Gameto has completed a $44 million Series C financing round led by Overwater Ventures bringing the total funding to $127 million, which the company describes as one of the largest investments in the U.S. reproductive biopharma sector to date.
The new funding will support Gameto’s ongoing Phase 3 trial for its lead program, Fertilo, and pursue regulatory approvals.
Fertilo, an engineered ovarian support cell (OSC) therapy derived from induced pluripotent stem cells (iPSCs), is designed to mature eggs outside the body. The company reports that this approach reduces the standard ovarian stimulation protocol from two weeks of daily hormone injections to 2–3 days. Fertilo is already cleared for commercialization in several markets outside the U.S., including Peru, Mexico, Australia, Japan, India, Singapore, Guatemala, Argentina, Dominican Republic, and Paraguay. According to Gameto, five babies have been born and over 20 pregnancies have been recorded using Fertilo so far.
Fertilo is the first iPSC-derived therapy to reach late-stage clinical development in the U.S. The ongoing Phase 3 trial, known as the Fertilo In Vitro Research Study and Trial (FIRST), is the first randomized, controlled, double-blind study in the U.S. focused on ex vivo (outside the body) egg maturation. The study is enrolling patients at up to 20 U.S. sites, including Shady Grove Fertility, Columbia University, and Prelude Fertility. Interim results are expected in late 2026, focusing on safety and efficacy outcomes.
Kristina Simmons, Founder and Managing Partner at Overwater Ventures, commented, “We believe Gameto has the potential to drive the biggest transformation in women’s health since the birth control pill. We have yet to see another company with the rare combination of determination, breakthrough science, and the potential to create a strong consumer brand in biotech. At Overwater, we invest in category-defining technology, and few areas of healthcare are more overdue for reinvention than female biology itself. The implications and impact go far beyond reproduction. This is why we’ve written our largest check to date.”
Gameto is also working on menopause therapies through its Ameno program, which recently received funding from the Advanced Research Projects Agency for Health (ARPA-H). This program includes an implantable cell therapy to restore ovarian hormone production and a next-generation vaginal ring designed to mimic natural hormone patterns. The company aims to bring the vaginal ring to Phase 1 clinical trials in the near future. These efforts are supported by Gameto’s AI-powered in vitro organoid platform, which is used for disease modeling, drug discovery, and safety testing in the female reproductive system.
Martin Varsavsky, co-founder and Chairman of Gameto, stated, “As someone who has built fertility clinic networks around the world, I know firsthand how urgently patients and physicians need better tools. Fertilo has the potential to transform IVF, making it faster, safer, and more accessible to patients. This financing round marks a major step toward realizing that vision.”
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