NEW YORK–(BUSINESS WIRE)–Today, on the International Day of Action for Women’s Health, Talkspace (NASDAQ: TALK), a leading online behavioral health care company, and Ovia Health by Labcorp, a digital health solution for women, families and family-building, announced the launch of the Women’s Health Coalition for Digital Solutions. Co-led by Talkspace and Ovia Health, this coalition brings together a founding group of member companies, including Conceive, Evernow, FitOn, Nurx, Cove, and Nutrium, to leverage technology, innovation, and collaboration to advance women’s health and well-being by holistically addressing their diverse health needs.

The Women’s Health Coalition aims to advance women’s health through technology-driven solutions, education, and advocacy. Through its member companies’ platforms, the Coalition will collaborate to:

• Facilitate communication and collaboration among member platforms to enhance the integration of women’s health services through enhancing employer benefits coverage.
• Advocate for workplaces that promote women’s health equity and access to comprehensive healthcare, starting with their own employees.
• Provide public resources and support to employers and organizations to empower women to take control of their health and wellness journey.
• Promote awareness and destigmatization of women’s health issues through thought leadership and focused initiatives.
• Foster innovation in women’s health technology by encouraging research and development.

Out-of-pocket healthcare costs for employed women in the U.S. are estimated to be $15 billion higher per year than for employed men, according to a Deloitte analysis. Additionally, more than one-third of U.S. women report they have skipped needed medical care because of high costs, according to a Commonwealth Fund study. A recent McKinsey Health Institute report found that closing the gender health gap could reduce the time women spend in poor health by almost two-thirds and add up to $1 trillion to the economy annually by 2040. Enhancing workplace benefits for women is a key way of addressing the care gap, and a Morning Consult survey found that a majority of women saw that health and wellness programs and mental health resources are a workplace benefit that is “very” or “somewhat” important to them.

“Talkspace and the charter members of the Women’s Health Coalition have come together to help create a world where every woman has access to high-quality, holistic healthcare tailored to her unique needs,” said Natalie Cummins, Chief Business Officer at Talkspace. “Recognizing the connectedness of mental and physical health, as well as the market demand for comprehensive women’s health solutions, the Coalition furthers our mission to make mental health care more accessible by collaborating with the preeminent women’s health leaders in the digital health space.”

“Ovia Health is committed to providing women with the tools and personalized resources they need to make informed decisions about their health,” said Corrinne Hobbs, General Manager and Vice President, Ovia Health Employer Enterprise & Strategic Partnerships. “We are proud to join forces with Talkspace and other leading digital health platforms to form the Women’s Health Coalition for Digital Solutions. Together, we will work to promote accessibility, affordability and empowerment in women’s healthcare.”

Follow Talkspace, Ovia Health and the founding members for more information on the Women’s Health Coalition for Digital Solutions and how the companies each strive to expand access to care.

About Talkspace

Talkspace (NASDAQ: TALK) is a leading virtual behavioral healthcare provider committed to helping people lead healthier, happier lives through access to high-quality mental healthcare. At Talkspace, we believe that mental healthcare is core to overall health and should be available to everyone.

Talkspace pioneered the ability to text with a licensed therapist from anywhere and now offers a comprehensive suite of mental health services, including therapy for individuals, teens, and couples, as well as psychiatric treatment and medication management (18+). With Talkspace’s core therapy offerings, members are matched with one of thousands of licensed therapists within days and can engage in live video, audio, or chat sessions, and/or unlimited asynchronous text messaging sessions.

All care offered at Talkspace is delivered through an easy-to-use, fully-encrypted web and mobile platform that meets HIPAA, federal, and state regulatory requirements. More than 140 million Americans have access to Talkspace through their health insurance plans, employee assistance programs, our partnerships with leading healthcare companies, or as a free benefit through their employer, school, or government agency.

For more information, visit www.talkspace.com.

About Ovia Health by Labcorp

Ovia Health by Labcorp has served more than 22 million family and parenthood journeys since 2012 and is on a mission to make a happy, healthy family possible for everyone. Ovia Health by Labcorp is the only family health solution clinically proven to effectively identify and intervene with high-risk conditions. The company’s 50+ clinical programs, including predictive coaching and personalized care plans, help prevent unnecessary health care costs, improve health outcomes and foster a family-friendly workplace that increases retention and return to work. For more information, visit OviaHealth.com.

Contacts

Media Contacts:
John Kim | jkim@skdknick.com

Menopause and neuroscience.

70% of women experience neurological symptoms during the menopausal transition, and while historically menopause was associated only with the ovaries, it’s now understood that symptoms such as hot flashes, forgetfulness, mood changes, and insomnia are all neurological symptoms, writes The Guardian.

While very few brain studies look at menopause, interest in the topic has been surging lately.

The 2021 study led by Lisa Mosconi, the largest examination of the menopausal brain to date, showed substantial differences in brain structure across the menopause stages. Critically, many of these changes are temporary, and the brain tries to compensate for these changes through increased blood flow and energy production.

