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Introduction

Women’s health has traditionally been assumed as equivalent to that of men. However, research has confirmed that health outcomes for many diseases are different for women. The differing biology of women poses very different types of risks as well as presentation of diseases, as compared to their male counterparts[1]. This presents both challenges and opportunities for development of novel platforms for women’s health. Devices and mobile applications are being developed, especially for women to address their health issues. In this context, there is an emerging industry that offers women-centric healthcare solutions based on their fundamental physiological and genetic gender differences, the market for which is predicted to be a $50 billion industry by 2025.

Femtech or ‘female technology’ encompasses diagnostics, feminine products and wearables that comprise devices and mobile apps. The apps also come with evidence-based recommendations offering holistic female health including fertility and pregnancy-related issues[2].

From adolescence to old age, females need different types of care during each phase. Femtech aims at dissemination of the required knowledge as well as appropriate solutions at each stage[3]. The balanced cyclical life of women represents three unique phases: Maiden, Mother and Crone, each representing specific challenges[4].

Maiden stage:  

The challenges in the maiden stage revolve around sexual health, including puberty, menstrual health, sexually transmitted infections and other conditions such as endometriosis, fibroids or polycystic ovarian syndrome. A few solutions available are listed below:

A. Puberty:

  • pubertyPuberty Clues, a mobile app, helps teens to learn about the variations in their bodies and emotions in a personalized and interactive way.[5]
  • Sirona First Period Kit educates young girls about periods and the associated changes in their bodies. A Sirona kit includes coloured biodegradable pads, panty liners and tampons, pain relief patch and anti-chafing rash cream etc[6]

B. Menstrual cycle tracking and pregnancy-avoidance:

  • My Calendar is a mobile app that helps in period tracking with various customizable features, including tracker start date, reminder style, units of measurement and color scheme. It allows users to record and track regular and irregular periods, menstrual flow and moods etc.[7]
  • Flo App helps in menstruation tracking and cycle prediction, and provides information regarding preparation for conception, pregnancy, early motherhood and menopause.[8]
  • Clue: The Clue Cycle Tracker gives insights on when a female might get periods, ovulation and PMS predictions besides changes in skin, stress and energy levels throughout the cycle, and a science-backed period, fertility and health encyclopedia at one’s fingertips. It also helps in customizing ovulation notifications and period reminders[9]
  • Apricity acquired Woom, a leading international women’s health app offering period tracking and community support for those looking to conceive a child. Woom has created a robust AI engine that offers a personalized period tracker and manages a community of 1.8 million registered users internationally [10].
  • IUB ballerine (Ocon healthcare): Small spherical device made of plastic and copper, consisting of 17 copper pearls that form a spherical shape. The frame is coated with polyethylene terephthalate that is inserted into the womb by a doctor or nurse. It helps in preventing pregnancy by releasing copper into the womb, which prevents the sperm and egg from meeting and also prevents fertilised egg from implanting in the womb[11].
my-calendar
flo-app
dotlab

C. Uterine malfunctions:

  • DotLab’s DotEndoTM offers a non-invasive solution for the diagnosis of active endometriosis. The breakthrough blood test analyzes the expression of microRNA biomarkers associated with endometriosis across all stages of the disease, regardless of hormones, cycle or symptom to provide a clear positive or negative result, and not just a risk profile.[12]
  • womed-leafs-intrauterine-adhesion-barrier-filmWomed Leaf’s intrauterine adhesion barrier film offers protection against adhesions to the entire uterine cavity for a week. It is inserted through the cervix with a flexible inserter, just like an IUD, at the end of the surgical procedure. The uterine film is not sticky and the insertion takes less than 1 minute, which after a week, breaks-up, dissolves and is naturally discharged through the cervix without any intervention of a healthcare professional.[13]
  • madorras-deviceMadorra’s device is aimed at alleviating symptoms of vulvovaginal atrophy (VVA), a condition that results from a decrease in the body’s estrogen levels. Used at the vaginal opening (not inserted), the device applies therapeutic ultrasound waves along the vaginal canal to stimulate local heat and blood flow, producing natural vaginal lubrication, which researchers claim will alleviate symptoms of VVA[14].
  • myelle-vaginal-rejuvenation-wandMYELLE™ Vaginal Rejuvenation Wand has nineteen red LED lights (650nm), out of which, three are located on the wand’s tip. These red LED lights (650nm) have a regenerative effect on the cells, and can enhance muscle repair, increase elasticity and promote cell turnover, creating healthier, younger skin. This allows for maximum exposure, and the freedom to insert the device is based on the user’s comfort level. Sonic vibrations stimulate the muscles of the pelvic floor, resulting in contraction and strengthening[15].
  • cytuityCytuity: Boston Scientific acquired women’s health-focused NVision Medical, which manufactures a FDA-cleared device designed to collect cells from fallopian tubes as an early diagnosis of ovarian cancer. nVision Medical developed the MAKO 7 device, which is used through the working channel of a hysteroscope for cell collection from the fallopian tube. nVision Medical was acquired by the Boston Scientific Corporation in 2018 and the MAKO 7 is now called Cytuity™[16].

