Auxogyn receives clearance from FDA for Eeva System

Auxogyn, Inc. a leader in women's reproductive health, today announced that its first product, the Eeva System, received clearance from the U.S. Food and Drug Administration through its de novo classification process, a regulatory pathway for select novel, low- to moderate-risk medical devices that are first-of-a-kind. The Eeva System enables in vitro fertilization (IVF) clinicians to offer the proprietary Eeva Test, which is the first prognostic, non-invasive test that provides objective information regarding embryo development to help optimize treatment plans for their patients.

"We're excited to receive the de novo FDA clearance for the Eeva System and believe this marks a significant milestone in the field of IVF," said Lissa Goldenstein, president and CEO of Auxogyn. "We have followed a rigorous, years-long clinical validation process and regulatory pathway to bring the Eeva Test to market. Our clearance provides a new level of confidence to IVF clinicians who, for the first time, have quantitative information that can be used in addition to traditional morphology to aid in deciding which embryo or embryos to transfer."

Auxogyn is dedicated to advancing women's reproductive health by translating scientific discovery into clinical solutions that may improve patient outcomes. The scientific foundation for its Eeva Test is based on groundbreaking research and innovation licensed from Stanford University, which was published in Nature Biotechnology, and further recognized for its clinical relevance as a top 10 Medical Breakthrough by TIME magazine. The Eeva Test utilizes proprietary software that automatically analyzes embryo development against scientifically derived cell-division timing parameters captured through continual video imaging.

Clearance of the Eeva Test was based on a multi-center, prospective clinical trial that clinically validated the test and found it to be informative in identifying embryos with the highest development potential, when used adjunctively after morphology¹. Results of a study, where a panel of five embryologists adjunctively used the Eeva Test, showed that the odds of an embryo reaching the critical blastocyst stage at day 5/6 is 2.57 times higher among embryos predicted to become a blastocyst versus those predicted to not reach blastocyst stage². Using the Eeva Test adjunctively to morphology, the odds ratio rose 53 percent over traditional, morphological grading.

"The Eeva Test represents a significant advancement in IVF that I believe will change the standard of care in our field," explained Dr. G. David Adamson, reproductive endocrinologist, CEO of Advanced Reproductive Care and past president of both the American Society of Reproductive Medicine (ASRM) and Society of Assisted Reproductive Technologies (SART). "With the Eeva Test, we now have novel information that when used adjunctively with traditional morphology provides us with more confidence in the embryo(s) we select for transfer, and more clinical information to share with our patients regarding their treatment plan."

The Center for Disease Control reports that, in the United States, one out of eight couples is impacted by infertility, and 40 percent of them seek treatment, many through IVF. Only about one-third of IVF cycles result in live births, and nearly one third of live births are multiples³.

"With the IVF clinical community, we share the widely recognized goal to decrease the multiple birth rate without lowering the success rate," Goldenstein said. "At Auxogyn, we are committed to improving the IVF journey for couples and giving them a better chance of a successful outcome."

The Eeva System received CE Mark and has been commercially available in the European Union since 2012 and Canada since 2013. In April 2014, a licensing agreement was signed with Merck KGaA, Darmstadt, Germany, for the exclusive rights to commercialize the Eeva Test in Europe and Canada. Its dedicated biopharmaceutical division is a leader in fertility treatment committed to developing innovative science, medicines and technologies that have the power to improve outcomes for patients throughout the IVF process.