• As birth rates decline and US IVF access falls further behind, Gameto recruits first Phase 3 patients for cutting-edge biotechnology to reignite reproductive health possibilities
• Company’s $127 million in total funding represents one of the largest investment in reproductive US biopharma sector to date

AUSTIN, Texas, Aug. 12, 2025 /PRNewswire/ — Gameto, a clinical-stage biotechnology company developing stem cell-derived therapies for reproductive health, today announced the completion of a $44 million Series C financing round led by Overwater Ventures, with participation 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 additional investors.

The financing brings Gameto’s total capital raised to an industry-leading $127 million, reflecting both the potential of the company’s platform and the speed with which it has progressed its scientific vision toward final stages of clinical development. The Series C funding enables Gameto to complete the ongoing Phase 3 trial for its lead program, Fertilo, and file for regulatory approvals globally. Fertilo is already cleared to commercialize many ex-U.S. jurisdictions and is currently used in clinics in Peru, Mexico and Australia, with additional clearances in Japan, India, Singapore, Guatemala, Argentina, Dominican Republic, and Paraguay. Five babies have been born with Fertilo so far and over 20 pregnancies have been recorded.

Beyond its first-in-class status for infertility, Fertilo is also the first induced pluripotent stem cell (iPSC)-derived therapy to reach late-stage clinical development in the United States, a long-awaited milestone following Shinya Yamanaka receiving the Nobel Prize for iPSC technology in 2012. Gameto’s novel technology is redefining reproductive care, with opportunities to shift the paradigm from IVF and egg freezing to ovarian therapeutics and delaying menopause.

“This is a defining moment for Gameto and for our broader mission of advancing women’s and family health,” said Dr. Dina Radenkovic Turner, CEO and co-founder of Gameto. “With this fundraising round we are now positioned to complete our robust Phase 3 trial of Fertilo and evaluate its safety and efficacy across leading U.S. study sites. Fertilo In Vitro Research Study and Trial (FIRST)¹ is the first randomized, controlled, double-blind trial to evaluate the maturation of eggs outside the body in the U.S., despite this technique’s decades of clinical use, as well as the first to explore stem cell technology in IVF. This funding enables us to advance and expand our pipeline of next-generation therapeutics and solidify our position as an emerging biopharma innovator in a field that remains deeply underserved, underresearched, and ripe for modernization.”

Gameto’s Fertilo represents a fundamental advancement in how eggs mature for IVF. The therapy uses engineered ovarian support cells (OSCs) derived from iPSCs to mature eggs outside the body, reducing the standard ovarian stimulation protocol from two weeks of daily hormone injections to 2-3 days.

The Fertilo Phase 3 trial is the first randomized, controlled, double-blind study evaluating ex vivo egg maturation, building on decades of clinical learnings. The trial will enroll patients at up to 20 U.S. sites, including Shady Grove Fertility, part of US Fertility and the largest fertility clinic chain in the country. It is expected to expand to other leading centers, such as Columbia University and Prelude Fertility, one of the nation’s largest clinic networks and part of Inception. The company anticipates an interim readout from FIRST in late 2026, evaluating both the safety and efficacy of Fertilo and positioning the product for potential market entry as birth rates continue declining and demand for fertility services expands.

“We believe Gameto has the potential to drive the biggest transformation in women’s health since the birth control pill,” said Kristina Simmons, Founder and Managing Partner at Overwater Ventures. “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.”

Beyond Fertilo, Gameto is developing therapies for menopause through its Ameno program, which recently received funding from the Advanced Research Projects Agency for Health (ARPA-H). The program includes both an implantable cell therapy designed to restore ovarian hormone production and a next-generation vaginal ring enabling cyclical hormone release patterns that more closely approximate natural physiology, and the company is hoping to bring the vaginal ring to Phase 1 clinical trials in the near future. The foundation of the company’s technology comes from Gameto’s AI-powered in vitro organoid platform of the female reproductive system for disease modeling, drug discovery and safety testing, designed to improve and accelerate the development of therapeutics for women.

“As someone who has built fertility clinic networks around the world, I know firsthand how urgently patients and physicians need better tools,” said Martin Varsavsky, co-founder & Chairman of Gameto and founder of Inception Prelude, the largest fertility clinic chain in North America (U.S. and Canada). “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.”

About Gameto

Gameto is a women’s health biotechnology company advancing programs from a cell engineering platform developed with George Church’s lab at Harvard Medical School. Founded by Dr. Dina Radenkovic, a medical doctor-turned-entrepreneur, and Martin Varsavsky, founder of one of North America’s largest fertility clinic network, Inception Prelude, Gameto has raised $127 million from leading investors to develop therapies that address fertility, menopause, and women’s and family health. The company’s lead program, Fertilo, is currently in Phase 3 clinical trials. For more information, visit gametogen.com.

Contact

Investor Contact
Kylie Jordan
kylie@gametogen.com

Consort Partners for Gameto
Patrick Schmidt
Gameto@consortpartners.com

¹ Fertilo In Vitro Research Study and Trial (FIRST). (2025). ClinicalTrials.gov, Identifier: NCT06858111. Retrieved from https://clinicaltrials.gov/study/NCT06858111.

SOURCE Gameto

Copyright © 2025 Cision US Inc.