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Postpartum depression digital therapeutic shows positive results in clinical trial

Postpartum depression is thought to affect more than one in every 10 women within a year of giving birth

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Curio Digital Therapeutics has announced positive clinical trial data for its postpartum depression digital therapeutic.

MamaLift Predict is a validated algorithm that has demonstrated success in identifying and stratifying women at risk for postpartum depression.

SuMMER, a study executed by HITLAB, assessed MamaLift Plus for eight weeks in 141 patients using the Edinburgh Postnatal Depression Scale (EPDS).

The EPDS is a clinically-validated tool that healthcare providers use to evaluate, diagnose, and monitor depression in pregnant and postpartum women. Scores 13 and above indicate depressive illness or a high risk of developing a depressive disorder.

Patients involved in the MamaLift Predict trial had baseline EPDS scores 13 and above but not exceeding 19, and a confirmed diagnosis of postpartum depression prior to enrollment.

The SuMMER study found that patients treated with MamaLift Plus showed a four or more points improvement in their EPDS scores. An improvement of four or more points is considered clinically meaningful.

Preliminary results indicated that approximately 83 per cent of participants in the intervention arm achieved a four or more points improvement in EPDS score, compared to only 22 per cent in the control arm.

Professor Stan Kachnowski, principal investigator and HITLAB chair, said: “We are excited to see the data on this critical research endeavour.

“The positive results from the SuMMER trial underscore the efficacy of MamaLift Plus to address postpartum depression and improve the lives of women experiencing perinatal mood disturbance.

“Our collaboration exemplifies HITLAB’s commitment to advancing women’s healthcare innovations, and we look forward to continuing to drive positive change in the field of digital therapeutics and mental health through rapid evidence generation.”

More than one in 10 women will experience postpartum depression after giving birth, with some studies reporting as many as one in seven women. However, researchers believe the condition is much more common than the data reveals.

Younger mothers, aged 25 and below, are thought to be more likely to develop postpartum depression or anxiety.

Shailja Dixit, chief executive officer at Curio, said: “We are delighted and encouraged by the strong findings from the SuMMER study.

“Digital therapeutics continue to be an important option for women suffering from depressive symptoms. We are profoundly grateful to the study participants and the research team for their contributions to this research.

“We look forward to continued guidance from the FDA to bring this important intervention to market.”

Sorina Mihaila is the Femtech World editor, covering technology, research and innovation in women's health. Sorina is also a contributor for the neuro-rehabilitation magazine NR Times.

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NIH grants US$2.3m to evaluate blood pressure monitor during pregnancy

ViTrack uses computer vision and artificial intelligence to measure both systolic and diastolic blood pressures on a beat-to-beat basis

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The National Institute of Health (NIH) has granted US$2.3m to evaluate the impact of a wearable blood pressure monitor on maternal and child health during pregnancy.

The research, funded by the NIH’s National Heart, Lung, and Blood Institute (NHLBI), will include at least 150 women who are pregnant or have recently given birth and will evaluate how the wearable technology could facilitate the accurate diagnosis of HDP and early detection of preeclampsia.

HDP, a group of high blood pressure disorders that may occur during pregnancy, affects both the mother and the child and is a leading cause of pregnancy-related complications and death globally.

While the risks posed by HDP have doubled over the past decade in the US, the effects on the maternal population are not evenly distributed. African American women are at five times the risk from eclampsia and preeclampsia, which are severe forms of HDP that can impair the liver and kidneys, trigger strokes and even result in death.

Over the last three years, this risk has been exacerbated by the COVID-19 pandemic, as evidenced by the increased incidence and severity of preeclampsia and an associated increase in preterm births and stillbirths.

ViTrack, a non-invasive, wearable blood pressure monitoring device, uses computer vision and artificial intelligence to measure both systolic and diastolic blood pressures on a beat-to-beat basis without the need for external calibration.

The device, Dynocardia claims, can perform these measurements regardless of patient movement or wrist position relative to the heart, which eliminates the impact of hydrostatic pressure changes.

“Hypertensive disorders of pregnancy pose a growing threat to pregnant women, especially among Black patients and other patients of colour who bear a disproportionate burden of maternal mortality and severe maternal morbidity,” said Dr Wendy Wilcox, chief women’s health officer at NYC Health + Hospitals.

“After an extensive review, the NHLBI selected ViTrack to address this challenge. We’re excited about the potential to mitigate risk among the women who rely on us for their prenatal care.”

Dr Daryl Wieland, chair of OB/GYN at NYC Health + Hospitals/Jacobi|NCB, said: “We’re thrilled to have a new tool that will enable us to identify subtle hemodynamic and vascular changes that can predict extreme fluctuations in blood pressure that may pose a threat to pregnant women.”

Dr Kecia Gaither, director of perinatal services and maternal foetal medicine at NYC Health + Hospitals/Lincoln, added: “ViTrack technology offers a new and unprecedented ability to continuously measure blood pressure and other critical heart and respiratory data, to enable predictive monitoring for early diagnosis and management of preeclampsia, and to prevent prenatal and postpartum complications.”

