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Intrauterine Ball: The next generation of ‘smart’ hormone-free IUDs

Intrauterine drug-delivery technology aims to improve women’s health and quality of life with ball-shaped device

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Ocon's IUB Ballerine device

The Intrauterine Ball can be both a contraceptive device and a carrier for multiple drugs to the uterus to treat a variety of conditions. Daniela Schardinger, Ocon’s VP marketing and medical affairs, tells FemTech World how the device could decisively change the IUD market. 

The first intrauterine device (IUD) was developed in 1909 by the German physician Richard Richter. After the increase of IUD use in the United States in the late 1950s, physician Howard Tatum determined in the 1960s that a T-shaped copper IUD would work better with the uterus shape.

“60 years ago, the tools and technology gynaecologists used were completely different than what we have today,” says Daniela Schardinger, Ocon’s VP marketing and medical affairs.

Schardinger has been working in women’s health for over 10 years and says that up until recently, the idea that the uterus is a flat organ was widespread. “Within a flat triangle, it made sense to put two dimensional devices,” the VP explains.

“But after learning that the uterus is, in fact, a three-dimensional cavity, we realised that traditional two-dimensional devices with designs that don’t fit well can cause issues such as pain, bleeding, perforation and malposition.”

A three-dimensional, ball-shaped device seems, therefore, a much safer and flexible option that maintains its shape and adjusts to contractions.

The intrauetrine ball (IUB) Ballerine, a copper-based hormone-free intrauterine contraceptive, is Ocon’s first product. The IUB, effective for up to five years, has already been used by over 120,000 women in countries across Europe, South Africa and Israel.

“The idea was essentially to have a better fitting design that fits both women’s anatomy and lifestyle better, minimising side effects,” says Schardinger.

A lack of research along with a lack of funding have led to little to no innovation in the IUD market. Despite an increase in the use of IUDs globally, larger surveillance studies have provided new estimates about the risks of complications such as perforation, especially in postpartum and breastfeeding women, according to the Journal of Contraception.

“We don’t know enough about women’s anatomy and the female body,” Schardinger thinks. “If you look at studies done on IUDs or on most women’s issues, they were all completed more than 30 years ago. There’s not recent research and women, in general, were not included in health research enough.

“But there’s also a lack of tools and a lack of education. I think [the sector] needs a systemic change altogether, to allow women to become drivers of new research that’s so desperately needed.”

However, educational content is still very much limited. Schardinger says that getting the message across is made even harder by social media giants that block a large number of contraception-related posts.

“We don’t talk about these issues enough,” she points out. “That’s also one of the reasons why we see a certain level of distrust towards IUDs. It takes other women sharing their experiences and starting the conversation around intrauterine products. With any innovation, there are early adopters and those who might wait a little bit longer and see.

“What we did was to design the thinnest insertion tube that can minimise the pain of insertion, but also the size of the product itself, so that women who haven’t given birth yet can wear it as well.”

The IUB Ballerine has received positive feedback, with over 80 per cent of users recommending it. “We’re still in early stages,” the VP tells me. “We’re expanding and we’re trying to make it widely available, but it’s not always easy to get through. We’re not available in the UK yet, but we’re working towards reaching that market.”

Ocon is also working on developing and improving its platform. IUB Spherical Endometrial Ablation Device (SEAD) is a pain-free in-office solution in the treatment of abnormal uterine bleeding and heavy menstrual bleeding the Israeli company wants to push forward.

“Procedures currently done in hospital are very, very invasive and painful,” says Daniela Schardinger. “With the SEAD we’ve seen incredible results in our clinical studies. Our aim is to shape the future of women’s health, and bring more options that are less invasive, better fitted for women’s anatomy and adapted to their different life stages.”

IUB SEAD is also a cost effective option that involves substance-derived ablation –  a procedure to remove a thin layer of tissue lining the uterus – technology, moving away from hormones, aggressive procedures and hysterectomies.