Other studies found an association between frequent hot flashes and an increased likelihood of having Alzheimer’s disease biomarkers and that the first signs of the brain disorder can appear at about the same time women start menopause, suggesting the hormonal event might have implications for disease risk.

There was a bunch of news around menopause, so I’m listing them right here as well:

• On February 28th, researchers from University College London pooled the data from 22 studies and concluded that talking therapies such as CBT and mindfulness-based interventions (MBI) could help with physical menopause symptoms, like hot flashes.
• March 5th, It’s time to stop treating menopause like a disease, according to Lancet: The article calls for a reframing of menopause and a management approach that is not simply focused on medical interventions that relieve symptoms.
• On March 22nd, the recent Nature study on whales may show the evolutionary nature of menopause (which presents itself in very few biological species). Just as in humans, menopause in toothed whales evolved by selection to increase their total lifespan without also extending their reproductive lifespan. This could provide insights for our understanding of the evolution of menopause in general.

While the studies have their limitations, it’s important to see the surge of research interest around the topic.

PMS

On March 5th, Flo Health Inc. shared the results of their RCT demonstrating the effectiveness of the Flo app in improving PMS symptom management. In 3 months, the use of Flo significantly reduced symptom burden and decreased the number of absent days from work (the study results were accepted for publication at JMIR).

Addressing PMS has the potential to contribute $115 billion to the global economy. But, as of 2015, the number of scientific studies about erectile dysfunction exceeded that of premenstrual syndrome by 5x.

A reminder: in January 2024, Flo published their research in Nature NPJ Mental Health, exploring the effects of acute stress on pain perception among women during the Russia-Ukraine conflict (based on de-identified data from over 88k Flo users in Ukraine). Higher stress levels were linked to lower pain sensitivity. See here for more.

IUD for fertility

This month, I was fortunate to visit the Montpellier regional development agency, AD’OCC Invest in Occitanie, thanks to Angélique CACHEUX, and read and learn more about the local startup scene, including its digital health potential. In a local magazine (practicing my French), I noticed an article about Womed, a startup developing the first fertility-oriented IUD (intrauterine device). The device is CE-marked and, in 2021, has already demonstrated its safety and efficiency in a trial of 23 patients.

Apparently, on March 7, 2023, Womed announced that the results of the PREG2 clinical trial demonstrated Womed Leaf® is effective in the management of severe and moderate intrauterine adhesions (IUAs), the primary mechanical cause of female infertility. At the 6-week follow-up visit, women who received Womed Leaf were 2.4 times more likely to have no adhesion than those in the control group.

Depression and cardiovascular disease

On March 12th, women with depression might face a higher cardiovascular disease risk than men:the study published in JACC: Asia tracked and reviewed medical claims between 2005 and 2022, analyzing more than 4 million patients. The results suggest that the hazard ratio of a depression diagnosis leading to CVD was 1.39 in men and 1.64 in women. While the study has some limitations, it raises the important point of treating patients as the whole person in the world of sub-specialties and considering connections between mental and physical health.

Latest research in endometriosis

Oxford University scientists conducted the largest genetic study of endometriosis to date, published in Nature Genetics (using the data of over 60,000 individuals diagnosed with endometriosis and more than 700,000 control subjects). The study revealed 42 genetic regions that are significantly associated with the disease, many of which are related to pain perception.

In 2023, researchers from Cedars Sinai used single-cell genomics technology to map out the molecular profile of endometriosis, providing detail on the condition’s complex cellular makeup (published in Nature Genetics), using nearly 400,000 cells from a total of 21 affected or healthy individuals. The study can be a game changer for identifying potential therapeutic targets at a cellular level; it could enhance treatment outcomes and reduce disease recurrence.

Other studies investigated connections between endometriosis, IBS, and the gut microbiome, as well as its association with mental health conditions. While past research suggested these mental health issues were merely byproducts of chronic pain, the study reveals their distinct genetic underpinnings, expanding our understanding of endometriosis beyond its reproductive implications.

A reminder: in February 2024, we saw the first promising results from the clinical trial of the first non-hormonal, non-surgical treatment for endometriosis (dichloroacetate) in Scotland. If the trial is successful, the drug (the first in 40 years!) could be on the market within 5-7 years.

March 19th, In the US, Biden signs an executive order to expand and improve how the US federal government funds health research about women, calling for an investment of $12 billion in new funding for women’s health research.

On March 19th, Bloomer Tech from Cambridge is launching a clinical trial for their smart bra that tracks heart health. The bra, which originated a decade ago at MIT, collects data about women’s cardiovascular system, hormones, and metabolism, showing the results on an app. The device underwent a feasibility study in 2018 and other tests with humans before Bloomer Tech prepared for the latest clinical trial.

