Gameto Secures $44M Series C as Stem Cell Fertility Therapy Advances to Phase 3 Trial

Clinical-stage biotechnology company Gameto has completed a $44 million Series C financing round to support its groundbreaking stem cell fertility therapy as it enters pivotal Phase 3 trials, positioning the company to potentially transform reproductive healthcare amid declining birth rates and limited IVF access.

Record Funding Reflects Industry Confidence

The Series C round was 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. This brings Gameto's total capital raised to $127 million, representing one of the largest investments in the US reproductive biopharma sector to date.

"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".

Fertilo Reaches Historic Milestone

Gameto's lead program, Fertilo, represents a fundamental advancement in IVF technology and holds the distinction of being the first induced pluripotent stem cell (iPSC)-derived therapy to reach late-stage clinical development in the United States. This milestone comes more than a decade after Shinya Yamanaka received the Nobel Prize for iPSC technology in 2012.

The therapy uses engineered ovarian support cells (OSCs) derived from iPSCs to mature eggs outside the body, dramatically reducing the standard ovarian stimulation protocol from two weeks of daily hormone injections to 2-3 days.

Phase 3 Trial Represents Industry First

The Fertilo Phase 3 trial, known as the Fertilo In Vitro Research Study and Trial (FIRST), marks several significant firsts in reproductive medicine. It is the first randomised, controlled, double-blind trial to evaluate the maturation of eggs outside the body in the US, despite this technique's decades of clinical use, as well as the first to explore stem cell technology in IVF.

The trial will enroll patients at up to 20 US 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.

"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".

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.

Global Commercial Success Already Underway

While awaiting US regulatory approval, Fertilo is already cleared to commercialise in many ex-US jurisdictions and is currently used in clinics in Peru, Mexico and Australia, with additional clearances in Japan, India, Singapore, Guatemala, Argentina, the Dominican Republic, and Paraguay. Five babies have been born with Fertilo so far, and over 20 pregnancies have been recorded.

The Series C funding enables Gameto to complete the ongoing Phase 3 trial for its lead program and file for regulatory approvals globally.

Expanding Beyond Fertility Treatment

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. 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 modelling, drug discovery and safety testing, designed to improve and accelerate the development of therapeutics for women.

Industry Veterans Back Revolutionary Approach

"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".

Gameto was founded by Dr. Dina Radenkovic, a medical doctor-turned-entrepreneur, and Martin Varsavsky, utilising a cell engineering platform developed with George Church's lab at Harvard Medical School.

The Austin, Texas-based company's technology platform represents a paradigm shift from traditional IVF and egg-freezing approaches toward ovarian therapeutics and delaying menopause, addressing a field that remains deeply underserved, underresearched, and ripe for modernisation.