Salvia Bioelectronics mechanism of action clinically validated in international multi-center study led by a member of Salvia’s clinical advisory board.
Salvia Bioelectronics aims to provide relief to migraine sufferers by electrically stimulating peripheral cranial nerves. As there is some commonality in the underlying disease physiology and associated signaling pathways, Salvia’s device technology also lends itself to treatment of other headache disorders, in particular cluster headache, also called suicide headache due to its severity.
A recent Lancet Neurology publication of the ICON study now further validates Salvia’s approach. The study investigated the off-label use of electrostimulation devices designed for treatment of chronic lower back pain for stimulation of the occipital nerve in cluster headache patients. The study results show marked and clinically meaningful reduction in attack frequency and attack intensity in medically intractable cluster headache patients when their occipital nerve is electrically stimulated. The study not only confirms the effectiveness of occipital nerve stimulation but it also made the limitations of existing devices painfully obvious, with a large portion of patients experiencing device- and procedure-related complications. Salvia Bioelectronics addresses these issues with the design of its proprietary device which allows for minimally invasive implantation. In addition, Salvia’s technology may be more effective by providing more extensive stimulation.
The ICON study was initiated and sponsored by one of the world’s leading neurologists, Prof. Ferrari of the Leiden University Medical Center. Prof. Ferrari is also a member of Salvia’s advisory board. The tremendous public interest in finding a solution for cluster headache sufferers is reflected in the reporting of the study in public news outlets, e.g. LUMC and the Volkskrant. Interestingly, even though the study was conducted with devices designed for a different indication, the severity of the disease and the pronounced clinical improvement prompted the Dutch health insurers to provide reimbursement for the treatment.
All in all, we expect the results of the ICON study to further the field of bioelectronics for primary headache disorders and provide a positive context for Salvia.