US20190126010A1 from Boston Scientific Scimed Inc. and Nvision Medical Corp., titled Systems, methods, and devices for delivering substances into a fallopian tube from Boston Scientific Scimed Inc. and Nvision Medical Corp. describes a system for delivering (radiopaque marker, radiopaque marking material, gel, chemotherapeutic, fertility therapeutic,  antibiotic, anti-inflammatory agent, tissue protecting substance, dissolvable object, impermeable object, or a radiation delivering object) into a Fallopian tube of a patient with the help of  balloon catheter including a tube having a distal end. A balloon may have a first end coupled to the distal end of the tube. A push wire having a distal end is coupled to the second end of the balloon. The balloon may be movable between an inverted position and an everted position by actuation of the push wire. The balloon catheter may be configured to receive the substances such that they are retained by the balloon, the push wire, or both, and may advance the push wire to evert the balloon such that the balloon extends at the distal end of the tube. In the everted position. the substances may be delivered into the Fallopian tube, to be used for diagnostic sampling and delivery of desirable substances. It is also used in the diagnosis of ovarian cancer by way of sample collection and helps in delivering substances to ovarian cancer region[17].

As per the latest data available on ClinicalTrials.gov of US Registry, Boston Scientific Corporation completed its study on Cytuity (NCT03593681) in December 2020. 130 participants were involved in the study.  In the final outcome, it was observed that there were a few serious adverse events, which include anemia, intra-abdominal hemorrhage and acute kidney Injury individually among 3 participants. In addition, other serious adverse events observed include fallopian tube perforation in one participant and uterine perforation in another participant [18] . It is possible that Boston Scientific Is currently working towards addressing the adverse events identified during the clinical trials.

  • Gameto, a US-based company, has developed a platform to produce female reproductive cell lines. It has developed biologic that treats oocytes outside the body, increasing maturation rates and oocyte quality to improve IVF and egg freezing outcomes [19].
  • Organon, a spin-off of Merck, acquired Forendo Pharma, a clinical-stage drug development company focusing on novel treatments in women’s health. It is known that women with endometriosis have higher levels of estrogen. Forendo’s lead candidate, FOR-6219, is an oral small molecule that inhibits oestrogen production by targeting the 17β-Hydroxysteroid dehydrogenase 1 (HSD17B1) enzyme, which catalyses the final stage of oestrogen biosynthesis[20].
  • Acessa Health’s radiofrequency ablation under laparoscopic ultrasound guidance is a minimally invasive technique for the treatment of uterine fibroids. The Acessa® procedure works by applying controlled heat directly into the fibroid, causing it to shrink over time, thereby offering uterine-sparing solutions for women with symptomatic fibroids. Acessa Health was acquired by HOLOGIC in 2020[21].

US20200268440A1 from Acessa Health titled Automated ablation control systems describes an automated ablation control system comprising a surgical workstation having robotic arm assemblies for ablation of a uterine fibroid. This system also includes ultrasound instrument coupled to robotic arm assembly. The ablation instrument has multiple deployable stylets reconfigurable from low-profile to a deployed configuration. The ablation instrument and imaging instrument are coupled to different robotic arm assemblies[22].

perspective-view-of-an-ablation-device

Perspective view of an ablation device

D. Infertility and Pregnancy:

Several technologies have emerged to provide women with resources to optimize fertility tracking and identify issues with fertility early.

clearblue-advanced-digital-ovulation-testClearblue® Advanced Digital Ovulation Test works differently from other ovulation tests as it is designed to detect two hormones, estrogen and Luteinizing hormone (luteinizing hormone). It tracks these two fertility hormones to identify high and peak fertility days, by which the woman can plan ahead and have more opportunities to get pregnant [23].

avaAva, a wearable fertility tracker, is an FDA-approved femtech device intended to measure and display physiological parameters (body temperature, resting pulse rate, heart rate variability and breathing rate) as an aid in ovulation prediction.   It tracks physiological parameters with built-in sensors. The temperature sensor provides information on skin temperature. A photo plethysmography (PPG) sensor measures the inter-beat interval (IBI) providing information on pulse rate (HR), heart rate variability (HRV), breathing rate (BR) and perfusion. Only HR, HRV, and BR are used by the algorithms for prediction of the fertile window. The user synchronizes the bracelet with the mobile app each morning, which provides Trying to Conceive Mode, Cycle Tracking Mode and Pregnancy Mode. The algorithm is run on the physiological parameters collected, thereby predicting the ovulation and the fertile window displayed in the mobile app along with single mean value for HR, temperature, HRV ratio, BR, and sleep duration from the prior night[24].