Schardinger is excited about the future, adding that a new movement empowers women to start researching, asking questions and demanding solutions.

“Because there are so limited options, I think any new modern technology for women is a win for all of us. We are 85 per cent women in our team at Ocon and we’re all grateful for competition and for companies that bring products in this space,” she adds.

“We’re certainly not afraid of competition. I think every woman needs to have more than one choice and we should all be given more choices and alternatives.”

For more info, visit oconmed.com.

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The start-up on a mission to transform metastatic breast cancer management

More than two million women globally were diagnosed with breast cancer in 2022 alone

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One in eight women in the US will be diagnosed with breast cancer in their lifetime and one in 39 will die from it. Could this start-up have the solution?

Nine years ago, Hollywood actress Angelina Jolie announced in a New York Times op-ed that she’d decided to go public about her elective double mastectomy to “encourage every woman” to think about their own risk of breast cancer.

The article went viral and increased breast cancer awareness around the globe, leading to the so-called “Jolie effect”.

But while campaigns like this have changed the way we talk about breast cancer, they haven’t translated into better patient outcomes.

The World Health Organisation revealed that in 2022 the “burden of breast cancer” caused 670,000 deaths globally.

In the UK, one woman is diagnosed with breast cancer every 10 minutes, leading to nearly 1,000 deaths each month.

Survival rates have indeed improved in many parts of the world and diagnostic methods have come a long way in identifying a tumour’s molecular profile. However, questions remain when it comes to choosing the most effective treatment combination for a particular tumour or patient.

“Oncologists consider multiple factors to determine the treatment strategy: the patient profile, the clinical tumour stage, the pathological tumour grade, the molecular tumour profile, treatment guidelines and study results, and patient-specific contra- indications,” Wolfgang Hackl, translational oncology scientist and founder and CEO of OncoGenomX, tells Femtech World.

“But there is nothing to assess whether a certain treatment works in a specific tumour. Oncologists can only be certain about that after the entire treatment journey, which can take months, sometimes years.”

Without a tool to support clinical decision-making, doctors turn to risk-adapted approaches, extending moderate therapies for low-risk cancers and intensive therapies for high-risk cancers. But this doesn’t solve the problem, says Hackl.

“Many patients are still over-treated for fear of being under-treated,” the founder explains.

“In breast cancer, about 60 per cent of women receiving treatment are over-treated. These patients end up having side effects which means they have to stop treatment. When they stop treatment, they are at risk of recurrence.

“This applies to under-treatment too. Under-treating and over-treating patients can both lead to sub-optimal treatment.”

The solution, however, could be closer that we might expect. PredictionStar, a decision support technology developed by Hackl and his team at OncoGenomX, could potentially transform breast cancer drug development, diagnosis and outcomes, facilitating individualised therapeutic decisions at any stage of the disease trajectory.

Wolfgang Hackl, founder and CEO of OncoGenomX

The tool, which uses AI and machine learning algorithms, identifies whether a certain therapy works in a particular tumour and finds the treatments proven to be the most effective for each patient and their specific tumour.

“It harnesses four patent-pending core technologies,” says Hackl.

“The first technology is an innovative tumour profiling test, the second one is an individualised prediction model, the third one is a digitalisation tool for information sharing without migrating patient data and the fourth one is a reinforcement technology, which helps the algorithm learn from treatment decisions.”

As far as tumour gene tests are concerned, PredictionStar works with standard, unsupervised, or commercial target gene panels, not only expanding their scope but also raising the applicability of test results from an average 65 per cent to more than 80 per cent.

For the first time, Hackl says, oncologists will be able to understand which treatment combination will work the best for a patient and their tumour.

“PredictionStar takes away the uncertainty around breast cancer treatment decisions and increases the likelihood of opting for the most effective treatment combination without delay and without exposing the patient to the side effects of an ineffective treatment.

“The whole technology is designed as an instrument agnostic which can work with any other existing technologies to allow for seamless interactions, irrespective of the systems that already exist in hospitals.”

