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Hormonal health

Understanding the contraception crisis

How the one-size-fits-all approach fails women and why it has to change

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Finding the right contraception method shouldn’t be trial and error, says Elena Rueda Carrasco. She tells FemTech World why understanding contraception is more important than ever. 

“Despite encouraging research, a male birth control pill remains elusive,” reads a recent headline in The New York Times.

Although, according to the article, scientists have been researching ways to create a male birth control pill since the 1970s, negative side effects, such as weight gain, acne, irritability and mood swings, have been responsible for not licensing any products for use.

“A woman can struggle with the same symptoms in silence – something rather normalised in our society,” says Elena Rueda Carrasco, medical scientist and co-founder and CEO of Dama Health, a company that offers personalised contraception recommendation. “Many women are being told from a very young age that the pain they are experiencing is normal,” she adds.

Indeed birth control side effects, such as weight gain, mood changes and headaches, affect eight in ten women, but are yet deemed too dangerous for developing a pill for men.

“The side effects and the impact of different contraception methods on women have been very normalised when you compare it to other areas of medicine,” Rueda explains. “In a lot of cases, women end up with conditions like endometriosis and PCOS – polycystic ovary syndrome – because their symptoms are often ignored and early diagnosis is not achieved.”

Elena Rueda Carrasco, co-founder and CEO of Dama Health

Figures suggest that medical consultations are too short to offer the right guidance and on average, women try 3.5 different contraceptive methods before finding the one that works for them.

“In the UK, we have such a fragmented [health] system,” the co-founder says. “As a woman, you can get your contraception through your GP, you can go to a sexual health clinic, you can speak to a nurse or a pharmacist. And from our own research, we found out that for many women, this is very confusing.

“Most of the time women will probably call or visit their GP and the GP is actually not a specialist,” Rueda points out. “The GPs are doing a bit of everything, with just a couple of contraception methods they’re comfortable prescribing. Therefore, communication is really hard when you have this fragmentation happening and you don’t really know where to go and who to speak to”.

Dama Health aims to personalise and tailor the way women are being prescribed contraception, screening for and identifying the side effects that women might experience individually. An algorithm would then match them to the recommended contraceptive options that are most suitable for them.

“As a team, we are all scientists and doctors by background, and we were all experiencing this problem of trial and error in the way that women were being prescribed hormonal medication and in this specific case, contraception,” the CEO says.

“I think it all came from personal experience and we all felt that it was an issue. Our chief medical officer, Dr Aaron Lazorwitz, is an OBGYN doctor and he experienced it in clinic, whereas myself and Paulina Cecula [her co-founder] experienced it as women. Paulina is also a medic and she was seeing that actually, doctors were having difficulties and the whole thing ended up being like ‘try this and come back if there’s a problem’.

“We thought that there’s a huge inefficiency [within the system] in this day and age. Women shouldn’t be having to trial and error to find if something is good for them,” Rueda adds. “So that drove us to start doing screening tests, making everything a lot more personal and helping the medical community to make the best decisions when it comes to contraception methods.”

She says that at the heart of this, education and communication are extremely important. “Women and young adults need to be educated around the topic of contraception better,” the CEO says.

“Women especially feel unable to verbalise how they feel, they can’t actually communicate it. So part of our solutions through the screening process, is to ask the right questions that help women understand their bodies and have a better conversation with their doctor.

“For that reason, I think personalised medicine is the future because actually, this one-size-fits-all approach isn’t working. When it comes to medication, you really do need to get that personalisation because the inside of us is so different and so unique.

“With technology becoming cheaper, we have the tools and the ability to make it more personalised and that essentially means taking into account medical history, preferences, maybe some biomarker information and just putting them together to be able to tailor the right treatment option.”

Experts like Rueda believe that very often huge amounts of data are being lost because of a lack of a data tracking system and that subsequently, makes the entire research process harder. “A doctor doesn’t tell you ‘Hey, try this contraception and tell me how you feel’ and actually write a report on it,” she explains. “That information is, therefore, not being captured. That’s dangerous because so much information is not being taken into account.”

