Merck Serono Announces FDA Clearance for Auxogyn's Early Embryo Viability Assessment (Eeva(R)) System

• FDA clearance validates Eeva System, which enables in-vitro fertilization (IVF) clinicians to offer the proprietary Eeva Test and further demonstrates commitment by Merck Serono and Auxogyn to bring innovative technologies to the IVF community
• Eeva Test first-of-a-kind prognostic, non-invasive test that provides IVF clinicians objective information regarding embryo development to help optimize treatment plans for their patients

DARMSTADT, Germany, June 11, 2014 /PRNewswire/ -- Merck Serono, the biopharmaceutical division of Merck, today announced that the proprietary Early Embryo Viability Assessment (Eeva^®) System of Merck Serono´s strategic partner Auxogyn received clearance from the U.S. Food and Drug Administration (FDA) through its de novo classification process, a regulatory pathway for select novel, low-to-moderate risk medical devices that are first-of-a-kind. Merck Serono is the exclusive commercial partner of Auxogyn, Inc., for the Eeva System in Europe and Canada.

The Eeva Test, used adjunctively to traditional morphology, is the first and only prognostic, non-invasive embryo test to receive clearance from the FDA. The Eeva Test utilizes proprietary software that automatically analyzes embryo development against scientifically derived cell-division timing parameters captured through continual video imaging. This objective information provided to reproductive endocrinologists and embryologists helps to optimize treatment plans for their patients.

"The FDA clearance of the Eeva System reinforces the value of the applicability of the Eeva Test in the IVF lab and may improve IVF outcomes. It marks another significant and exciting milestone in our continued collaboration with Auxogyn to further support the clinical development and commercialization of their Eeva Test," said Meeta Gulyani, Head of Strategy and Global Franchises at Merck Serono. "We, therefore, welcome this further validation for the potential of the Eeva Test to objectively identify the embryos with the highest implantation potential, which may ultimately improve patient outcomes."

The Eeva System received the CE Mark in 2012 and has been commercially available in the European Union ever since, and more recently in Canada since 2013. The potential of the Eeva System led to an expansion of the original partnership agreement to include a licensing agreement between Merck and Auxogyn, announced in April 2014 for the exclusive rights to commercialize the Eeva Test in Europe and Canada. Auxogyn plans to commercialize the Eeva Test in the United States later this year.

"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."

According to the European Society of Human Reproduction and Embryology (ESHRE), approximately five million additional babies have been born worldwide since 1978 as a result of assisted reproduction technologies (ART), like IVF.^[1] This trend may increase due to advancements in ART and IVF technologies such as the Eeva Test.