DARMSTADT, Germany, December 5, 2017 /PRNewswire/ --
Not intended for U.S. based media
- Expanded Fertility Technology portfolio highlights Merck ' s commitment to improve fertility
treatment outcomes for patients
- U . S . commercial availability expected in first half of
2018
Merck, 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 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'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™ 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 it direct
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 through its
Fertility Technologies unit, in accordance with a 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 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 ™ 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
Merck 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 generated sales of € 15.0 billion in 66 countries.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority
owner of the publicly listed corporate group. The company 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.
Your Contact: Dr. Raphaela Farrenkopf, +49 6151 72-2274
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