The fascinating part is that the tool has a feedback loop which means the technology improves, the more information it gets, refining its therapy guidance.

“This is dramatic if you think about it,” says Hackl. “The US, UK and European countries spend hundreds of billions on cancer treatment every year.

“However, data shows that in cancer R&D, the clinical failure rate is about 30 per cent, which means that one out of three phase three clinical studies fails.

“This is a problem because this is the part of the development which generates 70 per cent of the development cost. Based on the data we have, we believe PredictionStar could reduce treatment expenses by at least 20 per cent.”

At a time when healthcare budgets are being squeezed, this reduction would be significant.

“We tend to believe that healthcare costs are a problem of the poor economies, but richer countries struggle with high healthcare costs too,” Hackl points out.

“This is something that has become very clear in recent years. The way healthcare costs are incrementally increasing over time is not sustainable and needs to be addressed.”

With such impressive capabilities, it seems to be only a matter of time before the availability of robust patient data sets extends the scope of PredictionStar to other cancer types. Hackl doesn’t rule this out.

“Currently, we are focusing on breast cancer, but we are intending to roll this out in other cancer entities,” he says.

If everything goes according to plan, PredictionStar could be ready for use in clinical and translational studies in the next 15-18 months, the founder adds.

“OncoGenomX’s data on file suggest that PredictionStar is leading the game and we have good reasons to believe that it has significant potential to improve clinical and economic outcomes beyond today’s achievements.”

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Could an adhesive device be the answer to perineal tears? This start-up thinks so

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Ditte Marie Fog Ibsen, co-founder and CEO of oasicare

A new device promises to provide midwives with a “third hand”, substantially reducing perineal tears, but could it really work?

“Simply surviving pregnancy and childbirth can never be the marker of successful maternal healthcare”, the World Health Organisation concluded after a damning report revealed that 287 000 women died in 2020 during and following pregnancy.

While maternal mortality rates are down sharply from where they were 20 years ago, research by United Nations shows that progress toward reaching the UN’s sustainable development goal of reducing maternal mortality has stalled.

According to the United Nations Population Fund (UNFPA), every two minutes a woman dies because of complications due to child birth or pregnancy.

But maternal mortality is not the only problem – for every woman who dies, there are about 20 to 30 women who experience injury, infection, or other birth or pregnancy related complication.

“Maternal mortality is only the tip of the iceberg when it comes to maternal health,” says Ditte Marie Fog Ibsen, co-founder and CEO of oasicare, a medical device start-up based in Copenhagen.

“Maternal morbidity is the hidden base, predominantly featured by perineal ruptures.”

Perineal ruptures are extremely common and expected complications of vaginal birth. In the UK, about 85 per cent of women sustain some degree of perineal trauma during childbirth.

Multiple studies have found that some women who experience severe perineal lacerations suffer long term psychological trauma and social isolation. However, the stigma around the topic means that many feel too embarrassed to seek help.

“Postnatal care is mainly focused on women with higher grades of perineal ruptures, downplaying the impact of lower grade ruptures on woman’s quality of life,” says Fog Ibsen.

“Short, medium and long-term complications are fairly common but rarely acknowledged or prioritised in the global health landscape.”

‘Women’s tears are not properly assessed’

Fog Ibsen and her friend, Julia Sand, were working as industrial designers creating solutions for midwifes when they realised the scale of the problem.

“We were trying to help midwifes manage their work-related musculoskeletal symptoms when we came across a even bigger problem: perineal ruptures.

“At the time, we didn’t know much about it, but we knew we had to do something about it.”

The duo began researching the issue and came up with a single-use medical device designed to protect the perineum and reduce uterine ruptures.

The product, which is currently being tested in several hospitals in Denmark, is adhesive and acts like a protective layer that prevents ruptures during childbirth.

