Samphire Neuroscience advances hormone-free treatment option for PMDD
The NHS Innovation Accelerator Fellow’s hormone-free, drug-free wearable headband has received an expanded UK and EU indication to support the management of mood symptoms associated with premenstrual dysphoric disorder (PMDD), following positive findings from an independent clinical study.
Samphire Neuroscience, a Fellow of the NHS Innovation Accelerator (NIA), has announced an important milestone for its women’s health innovation, with its Samphire Headband (Nettle™) receiving approval for an expanded intended purpose in the UK and EU.
The CE-marked, at-home brain stimulation device, previously indicated for the management of premenstrual syndrome (PMS) and period pain, can now also be used to assist in managing mood symptoms associated with premenstrual dysphoric disorder (PMDD). The expanded indication specifically relates to improvements in anxiety symptoms.
PMDD is a severe form of premenstrual disorder that can have a significant impact on emotional wellbeing and everyday life. Despite affecting people’s mental health, relationships and ability to work, treatment options remain limited, with existing approaches often involving antidepressants, hormonal treatments and talking therapies.
Samphire is working to broaden the options available through a hormone-free and drug-free approach, using neuroscience to address the brain mechanisms involved in pain and emotional regulation.
Promising findings from independent clinical research
The expanded indication follows findings from ADAPT, an independent controlled study led by researchers at Queen Mary University of London. The study investigated whether Nettle™ could improve anxiety and emotional regulation in people experiencing PMDD.
Forty-two participants used the headband at home for 20 minutes a day during the second half of their menstrual cycle, over three cycles. Participants were split into two groups, with 22 receiving active brain stimulation and 20 using a placebo device designed to feel similar.
By the end of the third cycle, participants receiving active stimulation experienced an average 6.4-point reduction in anxiety scores, compared with a 2.1-point reduction in the placebo group, measured using the GAD-7 anxiety scale.
The study also found statistically significant improvements in emotional regulation among those receiving active stimulation, including their ability to manage emotional responses, control impulses and access strategies to regulate their emotions.
“PMDD can fully derail half of someone’s life emotionally, professionally, interpersonally, every month. We wanted to test a treatment people could use at home during that window that is drug- and hormone-free but still medical-grade. This study gives us an encouraging result on anxiety. The expanded indication gives us a way to make that option available while we continue to build the evidence basis across mood and pain conditions.”
The company was not involved in analysing the study results, and the devices were purchased independently for the trial to help minimise potential bias. No adverse events were reported. The findings have been submitted for peer review, with publication anticipated in 2027.
While further research involving larger groups will be important to establish the consistency and wider benefits of the treatment, the findings represent an encouraging step towards expanding the evidence base for non-pharmacological approaches to PMDD.
Supporting innovation in women’s health
Founded by neuroscientist Dr Emilė Radytė, Samphire Neuroscience was developed in response to the significant gap in research, innovation and treatment options for women’s health conditions.
Its Nettle™ headband uses transcranial direct current stimulation (tDCS), delivering a low-level electrical current through electrodes placed on the scalp. This non-invasive approach targets brain regions involved in pain perception and emotional regulation, with the device designed for people to use independently at home.
As an NHS Innovation Accelerator Fellow, Samphire is part of a national community of innovators receiving tailored support, mentorship and connections to help promising healthcare innovations overcome barriers to adoption and scale their impact across the NHS.
The Fellowship provides an opportunity to connect Samphire’s developing clinical evidence with the wider health and care system, supporting its ambition to improve access to new approaches to women’s health.
“Women’s health has historically been under-represented in research and innovation, and conditions such as PMDD can have a profound impact on people’s quality of life. It’s encouraging to see Samphire Neuroscience generating independent clinical evidence for a new approach to managing these symptoms. As an NHS Innovation Accelerator Fellow, Samphire is part of a community of innovators working to turn promising ideas into solutions that can make a meaningful difference for patients. This latest milestone highlights the importance of supporting evidence-led innovation in areas of significant unmet need, and helping innovators navigate the journey towards wider adoption and access.”
Looking ahead
The latest announcement marks another milestone for Samphire Neuroscience as it continues to develop its technology and build the evidence base for brain-based approaches to women’s health.
Recognised in TIME’s Best Inventions 2026 in the Health & Wellness category, and previously awarded MEDICA’s Innovation of the Year in 2024, Samphire is working towards its wider ambition of making innovative, accessible treatment options available to more people experiencing menstrual and related health conditions.
Through the NHS Innovation Accelerator, the team will continue to build connections across the health and care system and explore opportunities to support the wider adoption of its innovation.
