Leipzig, Feb. 23rd 2021 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.
Leipzig, Jan. 12th 2021 Since January 1st women and couples in Germany with an unfulfilled desire for children and their attending gynecologist are now able to access an additional treatment option. The treatment with OvulaRing, a medical device for precisely diagnosing the female cycle, will be reimbursed nationwide by four health insurance providers for both, doctors and patients.
Leipzig, January 12th, 2020: Since January 1st, women and couples in Germany with an unfulfilled desire for children and their attending gynecologist are now able to access an additional treatment option. The treatment with OvulaRing, a medical device for precisely diagnosing the female cycle, will be reimbursed nationwide by four health insurance providers for both, doctors and patients.
With OvulaRing, reproduction specialist Professor Henry Alexander and VivoSensMedical, a Leipzig based MedTech company, have launched a unique system for individual cycle diagnostics. Based on the diagnosis with OvulaRing, Professor Alexander has developed an innovative treatment scheme allowing for personalized and therefore more efficient therapies for women with an unfulfilled wish for a child.
With the reimbursement by the four German health insurance providers BIG direct gesund, HEK – Hanseatische Krankenkasse, IKK Südwest and mhplus Krankenkasse, the treatment based on the OvulaRing diagnosis will be established in the first healthcare market.
The four health insurance providers will cover diagnosis and treatment with OvulaRing for both patient and doctor for up to 12 months. They insure around 300,000 women between the ages of 20 and 44 within the OvulaRing target group. VivoSensMedical is supported by supply management company Convema in managing the interface to the gynecologists. The project includes a study on cycle diagnostics amongst women having trouble to conceive. This is the largest study of its kind worldwide to date. In the study, the efficiency of OvulaRing is scientifically evaluated by InGef, the Institute for Applied Health Research Berlin GmbH, an independent institute.
OvulaRing creates an exact image of the female cycle, the cyclofertilogram (CFG), based on a high resolution measurement of the body core temperature. A patented algorithm evaluates the data and determines an individual CFG score. This score can be used by doctors to assess the patient’s individual cycle and fertility health at a glance. The CFG provides information that is comparable to a continuous determination of hormonal blood levels. Based on the CFG, the gynecologist is able to initiate personalized therapies.
Over 3,000 women in Germany, Austria and Switzerland are already using OvulaRing.
Sebastian Alexander, founder and managing director of VivoSensMedical, is pleased about the cooperation: “We worked with the health insurance providers for almost one year to establish this cooperation. We are looking forward to support women and couples in Germany with additional options to treat infertility, reimbursed by health insurance. OvulaRing will facilitate an easier way to natural pregnancy for more women and thereby saves them from physically and psychologically stressful reproductive health treatments.”
The four health insurance companies are also looking forward to the cooperation. Peter Kaetsch, CEO of BIG Direct: “Many fertility treatments are premature and are weighing on couples who want children. With the cycle diagnostics from OvulaRing we want to increase the probability of a natural pregnancy.”
Daniel Schilling, Board Member of the IKK Südwest sees the cooperation as a big step for the future of his health insurance company: “We are always looking to identify the best startup ideas for patient care. OvulaRing as a digital tool for women who want to have children has impressed us. It is a groundbreaking step in matters of healthy and informed family planning that we are happy to support. “
The HEK – Hanseatische Krankenkasse is also delighted: “With OvulaRing, our customers receive a new type of digital medical product. This corresponds with our claim to offer first class quality of care through innovative treatment methods”, says board member Torsten Kafka.
Winfried Baumgärtner, CEO of mhplus Krankenkasse, sees a noticeable advantage for the members in particular: “Our cooperation with innovative startups such as VivoSensMedical GmbH opens up new, qualified options for our insured for optimal care.”
About VivoSensMedical and OvulaRing
The vision of VivoSensMedical is to improve diagnostics for women’s health and to set new standards for gynecology, reproductive and sexual medicine. Based on 40 years of medical research, the Leipzig based company has developed a platform technology for individual diagnostics based on the core body temperature and launched its first product in the field of women’s health, OvulaRing. OvulaRing is a certified medical product and, as such, has been clinically validated and meets the strict requirements for quality and data protection. The company was founded in 2011 and is funded by the European Regional Development Fund (EFRE), the Saxon State Ministry for Economics, Labor and Transport (SMWA), the State Ministry for Science and Art (SMWK) and the City of Leipzig. OvulaRing was supported by the Federal Ministry of Economics and Technology as part of an EXIST start-up grant.
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.