But how could data tracking help the medical world? “A doctor is always going to use quantitative and qualitative data to make decisions, so symptom-tracking is one of the most powerful things that we can do as patients,” Rueda adds. “Data has so much power because it helps you essentially prove your point in an argument and is the fastest way to get information and to accelerate research.”

Walking into the clinic, as a woman, and feeling empowered is something that the CEO would like to see in the future and she also hopes that her company will support all women equally.

“The most important thing [for Dama Health] is to be able to be as accessible as possible and help women from different backgrounds. That impact is really important for us and also just working with the medical community and trying to implement our screening tests that could be easily accessed by anyone.”

The team will also be recruiting for beta testers and clinical in Q4 of 2022. If you are UK-based, you can sign-up here to be part of future clinical trials and research programmes.

For more info, visit damahealth.com.

 

 

Hormonal health

US virtual abortion clinic to launch new reproductive health services

Women will be able to access the same FDA-approved medications they get from their doctor directly from home

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The US virtual abortion clinic Hey Jane has announced it will expand its reproductive and sexual health services to improve women’s access to healthcare at home.

The company will start offering vaginal infections treatment including UTIs, yeast infections, bacterial vaginosis and herpes both oral (HSV1) and genital (HSV2), birth control, and emergency contraception.

The clinic says women will be able to access the same FDA-approved medications they get from their doctor or local clinic directly from home.

After completing a quick intake, they will be connected to a provider through Hey Jane’s messaging platform, where they will be able to consult with clinicians via text, phone, or video.

“We have already earned the trust of tens of thousands of patients seeking medication abortions to help them with one of their most intimate health care needs, and are passionate about applying that same patient-centred approach to other equally important areas of reproductive health,” said Alyssa Wagner, Hey Jane’s medical director.

“We believe the best person to make decisions about their body is the patient themself. Our goal is to empower our patients with the knowledge and tools to prioritise their reproductive and sexual health and give them the support and prescriptions they need to do just that.”

The company says it is committed to making its services as safe, discreet and affordable as possible, partnering with select insurances for birth control and infection consultations and emergency contraception, as well as offering a sliding scale payment option for those paying out of pocket.

Kiki Freedman, co-founder and CEO of Hey Jane, said: “When we started Hey Jane, we were addressing one of the most critical health care needs: abortion.

“Along the way, we’ve listened to our patients and witnessed firsthand the deteriorating state of reproductive and sexual healthcare in our country.

“We knew it was time to help expand access to other crucial services while continuing to provide the care patients deserve.”

Hey Jane’s expansion of services is currently available in 11 states, with plans to launch in more states throughout 2023.

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Hormonal health

Femtech start-up OCON Healthcare reaches recruitment goal for study evaluating treatment for heavy menstrual bleeding

The company’s currently ongoing Phase IIb pre-pivotal clinical study assesses the safety and efficacy of the IUB™ SEAD

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OCON Healthcare, a women’s health company which develops, manufactures and commercialises an innovative 3D intrauterine drug delivery technology based on its patented IUB™ (Intra Uterine Ball) platform, has announced it had reached its recruitment goal of its Phase IIb clinical study evaluating its revolutionary IUB™ SEAD®, a non-invasive treatment for heavy menstrual bleeding.

OCON’s IUB™ SEAD is a disruptive non-invasive treatment for HMB, designed as an alternative to the traditional hormonal medication and/or aggressive and irreversible ablation procedures that are typically performed in the hospital, are non-reversible and remove the women’s chances for later pregnancy, requiring hysterectomy procedures in up to 25 per cent.

HMB is a prevalent medical condition affecting one in three women during reproductive age, causing heavy irregular bleeding from the uterus resulting in a significant decrease in their quality of life, fatigue, depression and can lead to iron deficiency, related anaemia and in acute and severe cases, can necessitate emergency medical care.

