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.
