Gameto, a clinical-stage biotech company that focuses on creating stem cell-based treatments for reproductive health, shared that they have successfully raised $44 million through a Series C funding round. This funding was led by Overwater Ventures and also included support from Insight Partners, RA Capital, Two Sigma Ventures, BOLD Capital Partners, Future Ventures, Ingeborg Investments, Arcadia Investment Partners, PAGS Group, Pontiva Healthcare Partners, Portfolia, and other contributors. This brings the total funding Gameto has raised to $127 million, showing how promising their platform is and how quickly they are moving toward late-stage clinical development.
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The new money will help finish the Phase 3 clinical trial for their main product, Fertilo, and also help with getting regulatory approval in many countries. Fertilo is already approved and available in clinics in Peru, Mexico, and Australia. It has also been approved in Japan, India, Singapore, Guatemala, Argentina, the Dominican Republic, and Paraguay. So far, five babies have been born using Fertilo, and over 20 pregnancies have been recorded.
Fertilo is special because it is the first induced pluripotent stem cell (iPSC) therapy to reach late-stage clinical trials in the United States. This is a big step, especially since Shinya Yamanaka won the Nobel Prize for iPSC technology in 2012. Gameto’s approach could change reproductive medicine by shifting care away from traditional IVF and egg freezing toward treatments that help with ovarian health and delay menopause.
Dr. Dina Radenkovic Turner, CEO and co-founder of Gameto, said, “This is a major moment for Gameto and our mission to improve women’s and family health. With this fundraising round, we are now ready to complete our Phase 3 trial of Fertilo and test its safety and effectiveness at top U.S. study sites. Fertilo In Vitro Research Study and Trial (FIRST) is the first randomized, controlled, double-blind trial to examine the maturation of eggs outside the body in the U.S., even though this method has been used in clinics for decades. It’s also the first to look into using stem cell technology in IVF. This funding allows us to move forward with our pipeline of next-generation treatments and strengthen our position as an innovator in biopharma, a sector that is still largely underserved and under-researched.”
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Gameto’s Fertilo technology helps eggs mature for IVF using engineered ovarian support cells made from iPSCs. This method reduces the usual two weeks of hormone injections to just two or three days. The Phase 3 trial of Fertilo is the first randomized, controlled, double-blind study to test this method of maturing eggs outside the body, built on a lot of clinical experience. The trial will include up to 20 U.S. sites, including Shady Grove Fertility, part of the largest fertility clinic network in the country, US Fertility. Other trial sites will include Columbia University and Prelude Fertility, a major clinic network within Inception. Gameto expects to share early results from the FIRST trial by late 2026, which will assess Fertilo’s safety and effectiveness and help prepare for market launch as demand for fertility services grows.
Kristina Simmons, Founder and Managing Partner at Overwater Ventures, said, “We believe Gameto has the potential to bring the biggest change in women’s health since the birth control pill. We haven’t seen another company that combines such strong determination, groundbreaking science, and the ability to build a strong consumer brand in biotech. At Overwater, we invest in technology that defines new categories, and few areas of healthcare need more innovation than female biology. The impact goes far beyond just reproduction. That’s why we’ve made our biggest investment to date.”
In addition to Fertilo, Gameto is developing therapies for menopause through its Ameno program, which recently got funding from the Advanced Research Projects Agency for Health. The program includes an implantable cell therapy aimed at restoring hormone production in the ovaries and a next-generation vaginal ring that mimics natural hormone cycles. Gameto plans to start Phase 1 clinical trials for the vaginal ring soon. The company’s technology is based on an AI-powered in vitro organoid platform of the female reproductive system. This platform is used for disease modeling, drug discovery, and safety tests, enabling quicker and more effective development of women’s health treatments.
Martin Varsavsky, co-founder and Chairman of Gameto, as well as founder of Inception Prelude, the largest fertility clinic chain in North America, said, “As someone who has built fertility clinic networks around the world, I know how much patients and doctors need better tools. Fertilo has the potential to change IVF, making it faster, safer, and more accessible. This fundraising round marks a big step toward achieving that vision.”
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