📋 Tender Overview
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.
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.
Funded Under
The European Innovation Council (Eic)
Total Cost
€ 3 727 218,75
Eu Contribution
€ 2 499 999,00
Coordinated By
Salvia Bioelectronics Bv
Netherlands
Start Date
1 February 2024
End Date
31 January 2027
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 freque
