Fertility Focus Announces Launch of OvuFirst Skin-Worn Sensor to Add Support for Women Starting Out on Their Journey to Pregnancy

Latest Addition to the OvuSense Family, Which Now Covers the Complete Trying To Conceive Pathway, is Proven in Side-By-Side Studies to be the Most Accurate Skin-Worn Sensor on the Market

OLD SAYBROOK, Conn. and WARWICK, United Kingdom, June 07, 2021 (GLOBE NEWSWIRE) — Fertility Focus, the manufacturers of the OvuCore and OvuSense Pro family of leading fertility monitoring solutions, with class II medical device classification and 510k FDA clearance – today announces the launch of OvuFirst, a completely unique patented sensor designed to measure skin temperature, providing women with an understanding of when to try and conceive naturally, and enabling them to determine what issues they may have trying to conceive.

Joining the OvuSense fertility monitoring family which now supports couples from their first months trying to conceive right the way through to monitoring clinical treatment, OvuFirst is targeted at women who wish to monitor their ovulation and cycles in a convenient, non-invasive way. By wearing the clinically-proven sensor on the arm or wrist overnight, OvuFirst confirms a woman’s fertile window with over 90% accuracy even if she has irregular cycles – making it the most accurate skin-worn sensor on the market. The OvuSense App then uses this information to provide women with a full 8-day fertile window at the start of their next cycle.

“We took our revolutionary OvuSense patented technology proven in over 190,000 cycles of use, and used it to develop and test the most accurate skin-worn fertility monitoring sensor available on the market,” said Fertility Focus CEO Robert Milnes. “We are proud to offer a convenient and easy-to-use solution to assist and support women during the early stages of their fertility journey, whether that is trying to start a family, or simply learning more about their bodies and cycles.”

In a side-by-side study volunteers wore the OvuCore vaginal sensor and OvuFirst skin sensor overnight for several cycles. The study concluded that the skin-worn sensor provides a convenient method of determining the presence or absence of ovulation, even in women who have a known history of ovulatory dysfunction, anovulation (the absence of ovulation), and/or ‘abnormal’ long cycles. The study is expected to be published later in the year.

“I love how easy and comfortable OvuFirst is. OvuFirst provided me with a non-invasive way to collect data and see trends to better understand my personal health. As a medical provider who takes care of women’s health, I am looking forward to this being a wonderful resource for all women to understand, be informed, and empowered to take control of their health,” commented Hina Mazharuddin, Physician’s Assistant – Certified, OvuFirst study participant.

At the heart of the OvuSense fertility monitoring family is the ability to provide clinically proven, accurate and useful information so every woman can best understand her unique individual cycle pattern. Robert Milnes continues: “For almost a decade, OvuSense has been at the forefront of breaking down the mythology surrounding the concept of what constitutes a ‘normal’ cycle, showing for instance that although traditional thinking holds that a large majority of women ovulate mid-cycle, only around 40% of OvuCore users show this pattern” ^[1] OvuSense’s OvuCore works by measuring female continuous core body temperature (cCBT) using a sensor worn in the vagina overnight.

Further ground-breaking 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 ^{[2, 3, 4]}. A presentation at the Vitalis conference in 2020 ^[5] detailed the added benefit of OvuSense Pro through a number of case studies: Because it can show what’s happening throughout the cycle, women and their doctors can also use OvuSense Pro to track medications and treatment, and understand if these are improving the regularity of ovulation, and the chances of a successful pregnancy.

To learn more about the OvuSense fertility monitoring family, visit ovusense.com.

Clinical References with hyperlinks

[1] 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.

[2] 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. Fertility and Sterility – September 2019 Volume 112, Issue 3, Supplement, Pages e244–e245

[3] 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 36^th Annual Meeting.

[4] 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

[5] Remote Diagnosis and monitoring of ovulatory issues with OvuSense Pro (2020) Vitalis Conference.

[6] The accuracy of ovulation confirmation by OvuSense is based on the data set originally published at the 2013 ASRM meeting as a quality index: Papaioannou S, Aslam M (2013), and developed in the key publication outlining the accuracy and positive predictive value of advance prediction of ovulation shown at the 2014 ESHRE meeting: Papaioannou S, Delkos D, Pardey J (2014).

US Patents: US8684944, US8496597, US9155522, US9155523, US20190110692; European patents: EP1485690, EP2061380, DE20 2014 011 334, DE20 2014 011 335; Chinese patent: CN1650154

About Fertility Focus

Driven by their own experiences with struggling to conceive, and the sometimes poor support they encountered along the way, the Fertility Focus team set out with the aim of empowering women by putting them back in control of the understanding of their cycles. The resulting OvuSense fertility monitoring family improves the chance of successful pregnancy whatever a woman’s previous history, and contributes to better treatment for common issues such as PCOS. OvuCore™ predicts the onset of ovulation one day in advance [6] with 96% positive predictive value, 99% accuracy for detection of the exact date of ovulation [6]. OvuSense® Pro, is proven to help with screening and remote monitoring of treatment [2-5]. No other method of cycle monitoring in the clinic or home offers these features. The company is continuously developing new technology to support women along all stages of their fertility journeys, and recently launched OvuFirst, a unique patented sensor designed to measure skin temperature, providing women with a convenient method of cycle tracking for when they are just starting out on their fertility journey. Internal side-by-side studies have shown OvuFirst confirms a woman’s fertile window with over 90% accuracy, using this information to provide users with a full 8-day fertile window at the start of their next cycle. Fertility Focus also manages the largest closed support group on Facebook for women who have PCOS and are trying to conceive called ‘PCOS Fertility Support Group’.

CONTACT: For more information, contact:

Rob Milnes
Fertility Focus
(203) 660 0500
+44 2476 980102         
robert.milnes@fertility-focus.com

Kate Nichols
Next Step Communications
(978) 609-0271
ovusense@nextstepcomms.com