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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.

Project description

Revolutionising treatment for chronic headaches

Chronic cluster headache and migraine are debilitating conditions that impact millions worldwide, causing intense pain and suffering. For many patients, current drug treatments provide insufficient relief. Salvia BioElectronics B.V. has developed an innovative, paper-thin implant designed to reduce the frequency and intensity of headache attacks. Salvia's minimally invasive implant is uniquely designed for the safe use in the cranio-facial region. The EIC-funded ReLife project aims to accelerate the availability the novel therapy for cluster headache, thereby supporting a transformative impact in the far larger migraine market.

Objective

Chronic cluster headache and chronic migraine pose a significant challenge for patients and neurologists worldwide. Approx. 48-64% of the patients experience only limited relief from drug-based treatments, they are drug-refractory. 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. In ongoing first-in-human studies, PRIMUS has demonstrated a 98.5% effectiveness in reducing the frequency of the debilitating headache attacks (100% patient response rate). PRIMUS advanced design, with a lead of only 0.1 mm and no large implanted battery, significantly mitigates the risks of systemic side effects (0% device-related events reported). This in contrast to existing and competitive neuromodulation devices that are incompatible with the intricate anatomy of the head, placing a heavy and stigmatising burden on patients with severe device-related adverse events such as skin erosion and lead displacement.

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 prioritise the severe, yet comparatively rare, cluster headache indication while simultaneously maintaining a strong commitment to the much larger chronic migraine market worth 109B and heavily supported by our investors. By leveraging the positive outcomes for refractory chronic cluster headache, Salvia aims to convince the key partners, neurologists, to facilitate an expedited market access and penetration, in particular for the large refractory chronic migraine market segment. 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 and accelerated yet sustainable company growth followed by a an IPO in 2027.

Fields of science (EuroSciVoc)

Keywords

Programme(s)

Topic(s)

Funding Scheme

HORIZON-EIC-ACC-BF - HORIZON EIC Accelerator Blended Finance

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Call for proposal

(opens in new window) HORIZON-EIC-2023-ACCELERATOR-01

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Coordinator

SALVIA BIOELECTRONICS BV
Net EU contribution
€ 2 499 999,00
Address
HIGH TECH CAMPUS 37
5656 AE Eindhoven
Netherlands
SME
Yes
Region
Zuid-Nederland Noord-Brabant Zuidoost-Noord-Brabant
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost
€ 3 727 218,75