SOURCE: Auxogyn


July 02, 2012 08:45 ET

Auxogyn Presents New Data Showing the Ability of Eeva™ to Non-Invasively Predict Embryo Advancement With Increased Accuracy

Company Expects Imminent CE Clearance of Eeva and Anticipates 510(k) FDA Filing in July of This Year

MENLO PARK, CA--(Marketwire - Jul 2, 2012) - Auxogyn, Inc., a company focused on revolutionizing the field of reproductive health, today presented data showing the ability of its flagship product, the Early Embryo Viability Assessment (Eeva) Test, to predict embryo advancement with a new level of accuracy. The Eeva™ Test uses intelligent computer vision software to measure key parameters from video images and predicts with high accuracy at the cleavage stage which embryos will likely grow to the blastocyst stage. These clinical data were presented today at the European Society of Human Reproduction and Embryology (ESHRE) Annual Meeting in Istanbul, Turkey. 

In a prospective multi-center cohort study of 160 patients and close to 1,800 embryos, the Eeva Test was able to predict blastocyst formation at the cleavage stage with 85 percent specificity, reducing the false positive rate from 43 percent to 15 percent compared with traditional morphology selection. Eeva also demonstrated the ability to track and analyze cell division timings with greater than 90 percent accuracy. Additionally, Eeva was able to increase the consistency of embryo assessment across embryologists. 

"Remarkably, we found that Eeva may in fact improve embryo selection for cleavage-stage transfer," said David Adamson, M.D., adjunct clinical professor at Stanford University, associate clinical professor at UCSF, director of Fertility Physicians of Northern California and principal investigator of the Eeva study. "Eeva provided early insights that we expect will prove to be valuable for cycle consultation and planning of future treatment with our patients. The ability to predict with an increased degree of accuracy appears to be outstanding and will change the way we care for our IVF patients."

"We are delighted that these study results both confirm the groundbreaking discovery published by Stanford University in Nature Biotechnology and demonstrate the clinical value that Eeva provides to reproductive specialists and their patients," said Lissa Goldenstein, president and chief executive officer of Auxogyn. "These data, which we included in both our CE and FDA regulatory filings, represent significant progress in our commitment to the rigorous study and validation of our technology, which we believe is essential in the IVF field."

"Given our progress to date, we expect to receive CE clearance for Eeva in the EU imminently," added Ms. Goldenstein. "We are also on track to submit our 510(k) filing to the FDA this month."

About IVF
Infertility affects one of every six couples, but little or no new scientific and clinical breakthroughs in reproductive health have occurred in decades. The demand for assisted reproduction tools and procedures is growing by approximately 10 percent per year due to higher infertility rates caused by an increasing maternal age as more women are starting families later in life. The demand is growing despite the fact that, in the U.S., the cost per cycle is between $13,000 and $15,000, and only one-third of cycles result in a live birth. This necessitates the transfer of multiple embryos and/or conducting multiple cycles, leading to greater physical, emotional, practical and financial costs, before determining if pregnancy can be achieved.

About the Eeva™ Test
Auxogyn's non-invasive, Early Embryo Viability Assessment (Eeva) Test is designed to improve IVF outcomes by providing clinicians and patients with objective information that will enable them to more confidently select embryo(s) for transfer. Eeva's proprietary software automatically analyzes embryo development against scientifically and clinically validated cell-division parameters. With Eeva's quantitative data for each embryo's potential development, IVF clinics may be able to optimize the treatment path for their patients undergoing IVF procedures. Eeva is limited by United States law to investigational use and is under clinical investigation in the European Union.

About Auxogyn
Auxogyn is revolutionizing the field of reproductive medicine by translating scientific discoveries in early embryo development into clinical tools. The Company's flagship product, the Eeva™ Test, delivers consistent, objective and quantitative information regarding embryo viability that reproductive endocrinologists and infertility patients can use to make important treatment decisions. Auxogyn is privately held and funded by Kleiner Perkins Caufield & Byers, Merck Serono Ventures, SR One and TPG Biotech. For more information regarding Auxogyn please visit

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