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Jun 17, 2015

OvaScience’s AUGMENT Treatment Shows Improved Pregnancy Rates and Live Births in Women with Poor Prognoses as Reported by Physicians During Annual International Fertility Meeting

- Additional Baby Born with AUGMENT Treatment -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 17, 2015-- OvaScienceSM (NASDAQ: OVAS), a global fertility company focused on the discovery, development and commercialization of new treatment options, announced that physicians continue to report improvements in pregnancy rates and live births with the AUGMENTSM treatment in women with very poor prognoses, including those with poor egg health and embryo quality. At a scientific symposium held during the European Society for Human Reproduction and Embryology (ESHRE) annual meeting, fertility experts discussed the importance of egg health for improving patient care and shared their patients’ experiences using the AUGMENT treatment during in vitro fertilization (IVF). The AUGMENT treatment is not available in the United States.

Speaking from the conference, Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience, said, “We were pleased to host fertility specialists from more than forty countries at our scientific session, which focused on improving egg health and featured additional positive patient experiences with the AUGMENT treatment. The clinical pregnancy rates and live births reported by physicians using the AUGMENT treatment are encouraging, and we look forward to more patients having access to the treatment.”

Positive Patient Experiences with the AUGMENT Treatment

During the scientific symposium entitled, “Experts in Egg Health: Advancing Fertility Patient Care,” physicians from leading clinics offering the AUGMENT treatment shared positive experiences in patients who had very poor prognoses and highlighted case studies of some of their most difficult-to-treat patients.

Michael Fakih, M.D., Founder and Chairman of Fakih IVF, a leading clinic in the United Arab Emirates (UAE), reported his patients’ experiences for the first time:

  • Dr. Fakih’s clinical experience showed positive results from 59 women with poor egg health and embryo quality who were given the AUGMENT treatment during IVF.
  • The average age of these women was 37.3 years, and they had an average of 4.3 prior IVF cycles.
  • Importantly, prior to using the AUGMENT treatment, the women had a combined 4 percent clinical pregnancy rate1 and a two percent live birth rate based on a combined total of 257 previous IVF cycles.
  • With the AUGMENT treatment, the patients’ combined clinical pregnancy rates increased at least five-fold.
      Previous IVF History     AUGMENTSM
Total cycles initiated     257     60
Average cycles initiated per patient     4.3     1
Total embryo transfers     Unknown     34
Clinical pregnancy rate per cycle initiated     4%     22%
Clinical pregnancy rate per embryo transfer     ---     38%
Ongoing clinical pregnancies and live births (rate per cycle initiated)     2%
(No currently ongoing and 4 live births)
    18%
(11 ongoing)

1 A clinical pregnancy is confirmed by ultrasound and the presence of a gestational sac in the uterus, which occurs at approximately 5-10 weeks.

“We offered the AUGMENT treatment to some of the most difficult-to-treat IVF patients who had a variety of factors impacting their ability to achieve a successful pregnancy,” said Dr. Fakih. “In spite of their poor prognoses, we saw clinical pregnancy rates climb to 22% from a 4% rate based on their combined prior IVF cycles. This is convincing evidence of the benefit of the AUGMENT treatment, and we are expanding on these initial experiences to include many more patients.”

The presentations from the scientific symposium include new patient experiences as reported by Dr. Fakih and summary information as previously reported by Robert F. Casper, M.D., F.R.C.S.(C), Medical Director of TCART Fertility Partners in Toronto, Ontario. Kutluk Oktay, M.D., F.A.C.O.G, of Gen-Art IVF in Ankara, Turkey presented updated patient experience and also shared the news of the first birth in Turkey by a woman who received the AUGMENT treatment. The healthy baby girl was born to a mother who had failed 7 previous IVF cycles and had never achieved a pregnancy. The presentations from the symposium are available at www.ovascience.com/technology/publications and the results are summarized in the table below.

      Patient History    

Previous Clinical
Pregnancy Rate
per Initiated Cycle

   

Clinical Pregnancy
Rate per Initiated
AUGMENT Cycle

 

   

Clinical Pregnancy
Rate per AUGMENT
Embryo Transfer

Canada    
  • Average age: 36.0
  • 1-5 prior IVF cycles
    11%     35%     46%
United Arab Emirates    
  • Average age: 37.3
  • 2-13 prior IVF cycles
    4%     22%     38%
Turkey    
  • Average age: 35.2
  • 2-7 prior IVF cycles
    0%     27%     33%

Introduction of EggHealth.com, a Patient-Focused Fertility Education and Resource Center

In line with OvaScience’s commitment to providing education and resources to patients and the fertility community, the Company announced a new egg health-focused patient education website, www.egghealth.com. The online resource was developed for women to gain a new perspective on female fertility and the extraordinary potential of a woman’s biology. The site highlights recent advances in reproductive technology, including the discovery of egg precursor (EggPCSM) cells, which are immature egg cells in the protective ovarian lining. The site also explores new fertility treatment options and provides the opportunity to connect with experts in egg health.

About the AUGMENTSM Treatment

The AUGMENT treatment is the first fertility treatment available to patients based on OvaScience’s proprietary egg precursor (EggPCSM) cell technology. The AUGMENT treatment is designed to improve the health of a woman’s existing eggs, and enhance the IVF procedure. The AUGMENT treatment uses energy-producing mitochondria from a woman’s own EggPC cells, which are immature egg cells found in the protective lining of the ovaries, to supplement the existing mitochondria in her eggs. This treatment is designed to improve egg health by increasing the eggs’ energy levels for embryo development. Egg health is a key factor in IVF success. The AUGMENT treatment is available in select international IVF clinics, and initial positive clinical experiences of pregnancies with the treatment have been reported. The AUGMENT treatment is not available in the United States. For more information, please visit www.augmenttreatment.com.

About OvaScience

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 connect with us on Twitter and Facebook.

Forward-Looking Statements

This press release includes forward-looking statements about the Company’s plans for the AUGMENT treatment and two fertility treatments in development. 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.

###

Source: OvaScience

OvaScience
Investors
Theresa McNeely, 617-299-7356
EVP, Chief Communications Officer
tmcneely@ovascience.com
or
Media
Cara Mayfield, 617-714-9638
Director, Corporate Communications
cmayfield@ovascience.com