Gameto’s Revolutionary Egg Maturation Technology Receives FDA Clearance for Phase 3 Clinical Trials!

Gameto has just achieved a significant step forward. The FDA has approved its Investigational New Drug (IND) application for Fertilo. This makes Fertilo the first therapy using induced pluripotent stem cells (iPSCs) to reach Phase 3 clinical trials in the U.S. This technology aims to change the IVF process by allowing eggs to mature outside the body, reducing the need for hormone injections.

Fertilo works by using specialized ovarian support cells (OSCs) to mimic natural egg maturation in the lab. This method shortens treatment time from the usual 10-14 days to just 2-3 days. It also cuts down on hormone injections by 80%, lowering the risk of complications like ovarian hyperstimulation syndrome.

Dr. Dina Radenkovic, CEO and Co-Founder of Gameto, noted this milestone as a breakthrough in iPSC technology. She highlighted the potential of Fertilo to empower women and improve the IVF experience, addressing the urgent need for innovative solutions in reproductive medicine. The treatment is designed for everyone, offering new hope for family planning in a world with declining birth rates.

The upcoming Phase 3 trial will take place at 15 locations across the U.S., following the first live birth achieved using Fertilo technology in December 2024 at Santa Isabel Clinic in Peru. The trial aims to measure success through pregnancy rates at 12 weeks and assess safety by monitoring maternal health and live birth rates.

Martin Varsavsky, Co-Founder and Chairman of Gameto, emphasized the long-awaited need for a safer and faster path to parenthood. He believes Fertilo’s three-day IVF and egg-freezing method could be the solution many fertility clinics are seeking.

Fertilo has already received regulatory approval in several countries, including Australia, Japan, Argentina, Paraguay, Mexico, and Peru. Recently, Gameto partnered with IVFAustralia to enhance access to this promising technology.