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Can metastasis prevention save breast cancer patients?

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Femtech World meets the Swiss company on a mission to enable optimal breast cancer treatment and make lasting metastasis prevention a reality.

Breast cancer is the most common cancer in the UK and the second most common in the US after skin cancer. The American Cancer Society suggests that in 2022 about 287,850 new cases will be diagnosed in women and other 43,250 women will die from breast cancer.

Additionally, studies have shown that an increasing number of patients are not getting the right treatment during therapy.

“Despite molecularly precise cancer tests, we have a situation where more than 50 per cent of the women diagnosed with breast cancer [in the US and Europe] are either under-treated or over-treated,” says Wolfgang Hackl, oncology scientist and founder of OncoGenomX – a Switzerland-based company that aims to create a treatment guidance software against breast cancer.

Their first product, PredictionStar, uses AI and machine learning algorithms to determine the correct cancer treatment regimen for permanent prevention metastasis. The tool essentially interprets the results of clinical and histological image assessments, tumour and blood gene tests and helps oncologists to find the optimal treatment with predictable outcomes.

“The solution that we have developed consists of four components,” Hackl explains. “Firstly, proprietary markers help us to type individual tumours and based on diagnostic properties. Then we have two types of AI-based software: one meant to achieve individualised drug-tumour matching and the other used to make outcome predictions. Lastly, we have a feedback learning solution for the continuous refinement of PredictionStar-guided therapy decision guidance.

“But we don’t leave things at predictions,” the oncologist adds. “We offer the decision-makers real-world outcome data, so that they don’t need to rely on predictions coming out of a black box. They can see recent clinical data from patients who have been treated, based on PredictionStar guidance, what the outcome was and then, they can make an informed decision.”

Hackl says that this is a move from a very “mouse-centric approach”. “We’ve been very good at mice and drug development, but not necessarily at curing patients,” he tells me.

“Current tests are very good at determining, whether a tumour is eligible for certain treatments. These tests, however, cannot predict, whether treatments will also be effective. PredictionStar predicts the effectiveness of treatments with an accuracy of 85 per cent, thus, taking oncology a step closer to the theoretical ideal of evidence-based precision cancer treatment.

“Currently, doctors and patients can learn if the tumour will be eliminated only during the treatment journey,” he continues. “The longer the tumour stays away, the higher the confidence in the treatment decision.

“The advantage of our approach is that doctors and patients would know that there’s a significant high chance the treatment will be effective before the start of the therapy, taking away the uncertainty and the randomness of treatment decisions. Imagine what this would mean for the quality of life of patients.”

Determining the optimal treatment option will not only reduce the risks of over or under-treatment for patients, but it will also diminish the costs on healthcare systems.

“Per year Europe and the US spend over $20B on breast cancer treatment. We are at the very beginning, but we think that consistent use of PredictionStar will incur significant cost savings,” Hackl points out.

The founder adds that: “In one year and a half from now we hope we’ll be ready to offer our services to pharmaceutical companies and drug developers and in two years, if everything goes by plan, we should be in a position to offer the service to cancer hospitals.”

However, stigma around medical patient data still exists. Scepticism about the supposed benefits of data sharing, fear of being disadvantaged and little confidence in data security are just a few of the reasons why some patients avoid such platforms.

“This is certainly something we still see in many countries,” says Hackl. “But we, as a company, never see the data. It will only be exposed to the algorithm. This is a very conventional approach which is used with great success and meets the requirements for the protection of data rights.

“Artificial intelligence and machine learning are widely recognised as a transformative healthcare innovation. However, unless introduced thoughtfully there are risks such as automation bias and over-dependence, in addition to already well-documented generic risks associated with AI, such as data privacy, algorithmic biases and corrigibility,” he continues. “We are fully aware of these risks and will undertake adequate measures to ensure that clinicians retain autonomy over the diagnostic and therapy decision making processes.”