“We are essentially trying to replicate the skin so we can prevent ruptures, which tend to happen when the vagina and perineum stretch during birth,” explains Fog Ibsen.

“We’ve made it very simple so that it can be easily applied and easily taken off.”

The interesting part, she says, is that women don’t actually notice it.

“That’s a quite good thing because there’s a lot of attention on the birth. The midwifes were a bit worried initially about the adhesive and whether it could last and stick to different types of skin, but so far it’s been great.”

The midwifes have played a crucial role in the product development process, helping the oasicare team identify issues early on and improve the device.

“We relied on their knowledge to get the balance right so that in the future we can give the product  to people who don’t have the same level of experience, but can still use it to prevent ruptures.

“The product is very easy to cut in, for example, so that midwives can adjust it easily.”

Currently, the team is not allowed to disclose any details about the efficacy of the product but a study, which is expected to conclude later this year, will establish how much the device could reduce ruptures.

“If all the studies go well and we get good data from the hospitals we work with we could see the product on the market in 2025,” says Fog Ibsen.

Her goal, however, is to launch the device outside Denmark where, she says, women desperately need it.

“In Denmark, I think, the midwives are doing a great job, but in other parts of the world the situation is very different. Women’s tears are not properly assessed, which means that despite having suffered serious tears they are being told that everything’s just fine.

“Our goal is to make the product available in countries like India, where a lot of women would benefit from it. It’s a simple device, but it can have such a big impact.”

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Could this app change the way we live and work?

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Imagine a tool that could help women align their daily schedules around their menstrual cycle – it exists thanks to two passionate tech entrepreneurs and start-up co-founders.

Elina Vale, chief executive officer and Rustam Galiev, chief product officer, are on a mission to dismantle society’s 24/7 work culture and replace it with an “evidence-based” approach where women can thrive – regardless of the menstrual phase they are in.

The concept, also known as cycle syncing, is a way by which women adapt their health and lifestyle habits to fit the four phases of their menstrual cycle, namely menstruation, the follicular phase, ovulation and the luteal phase. During these phases, it is thought, women experience changes in key hormone levels that can affect their mood, energy and productivity.

The idea isn’t new. In fact, the practice was introduced by nutritionist Alisa Vitti in her book WomanCode in 2014.

What is new, however, is the way Vale and Galiev adjusted the method to suit women’s needs in the workplace. The founders developed an employee benefits platform that claims to combine science, coaching and artificial intelligence to help female employees improve their productivity and performance by working with their menstrual cycle. 

The app, they say, combines a to-do list, habit tracker, period tracker and mindfulness app in one tool.

“The way women’s menstrual cycle works is very different from the common nine to five routine that we, as a society, tend to prioritise. That’s what we are challenging at Essence,” says Vale.

“We aim to provide women with a tool that allows them to think [of what they could do] based on the phases of their cycle and not just in the traditional work routine.

“We are looking at things such as the type of activity that you do, the intensity, your workload and what your needs are to balance your performance and wellbeing.”

While there aren’t many scientific studies to support cycle syncing, evidence does show that hormone fluctuations affect energy, mood, appetite and sleep.

Vale says there is some research on how each phase of the menstrual cycle affects the types of activities women do. “We know, for example, that in the follicular phase it’s better to start new projects and in the luteal phase it’s better to wrap them up.”

She also says there is evidence to suggest that cultivating an inclusive workplace and actively supporting employees could improve their wellbeing and unlock their full potential.

“An inclusive workplace has been shown to improve motivation and engagement. The problem is that currently, everything in the workplace is structured in a ‘gender neutral way’, which is, by default, very male-focused. From our research, we know that most women don’t know much about their menstrual cycle, so they don’t look at the month through the four phases of the cycle.

“However, we are trying to change this perception and help women think differently.”

The end goal, the founder says, is to make employers prioritise menstrual health in the workplace and take women’s needs seriously.

“Most companies have mental health and wellbeing programmes in place – we think menstrual wellbeing should be a part of that too.”

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