, Salvia aims to convince key partners, particularly neurologists, to facilitate expedited market access and penetration, especially for the large refractory chronic migraine market segment.

Future Goals

As such, reaching the full commercial potential of our product driven by its disruptive technology, we aim for market launch in Europe and the USA in 2026, followed by accelerated yet sustainable company growth and an IPO in 2027.