CE Mark Received for Non-Invasive Early Embryo Viability Assessment Test

Auxogyn, Inc., a company focused on revolutionizing the field of reproductive health, today announced that it has received CE mark approval to market its flagship product, the Early Embryo Viability Assessment (Eeva) Test, which is designed to improve in vitro fertilization (IVF) outcomes by providing clinicians and patients with objective information that will enable them to predict embryo viability with a new level of accuracy.

The Eeva™ Test uses intelligent computer vision software to measure key scientifically and clinically validated cell-division parameters from video images and predicts with high accuracy at the cleavage stage which embryos will likely grow to the blastocyst stage, a critical milestone in embryo development.

“Auxogyn is committed to improving the IVF process and we are pleased to be able to offer the first technological breakthrough in embryo assessment. Eeva is the first and only non-invasive test that provides clinically validated, consistent, objective and actionable information to identify those embryos which are the most appropriate for transfer,” said Lissa Goldenstein, president and chief executive officer of Auxogyn. “We are now able to bring clinically relevant discoveries to the field of assisted reproductive health by offering a tool that provides the objective data needed to improve decision-making and patient outcomes during embryo selection in the IVF process.”

“We are prepared to begin our commercialization efforts in the EU immediately to make Eeva available to infertility specialists and their patients,” added Ms. Goldenstein. “In addition, we have also recently submitted our 510(k) filing to the FDA in order to provide the benefits of Eeva to those in need in the U.S.”

The CE mark approval and FDA submission were based on data from a recently completed prospective, multi-center, 160-patient clinical trial that validated the safety and efficacy of Eeva. Results of the trial were presented earlier this month at the European Society of Human Reproduction and Embryology (ESHRE) Annual Meeting in Istanbul, Turkey. In the study, Eeva was able to predict blastocyst formation at the cleavage stage with 85 percent specificity, reducing the false positive rate from 43 percent to 15 percent compared with traditional morphology selection. Eeva also demonstrated the ability to track and analyze cell division timings with greater than 90 percent accuracy. Additionally, Eeva was able to increase the consistency of embryo assessment across embryologists.

Eeva is not yet cleared in the United States and is limited to investigational use only.