Smart bras might be a great twist in the medical device industry; check out IcosaMed from Switzerland, a smart bra for breast cancer monitoring. IcosaMed’s technology emits ultrasound waves to perform echography scans for potentially cancerous cells.

March 21st, An AI breast screening solution called Mia (CE Mark IIa) helped doctors find an additional 12% more cancers than in routine practice during the collaboration between Kheiron Medical Technologies, NHS Grampian, and the University of Aberdeen (as part of a study with 10,889 patients). The augmented AI workflow also showed a decrease in women recalled unnecessarily for further assessment and modeled a workload reduction of up to 30%.

About 20% of women with breast cancer have tumors that are missed by mammogram screening, which is why many countries mandate that two radiologists should read every mammogram.

Overall, it seems like McKinsey coined the term ‘closing the women’s health gap’ with their report on the state of women’s health, released this January. There’s been a handful of publications and interviews repeatedly referring to the report and the ‘gap term’, or citing the studies mentioned in this report. I hope that this awareness surge will greatly contribute and lead to concrete developments in the mid-term.

More from Anastasiya Markvarde:

A Stanford University School of Medicine-led study shows why women are at greater risk of autoimmune disease and why it has gone unnoticed for a long time in research.

Autoimmune diseases disproportionately affect women, with 4 out of 5 patients being female. The ratio for lupus is 9 women to 1 man, and for Sjogren’s syndrome, it’s 19 to 1. A molecule produced by one X chromosome in every female cell can generate antibodies to a woman’s own tissues. In female mammals, cells shut down one or both X chromosomes early in development to avoid overproducing certain proteins, which can lead to autoimmune disorders. This process, called X-chromosome inactivation, is controlled by a molecule called Xist. However, traditional testing methods, which use male cell lines lacking Xist, fail to identify anti-Xist complex antibodies in female patients, contributing to autoimmune susceptibility.

The first promising results from the clinical trial of the first non-hormonal, non-surgical treatment for endometriosis started in 2023 in Scotland, plus my deep dive into the endometriosis area.

A clinical trial for the first non-hormonal, non-surgical treatment for endometriosis showed promising results. The drug, dichloroacetate (DCA), reduces high levels of lactate, offering relief to patients. With larger trials underway, the drug could hit the market in 5-7 years. Meanwhile, innovations like Hera Biotech’s non-invasive test and Ziwig Biotech’s saliva test offer hope for a quicker diagnosis. Startups like Imagendo and Syrona Health also provide digital solutions for tracking symptoms and accessing information. More digital therapies are needed to offer immediate relief to endometriosis patients.

The first new endometriosis treatment in 13 years, Ryeqo by Gedeon Richter Australia, has been approved by Australia’s drug regulator, even though it won’t receive government subsidies.

Preliminary results from a 3-decade Finnish study show increased disease among women: almost 50% of women born in 1986 and followed since developed some kind of chronic disease, despite their young age.

The Swedish study finds that menopause is getting worse: the prevalence of symptoms increased from 24% to 35% over 1 generation, with no straightforward explanation to be found yet.

With 60% of women dropping out of their healthcare journey in France, Paris-based Sorella Care aims to transform women’s patient journeys with their hybrid clinics. Sorella announced a €5 million round just one year after launching its first multidisciplinary health clinic.

More from Anastasiya Markvarde:

Historically, women were excluded from drug trials due to concerns about potential fetal harm and economic factors related to data collection and side effect reporting. Even today, women experience more drug-related adverse events than men. Until recently, women’s disorders were dismissed as ‘hysteria’, perpetuating harmful stereotypes.
Diseases like migraines and endometriosis receive disproportionately low funding compared to their burden. Heart disease symptoms in women are often misdiagnosed, leading to undertreatment.
The Lancet highlighted long-term childbirth consequences affecting millions of women, exacerbated by a lack of high-quality guidelines, especially in low- and middle-income countries.
HIV trials also show underrepresentation of women. While recognition of these gaps is growing, concerted efforts are needed to ensure women’s inclusion in clinical research and advance femtech initiatives. Reflecting on historical facts can guide meaningful progress in women’s health research.

I feel like there is so much going on in the femtech space that I can’t possibly wait another 7 days in January with the risk of never finishing my article.

As always, I would like to share a quick resume of what is going on in the women’s health industry. The idea is to give an overview of the landscape, put together a condensed summary, and highlight the main points of what has happened in the space. The news is connected to new care programs, digital therapies, reports, and startup investments.

On January 9th, Canada launches the first self-screening cervical cancer plan in British Columbia.

A province-wide screening in British Columbia will allow women to order a quick, easy, and highly accurate test kit to use at home and will allow them to access a network of highly trained and compassionate medical professionals who will support those identified as being at higher risk. (Also, on January 19, the Femtech Canada initiative launches to support women’s health ventures.)

Also biotech research company Qvin announced the first ever FDA approval for a pad for menstrual blood health testing.

