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Ohana Biosciences Completes Enrollment in the SPRING Clinical Trial for Spertility, a Novel Sperm Cell Treatment to Improve Outcomes in Assisted Reproductive Technology

SPRING is a Randomized, Controlled Clinical Trial for People Using In-Vitro Fertilization

Endpoints Include High-quality Embryos and Pregnancy Outcomes

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Ohana Biosciences, a pioneering reproductive health company that created the world’s first sperm biology platform for sperm-based products, today announced it has completed patient enrollment in its SPRING study (SPeRtility, IVF Next Generation) of Spertility™. Spertility is a sperm cell treatment designed to improve outcomes for people using Assisted Reproductive Technology (ART), such as In-Vitro Fertilization (IVF).

“Completing enrollment in our initial clinical study of Spertility represents a significant milestone for our first product and Ohana. We extend our gratitude to the couples, clinical trial sites, and healthcare providers who helped us achieve this goal in the midst of a pandemic,” said Amber Salzman, Ph.D, President and Chief Executive Officer of Ohana. “Spertility offers the potential to be the first significant medical advance focused on sperm in ART in nearly 30 years. By improving embryo development, Spertility has the potential to improve pregnancy outcomes. Our ultimate goal focuses on reducing the number of cycles needed to achieve having a baby, without adding treatment burden for women and additional costs to the healthcare system. We believe Spertility can potentially make a positive impact for women using ART irrespective of the source of infertility.”

“Every person who walks through our doors has the same goal: to achieve a healthy pregnancy. While this journey looks different for everyone, it can take several years to have a baby. Any innovation that could potentially offer our patients a better chance at achieving their dreams is meaningful. This is why we were excited by the opportunity to participate in Ohana’s clinical trial for Spertility,” said Dr. Michael Glassner, Founding Partner and Medical Director of Main Line Fertility. “By focusing on the treatment of sperm – an area lacking in treatment options – we have the potential to improve pregnancy outcomes for our patients, while not adding treatment burden. (Read more…) We’re proud to be on the leading-edge of evaluating new treatments that could represent a meaningful advancement in IVF treatment.”

As more people rely on ART to conceive, there is a growing need to improve success rates. While IVF accounts for 8 million babies born since 1978, only 10% of infertile couples access fertility treatment annually. For the few that are able to access treatment, only 50% will have a baby after three cycles1,2. Ohana’s proprietary understanding of sperm biology has led to discoveries in how sperm-based treatments could improve outcomes for anyone using ART, regardless if the source of infertility is male- or female-related. Spertility is a patent-protected, ex vivo sperm cell treatment that in animal studies shows higher quality embryos and improves pregnancy outcomes. Intended for use by licensed healthcare providers, Spertility was developed to optimize sperm metabolism to improve sperm function for ART, mimicking what occurs as sperm travel through the female reproductive tract during natural conception with the goal of improving embryo quality and pregnancy outcomes.

84 couples are enrolled in SPRING, a randomized, blinded standard-of-care versus Spertility controlled study (NCT04142112) across seven fertility centers in the U.S. The study is designed to quantify the number of high-quality euploid embryos and pregnancy outcomes, including rates of pregnancy, miscarriage, and full-term birth, comparing standard-of-care versus Spertility.

About Ohana Biosciences

At Ohana Biosciences, we work on pioneering reproductive health advances for all people through our industry-first platform of sperm-based treatments. We began with a vision to understand the power of a single sperm cell: to dictate conception, to reflect the overall health of a man, and to influence the health of pregnant women and their children. We aspire to revolutionize global reproductive health by enabling all people to create the healthy family they dream of – when they are ready. Today, we believe our industry-leading understanding of sperm biology, coupled with our pioneering research, will turn our vision into a reality. By advancing our research in fertility treatments, new treatments to reduce pregnancy complications, disease transmission, and developmental disorders, and enabling non-hormonal contraception, we hope to lead the revolution in reproductive health and offer life-changing options for all people. We anchor our aspirations in our name Ohana, which means “the family you choose” in Hawaiian. Ohana was founded in 2016 by Flagship Pioneering and is based in Cambridge, Mass. For more information, please visit www.OhanaBio.com.

1 Smith A., Tilling K., Nelson S., Lawlor, D., 2015, “Live-Birth Rate Associated With Repeat In Vitro Fertilization Treatment Cycles.” JAMA, 314(24):2654-2662

2 Malizia, B., Hacker, M., Penzias, A., 2009, “Cumulative Live-Birth Rates After In Vitro Fertilization.” N Engl J Med; 360:236-43.

Contacts

Amanda Galgay

Vice President, Corporate Affairs

news@ohanabio.com

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