EMD Serono Announces FDA 510(k) Clearance of Partner Genea Biomedx's Fertility Benchtop Incubator Geri™

ROCKLAND, Mass., Dec. 5, 2017 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the FDA 510(k) clearance of the benchtop embryo incubator Geri^TM. This innovative technology, designed to improve processes in fertility laboratories, will be commercially available to IVF clinics in the U.S. in the first half of 2018.

With the FDA 510(k) clearance of Geri^TM, an incubator for continuous embryo monitoring, EMD Serono will help to advance assisted reproductive treatment (ART) technologies by offering new, relevant solutions to patients and their healthcare professionals.

"Geri^TM is one of the flagship products of our fertility technologies portfolio and has been successfully used in clinics across Australia, Europe and Asia for the last two years," said Rehan Verjee, Chief Marketing and Strategy Officer of the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. "Offering Geri^TM in the U.S. will allow us to further our aspiration of becoming an integrated fertility treatment partner, continuously aiming to improve treatment outcomes."

An incubator is critical for embryo development while it is being cultured outside of the uterus. Getting as close as possible to in-vivo incubation conditions is essential to ensure the most favorable environment for embryonic development, given that exposure to non-optimal conditions outside of an incubator may affect the viability and quality of embryos.^i,ii,iii,iv

Geri^TM was designed by embryologists who know the lab processes and what optimizes successful embryo growth. Geri^TM has six individual chambers, each independently controlled, facilitating the care of the embryos of six patients at the same time. It is equipped with high-definition cameras to take a picture of the embryos every 5 minutes and provide continuous imaging so the supervising embryologist can observe embryos as they develop without removing them from their optimum environment. This minimizes lid openings and potential disruptions that can cause stress to embryos.

"Genea Biomedx is an IVF medical device company uniquely positioned within a clinical fertility business allowing it direct access to world leading IVF laboratories. This enabled us to develop Geri^TM in collaboration with the embryologists that use it day in, day out," said Dr. Tammie Roy, General Manager at Genea Biomedx. "We are looking forward to working with EMD Serono to bring our innovative technology to clinics across the U.S."

Geri^TM will be distributed by EMD Serono in the U.S. through its Fertility Technologies unit, in accordance with a global distribution agreement executed with Genea Biomedx in May 2015. Additional products in EMD Serono's Fertility Technologies portfolio include Gems^TM, culture media allowing for high-quality embryo cultivation that was granted an FDA 510(k) clearance this summer, and Gidget™, a hand-held witnessing system that provides electronic witnessing, visual lab workflow management and support for traceability and audit reporting.

About Geri^TM
Geri^TM is a benchtop incubator with individually controlled incubation chambers per patient to minimize disruptive events to the early-stage embryo. It also incorporates a camera to real-time monitor the developing embryos. Geri™ was developed by Genea Biomedx, a company that creates and manufactures practical, accessible and precise fertility technologies that help standardize and automate fertility treatment.

About Gems^TM
Gems^TM is the latest generation of Genea Biomedx's culture media suite for high-quality embryo cultivation.

About Gidget™
Gidget™ is a hand-held witnessing system for the IVF laboratory that allows the embryologist to focus on the science by helping to ensure that gametes and embryos are matched correctly.  Gidget™ provides electronic witnessing, visual lab workflow management and support for traceability and audit reporting.

About EMD Serono, Inc.
EMD Serono is the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the business has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas. Today, the business has approximately 1,300 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. www.emdserono.com

ⁱ Zhang et al. Reproductive BioMedicine Online (2010) 20, 510–515
ⁱⁱ Swain, J.E., Decisions for the IVF laboratory: comparative analysis of embryo culture incubators, Reproductive BioMedicine Online (2014), doi: http://dx.doi.org/10.1016/j.rbmo.2014.01.004
ⁱⁱⁱ Bontekoe S, Cochrane Database of Systematic Reviews 2012, Issue 7
^iv Kirkegaard, K.et al. Fertility and sterility 99.3 (2013): 738-744

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