Launched 2016 in the US, the Ava bracelet is sold in 36 countries and has helped thousands of women become pregnant. This device is protected by  US10779802B2, which was filed initially by AVA in 2016, and in July 2022 Ava assigned it to FemTec Health, Inc[25].FemTec Health, the health and beauty Sciences Company acquired Ava AG in July 2022[26]. 

miraMira: The Mira Fertility tracker monitors menstrual cycles and ovulation by measuring basal body temperature as well as hormonal changes in urine or saliva. It includes an analyzer, which is an oval, pod shaped device that evaluates hormone levels in the urine collected by the dip system, and syncs with the Mira App and uses artificial intelligence to track hormone patterns [27].

Mother stage:

At the mother stage, Femtech can help in pregnancy care, contraception, breastfeeding, weight and stress management, urinary incontinence etc., a few examples of which are presented below.

During pregnancy:

accusureAccuSure Fetal Doppler is a radiation-free Heartbeat Monitor with TFT display. The Fetal Doppler can be utilized after about four months of pregnancy. The device brings out a clear sound of the baby’s heartbeat[28].

Pregnancy+ App: The Pregnancy+ app features expert advice, daily articles, healthcare tips and interactive 3D models, so one can track the baby’s development.

Health & Parenting, founded in 2012, offers several apps for expectant and new parents, including the popular Pregnancy+ app, which the company says has been downloaded millions of times across iPhone and Android [29]. Royal Philips acquired London-based Health & parenting Ltd in July 2017 [30].

Postpartum Care:

Pregna Copper T 380A/Copper T Intrauterine device is a birth control device that addresses unwanted pregnancy for up to 10 years. This device offers complete restoration of fertility upon removal, which too is very easy. It is ideal for women who want to space their children or are looking for long-term contraception[31].

elvie-pumpElvie Pump: A wireless, wearable pump that fits directly on to breasts, Elvie Pump features a motor located within the breast cup itself. The breast pump tells how much milk is produced and has a mechanism to stop automatically while preventing leaks. Elvie Pump is a silent wearable breast pump, making it possible for new mothers to pump anytime, anywhere[32]. This product is protected by US11357894B2.

US11357894B2 titled Breast pump system describes wearable breast pump system including a housing shaped in part to fit inside a bra and, a piezo air-pump. The piezo air-pump fitted in the housing, forms part of a closed loop system that drives a separate, deformable diaphragm to generate negative air pressure. The diaphragm is removably mounted on a breast shield[33].

Crone stage:

At the crone stage, due to menopause and hormonal changes, women have more chances of experiencing health complications. Bone density, cardiovascular disease and breast cancer are risks of concern during menopause, particularly during an early onset of menopause. Mobile applications are designed to provide support for the emotional and physical changes accompanying menopause.

health-her-menopause-trackerHealth & Her Menopause Tracker: Health & Her helps in menopause management. It includes several alternative techniques to treat various symptoms of menopause, such as cognitive behavioral therapy (CBT) for hot flashes, depression and night sweats. Also provided are guided imagery meditation for insomnia and deep breathing for stress and anxiety.

In addition, this app offers standard symptom-tracking tools as well as a menstrual cycle monitor for perimenopausal women. Various “clinically proven” supplements and menopause products are available to purchase through Health & Her [34].

UK-based KaNDy Therapeutics is working on a dual NT-814, neurokinin-1,3 receptor antagonist, developed as a non-hormonal alternative to hormone replacement therapy for treating postmenopausal symptoms (PMS). Founded in 2017 and acquired by Bayer, KaNDy Therapeutics is a spin-off from NeRRe Therapeutics Ltd.[35]. It has recently completed the Phase IIb trial of NT-814, and is now regarded as BAY3427080 (Elinzanetant), which is in phase 3 [36].

