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 company has raised a total of $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.
Fertilo is already cleared for use in multiple international markets including Peru, Mexico, Australia, Japan, India, Singapore, and several Latin American countries. Five babies have been born using Fertilo, with over 20 pregnancies recorded to date.
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.
“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 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.
“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.”
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 and a vaginal ring for hormone delivery.
The company anticipates an interim readout from the Phase 3 trial in late 2026. Gameto was co-founded by Dr. Radenkovic Turner and Martin Varsavsky, founder of Inception Prelude fertility clinic network.
