(Updates with investors in sixth paragraph.)
June 10 (Bloomberg) -- Women in the U.S. having trouble conceiving the natural way now may use a new tool to help choose the lab-dish embryo most likely to result in a pregnancy.
The Food and Drug Administration cleared for sale Auxogyn Inc.’s time-lapse photography device that assists fertility doctors who typically eyeball embryos to pick the most viable ones for placing in the womb. The closely held Menlo Park, California-based company’s Eeva System assesses the timing of important changes in embryos’ development to differentiate between ones that look equally healthy.
The cost of a single attempt to create a test-tube baby can reach $17,000 and chances of giving birth after in-vitro fertilization are as low as 13 percent for women older than 40, according to the National Institutes of Health. In a clinical trial, the Eeva System boosted doctors’ chances of picking a viable embryo by 53 percent.
“It’s helpful beyond words,” Michael Glassner, division head of infertility for Main Line Health System in Bryn Mawr, Pennsylvania, said in an interview. “It’s going to give more clarity to the patient. It’s going to give a higher pregnancy rate. The miscarriage rate goes down. It’s just going to change the field.”
Glassner has used the Eeva System on about 40 of his patients in the last two months as part of a clinical trial evaluating the device.
Merck Serono Ventures, a biotechnology investment division under Merck KGaA, and SR One, the venture capital arm of GlaxoSmithKline Plc, are investors in Auxogyn. The investment firms Kleiner Perkins Caulfield & Byers and a fund of TPG Capital are also backers.
The company plans an additional round of financing to raise as much as $30 million in the next year, Chief Executive Officer Lissa Goldenstein said in an e-mail. She declined to comment on whether the company may go public with the Eeva clearance or possibly sell.
The system was cleared under the FDA’s de novo process for first-of-a-kind devices with low-to-moderate health risks. The device was cleared for sale in the European Union in 2012 and Canada last year. Merck KGaA, based in Darmstadt, Germany, is licensed to sell the system in Europe and Canada. Auxogyn plans to market the Eeva System on its own later this year in the U.S., Goldenstein said in an interview.
Auxogyn doesn’t have data on how the Eeva System affects women’s chances of getting pregnant though the company plans to collect it, Goldenstein said.
Eeva isn’t supposed to replace genetic testing, she said, though it does augment it and can help couples choose which embryos are best to biopsy for testing. The device may also cut down on multiple births if couples choose to implant only one embryo.
In the U.K., patients pay about 800 pounds ($1,343) to use Eeva at fertility clinics that pay about 500 pounds for every test run, Goldenstein said.