Spermosens enters into agreement regarding validation for CE marking with the Center for Reproductive Medicine (RMC) Malmö
Spermosens and Reproductive Medicine Center in Malmö enters into an agreement regarding clinical validation of Juno-Checked to obtain CE marking. The study is planned to be conducted in 2022.
RMC is one of the largest public IVF clinics in Sweden and is part of Region Skåne. In 2019, RMC performed 14% of all fresh embryo transfers reported in Sweden and 26% of all public fresh embryo transfers.
The conclusion of a clinical validation is a requirement for obtaining CE marking from JUNO-Checked, which in turn opens up for full commercialization. Spermosens AB is the sponsor of the clinical validation and will provide the JUNO-Checked system. The purpose is to perform the validation under IVDR (in vitro diagnostic medical device regulations) to validate the cassettes before CE marking, which enables sales as an in vitro diagnostic in the EU as well as other countries that accept CE marking. Spermosens will be entitled to all material rights for commercial use of the results generated during the study.
“I am very proud that Spermosens is now establishing a deeper collaboration with RMC, to obtain CE marking of Spermosens products, which prepares us for the next step in introducing Spermosens pioneering products to the global market. Following the announcement in our collaboration with Seattle Sperm Bank regarding the use of our technology for research use, we are now also approaching the general market and look forward to helping to improve the quality of life of the many who are affected by infertility “, concludes John Lempert, CEO of Spermosens.
For more information please contact:
John Lempert, CEO
+46 (0)76-311 40 91
Spermosens AB (publ)
Spermosens was founded in 2018 and develops medical technology products for male infertility to individualize and adapt In Vitro Fertilization treatments. The technology is based on two independent research groups’ discovery of the so-called JUNO protein, in human egg cells in 2018. Spermosen’s first patent-applied product consists mainly of two components; one measuring instruments with associated software, as well as disposable chips. The measuring instrument analyzes the sperm applied to the chip and finds out if they can bind to the egg cell via the JUNO protein.