Piloting the Samphire Nettle in clinical settings

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A large majority of reproductive-age women experience menstruation-related symptoms and have missed work as a result, which has led to a loss of productivity through sickness, absence and underperformance by those women who go to work while feeling unwell. The annual cost of this productivity loss in the UK has been estimated at £17.4B. Current options for dealing with menstrual symptoms are limited, with a large emphasis on pharmacological solutions. This leaves women with few options to manage their symptoms. While most of these conditions go undiagnosed for years, women who end up receiving a diagnosis, such as endometriosis, uterine fibroids, PMDD or others, are often left with limited solutions, often starting with intensive hormonal treatments and ending with hysterectomies.Samphire has developed a wearable, non-invasive medical device called the Nettle in the form of a hairband that uses personalised neuromodulatory technology to address mood and pain-related menstrual health symptoms. The device is currently undergoing regulatory clearance in the UK and EU.In this project, Samphire is collaborating with the Birmingham Healthcare Technologies Institute, as well as the University of Birmingham to run a hospital-based feasibility study that tests the clinical benefit, health economics and accessibility of integrating the Nettle device into the NHS care pathways. In this study, 50 patients undergoing treatment in the University hospital will be offered Nettle as a treatment option alongside state-of-the-art alternatives (such as hormonal contraceptives, GnRH replacement therapy, antidepressants, hysterectomy), and their outcomes will be followed and compared. The purpose of this study is to demonstrate the feasibility of integrating a novel, non-invasive medical device alongside more invasive standard of care for common, and neglected women's health conditions.