Eeva Receives FDA Clearance

Auxogyn is advancing women’s reproductive health by translating scientific discoveries into clinical solutions that are aimed at improving patient outcomes.

Improving patient outcomes

Focusing on patient outcomes

Auxogyn understands the anguish of an infertility diagnosis and strives to help women and couples have a successful IVF journey, a cost effective treatment plan and reduce the heartache of uncertainty.  The Eeva™ Test was created in order to aid the embryologist in embryo selection.   The IVF team can use this additional, objective information to help educate couples on how they used the Eeva Test adjunctive to morphology to help select the best embryos for transfer.

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Advancing reproductive health

Advancing reproductive health

Auxogyn anticipates – and works to quickly address – the needs of IVF clinicians and patients through innovative technologies and clinically relevant discoveries in early embryo development.

Through ongoing research and strategic partnerships, Auxogyn is committed to providing new scientific and clinical benchmarks to improve patient care and outcomes in the field of reproductive health – benefitting the growing number of patients suffering from infertility.

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Developing standard of care products

Developing standard of care products

Auxogyn’s first product, the Eeva™ Test, is a clinically validated, first-in-class test – and one of the most significant IVF breakthroughs in decades.   Enabled by time-lapse imaging analysis, this prognostic test, when used adjunctively to traditional morphology, aids in the selection of embryos, when there are multiple embryos suitable for transfer. The FDA recently allowed marketing of the Eeva System in the U.S. through its de novo classification process, a regulatory pathway for some novel, low- to moderate-risk medical devices that are first-of-a-kind.  The Eeva System is also CE Marked and available for use in the EU, and is licensed for use in Canada by Health Canada.

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Fueling innovation through Science

Fueling innovation through science

The company takes an interdisciplinary, science-based approach to creating reproductive health solutions. Significant investments are made in scientific and clinical research, and in translating scientific discoveries in early embryo development into highly valued clinical tools.  The company is building upon the work of pioneering scientists from Stanford University who conducted landmark research on embryo development and continuing research programs with prestigious clinical sites, which share our commitment to advancing the field and helping to improve IVF outcomes.

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Committing resources for growth

Committing resources for growth

The company has the freedom to operate with a broad patent strategy to protect its product platform and ongoing research and development plans.  The seasoned management team and the wide-ranging expertise of the employees at Auxogyn (embryologists, bio-researchers and computer algorithm experts) promotes on-going innovation, and with strong financial backing from top tier investors and strategic partners the company is well positioned for success.

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