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

Darmstadt, Germany (ots/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(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.

(Photo: http://mma.prnewswire.com/media/615557/Merck_Geri.jpg )

With the FDA 510(K) clearance of Geri(TM), 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(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 at Merck's biopharma
business. "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.[1],[2],[3],[4] 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."

With the exception of Australia, Geri(TM) 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(TM), culture media allowing for high-quality
embryo cultivation that was granted an FDA 510(k) clearance this
summer, and Gidget(TM) a hand-held witnessing system that provides
electronic witnessing, visual lab workflow management and support for
traceability and audit reporting.

References

1. Zhang et al. Reproductive BioMedicine Online (2010) 20, 510-515
2. 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
3. Bontekoe S, Cochrane Database of Systematic Reviews 2012, Issue 7
4. Kirkegaard, K.et al. Fertility and sterility 99.3 (2013): 738-744

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 and blastocyst. It also incorporates a camera to
real-time monitor the developing embryos. Geri(TM) 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(TM)

Gidget(TM) 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(TM)
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 EUR 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.

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