The Q-pad offers a less invasive and more accessible alternative to a blood test and, more importantly, makes a very important step to use menstrual blood (historically neglected in research) for healthcare screening purposes.

On January 10th, Flo publishes groundbreaking research in Nature NPJ Mental Health, exploring the effects of acute stress on pain perception among women during the Russia-Ukraine conflict (based on de-identified data from over 88k Flo users in Ukraine).

Higher stress levels were linked to lower pain sensitivity. This discovery is the first documented real-life example of extreme stress being connected to reduced pain sensitivity, ‘or’stress-induced analgesia’, and the first study to explore SIA in a real-world setting.

On January 17th, McKinsey releases a fundamental report on the $1 trillion opportunity to close the women’s health gap.

The report highlights that women spend 25% more time in poor health compared to men, with 64% of interventions resulting in disadvantages due to access issues or lower effectiveness. Women’s health research often overlooks diseases with higher mortality rates and lacks sex- and gender-specific data. Women also face delays in diagnosis, with studies showing it takes 2.5 more years for cancer and 4.5 more years for diabetes. Access to care is also disparate, with women in Switzerland paying 37% more than men. Investors are encouraged to support women-centric research and financing models.

As a response to the report, a new Global Alliance for Women’s Health initiative has been launched, with $55 million allocated to women’s health.

Supported by 42 organizations and pledging $55 million, the alliance responds to a report highlighting the underestimated health burdens faced by women. Investing in women’s health could yield up to $1 trillion annually by 2040, improving outcomes for over 3.9 billion people globally.
The alliance focuses on financing, science and innovation, and agenda-setting, with commitments from governments, philanthropies, and pharmaceutical companies.
Key commitments include $25 million from Tower Capital Group and $30 million from Rotary International for maternal and child health initiatives in several countries.

On January 18th, Kearney and FemTechnology presented their open letter and report for change on redesigning healthcare with women in mind in Davos.

Although women account for 70% of chronic pain patients, (yet of) pain medication has been tested only on men or male mice. On average, women wait 4 years longer than men to receive a diagnosis for the same disease.

The letter encourages action by tackling the public health agenda, building women-centric care pathways, and accelerating investment.

On January 17th, the UK health secretary announced new women’s health priorities for 2024.

Top priorities under the Women’s Health Strategy in 2024 include menstrual problems and menopause, maternity care, and birth trauma support. £50 million for research to tackle maternity disparities through the NIHR research inclusion strategy.

The priorities result from input from healthcare professionals and the public. The strategy aims to break historical barriers, reduce disparities, and enhance overall women’s health, with a renewed focus on menstrual conditions, women’s health research, and support for abuse victims. The government also reappointed Professor Dame Lesley Regan as Women’s Health Ambassador for England, emphasizing the ambition to provide world-class treatment and improve healthcare outcomes for women.

On January 19th, Midi, a startup offering virtual menopause care, raised $60 million in the tough investment market just 4 months after their last founding round.

***

It’s promising that the historical gap and disregard for women’s health are now recognized, and efforts are being made to address them. I do hope we will start seeing the results in the coming years and decades. It’s quite obvious that we need to involve more women in trials and invest more in women’s technology, but what about small first steps that could have an immediate effect?

I thought of a basic blood test. As a rule, it doesn’t carry information on a woman’s day of cycle, only when the tested values are directly linked to women’s hormones. However, the menstrual cycle can influence various biomarkers in a complete blood count. For example, the leukocyte count increases in the second phase of the cycle. Other parameters that can significantly fluctuate across the cycle are iron, lipids, thyroid hormones, insulin, blood glucose, and even vitamin D.

It could cost little or nothing to include the information on the day of the cycle in each blood test and start yielding results already today, even before we can leverage the collected data for research purposes. Thoughts?

Study begins in Nigeria and Kenya; data available in late 2023

NEWTON, Mass.–(BUSINESS WIRE)–#DigitalHealth–Axena Health, Inc. (Axena Health), a women’s health medical device company focused on scalable treatments for female pelvic health, announced today a large-scale study that will investigate the burdens of incontinence on women in low- and middle-income countries to support equitable access to treatment. The first-of-its-kind study will examine how women could access treatment within local healthcare delivery systems and in a manner that accommodates cultural norms. Study results will be available in late 2023 and will inform the development of new treatment options based on the Leva^® Pelvic Health System, a digital health treatment for urinary incontinence (UI) with published studies supporting its effectiveness, including durable, long-term symptom relief.

“When it comes to incontinence, there is a need to generate community awareness that it is treatable and sensitization and training of health workers to increase screening, deliver conservative and surgical treatment, and provide adequate follow-up,” says Mohan Chandra Regmi, MBBS, MD, Professor of Obstetrics and Gynecology, Director of the Foundation for International Urogynecological Assistance Fellowship Program in Nepal, and Chief Policy Advisor for the Government of Nepal. “The scope is simply huge.”

