viO HealthTech Broadens Fertility Offerings to Provide Digital Solutions for the Complete Women's Health Journey

viO HealthTech Builds on the Experience of Over 40,000 Women with its OvuSense Fertility Monitoring Portfolio to Personalise Support for Common Women's Health Issues, Unveils Plans for Digital Therapeutic Solutions for PCOS, and more

OLD SAYBROOK, Conn. and CAMBERLEY, United Kingdom, Feb. 11, 2022 /PRNewswire/ -- Today Fertility Focus, the manufacturer of the OvuSense^Ⓡ family of fertility monitors, became viO HealthTech. Derived from the Spanish meaning "a view" and Latin "I journey", the name change reflects the Company's natural evolution into Digital Therapeutics (DTx) as it looks to expand its current fertility offerings to encompass clinically-proven digital solutions for a woman's entire health journey. Trusted all over the world for over a decade, viO HealthTech's line of OvuSense solutions help women understand the best time to try to conceive in each cycle by identifying key cycle patterns over time, giving the best possible chance of pregnancy.

Over 215,000 reproductive cycles recorded with OvuSense led to the publication of ground-breaking research into screening for and monitoring of the treatment of common issues, which impact fertility but also women's health from puberty to menopause. viO HealthTech will roll out a range of products that provide a targeted personalised approach to not only conception, but the management of Polycystic Ovary Syndrome (PCOS), endometriosis, miscarriage risk, pregnancy complications, diminished ovarian reserve and the link to peri-menopause, and the management of menopause itself.

The Company is uniquely placed to provide this offering with best-in-class sensor technology, AI algorithm leadership, 10 granted patents, a weight of clinical evidence, FDA and CE class 2 clearance, and a unique app that already complies with Software as a Medical Device (SaMD) standards.

"Today's healthcare systems tend to manage women's health as a disjointed set of one-off needs that are only investigated and treated after valuable time has elapsed. My wife and I experienced this firsthand when struggling to conceive due to issues with insulin resistance and endometriosis, and again recently when she went through early menopause," said viO HealthTech CEO Rob Milnes. "Women want access to personalised health information and insights that can help them make informed decisions about their health not only when issues occur but to avoid those issues in the first place. The insight our products have already offered has led to a far more informed conception journey for our customers, and viO HealthTech now wants to help put women in control of their whole health journey. "

Like Rob, the viO HealthTech team has one thing in common – they've been directly or indirectly affected by women's health issues, whether through struggling to conceive, PCOS, endometriosis, or irregular cycles. It's this collective experience that has driven viO HealthTech to pioneer products that provide clinically proven, accurate, and actionable information so that every woman can better understand her body on an individual basis. For almost a decade, viO HealthTech has been at the forefront of breaking down the mythology of what constitutes a 'normal' cycle, supporting more recent evidence, for instance, that although traditional thinking holds that a majority of women ovulate mid-cycle, less than 40% that struggle to conceive actually do.

Further cutting-edge clinical research led to the development of OvuSense® Pro, which provides doctors with detailed remote screening for potential causes of female sub-fertility, risk of miscarriage, and potential pregnancy complications. The Company has now taken this one step further, utilising this clinical research to expand its offerings to the entire women's health continuum.

"As a medical provider, understanding a woman's cycle is an important part of understanding her holistic health. What is most impressive about viO's health tech is its unique ability to easily capture nuances such as prolonged or shortened cycle phases using their unique OvuSense App coupled with the OvuCore Sensor for continuous Core Body Temperature (cCBT) measurements. This provides us with data for better management of medical conditions like PCOS, Infertility, Perimenopause, Menopause, and various menstrual disorders," said Hina Mazharuddin, Executive Vice President of PAVMT, an organisation dedicated to the rapidly growing field of virtual care and telemedicine.

"Ultimately, these remote monitoring solutions are an excellent tool for healthcare professionals like myself to gain more insight into women's health. Knowing this Class II medical device has been tested with clinical studies and holds multiple patents and publications is reassuring," concludes Hina.

viO HealthTech's collective experience with women's health issues has also inspired the Company to provide exceptional customer service to its community, as the team understands firsthand the heartache associated with feeling lost and in search of answers. Recently, the Company was awarded the Feefo Platinum Trusted Service award, which recognises businesses that deliver exceptional customer experiences. The Trusted Service award is based purely on feedback from real customers, meaning it is a true reflection of commitment to outstanding customer service.

To learn more about viO HealthTech for the consumer, visit www.hellovio.com, or visit www.viohealthtech.com for corporate information.

Clinical References with Hyperlinks

• Hurst BS, Karoshi M (2020) Atypical Core Body Temperature patterns and the wider implications for conditions related to pregnancy, infertility, and miscarriage risk P-833 American Society for Reproductive Medicine 76th Annual conference.
  Poster; Fertility and Sterility - September 2020 Volume 114, Issue 3, Supplement, Pages e446–e447
• Karoshi M, Hurst B (2020) Atypical Temperature Patterns as an Aid to Identify Infertility Issues and Miscarriage Risk. P-628 European Society of Human Reproduction and Embryology 36th Annual Meeting.
• Hurst BS, Pirrie A (2019) Atypical vaginal temperature patterns may identify subtle not yet recognised causes of infertility P-345 American Society for Reproductive Medicine 75th Annual conference.
  Poster; Poster Plus Presentation; Fertility and Sterility - September 2019 Volume 112, Issue 3, Supplement, Pages e244–e245
• Vitalis 2020 – Video Presentation
• Hurst BS, Citron C (2020) Normalised Ovulation Timing in Population using Core Body Temperature Monitoring to conceive S-194 Society for Reproductive Investigation, 2020 Annual Meeting.
• Papaioannou S, Delkos D, Pardey J (2014) Vaginal core body temperature assessment identifies pre-ovulatory body temperature rise and detects ovulation in advance of ultrasound folliculometry. European Society of Human Reproduction and Embryology 30th Annual Conference.
• Papaioannou S, Aslam M (2013) Quality Index assessment of vaginal temperature based fertility prediction and comparison with LH testing, ultrasound folliculometry and other home cycle monitors. American Society for Reproductive Medicine 69th Annual conference.

About viO HealthTech

viO HealthTech provides digital monitoring and therapeutics for the entire women's health journey, from puberty to menopause. viO HealthTech with the soon to be launched viO app platform offer information and resources on issues of conception, but management of Polycystic Ovary Syndrome (PCOS), miscarriage risk, pregnancy complications, diminished ovarian reserve and the link to peri-menopause, and the management of menopause itself.  Building on the OvuFirst, OvuCore, and OvuSense Pro family of leading fertility monitoring solutions with over 40,000 women and 215,000 reproductive cycles, class II medical device classification, CE and 510k FDA clearance, the Company is now expanding upon its tried, tested, and trusted technology. viO HealthTech will further leverage information and data collected from the OvuSense fertility monitoring solutions through its corresponding viO app platform, which will offer much broader and deeper help to women who are suffering from health issues, and the personalization of treatment. For more consumer based information, visit www.hellovio.com, for corporate information www.viohealthtech.com, or follow viO HealthTech on LinkedIn, Facebook, Instagram, and Twitter.

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