CAMBRIDGE, Mass.--(BUSINESS WIRE)--OvaScienceSM (NASDAQ: OVAS), a global fertility company focused on the discovery, development and commercialization of new treatment options, announced today that additional clinical experience of the Company’s AUGMENTSM treatment demonstrated improved pregnancy rates in women who had failed three to seven prior in vitro fertilization (IVF) cycles. These results were reported at the Society for Reproductive Investigation (SRI) 62nd Annual Scientific Meeting being held in San Francisco, CA. The AUGMENT treatment is not available in the United States.
Kutluk Oktay, M.D., F.A.C.O.G, of Gen-art IVF in Ankara, Turkey, and one of the initial IVF specialists to use the AUGMENT treatment in clinical practice, presented initial clinical experience in eight women whose ages ranged between 27 and 41 years with three or more IVF failures and poor egg and embryo quality. In eight women who received the AUGMENT treatment, there were two clinical pregnancies out of eight embryo transfers (25%).1 Most notably, the two pregnancies occurred with single embryo transfers in women aged 34 and 41 who had previously failed to become pregnant following seven and three IVF cycles, respectively. One patient has an ongoing clinical pregnancy.2
“These initial AUGMENT pregnancy rates are quite encouraging, especially given that these were women who had failed multiple IVF cycles and were running out of options to use their own eggs,” said Dr. Oktay. “We were also pleased to see these pregnancy rates achieved with single embryo transfers during IVF, a practice that may limit the number of multiple births, which can cause health risks to the mother and infant during pregnancy and delivery and after. Based on our experiences to date, the AUGMENT treatment appears to benefit women with poor egg quality and we look forward to continuing to share our clinical experiences.”
The results reported in the poster presentation represent experiences from a small number of patients with different diagnoses, ages and prior IVF history. As of this reporting, pregnancy rates across IVF clinics that offer the AUGMENT treatment currently range from 25% - 53%, which includes clinics that are treating some of the more challenging infertility patients. OvaScience is collecting AUGMENT patient experience in a first-of-its-kind international registry, and anticipates sharing information from a broader patient experience when it is available.
The AUGMENT treatment is a fertility treatment specifically designed to use the mitochondria, or energy, from a woman’s own egg precursor cells – immature egg cells found inside the protective ovarian lining – to improve egg health. The treatment is available to patients in select international IVF clinics. Additional information can be found at www.augmenttreatment.com.
“The positive clinical evidence continues to build in support of our AUGMENT treatment,” stated Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience. “These improved pregnancy rates in women who have failed IVF multiple times, coupled with similar encouraging clinical AUGMENT experiences at other IVF clinics, provide physicians and patients with important information about how the AUGMENT treatment may improve egg health in women with infertility.”
Dr. Oktay’s poster presentation follows an AUGMENT presentation made by Robert Casper, M.D., F.R.C.S.(C), Medical Director of TCART Fertility Partners, at the SRI meeting. Both presentations can be found at www.ovascience.com/technology/publications. The AUGMENT treatment presentations at SRI are based on self-reported patient experiences and physician evaluations.
OvaScience (NASDAQ: OVAS) is a global fertility company dedicated to improving treatment options for women around the world. OvaScience is discovering, developing and commercializing new fertility treatments because we believe women deserve more options. Each OvaScience treatment is based on the Company’s proprietary technology platform that leverages the breakthrough discovery of egg precursor (EggPCSM) cells – immature egg cells found inside the protective ovarian lining. The AUGMENTSM treatment, a fertility option specifically designed to improve egg health, is available in certain IVF clinics in select international regions outside of the United States. OvaScience is developing the OvaPrimeSM treatment, which could increase a woman’s egg reserve, and the OvaTureSM treatment, a potential next-generation IVF treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections. For more information, please visit www.ovascience.com and www.augmenttreatment.com and connect with us on Twitter and Facebook.
This press release includes forward-looking statements about the Company’s plans for the AUGMENT treatment and future pregnancy rates. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: the possibility that international IVF clinics that we work with may determine not to begin or continue providing the AUGMENT treatment for commercial or other reasons; our expectation that the AUGMENT treatment and OvaPrime treatment meet the requirements of a class of products exempt from premarket review and approval under applicable regulations in those countries where we have launched or plan to introduce the AUGMENT treatment and plan to introduce the OvaPrime treatment; the commercial ramp up of the AUGMENT treatment, which we expect will depend upon the successful transition of ACE clinics to commercial operations, the addition of new ACE clinics, and the results from ACE clinic experience as they become available; the science underlying our treatment and treatments in development (including the AUGMENT, OvaPrime and OvaTure treatments), which is unproven; our ability to obtain regulatory approval where necessary for our potential treatments; our ability to develop our potential treatments, including the OvaPrime and OvaTure treatments, on the timelines we expect, if at all; our ability to commercialize the AUGMENT treatment and our potential treatments, including the OvaPrime treatment, on the timelines we expect, if at all; as well as those risks more fully discussed in the “Risk Factors” section of our most recently filed Quarterly Report on Form 10-Q and/or Annual Report on Form 10-K. The forward-looking statements contained in this press release reflect our current views with respect to future events. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our view as of any date subsequent to the date hereof.
1 Outcomes presented show percentage of clinical pregnancies from embryo transfer.
2 Clinical pregnancy is defined as a pregnancy diagnosed by ultrasound. http://www.eshre.eu/Guidelines-and-Legal/ART-glossary.aspx