It is the fourth most common reason for an OB-GYN visit and has significant indirect costs associated with it, such as missed work or school days, decreased productivity, and increased healthcare utilisation.

Globally, the cost of HMB is estimated to be in the billions of dollars annually, highlighting the need for better solutions and management strategies for this condition.

“More women and doctors are looking today for innovative and simple solutions to treat HMB,” said Professor Sergio Haimovich, chief medical officer at OCON Healthcare.

“The IUB™ SEAD solves this medical condition with no need for irreversible ablation techniques or hysterectomies.

“This ground-breaking technology already made a positive impact on women’s lives and we are certain we will see more of it during our clinical studies in the near future.”

“The treatment with SEAD was so quick without any pain. It gave me my life back,” reported one SEAD study participant.

“I can finally leave the house without a second set of clothing after only one month.”

Keren Leshem, CEO at OCON Healthcare, added: “It breaks my heart to see so many women normalise and suffer, and even endure hospitalisation due to anaemia resulting from their heavy periods.

“It is incredibly rewarding to be part of a clinical study with one simple 30-minute procedure in the doctor’s office, that provides hope and relief to these women, and we will continue to strive towards improving their quality of life.”

The in-office procedure has been completed in over 35 women to date demonstrating safety, efficacy and significant reduction in bleeding without side effects, avoiding the need to undergo invasive uterine ablation procedures or even a hysterectomy.

Results from the company’s earlier PhIIa clinical trial showed significant reduction in bleeding of 83 per cent with 95 per cent reported quality of life satisfaction and mild pain scores (≤2 of 10).

As far as OCON is aware, the global HMB surgery market is expected to reach US$1.3bn by 2024, with 1.4 million women per year who report HMB.

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US telehealth platform secures US$7m to ‘transform’ OB-GYN care

A telehealth approach could modernise OB-GYN services in the US where 75 per cent of women are dissatisfied with their care

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Tara Raffi and Carly Allen, Almond co-founders

The telehealth platform Almond has raised US$7m in seed funding to modernise obstetrical-gynaecological care.

Almond, a California-based women’s health company, aims to offer telehealth and flexible office visits on topics such as pregnancy planning, birth control counselling, infections, period management, sexual health and general wellness.

Evidence suggests that telehealth provides comparable health outcomes when compared with traditional methods of health care delivery without compromising the patient–physician relationship and could enhance patient satisfaction and improve patient engagement.

Obstetrician–gynaecologists and other physicians who practice telehealth have to make sure they have the necessary hardware, software and reliable, secure internet connections to ensure quality care and patient safety.

Adopting such an approach would modernise the OB-GYN care system in the US where 75 per cent of women are dissatisfied with their care, according to a 2020 report published in the Commonwealth Fund.

The specialty is the second-largest specialty by spend, right after primary care.

“The patient experience today is slow, it’s incomplete, and ultimately it’s delivering not great outcomes,” co-founder Tara Raffi, told TechCrunch.

“We are under-delivering as a country. Almond is coming in and modernising the OB-GYN office.”

Users will be able to purchase an annual subscription that will give them access to the company’s platform, care team and personalised plans.

Prior to the appointment, patients have to fill out a health questionnaire detailing the reasons for their visit. They also have the possibility of scheduling next-day telehealth appointments if they can’t attend in person.

The average cost for a general OB-GYN visit in the US can range anywhere from US$90 to US$500, according to UCLA Health.

Almond aims to make care more affordable and extend its services to include abortion and reproductive care, following the Supreme Court’s decision to overturn Roe v Wade in June.

“The overturning of Roe is a reminder that women still aren’t given the right to be decision-makers of their own bodies. That is infuriating,” said Raffi.

The round led by True Ventures will help the company grow the practices’ staff and develop and expand its platform.

Last month, the US telehealth platform Wisp also announced expanding its abortion care services, becoming the largest, most accessible medical abortion provider in the country.

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