WO2019175253A1– titled Novel pharmaceutical formulation comprising dual nk-1/nk-3 receptor antagonists filed by KaNDy Therapeutics describes a pharmaceutical formulation containing 2-[3,5-Bis(trifluoromethyl)phenyl]-N-{4-(4-fluoro-2-methylphenyl)-6-[(7S,9aS)-7- (hydroxymethyl) hexahydropyrazino [2,1-c][1,4]oxazin-8(1H)-yl]-3-pyridinyl}-N,2-dimethylpropanamide, for use in the treatment or prevention of a sex hormone dependent disease, or a condition associated with the perimenopause, the menopause, or the post menopause [37]. Kandy Therapeutics was acquired by Bayer in August 2020.

Scientists are also studying very different approaches for treating menopausal conditions in women. One such interesting approach is described in US11260087B2, titled ‘Composition for preventing or treating menopause’. The patent filed by Korea Food Research Institute, describes a novel Lactobacillus acidophilus YTI strain and a composition containing the same for treating Menopause. When compared to other strains of Lactobacillus in menopausal rat models (with ovariectomy), Lactobacillus acidophilus strain showed increase in femoral bone mineral density (BMD), which was confirmed by using a bone densitometer. It also showed decrease in pain sensitivity when compared with Lactobacillus (L. reuteri) which was confirmed by von Frey filament test [38].

III. Cardiovascular Health, Mental Health, Bone Health and Cancers:

In addition to the above, Femtech companies have also been focusing on cardiovascular, mental, bone health and cancers that affect women.

Cardiovascular Health

Women manifest cardiovascular disease symptoms differently from men. In premenopausal women, estradiol (E2) provides overall cardio-protection from vascular dysfunction and cardiovascular disease. Due to the influence of estradiol, women’s blood pressure and platelets react differently under stress. Increase in the number of platelets and reduction in microvascular blood flow can cause ischemia in critical organs such as the heart [39].

According to Prof. Hugo Katus, the Chair of European Society of Cardiology Advocacy Committee, cardiovascular diseases kill more women than men, and particularly, in women aged 65 years or less as compared to breast cancer, more than twice the number of women die of cardiovascular diseases. Unfortunately, cardiovascular mortality in women is – in contrast to cancer – not on a decline but has stagnated or increased and many women live with chronic, non-curable cardiovascular diseases[40].

According to Dr. Annemarijn de Boer of the University Medical Centre Utrecht, the Netherlands, heart attack symptoms are often labelled as ‘typical’ in men and ‘atypical’ in women. However, while symptoms can differ between the sexes, there are also many similarities. A compilation of 27 studies from the past two decades detailing symptoms in patients with confirmed acute coronary syndrome showed that compared to men, women were more than twice as likely to have pain between the shoulder blades, 64% more likely to have nausea or vomiting, and 34% more likely to experience shortness of breath. Although chest pain and sweating were the most frequent symptoms in both women and men, they occurred less often in women[41].

Mental Health Changes:

It is known that perimenopausal women experience more symptoms of depression than premenopausal women[42]. It was observed in a study, that amplitude of low-frequency fluctuation (ALFF) and gray matter volume (GMV) values of certain brain regions related to cognitive function were different in perimenopausal women[43]. Women not only have a higher prevalence of Alzheimer’s disease than men of the same age, but also show significant greater decline and deterioration[44].

WO2018053595A1 from Newcastle University, titled Methods for improving cerebrovascular function and cognition in peri- and post-menopausal women, describes a method for improving cerebrovascular function and cognitive performance by administering an effective amount of resveratrol. The inventor’s hypothesis is that resveratrol elicits its benefits on cognition and mood through its ability to modulate cerebral perfusion during times of demand. The beneficial effects observed may be due to actions of resveratrol, either directly or indirectly, on estrogen receptors in the brain. The estrogen receptors may be α or β- receptors [45].

The Tulane Brain Institute, founded in 2016, focuses on understanding why estrogen therapy helps protect some women from age-related brain problems. The $14 million NIH grant to study why heart disease, diabetes may blunt brain benefits of estrogen therapy, will determine if and how estrogens interact with cardiovascular and metabolic health to impact the brain and cognitive aging [46].

Bone Health:

It is known that after menopause, women’s bodies produce low levels of estradiol. A study demonstrates that estrogen plus progestin increases Bone Mineral Density (BMD) and reduces the risk of fracture in healthy postmenopausal women [47]. In another study, it was observed that ultra-low doses of estradiol may potentially prevent bone loss in old women [48]. In another study, a five-year sequential therapy with estrogen and progesterone can increase or maintain the BMD of women in their menopausal transition and early menopause [49].

