In broad terms, this means we are currently demonstrating to the competent authorities that there is appropriate clinical and safety evidence for the Samphire Headband to be used as a medical device for the amelioration of certain symptoms associated with PMS, PMDD and menstrual pain.

Until this process is completed, we are unable to provide you with the Samphire Headband, and the Samphire Headband remains unavailable to purchase. We expect this process to be completed in early 2024.

At launch, we'll provide our exclusive waitlist members the opportunity to confirm that Samphire Headband, as approved, is an appropriate medical treatment for them.

Yes. As with all medical technologies, however, there will be certain people for whom the Samphire Headband is an inappropriate choice.

At launch, the Samphire Headband will be a regulated medical device, meaning the competent authorities in your jurisdiction will have assessed the Samphire Headband as having appropriate clinical and safety evidence for the Samphire Headband to be used as a medical device for the amelioration of PMS, PMDD and menstrual pain symptoms.

As part of this process, the Samphire Headband is subjected to extensive safety testing, including ensuring the device's electrical and wireless emissions are well below the required limits for safety. For example, the Samphire Headband's wireless emissions are much less than those emitted by your mobile phone.

At launch, we'll provide our exclusive waitlist members the opportunity to confirm that the Samphire Headband, as approved, is an appropriate medical treatment for them.

FireBand is not designed to cure PMS, PMDD, dysmenorrhea, or any other women’s health condition. However, the Samphire Headband is designed and intended to alleviate a range of physical and psychological symptoms that are commonly experienced by people diagnosed with such conditions.

Once the Samphire Headband is approved, waitlist members will have early access to assess whether their symptoms are a match for those approved for treatment with the headband.

The Samphire Headband is intended to help alleviate a range of both physical and psychological symptoms. Physical symptoms include menstrual pain and cramping. Psychological symptoms include low mood, irritability, anger management, mood instability, and cravings.

There is stronger evidence of the Samphire Headband working for certain symptoms, compared to others, and the headband's technology has gone through multiple clinical trials, and is continuously undergoing additional ones, assessing its effectiveness against a range of clinical endpoints.

The physical and psychological symptoms that the Samphire Headband is designed to address all manifest as brain activity. The Samphire Headband has different modalities that target different brain regions. One, aimed at addressing physical symptoms, is designed to target the way the brain reacts to and processes pain signals. The other, aimed at addressing psychological symptoms, is designed to modulate the way the brain’s cognitive centres work.

Yes, extensively. We have run more than two years of tests on the Samphire Headband itself, and this builds on decades of research into the underlying neurotechnology and its mechanisms. These tests range across safety, efficacy, ergonomics, and more. We are actively updating our website to provide further details on these trials, and there is high level information on our research page already. If you’d like to know more - please reach out.

No, the Samphire Headband does not have any impact on the hormone levels in your body and will not affect your menstrual cycle. The physical and psychological symptoms that the Samphire Headband is designed to address all manifest as brain activity in the dorsolateral prefrontal cortex and motor cortex.

The Samphire Headband uses a form of non-invasive neurotechnology to influence brain activity.

It does this by applying light electricity to specific parts of the brain using well-known and validated technology from the fields of depression and chronic pain treatment.

We, like you, are frustrated by the lack of research and effective solutions for chronic women's health conditions. Endometriosis - experienced by 1 in 10 women - is high up on that list. One of the landmark symptoms of endometriosis is serious menstrual pain - commonly know as dysmenorrhea.

The Samphire Headband is not intended to cure any conditions. However, while the Samphire Headband does not treat endometriosis, it is intended - once approved - to help manage one of its most debilitating symptoms - that of menstrual pain, making the life of women with endometriosis easier.

So far, women with endometriosis are common among our early testers, and say their lives are much better once they have an option of drug-free pain management, which also helps them with mood management during PMS.

At launch, we'll provide our exclusive waitlist members the opportunity to confirm that the Samphire Headband, as approved, is an appropriate medical treatment for them.

Premenstrual dysphoric disorder (or PMDD) a serious condition that - like much of women's health - has been largely ignored by research, clinicians and solutions for too long.

PMDD is a complex condition, with complex symptomatology, and women with PMDD do not necessarily have the same symptoms or experiences.

The Samphire Headband has been designed specifically with women in mind who have certain types of PMDD symptoms. Examples of such symptoms are low mood, irritability, anger management, mood instability, and cravings, however we will confirm the exact list prior to launch of the Headband, upon approvals.

So, if you have PMDD - the Samphire Headband may be the first solution on the market working to alleviate your symptoms, while designed to fit with your life. We'd encourage PMDD sufferers to sign up to our waitlist, and we'll keep you up to date.

At launch, we'll provide our exclusive waitlist members the opportunity to confirm that the Samphire Headband, as approved, is an appropriate medical management solution for them.

Women's health problems have been misunderstood and ignored for too long.

We know how hard it is to receive appropriate diagnoses in this area, and we're working to make FireBand available to everyone who needs it. At launch, we intend to make the Samphire Headband available for the amelioration of certain symptoms associated with PMDD, PMS and menstrual pain, including without a formal clinical diagnosis.

If you feel cognitive symptoms of PMS on the days leading up to your period, such as low mood, mood changes, irritability, anger, and cravings; and/or you feel menstrual pain that impacts your wellbeing during menstruation - the Samphire Headband may be for you. At launch, we'll provide our exclusive waitlist members the opportunity to confirm that the Samphire Headband, as approved, is an appropriate medical treatment for them

If you feel cognitive symptoms of PMS that seem to be cyclical, such as low mood, mood changes, irritability, anger, and cravings - FireBand may be for you. Sometimes, women on hormonal contraception or otherwise experiencing amenorrhea - missing periods - may still get cognitive symptoms associated with hormonal fluctuations. However, those cycles may be a bit different than their normal "period" cycles.

We intend for the Samphire Headband, once approved, to help manage those cyclical symptoms. The Samphire App will learn alongside you about your symptom's predictability, making management easier over time.

You control the Samphire Headband through the Samphire mobile application on your phone, using Bluetooth. The Samphire application will launch later this year. It will give full control over the headband and help you see your progress over time. The application integrates with cycle tracking, allowing you to create personalised schedules and routines, learn about symptoms over time, and improve predictability.

No. In fact, the Samphire Headband is currently unavailable to purchase. We are unable to offer the Samphire Headband for purchase, or otherwise place it on the market, until it has been approved for sale by the competent authorities.

However, joining the waitlist does guarantee you a first assessment of whether the Samphire Headband, once approved, is an appropriate solution for your needs.

At the time of launch we estimate FireBand to cost £449. Our ultimate mission is to make the Headband accessible to all users, and the more women and individuals assigned female at birth who purchase the Samphire Headband the more affordable it will become.

No. Joining the waitlist is not the same as purchasing the Samphire Headband. As the Samphire Headband will be a medical device, it can only be purchased and used by those for whom it is appropriate, after it has been approved by the competent authorities. Waitlist members will have the first opportunity to assess whether the Samphire Headband is suitable for them.