Approximately one-third of women in low- and middle-income countries experience at least one pelvic floor disorder, such as urinary or fecal incontinence (FI). Pelvic floor muscle training (PFMT) is globally accepted as first-line treatment for bladder and bowel leakage. Beginning in Nigeria and Kenya, the study will gather feedback from women living with incontinence, their family members, and clinicians to gain perspective on the impact of incontinence on women’s daily lives, symptom management strategies and how they access treatment through local healthcare systems. Axena Health will use these data to develop a treatment with Leva technology to support access to effective treatment for incontinence that is culturally acceptable and available within existing healthcare pathways. A second phase of the work will include formative and implementation research and is expected to include additional countries in Africa and South Asia.

“Urinary incontinence is a global health problem,” said Jessica McKinney, DScPT, MS, co-author of ‘Implementing Physical Rehabilitation Services into Comprehensive Fistula and Maternity Care: A Training Guide for Health Workers’, and Axena Health’s VP of Clinical Affairs and Global Health. “The physical, psychosocial, and economic burdens for women are significant and have been well documented primarily in high income countries. There is evidence in all settings that women’s livelihoods may be negatively impacted, and they may experience limited participation in family and community life. It is also true that UI is universally undertreated, and many women live with the health condition for the rest of their lives. Our intention with this study is to better understand and share women’s lived experiences with incontinence and direct actionable changes in awareness and treatment.”

The World Health Organization identifies urinary incontinence as a maternal morbidity and as a health priority for aging women, which includes a “strong recommendation” for PFMT. Data from the U.S. indicates that as few as 25 percent of women with a pelvic floor disorder perform PFMT despite a clinician’s direction. Of those who perform PFMT, fewer than 25 percent perform exercises adequately.

Currently available only in the U.S., the Leva System is a prescription, at-home medical device that guides a woman through first-line treatment for both UI and FI. The Leva System enables supervised PFMT in a manner that’s scalable, allowing clinicians to deliver effective, first-line treatment for incontinence to women. Study findings will inform a solution for use in low- and middle-income countries using Leva’s technology.

“We believe this is the first large, multi-faceted research study focused on how to deliver first line, non-surgical, drug-free treatment for incontinence aligned with the United Nations’ Sustainable Development Goals: specifically, ‘No Poverty,’ (goal one); ‘Good Health and Well-Being’ (goal three), ‘Gender Equality,’ (goal five) and ‘Reduced Inequalities,’ (goal ten). The burden of incontinence is gendered, and the costs borne by individuals and societies is multifactorial,” said Laura Keyser, DPT, MPH, co-author of the aforementioned Training Guide, and Director of Clinical Strategy and Global Health at Axena Health. “In addition to improving access to treatment, we hope to engage multiple stakeholders within the private and public healthcare sector, academics, women’s networks, government, nongovernmental organizations and employers—to join us in supporting health equity and access to those most in need.”

Strong clinical data support the efficacy of the Leva System, including two studies published in Obstetrics and Gynecology (The Green Journal). The first publication, an eight-week randomized controlled superiority trial (RCT) showed that the Leva System significantly improved symptoms of UI in women compared to PFMT (commonly referred to as Kegel exercises) alone. The second Green Journal publication, a one-year longitudinal follow up from the RCT, showed that women who used the Leva System for just eight weeks achieved long-term symptom relief that was durable. Shortly after the publication of that one-year durability data, Cigna Healthcare issued a positive medical policy coverage decision for the Leva System.

“Female incontinence is a significant unmet health need for millions of women worldwide, and we believe we’re uniquely able to help,” said Eileen Maus, CEO of Axena Health. “We’re grateful to our funding partner, AXA IM Alts, which is committed to providing innovative solutions to global health challenges and supports our goal to provide a Leva solution that is commercially available and broadly accessible to women and their clinicians in low- and middle-income countries. Our hope is that this work will help strengthen health systems and build greater capacity for women’s healthcare with key partners in lower-resourced settings in and outside of the U.S.”

The study will be conducted in collaboration with ThinkPlace, a global Design, Strategy & Innovation firm operating in over 10 countries. ThinkPlace works with leaders and organizations to tackle some of the world’s most pressing issues and has previously worked with renowned global organizations like the John Hopkins University, the Bill and Melinda Gates Foundation, Ministry of Health (Singapore), JnJ, BOSCH, UNICEF, and GAVI, among others.

