DARMSTADT, Germany, December 5, 2017 /PRNewswire/ --
- Expanded Fertility Technology portfolio highlights Merck KGaA, Darmstadt, Germany ' s commitment to improve fertility treatment outcomes for patients
- U . S . commercial availability expected in first half of
2018
Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced the
FDA 510(K) clearance of the benchtop embryo incubator Geri™. 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.
(Photo: http://mma.prnewswire.com/media/615557/Merck_Geri.jpg )
With the FDA 510(K) clearance of Geri™, an incubator for continuous embryo monitoring, Merck KGaA, Darmstadt, Germany will help to advance assisted reproductive treatment (ART) technologies by offering new, relevant
solutions to patients and their healthcare professionals.
"Geri™ 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 at Merck KGaA, Darmstadt, Germany's biopharma business. "Offering Geri™ 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.[
1 ] , [ 2 ] , [ 3 ]
, [ 4 ] Geri[ TM ] was designed by embryologists who
know the lab processes and what optimizes successful embryo growth. Geri™ 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 itdirect
access to world leading IVF laboratories. This enabled us to develop Geri™ 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."
With the exception of Australia, Geri™ is distributed by Merck KGaA, Darmstadt, Germany through its Fertility Technologies unit, in accordance witha global distribution agreement executed
with Genea Biomedx in May 2015. Additional products in the Fertility Technologies portfolio of EMD
Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and
Canada, include Gems™, 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.
References
- Zhang et al. Reproductive BioMedicine Online (2010) 20, 510-515
- 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
- Bontekoe S, Cochrane Database of Systematic Reviews 2012, Issue 7
- Kirkegaard, K.et al. Fertility and sterility 99.3 (2013): 738-744
About Geri™
Geri™ is a benchtop incubator with individually controlled incubation chambers per patient to minimize disruptive events to
the early-stage embryo and blastocyst. 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™
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.
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About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, is a leading science and technology company in healthcare,
life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance
life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and
production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck KGaA, Darmstadt, Germany, generated sales of € 15.0 billion in 66 countries.
Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and
chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt,
Germany, holds the global rights to the "Merck" name and brand. The only exceptions are
the United States and Canada, where the company operates as EMD
Serono, MilliporeSigma and EMD Performance Materials.
Contact: Dr. Raphaela Farrenkopf +49 6151 72-2274
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SOURCE Merck KGaA, Darmstadt, Germany