The company has already analysed data from more than 4,500 patients and four trials and has very high ambitions for the future. “We are very confident and we hope to get one step closer to the theoretical ideal of what it means to practice precision diagnosis and medicine as the core of personalised cancer care,” adds Hackl.

“But in the medical area, you always have to prove that your claims are the results of a well-designed, prospective clinical trial. And that’s why we’re here for.”

For more information, visit oncogenomx.ch.

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‘We need to disrupt the system’- the founder redefining maternal health outcomes through ultrasound technology

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Blanca Lesmes, co-founder and CEO of TeleScan

The use of ultrasound in pregnancy is vast and has become the standard of care during pregnancy.

Ultrasound scanning machines have become central in the management of the problems of early pregnancy, particularly but not exclusively in the management of women after assisted conception and those with a high risk of miscarriage.

But despite the increasing importance of this imaging technique, the United States is struggling with a shortage of sonographers.

A study published earlier this year found that from 2011 to 2021, the increase in the number of ultrasound exams has significantly outpaced the increase in the number of sonographers.

Furthermore, the increase in demand for sonographers has grown significantly faster than the supply, leading to a shortage and consequent strain on the healthcare system.

To address the shortage, the study suggested that the number of sonography school openings should be increased and the attendant challenges addressed.

While these measures could help, they don’t address a bigger problem, namely performing ultrasounds more effectively and conveniently.

Blanca Lesmes, co-founder and CEO of the telesonography provider TeleScan, says the missing piece is innovation.

“Women’s health has traditionally taken a back seat,” Lesmes tells Femtech World. “When you look at investment dollars globally, the money is not there. It’s an unfortunate state of affairs, but it’s true.

“The way ultrasound is delivered has not changed since it started back in the 70s. However, if we want to have different outcomes for women we need to disrupt the system.”

Improving health outcomes through innovative ultrasound technology

Disruptive thinking, Lesmes says, is key to bringing high-quality prenatal ultrasound care to patients. She believes that focusing on increasing accessibility to maternal health services, like prenatal ultrasounds, would in turn solve the shortage of sonographers and ensure better patient outcomes.

“Most women do want to see their foetus, they want to have that experience. However, if they live in areas that are underserved by specialised healthcare professionals or they have limited access to healthcare facilities, they are less likely to show up.

“By putting a software like TeleScan as close to them in the community as possible, we can enable medical professionals to perform diagnostic ultrasounds remotely, identify high-risk pregnancies and intervene early.”

The winner of this year’s Femtech World Maternity Innovation award, TeleScan is an ultrasound delivery software that allows for remote ultrasounds to occur anywhere.

The tech-enabled solution connects healthcare facilities with remote perinatal sonographers, making ultrasound more accessible and helping providers identify high-risk pregnancies.

“TeleScan allows health professionals to be able to hold a probe with couple of days of training,” explains Lesmes.

“We’re not asking them to be able to do an ultrasound; we’re doing the ultrasound remotely. We essentially capture video clips at the patient bedside but do all of the diagnostics remotely.”

The software, currently set up to serve OB practitioners, family practice providers, radiologists and maternal-foetal medicine specialists, has been shown to reduce examination and report turnaround times, allowing professionals to see more patients and decreasing the time until the next available appointment.

“We’ve served over 2,000 patients and we are seeing the impact,” says Lesmes. “I think for me it wasn’t surprising that we saw the outcome shift but it was surprising that we saw it shift that fast.

“We’ve even had interest from providers from Pakistan, India, Morocco and Brazil. It’s incredible.”

With nine locations already secured in the US, Lesmes and her team are now working to reduce the costs to make the model sustainable globally.

“We are working with Philips and the March of Dimes on a project where we hope we can package more of the remote monitoring piece of it,” the co-founder explains.

“Serving the underserved is not just good for business, but good for our greater human community and if we’re going to have a global impact, we know we have to be at the heart of the community.”

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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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