Gameto
Gameto is a New York clinical-stage biotech developing iPSC-derived ovarian support cell therapies for fertility care.
Founded
2020Gameto is a New York clinical-stage biotech developing iPSC-derived ovarian support cell therapies for fertility care.
Gameto's platform was developed in stealth under a research agreement with George Church's lab at Harvard Medical School and the Wyss Institute, engineering ovarian support cells from induced pluripotent stem cells with AI and ML modeling. It is the first iPSC-derived therapy to enter US Phase 3 trials.
The platform yields three programs (Fertilo, Deovo, Ameno) from one cell-engineering base, and Fertilo reports landmark pregnancy rates at more than double standard IVM with 5 live births and 20-plus pregnancies by August 2025.
Source: femtechinsider.com
Gameto raised a $33M Series B in May 2024 co-led by Two Sigma Ventures and RA Capital bringing the total to $73M, and a $44M Series C in August 2025 led by Overwater Ventures bringing the total to about $127M, to complete the Fertilo Phase 3 trial and file global regulatory submissions.
Its Ameno menopause program received a $10M ARPA-H Sprint for Women's Health award in October 2024 to advance through animal studies toward first-in-human trials, extending the platform beyond fertility.
Source: femtechinsider.com
Fertilo is Gameto's lead in-vitro maturation biologic: engineered iPSC-derived ovarian support cells co-culture immature eggs retrieved after 1-3 days of minimal stimulation and mature them ex vivo in about 24 hours. It replaces about 80 percent of hormone injections and compresses cycles to 2-3 days.
Fertilo is investigational in the US under the Phase 3 FIRST trial with FDA IND clearance in January 2025 and is not FDA-approved, while cleared and commercial in Australia, Argentina, Peru, Mexico, Japan and Paraguay via partner clinics with training and protocol support. The first live birth was achieved in Lima, Peru in December 2024.
Source: gametogen.com