Dr Mohan Thanikachalam, cardiac surgeon and CEO of Dynocardia, commented: “We are truly grateful to the NHLBI for their continued support and this initial opportunity to partner with NYC H+H.

“We recognise the crucial role of accurate and continuous blood pressure monitoring in ensuring optimal care during pregnancy, especially among African American women.

“Given the known challenges of HDP, we believe that the implementation of ViTrack technology can significantly contribute to safeguarding and promoting the wellbeing of all expectant mothers.”

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Menopause start-up raises US$3.3m to expand digital health platform

The funding will be used to expand Elektra’s care delivery platform across payers, self-insured employers and new markets

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Elektra Health Board of Directors | From left to right: Craig Bell (UPMC), Kathryn Heffernan (UPMC), Dr Nora Lansen (Elektra Chief Medical Officer, non-board member), Jannine Versi (Elektra co-founder), Dr Monica Jain (Wavemaker 360), Alessandra Henderson (Elektra co-founder), Katelin Cruise (Seven Seven Six), Vic Lanio (Flare Capital Partners)

The US menopause start-up Elektra Health has raised US$3.3m in new financing to expand its digital health platform.

Elektra Health, a telemedicine platform offering education and one-to-one support, aims to help women understand and manage their menopause symptoms.

Today, 50 million women are currently navigating menopause in the US. However, around 20 per cent of OB/GYN residency programmes offer menopause training, resulting in a care gap.

Research underscores the connection between menopause and the risk and prevalence of chronic conditions such as heart disease, hypertension and osteoporosis, among others.

Elektra’s Actuarial Study (2023) revealed that women diagnosed with menopause incur significantly increased healthcare spend (45 per cent), and often suffer poorer outcomes.

The company’s menopause care model aims to combine telemedicine care with one-to-one support from health experts to help women better navigate menopause.

“Elektra Health’s three core pillars – education, care, and community – lay the foundation for women to not only understand menopause, but to also take actionable steps to optimise their long-term health and wellness,” said Alessandra Henderson, co-founder and CEO of Elektra Health.

The funding round, led by UPMC Enterprises with participation from Wavemaker 360 and existing investors Flare Capital Partners and Seven Seven Six Fund, brings the total amount of equity finance raised to US$7.6m.

The capital will be used to expand Elektra’s care delivery platform across payers, self-insured employers and new markets.

Jannine Versi, co-founder and COO at Elektra Health, said: “We’re thrilled to have UPMC joining as lead investor for this round.

“They are exemplary in their dedication to holistic care for women across the lifespan, including menopause and the intersecting health needs of an aging population that has been wildly underserved to date.”

Kathryn Heffernan, senior director of strategic product management at UPMC Enterprises, added: “UPMC is interested in investing in solutions that focus on empowering women and Elektra proved to have all the elements UPMC values in this space: evidence-based education and care that prioritises women’s health needs and drives outcomes.

“The goal of the Elektra platform is to fill a gap and provide innovative opportunities to strengthen the doctor-patient relationship as women move through the menopause transition.”

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Tech4Eva launches its fourth edition and call for application

Tech4Eva is searching for entrepreneurs ready to address the unmet health needs of women worldwide

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Tech4Eva, a pioneering accelerator programme dedicated to the femtech sector, is opening its call for applications, inviting femtech start-ups to join its mission to improve women’s health.

The programme is searching for entrepreneurs ready to address the unmet health needs of women worldwide, promising to help entrepreneurs to take their start-ups to the next level.

What is Tech4Eva?

Tech4Eva, is a joint programme between EPFL Innovation Park and Groupe Mutuel for companies developing innovative technology solutions to improve women’s health globally.

What is Tech4Eva looking for? 
Why join?

Applying to the Tech4Eva accelerator programme is a pivotal step for any femtech start-up looking to elevate its impact and reach in the women’s health sector.

Here is an overview of the benefits the programme offers:

  • Strategic refinement: Sharpen your business model and go-to-market strategy with expert guidance, positioning your start-up for sustainable growth and success.
  • Enhanced visibility: Participate in roadshows to showcase your innovative solutions, broadening your exposure to key stakeholders in the Tech4Eva femtech ecosystem.
  • Direct connections: Gain invaluable access to a network of investors and potential customers.
  • Personalised coaching: Receive targeted technical and business coaching tailored to your start-up’s unique challenges.
  • Peer learning: Benefit from Peer2Peer sessions that foster exchange of insights and experiences with fellow founders.
  • Community engagement: Become an integral part of a global femtech community, connecting with like-minded innovators committed to transforming women’s health.
The time is now

This is more than a call for applications, it’s a call to action. The Tech4Eva accelerator programme offers more than growth – it offers a chance to be part of a movement set to redefine the future of women’s health.

If your start-up is ready to take the next step, your time is now. Apply here to join the Tech4Eva programme now.

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