About the Leva^® Pelvic Health System

The Leva^® Pelvic Health System is a prescription digital therapeutic (PDT) available in the United States that offers an innovative, non-invasive, medication-free way for women to train and strengthen their pelvic floor muscles—at home in just five minutes a day—to treat urinary incontinence (UI) and chronic fecal incontinence (FI). Combining a small FDA-cleared vaginal motion sensor connected to a smartphone app, the Leva System offers precise visualization of pelvic movement in real-time, enables progress tracking and allows active clinician involvement, all of which support women’s success. Recognizing that level-one evidence shows pelvic floor muscle training is most effective when performed under the supervision of a skilled healthcare provider, the Leva System is available by prescription only, allowing physicians the opportunity to treat UI and chronic FI on a broad scale and with continued involvement in patient success. The Leva System is the first femtech product included in the Digital Therapeutics Alliance product library and has multiple clinical trials and published data from globally recognized medical centers supporting its efficacy in treating UI, including two studies in Obstetrics and Gynecology (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists (ACOG).

About Axena Health

Axena Health, Inc. is a women-led company dedicated to improving the lives of women with pelvic floor disorders. Axena Health’s flagship product, the Leva^® Pelvic Health System, offers a novel, effective, first-line treatment for urinary incontinence (UI) and chronic fecal incontinence (FI), underreported conditions affecting over 78 million and 12 million women in the U.S. alone. Axena Health’s technology enables non-invasive, drug-free treatment via precise visualization of movement in real time during pelvic floor muscle training, while monitoring usage and progress. For more information, please visit www.axenahealth.com or www.levatherapy.com and follow Axena Health on LinkedIn.

Important Indication and Other Information for the Leva® Pelvic Health System

The Leva^® Pelvic Health System is intended for (1) strengthening of pelvic floor muscles, (2) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women and (3) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (>3-month uncontrolled passage of feces) in women. Treatment with the Leva System is by prescription and is not for everyone. Please talk to your prescriber to see if Leva System is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use Leva System while pregnant, or if you think you may be pregnant, unless authorized by your doctor. For a complete summary of the risks and instructions for the Leva System, see its Instructions for Use available at www.levatherapy.com.

At this time, the Leva^® Pelvic Health System is only available in the United States.

Contacts

Media: Shanti Skiffington
617-921-0808

LOS ANGELES, Feb. 9, 2023 – The Wingwomen Inc. a California-based women’s health company announced its pivot beyond platform peer support today, towards fertility-focused reproductive health literacy programs and health coaching. The new programs feature a curriculum for preconception and postnatal health for women including those with Polycystic Ovary Syndrome (PCOS), Endometriosis, Hashimoto’s, Diabetes, Preeclampsia, Advanced Maternal Age, Sickle Cell Disease, in addition to a program for Perimenopause. The Startup Health portfolio company plans to improve fertility and pregnancy outcomes amongst women who may face additional challenges to conception due to preexisting health conditions. Their programs aggregate hard-to-find evidence-based information attained from their medical advisory board to use for the education of participants through their classes. 

Check out more on the femtech company by watching the interview taken in October at the Frontiers Health Global Conference 2022.

These offerings come less than one year after the historic overturning of Roe v Wade, at a time when access to reproductive health care and access to reproductive health literacy programs have become limited. The newly launched website hosts a menu of virtual reproductive health literacy programs which also combine group education, with 1:1 health coaching and interactive exercises for participants. 

In the United States, more than 18 million women face issues like infertility, miscarriage, and preterm birth. Some of these difficulties are incredibly prevalent: about 10–15% of known pregnancies end in miscarriage in women less than age 35; the prevalence of infertility is one in eight women; Polycystic Ovary Syndrome (PCOS) is one of the most common causes of female infertility, affecting 8% to 13% (as many as 5 million) of US women of reproductive age, and Endometriosis, is estimated to impact 10% of women (190 million) globally. These conditions are far more prevalent than the media and news cycles portray. But despite these statistics and the clear need for programs that would support healthier reproductive outcomes, women enduring one or several of these issues often find themselves alone.

Wingwomen is on a mission to support positive health outcomes from preconception to perimenopause for Gen Z and Millennial women,” said Adonica Shaw, Wingwomen Founder & CEO. “ After being diagnosed with Preeclampsia in 2017, I had no idea what steps I needed to take to reestablish my health, and I didn’t understand medical terminology. After experiencing the frustration women have around understanding their reproductive health firsthand, I wanted to create something that would make this process easier for other women and their families. Our team believes that by encouraging reproductive health literacy, we can contribute to healthier conception and pregnancy outcomes in the preconception, pregnancy, and postpartum periods to benefit the next generation of mothers. 

Reproductive health disorders in women have long remained in the shadows of research and advocacy,” said Mark P. Trolice, M.D., FACOG, FACS, FACE, Wingwomen medical board member. “Funding for vital medical studies and education are dramatically deficient. The number of women affected by these disorders is staggering and, consequently, results in impaired quality of life and negative effects on the economy from missed days of work. A woman facing infertility has been shown to have an equivalent emotional impact as being diagnosed with cancer or other major medical disorders. By understanding and gaining knowledge on managing their disease, women become empowered to potentially improve their physical and mental health. I applaud Wingwomen for their outreach, compassion, and dedication toward supporting women affected by reproductive health issues with their goal of a new “ERA” (education, research, and advocacy).

