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Home insemination makes fertility care more affordable for thousands ineligible for NHS treatment

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At-home artificial insemination sees increasing popularity, as only 32 per cent of the IVF cycles in England are covered by the NHS.

The medical firm Béa Fertility is preparing to launch an intracervical insemination (ICI) kit that can safely be used at home, aiming to make fertility treatment more affordable for those who can’t afford IVF.

ICI is a type of artificial insemination that involves inserting sperm into the cervix by using a cervical cap. Unlike IVF, when an egg is removed and fertilised with sperm in a laboratory, ICI is a less invasive process that does not involve any hormonal or injectable treatment.

Nicole Leeds, Béa Fertility chief marketing officer, said: “IVF is the tool that is used most often, but it is not needed by everybody and it can be very expensive and invasive. There’s also a hidden cost of it  because unless you live in a big city, it can be quite hard to access multiple clinics for appointments.

“That’s why our focus is to make infertility care more accessible and affordable, but keeping the clinical standard. We wanted Béa to offer everything that you need within a kit sent to your home.”

According to recommendations by the National Institute for Health and Care Excellence (Nice), the NHS should fund three full IVF cycles to women under 40 who have been trying for at least two years, and one cycle for some women aged 40 to 42.

Yet, according to a recent report, more than 80 per cent of NHS clinical commissioning groups fail to meet this guidance, forcing couples to go private, where the average cost of a cycle is roughly £5,000.

For those who can’t afford these costs, ICI is a much cheaper alternative. Recent data suggests that ICI has a pregnancy success rate of 37 per cent after six treatment cycles and the trust in this kind of treatment is constantly growing.

“With medical devices is all about being able to speak clearly and honestly about efficacy making patients aware of their options,” Nicole adds.

“One of the most important things is that we will have medical device regulation under the UK regulator,” she explains. “All of our evidence, procedures and manufacturing will be approved in the same way that a device used in a clinician’s office is approved.”

A future partnership with clinics across the country could mean that the ICI home kit would be directly recommended by doctors to those patients who can’t afford IVF.

However, a problem remains unsolved. The UK law for single people or those in same-sex couples means that they will not be eligible for this kit because sperm bought from a sperm bank must be processed through a private fertility.

Nicole explains that unless the law is changed there is little companies can do. “Making sure that all couples can build the family they want is very important to us, but so is obeying the laws of the country that we operate in,” she adds.

“We are actively trying to help people understand fertility better and we are exploring making care accessible to everybody.”

The kit is set to launch later this year and will be priced between £250 and £300 estimated to be around five times cheaper than one round of IUI. The price includes two artificial insemination devices, as well as 20 ovulation tests, a few pregnancy tests and two semen containers.

For more info visit Béa Fertility.

 

 

 

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Fairtility’s AI decision-support tool granted CE mark under new MDR

CHLOE EQ™ is the first AI-powered tool for embryo classification and selection to achieve CE MDR approval

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Fairtility’s AI decision-support tool CHLOE EQ™ has earned the CE Mark under the European Medical Devices Regulation (MDR) regulatory requirements and is now commercially available to fertility clinics across Europe.

CHLOE EQ™ is an AI decision-support tool that was developed to provide embryo viability assessment which supports the prediction of blastulation, the prediction of implantation and ploidy and ranks embryos in order of priority.

It provides automatic annotations for morphokinetic and PN count which support fertilisation assessment.

According to Dr. Cristina Hickman, Fairtility VP of Clinical Affairs and leading embryology expert, embryo evaluation and selection has traditionally been a manual process, limiting patient access to treatment while also opening the door for human error.

“One of the key advantages that CHLOE EQ™ was designed to offer is accuracy and consistency in assessment,” she adds. “CHLOE’s proprietary AI-based algorithms become more accurate the more data it gathers, leading to uniform and accurate embryo assessment.”

The information provided by CHLOE EQ™ can then assist embryologists and IVF professionals in the decision of prioritising the most viable embryo for treatment, especially when there are multiple embryos deemed suitable.

