OvaScienceSM (NASDAQ: OVAS), a global fertility company focused on the discovery, development and commercialization of new fertility treatment options, today announced its plans for 2016. OvaScience will present in a live webcast at the 34th Annual J.P. Morgan Healthcare Conference on Thursday, Jan. 14, 2016, at 9:30 a.m. PST (12:30 p.m. EST) from the Westin St. Francis Hotel in San Francisco.
“In 2016, we plan to expand access to the AUGMENT treatment, determine the OvaPrime treatment’s clinical feasibility by the end of the year and continue our development of the first zero-hormone fertility treatment, OvaTure.”
OvaScience’s goals for 2016 include building its global infrastructure to support the availability of the Company’s AUGMENTSM treatment and driving the development of OvaPrimeSM and OvaTureSM treatments, with a focus on expanding in key strategic regions such as Japan, Western Europe and Canada.
“OvaScience is committed to offering new fertility treatments for patients,” said Michelle Dipp, M.D., Ph.D., Executive Chairman and Chief Executive Officer of OvaScience. “In 2016, we plan to expand access to the AUGMENT treatment, determine the OvaPrime treatment’s clinical feasibility by the end of the year and continue our development of the first zero-hormone fertility treatment, OvaTure.”
- AUGMENT Treatment
Building on the positive patient experiences to date, OvaScience plans to expand the network of clinics and clinicians offering the AUGMENT treatment in 2016, focusing in Japan, Western Europe and Canada. The Company also announced it will be working with clinic partners to obtain prospective patient experience data, including the IVI Group, the largest IVF clinic network in the world. In 2016, the IVI Group plans to continue enrollment of patients in its controlled, double-blind, prospective and randomized egg allocation study of the AUGMENT treatment. This adaptive study compares standard IVF to AUGMENT.
In connection with AUGMENT’s recent approval in Japan, OvaScience plans to build the infrastructure to support a non-commercial preceptorship training program in Japan, one of the largest IVF markets in the world.
The AUGMENT treatment is designed to improve egg health by supplementing a woman’s mature eggs with mitochondria from egg precursor (EggPCSM) cells, immature egg cells found inside the protective ovarian lining, during IVF. The treatment is not available in the U.S.
- OvaPrime Treatment
In December 2015, OvaScience commenced a non-commercial preceptorship training program with the OvaPrime treatment outside the U.S. OvaScience will decide whether to progress the program, based on data, by the end of 2016.
The OvaPrime treatment is a potential fertility treatment that could enable a woman who makes too few or no eggs to increase her egg reserve. Poor egg reserve affects approximately 25 percent of those seeking fertility treatment. The OvaPrime treatment is designed to transfer a woman’s EggPC cells to her own ovary where they may mature into fertilizable eggs during a standard IVF process. The treatment is not available in the U.S.
- OvaTure Treatment
In 2016, OvaScience will continue development of the OvaTure procedure, with a goal of further understanding the clinical path forward. The aim is to characterize EggPC-derived mature eggs.
The OvaTure treatment is a potential next-generation IVF treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections by maturing EggPC cells into eggs outside the body. It may be an option for women with compromised eggs, who are unable to make eggs, or who may be unwilling or unable to undergo hormone hyperstimulation, such as women diagnosed with cancer.
J.P. Morgan Healthcare Conference
OvaScience will present at the 34th Annual J.P. Morgan Healthcare Conference on Thursday, Jan. 14, 2016, at 9:30 a.m. PST (12:30 p.m. EST) at the Westin St. Francis Hotel in San Francisco. A live audio webcast of OvaScience’s presentation can be accessed by visiting the Investors section of the Company’s website at www.ovascience.com. A replay of the webcast will be archived on the OvaScience website for two weeks following the presentation.
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. OvaScience has commenced a preceptorship program with the OvaPrimeSM treatment, which could increase a woman’s egg reserve, and is developing the OvaTureSM treatment, a potential next-generation IVF treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections. OvaScience treatments are not available in the U.S. 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, OvaPrime treatment and OvaTure treatment, including statements relating plans to expand the network of clinics and clinicians offering the AUGMENT treatment, focusing in Japan, Western Europe and Canada, plans to work with clinic partners to obtain prospective patient experience data, plans to determine whether to progress the OvaPrime program, based on data, by the end of 2016, and plans to continue development of the OvaTure treatment, with the aim to characterize EggPC derived eggs. 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 provide or continue providing the AUGMENT treatment, or to delay such treatment, based on clinical efficacy, safety or commercial, logistic, regulatory 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 continued use of the AUGMENT treatment in our partner clinics in new and existing regions, significant uptake in the UAE as a result of the recent coverage, and other programs that include driving first-line use of the AUGMENT treatment, and further 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 or licenses 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.