Clinical-stage biotechnology company Gameto has completed a $44 million Series C funding round led by Overwater Ventures to advance its stem cell-derived reproductive health therapies. The financing brings the company's total capital raised to $127 million, positioning it among the largest funded companies in the reproductive biotechnology sector.
The funding will support completion of Gameto's Phase 3 trial for Fertilo, its lead therapy that uses engineered ovarian support cells derived from induced pluripotent stem cells to mature eggs outside the body for IVF. The technology reduces standard ovarian stimulation protocols from two weeks of daily hormone injections to 2-3 days.
First-in-Class iPSC Therapy Reaches Late-Stage Development
Fertilo represents the first induced pluripotent stem cell-derived therapy to reach late-stage clinical development in the United States, building on Nobel Prize-winning iPSC technology developed by Shinya Yamanaka in 2012. The therapy uses engineered ovarian support cells (OSCs) derived from iPSCs to mature eggs outside the body, representing a fundamental advancement in how eggs mature for IVF.
"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."
Phase 3 Trial Marks Historic Milestone
The Phase 3 trial, called Fertilo In Vitro Research Study and Trial (FIRST), represents the first randomized, controlled, double-blind study evaluating ex vivo egg maturation in the United States. The trial will enroll patients at up to 20 U.S. sites, including Shady Grove Fertility and is expected to expand to Columbia University and Prelude Fertility.
FIRST 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. The company anticipates an interim readout from the Phase 3 trial in late 2026.
International Market Success Demonstrates Clinical Potential
Fertilo is already cleared for use in multiple international markets including Peru, Mexico, Australia, Japan, India, Singapore, and several Latin American countries including Guatemala, Argentina, Dominican Republic, and Paraguay. Five babies have been born using Fertilo, with over 20 pregnancies recorded to date, demonstrating the therapy's clinical potential.
"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."
Expanding Pipeline Beyond Fertility
Beyond Fertilo, Gameto is developing menopause therapies through its Ameno program, which recently received funding from ARPA-H as part of the White House Initiative on Women's Health Research. The program includes an implantable cell therapy designed to restore ovarian hormone production and a vaginal ring for hormone delivery that enables cyclical hormone release patterns more closely approximating natural physiology.
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.
Industry Leadership in Reproductive Biotechnology
Gameto was co-founded by Dr. Radenkovic Turner, a medical doctor-turned-entrepreneur, and Martin Varsavsky, founder of Inception Prelude fertility clinic network. "As someone who has built fertility clinic networks around the world, I know firsthand how urgently patients and physicians need better tools," said Varsavsky. "Fertilo has the potential to transform IVF, making it faster, safer, and more accessible to patients."
The Series C round included 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, reflecting broad investor confidence in the company's platform and clinical progress.