The tool is designed to add efficiency to embryologists’ workflow, automating manual steps, including annotation of each embryo and written daily observations into each patient’s electronic medical record (EMR).

Embryologists verify the system’s automatic annotations that are then immediately integrated from the Time Lapse Incubator (TLI) directly into the EMR.

Eran Eshed, CEO and Co-Founder of Fairtility, says that: “Having gained regulatory acknowledgement in Europe, under the more stringent directive that the CE MDR provides, we are now commercially launching CHLOE EQ™ in clinics across the EU while continuing to uphold the highest standard of this classification.

“With the EU IVF market size estimated to reach over $2 billion by 2027, we see tremendous opportunities to demonstrate the clinical efficacy and impact of CHLOE EQ™ ahead of US market entry.”

The European MDR came into effect in May 2021 and serves as the new European legal framework for medical devices. MDR has more stringent requirements for demonstrated compliance, vis a vis the obsolete Medical Device Directive (MDD), the previous industry standard.

Fairtility is showcasing CHLOE EQ™ at the 38th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE), taking place in Milan Italy from July 3-6, 2022 with five oral presentations and seven posters supporting the clinical impact of the product.

In vitro fertilisation (IVF) is the most effective form of assisted reproductive technology. Due to the complexity of the procedure, however, prediction of embryonic implantation prior to IVF is key in decision-making.

The Israeli software company Fairtility aims to maximise IVF outcomes by using AI and computer vision algorithms to provide early, data-driven embryo quality.

For more info, visit fairtility.com.

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True Wealth Ventures raises US$35m to back its gender-diversity strategy

The Austin-based venture capital firm invests in companies improving human and environmental health

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General partners, Kerry Rupp and Sara Brand

True Wealth Ventures has announced the close a US$35m Fund II, focusing on investing in women-led companies.

True Wealth Ventures’ investment thesis is that women-led companies perform better financially, yet remain an untapped market.

Just 2.3 per cent of total capital invested in U.S. venture-backed start-ups in 2021 went to companies solely founded by women, and only 14.8 per cent of that capital went to companies co-founded by women, according to a May PitchBook report.

“While our primary mission continues to be getting early-stage capital to female founders whose core value proposition is improving environmental or human health, our secondary mission has been to facilitate more women investing into this asset class as LPs – limited partners,” says Sara T. Brand, True Wealth Ventures founding general partner.

“We not only believe this is the fastest way to change the gender inequality in the VC ecosystem, we also believe it is critical for our country’s innovation economy with the wealth shifting to women.”

Fund II will invest across the spectrum of software, hardware and consumer packaged goods start-ups. First checks typically range between US$500,000 and US$1m. True Wealth Ventures LPs often co-invest an additional 50 per cent on top of the Fund’s investment, with total rounds most often ranging up to US$3.5 to US$4m.

True Wealth already has already made investments from Fund II since its first close in May 2021, including Flourish, a start-up headquartered in Austin, Texas, which educates women how to build sustainable habits in nutrition, hydration, sleep, stress, relationships and movement.

The firm intends to invest in 15 companies from Fund II. Those start-ups must be women-led, meaning at least one woman with significant decision-making power must be on the founding or executive team.

About 80 per cent of U.S. assets will be controlled by women by 2030, but women largely are not active in investing in VC funds today.

“Investing in women-led companies personally resonates with women who know their peers have potential and should be backed much more than a mere 2.3 per cent,” says Kerry Rupp, True Wealth Ventures general partner.

“There’s a feeling of, ‘If not us, then who?’ Women are twice as likely to invest in companies that will have a positive social impact, and 10 times as likely to invest in companies with diverse teams.”

Brand and Rupp posit bringing more women to invest as LPs likely will pave the way for more women general partners to join the investment-decision-making VC table to ultimately fund more women entrepreneurs.

