MENLO PARK, Calif., Oct. 13, 2014 /PRNewswire/ -- Auxogyn, Inc. a company focused on advancing women’s reproductive health by translating scientific discoveries into clinical solutions, today announced that Brigham and Women’s Center for Infertility and Reproductive Surgery (CIRS) has initiated its Pregnancy Pilot Study using the Eeva System. The Pregnancy Pilot Study is a single-site randomized controlled trial designed to gather pilot data to evaluate the effect of use of the Eeva Test on clinical pregnancy rates in IVF patients who undergo elective single embryo transfer (eSET). The Eeva Test is the first prognostic non-invasive test providing objective information to aid in embryo selection when used in combination with traditional morphology.
“We are very proud of the research we conduct at CIRS to help advance reproductive medicine,” stated Catherine Racowsky, PhD, HCLD and Director of the ART Laboratory. “CIRS is a leader in research that has advanced ways to maximize the chance of a successful pregnancy while reducing the birth rates of multiples, which can place the mother and child at greater risk.”
“We are pleased to be sponsoring this very important study at CIRS,” said Lissa Goldenstein, President and CEO of Auxogyn. “Dr. Racowsky and her world-renowned colleagues share the same opinion as Auxogyn of the critical importance of clinical research and validation to support new technologies in the IVF field. Our company was founded on the importance of scientific and clinical rigor, which is the basis of the Eeva System’s first-of-a-kind FDA clearance.”
Clearance of the Eeva Test was based on a multi-center, prospective clinical trial that clinically validated the test and found it to be informative in identifying embryos with the highest development potential, when used adjunctively with morphology. Results of a study, where a panel of five embryologists adjunctively used the Eeva Test, showed that the odds of an embryo reaching the critical blastocyst stage at day 5/6 is 2.57 times higher among embryos predicted to become a blastocyst versus those predicted to not reach blastocyst stage. Using the Eeva Test adjunctively to morphology, the odds ratio rose 53 percent over traditional, morphological grading.
“This study, along with others underway, will help guide our product development and regulatory pathway to improving pregnancy rates of single embryo transfer,” states Goldenstein. “Partnering with Dr. Racowsky and CIRS is a great step in this process and we look forward to the results of this very important study.”
To learn more about this study go to www.clinicaltrials.gov.
About Auxogyn
Auxogyn is a leader in reproductive health that provides novel scientific and clinically validated solutions to IVF clinicians and their patients by translating scientific discoveries in early embryo development into clinical tools that improve patient outcome. The company’s flagship product, the Eeva Test, delivers objective information regarding embryo development that IVF clinicians and 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, visit auxogyn.com and follow the company on Twitter @Auxogyn.
About the Eeva System
Auxogyn’s Eeva System is a first-in-class, non-invasive device cleared by the FDA to aid in embryo selection. The Eeva Test is scientifically derived and clinically validated to identify embryos with the greatest developmental potential when used adjunctively to traditional morphology in women with multiple embryos. Utilizing proprietary software and sophisticated computer vision technology, the Eeva Test automatically analyzes embryo development against scientifically and clinically validated cell-division timing parameters. With the Eeva Test’s quantitative data on each embryo’s potential development, IVF clinicians can optimize the treatment path for their patients undergoing IVF procedures. Auxogyn received FDA clearance for the Eeva System in June, 2014. The Eeva System also received the CE mark in July 2012, and it is currently available for use in selected countries in the EU and Canada. For more information, visit www.eevaivf.com and follow us on Twitter @Eevaivf.
SOURCE Auxogyn, Inc.
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