Auxogyn, Inc. and Hewitt Fertility Center Announce First Availability of New Non-Invasive Early Embryo Viability Assessment (Eeva) Test in the European Union

MENLO PARK, CA and LIVERPOOL, UNITED KINGDOM--(Marketwire - September 17, 2012) -

Auxogyn, Inc., a company focused on revolutionizing the field of reproductive health, today announced the launch of its Early Embryo Viability Assessment (Eeva) Test in the European Union (EU), with the first installation at the Hewitt Fertility Centre in Liverpool. The Eeva™ Test is designed to improve in vitro fertilization (IVF) outcomes by providing clinicians and patients with objective information that will enable them to predict embryo viability with a new level of accuracy. Eeva uses intelligent computer vision software to measure key scientifically and clinically validated cell-division parameters from video images. It predicts with high accuracy at the cleavage stage which embryos will likely grow to the blastocyst stage, a critical milestone in embryo development.

“We are proud to be the first clinic in the world to offer the Eeva Test, giving our patients the best chance at a successful embryo implantation,” said Charles Kingsland, lead consultant at the Hewitt Fertility Centre and consultant gynaecologist at the Liverpool Women’s National Health Service Hospital Foundation Trust. “At the Hewitt Fertility Centre, we are committed to doing everything we can, including adopting breakthrough technologies, to improve embryo selection in order to increase a patient’s success of pregnancy while reducing the risks associated with multiple births. By using Eeva, we will be able to help our patients make more informed personal decisions and provide them with the best care possible.”

“Until now, the field of reproductive medicine has been using subjective observation to determine embryo viability. With the commercial launch of Eeva, IVF clinics and their patients will now have access to the first and only noninvasive test that delivers consistent, objective and actionable information to help identify viable embryos and determine which ones offer the greatest potential for transfer,” said Lissa Goldenstein, president and chief executive officer of Auxogyn. “Our goal in developing Eeva is to help infertility patients achieve a successful pregnancy. We expect that the availability of Eeva will help IVF clinics optimize the treatment path for their patients who are undergoing IVF procedures.”

About Eeva
Eeva 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, not only providing novel quantitative information, but also ensuring consistent measurements to assess embryo development versus the manual methods used today in clinical practice. 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.

The safety and efficacy of Eeva were validated in a prospective, multi-center, 160-patient clinical trial, results of which were presented in July 2012 at the European Society of Human Reproduction and Embryology (ESHRE) Annual Meeting in Istanbul, Turkey. In the study, Eeva 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.

Auxogyn received CE mark approval to market Eeva in the EU in July 2012. Eeva is currently approved and available for use only in the EU. It is not yet cleared in the United States and is limited to investigational use only.

Benefits of Eeva to IVF Clinics
Eeva provides not only unique, definitive data about embryo viability that has not been available previously, but also provides early results that allow for timely decision-making. During the IVF cycle, there is a checkpoint on Day 3 in which clinicians make decisions about whether to transfer embryos. Only Eeva provides information about embryo viability early in the process -- as early as Day 3 -- allowing clinicians to select a viable embryo in a timely manner, thereby increasing the likelihood of a successful patient outcome.

In addition, Eeva integrates easily into the existing IVF lab environment and fits in with routine workflow, ensuring lab efficiency. It is intuitive and easy for embryologists to use, as it fits into a standard incubator; provides group culture in a stable incubator environment; offers real-time analysis without manual measurements; and improves consistency of embryo grading.

About IVF
Infertility affects one of seven couples, or 3.5 million people, in the UK(1) -- many of whom try to conceive through IVF. The demand for assisted reproduction tools and procedures is growing by approximately 10-15 percent per year worldwide (5.9 percent per year in the UK) 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 significant cost per cycle (£ 4000 to £ 8000 in the UK) and the low success rate, with approximately one-third of cycles resulting 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 Hewitt Fertility Centre at Liverpool Women’s NHS Foundation Trust
Established in 1989, the Hewitt Fertility Centre is now Britain’s largest NHS IVF clinic. The Hewitt Fertility Centre is the largest provider of NHS-funded assisted conception services in the UK and one of the largest centres in Europe. Its staff of over 85 specialist doctors, embryologists and andrologists, fertility nurses and counsellors, provide over 2500 cycles of treatment per year ranging from the most basic diagnosis through to the latest cutting-edge technologies.

The Hewitt Fertility Centre prides itself on its evidence-based approach to fertility treatment and achieves excellent outcomes often in excess of national averages. For example, in the last twelve months, patients under the age of 35 having a single embryo transferred after IVF treatment stood a 47% chance of achieving an ongoing pregnancy.

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 www.auxogyn.com.

(1) Human Fertilisation and Embryology Authority. Fertility treatment in 2010: Trends and figures. p. 39.