Periodic Reporting for period 1 - ReLife (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.)
Reporting period: 2024-02-01 to 2025-07-31
Chronic cluster headache and chronic migraine impose a significant burden on the global population, affecting 0.017% and 0.95% respectively. With approx. 7.9M sufferers in Europe (EU) (incl. the UK) and 3.2M in the USA, these conditions lead to substantial reductions in patients' quality of life. Per patient, an average loss of 5 Quality-Adjusted-Life-Years is estimated. This is compounded by high rates of comorbid affective disorders such as depression, sleep deprivation, and suicidal ideation and attempts. Chronic cluster headache patients, for instance, report 36% active suicidal ideation, 85% severe impact on work and 100% severe impact on daily life.
Despite therapeutic advances, 48-64% of these chronic cluster headache and chronic migraine patients, equivalent to approx. 3.9M individuals in EU (incl. the UK) and 1.6M in the USA, remain unresponsive to current disease management (pharmacological interventions). These patients are called drug-resistant or drug-refractory. The available drug-mediated treatments are also often contra-indicated and prone to side-effects. There consequently exists a large unmet clinical need and considerable commercial potential for non-pharmacological approaches.
Neuromodulation is a cutting-edge technique utilizing gentle electrical pulses to modulate the nerves associated with the debilitating headache attacks. It has garnered robust support from scientific research and clinical trials in the context of refractory chronic cluster headache and refractory chronic migraine, with over 65% patient satisfaction and 89% of patients that experience a long-term (7+ years) benefit.
For neuromodulation therapy to be delivered efficiently, patients necessitate the implantation of a specialized device capable of applying the precise electrical pulses adjacent to the skull, discreetly positioned beneath the skin. However, currently there are no approved devices. Occasionally spinal cord neuromodulation devices are used off-label use for this purpose, which are however not designed for the application in the cranio-facial region, and are associated with adverse events ranging from skin erosion, lead migration and breakage to infection and localized pain.
Salvia BioElectronics is developing a paper-thin implant, that is placed via a minimally-invasive implantation procedure. Salvia's neuromodulation system stands out through its paper-thin implant and the absence of a large implanted battery, critically mitigating the risks for systemic adverse events. The EIC Accelerator project enables Salvia to address in addition to chronic migraine, also the far rarer yet highly severe and distressing condition of refractory chronic cluster headache, known as ‘suicide headache’.
This project collects the clinical evidence needed to bring the device to the market, regulatory submission and additionally develop the appropriate go-to-market route.
Despite therapeutic advances, 48-64% of these chronic cluster headache and chronic migraine patients, equivalent to approx. 3.9M individuals in EU (incl. the UK) and 1.6M in the USA, remain unresponsive to current disease management (pharmacological interventions). These patients are called drug-resistant or drug-refractory. The available drug-mediated treatments are also often contra-indicated and prone to side-effects. There consequently exists a large unmet clinical need and considerable commercial potential for non-pharmacological approaches.
Neuromodulation is a cutting-edge technique utilizing gentle electrical pulses to modulate the nerves associated with the debilitating headache attacks. It has garnered robust support from scientific research and clinical trials in the context of refractory chronic cluster headache and refractory chronic migraine, with over 65% patient satisfaction and 89% of patients that experience a long-term (7+ years) benefit.
For neuromodulation therapy to be delivered efficiently, patients necessitate the implantation of a specialized device capable of applying the precise electrical pulses adjacent to the skull, discreetly positioned beneath the skin. However, currently there are no approved devices. Occasionally spinal cord neuromodulation devices are used off-label use for this purpose, which are however not designed for the application in the cranio-facial region, and are associated with adverse events ranging from skin erosion, lead migration and breakage to infection and localized pain.
Salvia BioElectronics is developing a paper-thin implant, that is placed via a minimally-invasive implantation procedure. Salvia's neuromodulation system stands out through its paper-thin implant and the absence of a large implanted battery, critically mitigating the risks for systemic adverse events. The EIC Accelerator project enables Salvia to address in addition to chronic migraine, also the far rarer yet highly severe and distressing condition of refractory chronic cluster headache, known as ‘suicide headache’.
This project collects the clinical evidence needed to bring the device to the market, regulatory submission and additionally develop the appropriate go-to-market route.
1. Demonstrate the usability, safety and effectiveness of the neuromodulation system in treating refractory chronic cluster headache patients and its favorable benefit/risk ratio (absence of device-related adverse events). Clinical data will be compiled to conclude on primary safety and effectiveness endpoints. These will be determined upon concordance relative to baseline measurements and sham-treated patients. This activity includes the preparation, execution and reporting of the clinical pivotal study.
2. Prepare and submit the market approval application of the neuromodulation system, based on the evidence generated during the clinical pivotal study and summarized in the clinical evaluation report.
2. Prepare and submit the market approval application of the neuromodulation system, based on the evidence generated during the clinical pivotal study and summarized in the clinical evaluation report.
Expected results and impacts include:
1. Commercialization of the neuromodulation system both in EU and the US. The market strategy will initially target KOLs as ambassadors to drive sales. Subsequent market expansion will be augmented by increasing product awareness and the adoption of neuromodulation therapy in the clinical guidelines through our KOLs that draft the guidelines in the Headache Societies.
2. By demonstrating a favorable benefit/risk ratio and added value for refractory chronic cluster headache patients, the neuromodulation system will earn the trust of neurologists that also recommend therapy to refractory chronic migraine patients. As such, through enhancing our credibility and product awareness, market presence will be boosted and sales accelerated.
3. The most significant impact will be for patients, who will, upon successful completion of the study, receive safe and effective neuromodulation treatment thereby enhancing their overall quality of life, with the additional focus on cluster headache.
4. Payers will benefit from a cost-effective therapy solution, reducing the burden of healthcare costs associated with patients suffering from these refractory chronic neurovascular headache. An estimated € 36M annual direct healthcare savings from 2029 onwards.
1. Commercialization of the neuromodulation system both in EU and the US. The market strategy will initially target KOLs as ambassadors to drive sales. Subsequent market expansion will be augmented by increasing product awareness and the adoption of neuromodulation therapy in the clinical guidelines through our KOLs that draft the guidelines in the Headache Societies.
2. By demonstrating a favorable benefit/risk ratio and added value for refractory chronic cluster headache patients, the neuromodulation system will earn the trust of neurologists that also recommend therapy to refractory chronic migraine patients. As such, through enhancing our credibility and product awareness, market presence will be boosted and sales accelerated.
3. The most significant impact will be for patients, who will, upon successful completion of the study, receive safe and effective neuromodulation treatment thereby enhancing their overall quality of life, with the additional focus on cluster headache.
4. Payers will benefit from a cost-effective therapy solution, reducing the burden of healthcare costs associated with patients suffering from these refractory chronic neurovascular headache. An estimated € 36M annual direct healthcare savings from 2029 onwards.