VivoSensMedical GmbH has applied for a patent for a new measurement method together with its development partner inotec. By continuously measuring the impedance of the cervical mucus, biomarkers were identified that enable a direct correlation to the hormonal course of estradiol in the female cycle. With this important step and after more than ten years of research and development, the OvulaRing patent family is expanding.
VivoSensMedical has been on the market since 2012 with OvulaRing, a system for diagnosing the female hormonal cycle. Its core is a biosensor that continuously measures body data. By integrating another biomarker into OvulaRing’s vaginal measuring system the technology platform will not only map and evaluate progesterone levels via core body temperature, but also enable a correlation to estradiol and the pH value of the vaginal medium via impedance.
“The results are comparable to laboratory and ultrasound examinations that take place several times a day at a gynecologist and provide novel findings for women’s health,” explains Prof. Henry Alexander, reproductive medicine specialist and inventor of OvulaRing. “We can de facto precisely analyze the development of estrogen and progesterone levels in the body every day and derive individual information. With the results we will be able to develop completely new, personalized therapies, for example, for monitoring pregnancy and diagnosing the menopausal phase.”
The innovation also offers a wide range of options for supporting hormone-free contraception. Today, the safest hormone-free method is the fertility awareness method, where the woman measures her morning wake-up temperature and subjectively observes changes in composition of the cervical mucus. In perfect use this method has the same efficacy as hormonal contraceptives. But since it requires a lot of discipline, experience and a regular lifestyle in typical use the fertility awareness method is not considered a safe contraception option for every cycle type and lifestyle.
“With the new biomarkers, we can establish an exact preovulatory correlation to estrogen-related changes in the mucous membrane. We have thus objectified the previously subjective observation of the cervical mucus and integrated it into the OvulaRing measurement system for an error-free diagnosis,” says Prof. Alexander happily. “Our system thus offers the basis for reliable support for hormone-free contraception, but also the option of contraception with reduced hormone release.”
VivoSensMedical and its partners are planning clinical validation as part of a registration study for 2021. “If everything goes according to plan, we will be able to introduce a groundbreaking world first to the market in 2022,” says Holger Runkewitz, managing director of inotec Forschungs-und Entwicklungsgesellschaft mbH.