Cancers:

MammoRisk®, the breast cancer risk prediction solution from Predilife, offers women in Europe a clear report for personalized screening. “Polygenic Risk Score” is performed through genotyping of saliva samples. A mammogram may be recommended based on the genetic screening. DenSeeMammo and MammoRisk software developed by Predilife show good correlation between the breast density assessed by AI software (DenSeeMammo) and an assessment by a radiologist. Predilife developed the AI-based software in collaboration with the Radiology Department of the AP-HP Sorbonne University Hospital in Tenon, Paris [50].

Olema Oncology, a clinical-stage biopharmaceutical company, is focusing on developing targeted therapies for women’s cancers [51]. OP-1250 is an oral compound that antagonizes the estrogen receptor (ER) and blocks the ER-mediated cancer cell growth and proliferation signal.

In July 2022, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to OP-1250, the company’s novel, oral estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD), for the treatment of ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor. OP-1250 is currently being evaluated as a single agent in an ongoing Phase 1/2 clinical trial and in Phase 1b in combination with Palbociclib, in patients with recurrent, locally advanced or metastatic ER+/HER2- breast cancer.

IV. Natural extracts in Fem care:

Many patents have been filed from Asian countries on the use of herbal extracts to address women-centric disorders.

KR20110088814A from Korea University Research and Business Foundation titled Composition of Pueraris lobata extracts for menopausal symptoms describes a composition for improving women’s health during menopause, contains Pueraria lobata extract as an active ingredient for reducing body fat and blood neutral fat level and suppresses bone density loss and breast cancer risk [52].

CN103784497A titled Composition for improving bone and intestinal tract health of menopausal women and preparation method thereof, from Tiens Group, discloses a composition prepared from the raw materials comprising 1-200 parts of enzymolysis bone calcium, 5-50 parts of a radix puerariae extract, 10-100 parts of fructo oligosaccharide, 0-800 parts of honey, and 0-50 parts of sodium citrate for improving menopausal women bone and intestinal tract health [53].

KR20160135037A titled Compositions for preventing or treating metabolic disorders comprising an extract of Caragana Sinicafiled by Kyungpook National University-Industry-academic Co-op. Found describes composition comprising Caragana Sinica extract as an active ingredient for preventing and treating metabolic diseases in women after menopause, wherein such disorders are lipid and sugar metabolism, particularly dyslipidemia, hypertension, arteriosclerosis, hyperinsulinemia, diabetes and liver diseases i.e. fatty liver, steatohepatitis, and non-viral hepatitis [54].

In addition to estrogenic activity, herbal extracts provide many other benefits to women.

Some of the herbs that possess estrogenic activity as well as other additional benefits have been presented with animal study evidences.

  • Praval bhasma is effective in the prevention of calcium and estrogen deficient bone loss.
    Animals with ovariectomy and concurrent calcium deficiency (CD-OVX) showed increase in urinary excretion of calcium (Ca) and phosphorus (P), decrease in femoral weight and density, which were significantly reversed in Praval bhasma-treated animals [55].
  • Albergia sissoo leaves are used for the treatment of neurological disorders. They exhibit anti-inflammatory, anti-oxidant effects and also estrogenic properties. Ethanolic extract of Dalbergia sissoo leaves (3- Nitropropionic acid) significantly attenuated behavioral alterations, oxidative damage, mitochondrial dysfunction, and striatal/hippocampus damage in 3-Nitropropionic acid treated rats[56].
  • Asparagus racemosus, Cissus quadrangularis, Punica granatum and Pueraria tuberosa extracts show potential estrogenic activity and help in the treatment of postmenopausal osteoporosis. The animals treated with a mixture of extracts of four drugs, namely Asparagus racemosus, Cissus quadrangularis, Punica granatum and Pueraria tuberosa extracts showed significant increase in uterine weight, femur BMD, femur hardness, levels of calcium and phosphorus in serum and significant decrease in urine as compared to the control group [57].
  • Ginger and cardamom show estrogenic effect, and also help in improving learning and memory58.

V. Conclusion

With development of technology and people’s adaptation of the same, apps and various devices and are being used to address problems in women’s health. While a plethora of new technologies are being developed for women, there is still vast potential to create an impact on improving women’s health. Natural extracts are being used to address women’s health issues. While regulatory challenges can be expected, other limitations could be around high device costs, insufficient accurate data and unbiased clinical trials. If these impediments can be overcome, the implementation of new femtech resources will be faster.

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Disclaimer:

  • This document has been created for educational and instructional purposes only
  • Copyrighted materials used have been specifically acknowledged
  • We claim the right of fair use as ascertained by the author

Posted Date: December, 2022

AUTHOR

Mr. N.Naveen kumar
Author
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