Ameliorating poor health outcomes requires a trio of interventions: utilization of patient educational platforms that are easily navigated, interaction with health care teams that are culturally competent, and practice cultural humility,” said Dr. Linda D. Bradley, Wingwomen medical board member. “The mission and vision of Wingwomen support women throughout their reproductive life cycle.

Research shows that low health literacy in women hoping to conceive and pregnant women, impacts their ability to find, understand, navigate, and apply health information before, during, and after pregnancy, and may be associated with maternal obesity, prolonged infertility, and complications during pregnancy and birth for both mother and child. Through their programs, they hope to play an important role in the retention of reproductive knowledge amongst Gen Z and Millennial women and impact positive behaviors and outcomes. 

The difference in health between men and women is a significant drawback for the latter. Women have an average life expectancy that’s just under 80 years, but this may change depending on their lifestyle choices; while males can expect to live around 85-90 years if they lead ordinary indexed lives without any major disabilities or illnesses during childhood up until old age (though there are many factors which affect our quality of life).

The good news is that we have never been more aware of this inequality, and it’s because technology companies are driving change. In recent years we’ve seen a move towards personalization in healthcare which leads us to understand how women’s health can be improved through data analysis with Artificial Intelligence (AI). Powered by these two factors – digital proactive populations & AI- our goal is closing the gender gap while improving patient outcomes across all demographics worldwide!

Provider-to-Provider Telecare

The Internet of Things will soon become a part of everyday life. The healthcare industry is one that has embraced this new technology, as it can be used for both clinical purposes and administrative tasks in hospitals or clinics.

The use cases within women’s health are particularly interesting because they allow patients access medical advice from experts without having them drive long distances to get treatment at once time-consuming inconvenient hours – all while saving money by not spending gas getting there!

With the growth in digital technology, it is now possible for one expert to oversee a group of trainees and junior staff remotely. This allows them all have access not just through their work but also at home or on vacation as well!

Telemedicine is set to make a profound difference in women’s health. For many of the world’s woman, accessing healthcare can be difficult; arranging childcare or missing time from work because they need care that isn’t always available locally – but what if there was an easy way?

Enabling them do so with their familiar providers will allow these individuals feel more comfortable during treatment while also making sure all issues are dealt within one visit instead spread across multiple visits which adds extra stress on top of everything else.

The future of healthcare is going to be all about using ehr solutions the best way possible. In order for that plan succeed, providers need help from each other and technology can’t do it alone – but luckily there are new technologies out on loan at just what they need!

Benefits of Digital Health for Clinician Decision Support

The ability to access high quality healthcare has become an issue for women in low resource settings. One important factor is ensuring that local health workers have the training and support they need so their decisions can be made with confidence, no matter where you are or what type of setting it’s happening.

Clinicians often want proof before acting on behalf of our patients-but now there’s never been a better time than ever! With new digital platforms which offer expert input at every point throughout patient care process from diagnosis all way through treatment recommendations; we’ll always know exactly why things happen along.

AI is a powerful tool for healthcare professionals, especially in the diagnosis and treatment of cancers. AI algorithms can be trained to recognize patterns at an accuracy comparable with human experts or even better than them depending on how much data you put into your training set-up! This has been demonstrated time after again across many different fields including cervical cancer screening where Google’s work helped diagnose nearly 5000 cases before any humans could do.

The AI-powered clinician decision support will be a game changer in the medical world. With it, more people can get access to advanced care and diagnosis that was previously limited only by their location or money belt size!

Digital Healthcare for Women Significance

Women are the primary caregivers for their families, often taking on tasks that would otherwise be looked after by government or private providers. For example, 50% of all newborns in America have a mother who is also either breastfeeding them personally or supporting another method like bottle feeding because they know it’s better nutrition than what many mothers receive during pregnancy and postpartum periods.

When women invest time into researching technology which supports lifestyles compatible with staying healthy while balancing work/life balance, it can be a good decision for the whole family done by women.

Technology is bringing the world of healthcare into modern day standards. Women can now benefit from digital tools that will connect them with doctors through patient portals, allowing for monitoring and advice as well as referral in a safe way no matter what their circumstances may be!

It’s important too because we don’t want any woman left behind when it comes to accessing quality care – especially if there are AI programs available which allow experts AND laypeople alike access high-quality procedures such these new gadgets created by smart people who know how things work best.

And Maureen Fura, CEO & Co-founder of Mammha, knows it well.

While expecting her son, she found herself hanging in suicidal thoughts, and looked for a doctor who could hear her. Eventually she found a therapist who named what she was experiencing and finally got the help she needed.

She then wondered why she went untreated for so long and how many other women were in the same situation.

She finds Jennifer, fighting a one-woman campaign to bring maternal mental health services to women who also suffered from the same debilitating disorder when she was pregnant.

Together they produced a documentary, Dark Side of the Full Moon, but it was not enough.

