Gameto has received FDA clearance for its Investigational New Drug (IND) application for Fertilo, marking the first induced pluripotent stem cell (iPSC)-based therapy to advance to Phase 3 clinical trials in the United States. The technology aims to transform IVF by maturing eggs outside the body with significantly reduced hormone injections.
Fertilo uses engineered ovarian support cells (OSCs) to recreate natural egg maturation in a laboratory setting. The approach reduces treatment cycles from 10-14 days to just 2-3 days and eliminates 80% of hormone injections typically required in traditional IVF, potentially reducing risks like ovarian hyperstimulation syndrome.
“FDA clearance to advance Fertilo into a Phase 3 trial is a significant milestone for Gameto, and a landmark moment in iPSC technology,” said Dr. Dina Radenkovic, CEO and Co-Founder, Gameto. “We are proud to be pioneers in this field, with technology that has the potential to transform reproductive medicine. I’d like to express my gratitude to our team, whose work is focused on empowering women by offering a solution that is less invasive and improves the IVF journey. Fertilo is a solution for both men and women from all walks of life, offering millions of people new possibilities for family building at a time when declining birth rates present a growing global challenge.”
The Phase 3 trial will launch across 15 U.S. sites, following the world’s first live human birth using Fertilo technology at Santa Isabel Clinic in Lima, Peru, in December 2024. The study will evaluate efficacy through pregnancy rates at 12 weeks and safety through maternal health and live birth rates.
“Fertility clinics have been hoping for a solution that makes the journey towards parenthood shorter, safer and more likely,” said Martin Varsavsky, Co-Founder and Chairman, Gameto and Founder, Prelude Fertility. “Fertilo’s three-day IVF and egg freezing is the answer.”
The technology has already secured regulatory clearance in Australia, Japan, Argentina, Paraguay, Mexico, and Peru. Gameto recently partnered with IVFAustralia to expand access to the technology.