About 2.4 per cent of investment decision-making partners at VC funds are women. True Wealth Ventures emphasises that women accredited investors should have the opportunity to benefit from financial gains yielded by investing in venture capital. However, most are not invited to invest.

A majority of True Wealth Ventures Fund I women LPs, including the general partners themselves, previously had never had been invited to invest in a VC fund, according to a survey conducted by the firm.

The venture capital firm also believes that women are more likely to back femtech and silvertech companies than their male counterparts, presumably because the latter have less first-hand experience with the problems and opportunities in those sectors.

True Wealth Ventures Fund I has invested in 12 companies, all of which remain active.

For more info, visit truewalthvc.com.

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The Irish start-up on a mission to help women navigate menopause

identifyHer’s medical device will be able to monitor menopausal symptoms and help clinicians give a better diagnostic

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Heidi Davis, co-founder of identifyHer

Disease prevention means data. Heidi Davis, co-founder of the Irish start-up identifyHer, tells FemTech World why a medical wearable device is essential in understanding menopause and predicting future disease. 

The effect of menopausal symptoms on women’s future health is rarely talked about.

In the UK and Ireland, 3.7 million women are experiencing  symptoms that negatively affect their lives during perimenopause and menopause and untreated, such symptoms can lead to chronic diseases.

“Understanding menopause is extremely important to assess the future risks of disease,” says Heidi Davis, co-founder of identifyHer. The Irish digital health company focuses on predictive health services for women going through menopause, guiding personalised management of menopausal symptoms.

“When we started, we realised that nobody knew anything about menopause and that there was no real objective data to understand this life stage,” the co-founder explains. “So, we looked at a range of symptoms that we believed we could capture with a wearable sensor that could identify those physiological changes.

“We collected data from women who were going through menopausal symptoms and we understood that they are the ones who are looking for this information, who need this information and who are desperate to understand what’s going on.”

Along with the American manufacturing company, Analog Devices, the identifyHer team is developing a medical device that uses AI-enabled technology to capture physiological signals and personalise the management of menopausal symptoms to reduce the risk of disease in the future.

“The symptoms women experience [during perimenopause and menopause] can overlap with other symptoms that happen in daily life,” Davis points out.

“For that reason, clinicians find it hard to diagnose and give treatment because they don’t have diagnostic tests that can give a clear image. So, our mission is to help them differentiate those symptoms and provide objective data.”

The identifyHer tracker, which can be used from perimenopause onwards, sits under the breast and is activated by an app. The wearer goes about their business as normal and they will get daily, weekly, and monthly reports on their menopausal symptoms and lifestyle data.

The woman will wear the sensor for three months to track her symptoms and the data collected during that time will be used to initiate or evaluate the treatment she is already on.

The device will not only save clinicians time, but it will also offer them a better diagnostic tool and help them improve and change the treatment accordingly.

“Managing those symptoms correctly can actually set women up for a better future post-menopause because the severity and the frequency of the symptoms themselves are indicators of future risk of disease,” Davis adds.

“Women who seek medical help will be offered our solution and get remote monitoring of their symptoms while clinicians can use it for diagnosis and treatment.”

The device will be regulated both for cybersecurity and data protection and it will first launch in the UK and Ireland, followed by the EU and the US. The company will be working with health insurance companies on a paying claim policy and hopes that with time, the tracker will be integrated into the national healthcare systems.

“It’s been great to be working in women’s health,” the entrepreneur tells me. “It has been challenging, but the overall experience was good.

“We are hoping to close a round of €2.2 million by the end of this year and our aim is to become the gold standard in clinics to diagnose and help women get the right treatment. So far, we’ve had some good conversations and we are moving forward.”

Before we wrap up our Zoom call, I ask Heidi what is her biggest achievement since establishing identifyHer.

“Building the team. We wouldn’t be where we are now, if it wasn’t for the people that have helped us along the journey. It took us a long time to find them, but we knew they were the right people straight away.

“I hope we can continue growing it with as good people as we have now.”

For more info, visit identifyher.ai.

 

 

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