“A change in knowledge isn’t equal to a change in behavior. People knew women were dying but they still didn’t know what they could do to stop it.” Fura wanted to do more than educate about the problem. (Ref. healthtransformer.co)

Mammha (r. mama)

The idea behind Mammha is very simple: providing women with routine mental health screening during pregnancy and the postpartum period.

The aim was to create a go-to solution for providers, hospitals, and NICUs to screen, refer, support, and educate pregnant and postpartum women who may be experiencing maternal mental health complications like depression and anxiety.

As Fura explained to StartupHealth, Mammha is made by women for women. And that is making it really effective.

How it works.

A mom screens herself via the mobile app or the web-based platform. Her doctor receives the test results and, if applicable, activates immediate support through the Mammha Care Coordinator.

The Mammha Care Coordinator steps in to follow the patient through the journey of care, which lasts from 6 weeks to 10 months.
There is not always a need for therapy or medication, very often these moms just need to tell their story to a support group that understands them.

To summ it up, Mammha is about friendship, shared experience, lived wisdom, and love. And we might need more of these solutions to support the health care journey of women.

“Too often, people encounter misinformation when searching on the internet for signs and symptoms of conditions, especially when it comes to taboo topics such as menstrual and sexual health,” said VP of Product, Cath Everett. “Our users often come to Flo for period or ovulation tracking, and stay for the wealth of science-backed content, expert-led courses and accurate cycle predictions. We’re fortunate to partner with the top universities and conduct cutting-edge medical research. With this funding, we’ll be able to further democratize access to credible health information, helping people better understand their unique signs and symptoms on an even larger scale.“

Flo will also use the funding to fuel the company’s continued headcount growth as it targets top talent across product, engineering, R&D, data science and medical roles. Headquartered in London and with a footprint across Europe and the US, the employee base has more than doubled in the last two years to 350, with the growth trend set to continue.

Flo’s growth

With a community of over 200 million users, coming from all corners of the world, Flo has gained significant traction. In the last twelve months, Flo has experienced hyper-growth: the app has increased its active subscribers’ base 4 times reaching 1.5M in August 2021. By the end of 2021 Flo aims to reach $100M Annual Run Rate. Flo’s business model is purely subscription-based. The company recently introduced Flo as a benefit to US employers to better support women in the workplace with the resources they need to thrive — physically and mentally.  

“Flo is a category-defining company in the femtech industry,” said Alexander Frolov, CEO and Co-founder of Target Global. “As of this year, we’re just starting to see a shift in startups addressing specific female health conditions — but there are very few companies that are addressing the root causes of these conditions. Flo’s proactive platform is ahead of the curve, and has raised the bar for what consumers should expect from consumer health apps“.

Flo provides curated cycle tracking and predictions, personalized health insights, and real-time health alerts based on tracked symptoms in an easy-to-use interface. Over 1 billion menstrual cycles have been tracked within the app, and 95% of users say Flo contributed to their overall well-being. To date, 27.7 million women got pregnant while using Flo. With over 200M of Flo users, every tenth woman between ages 15 to 49 in the world manages her cycle using the app.

“Flo’s long-term value and impact on its users is truly unmatched in the industry,” said Per Brilioth, CEO of VNV Global. “With its deep medical expertise and advanced product, Flo is addressing a critical gap in preventative care, an area that has been neglected for far too long. Flo’s strong position in this space and already impressive user base make the company well-positioned to continue to be a pioneer and true market leader over the coming years. We couldn’t be more thrilled to contribute to the next stage of its evolution“.

Both studies illustrate the progress that can be made when women’s health challenges are brought to the fore. But women’s health advocates caution that the field is often still viewed too narrowly.

The study of health and disease in women should not be limited to conditions that affect only women. Conditions such as type 2 diabetes, Alzheimer’s disease and heart disease affect men and women differently.
Such diseases must be studied in both men and women, with the recognition that diagnosis, prognosis and treatment might need to be different between the sexes.

Heart attacks, for example, are a leading killer of both women and men, but women don’t always experience the ‘typical’ symptoms usually seen in men.

Women are also more prone to blood clots after a heart attack, yet less likely to be prescribed anti-clotting medication by their doctors. Women are 50% more likely than men to receive an initial misdiagnosis after a heart attack, and are less likely to be prescribed medicines to reduce the risk of a second attack, according to the British Heart Foundation.

Since 2016, the US National Institutes of Health has required researchers to carry out pre-clinical studies in both male and female animals, tissues and cells, or to provide an explanation for why it is not appropriate to study both sexes. Now it is up to other funders, researchers and journals to amplify the impact of this change by taking care to report sex-specific data in publications.

Funders should also bolster the resources given to support studies of health and disease in women, and track how much money goes to supporting such research across all domains, not merely gynaecological conditions. That which gets measured gets done.

Read the full article at https://www.nature.com/articles/d41586-021-02085-6