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

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DARMSTADT, Germany, Dec. 5, 2017 /PRNewswire=KYODO JBN/ --

    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.

    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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SOURCE: Merck