Samphire aims to offer women a new standard of care by developing scientifically validated wearable medical solutions that can be easily integrated into their everyday lives.
Samphire's medical device uses non-invasive transcranial electrical stimulation to stimulate specific regions of the brain that have been associated with the reduction of menstrual mental and physical health symptoms.
Some commonly experienced menstrual mental health symptoms include but are not limited to the conditions of PMS (premenstrual syndrome, ICD-11 GA34.4, MF33), PMDD (premenstrual dysphoric disorder, ICD-11 GA34.41), generalised anxiety, fatigue, low mood, mood instability, and irritability. Commonly experienced menstrual physical health symptoms include but are not limited to dysmenorrhea (ICD-11 GA43.3), known colloquially as menstrual pain/cramps, and menstrual migraine (as part of premenstrual tension syndrome (ICD-11 GA34.40), among others.
Based on our research, consistent with larger meta reviews (such as this one from Schoep et al., 2019), four out of the top five complaints women report around their menstrual cycle are associated with mental rather than physical health. In order, the complaints are those of low mood (75%), cramps (66.7%), fatigue (62.5%), irritability (62.5%) and mood shifts (56.2%). Perhaps surprisingly, though, cramps don’t even make the top five of the most difficult symptoms to deal with (which are fatigue, low mood, irritability, mood shifts and brain fog). All these symptoms have to do with the brain, and therefore demand a brain-based solution with few side effects.
Non-invasive transcranial electrical stimulation has a literature of over 30 years across psychiatry and cognitive neuropsychology, documenting its safety and efficacy in targeting specific brain regions to provide relief from symptoms, many of which are experienced around women's menstrual cycles. It is well established in psychiatry, as a treatment (or maintenance) option for clinical depression, neuropathic pain and fibromyalgia, and some anxiety disorders. The best literature review on the safety of tES is here, and the best evidence-based review of its efficacy across clinical conditions is here.
The Samphire Hairband was developed alongside women as a medical device that 1) is effective in addressing complaints associated with the natural fluctuations over the menstrual cycle (and helps you understand those fluctuations in the process), 2) is fashionable and can be worn in public as well as in private, whatever suits the user's needs, and 3) is built to advance the clinical, diagnostic and therapeutic understanding of unaddressed women's needs (all of these menstrual symptoms are currently identified as idiopathic).
The Samphire Hairband will be available in the EU and UK markets in late 2023 (US - 2024), and we are already partnering with private and public clinics and doctors across these geographies to share more about Samphire's product, the diagnostic criteria it addresses, and its mechanism of action. If you're interested in working with us to deliver state-of-the-art care to your patients, reach out to us directly here.