Gameto Announces Landmark Pregnancy Rate for iPSC-Derived Fertilo, Achieving More Than Double the Success Rate of Standard IVM

- Mini stim cycles supplemented with Fertilo achieved a 44% pregnancy rate per cycle after the first transfer, more than twice that of traditional IVM (20%)

- Patients that underwent mini stim with Fertilo had more viable embryos available for transfer, improving their chances of conception

Gameto, a clinical-stage biotech company developing iPSC-based therapies to transform fertility care, announced today positive data from a 40-patient cohort demonstrating the efficacy of its lead product, Fertilo. The evaluation showed that Fertilo, which uses lab-engineered ovarian support cells (OSCs) derived from human-induced pluripotent stem cells (iPSCs), significantly enhances in vitro maturation (IVM) outcomes, resulting in improved rates of oocyte maturation, embryo formation, and clinical pregnancy compared to standard treatment.

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Photo caption: Gameto's Fertilo investigational product made of ovarian support cells (OSCs) in a vial. Photo credit: Gameto

The findings, published as a preprint in medRxiv, provide evidence that Fertilo can effectively promote egg maturation, subsequently resulting in a greater number of embryos and improved pregnancy success rates.

The 40-patient evaluation was conducted in two parts. In the first phase, 20 patients received Fertilo in a multi-center observational evaluation to collect safety and establish success metrics. In the second phase, 20 additional patients were randomized 1:1 to receive either Fertilo-supplemented or standard IVM media at the time of egg retrieval. This design enabled direct comparison of key outcomes between groups.

The study found that eggs matured with Fertilo were significantly more likely to develop properly, with a 70% maturation rate compared to 52% using standard in IVM. Once matured, these eggs were also more likely to be fertilized and produce blastocysts compared with conventional methods. The rate of producing euploid blastocysts - embryos with the correct number of chromosomes and a higher likelihood of resulting in a healthy pregnancy - was 10% per egg with Fertilo, compared to only 2% with standard IVM.

This translated into meaningful outcome differences. Fertilo-supplemented mini stim cycles resulted in a 44% pregnancy rate per cycle after the first transfer, more than double the 20% achieved with conventional IVM. Patients in the Fertilo group also had more embryos available for transfer, increasing their chances of success. Notably, 8 out of 10 Fertilo patients in the comparative evaluation had at least one viable, euploid embryo suitable for implantation, compared to only 3 out of 10 patients in the control group.

“Fertilo represents a new era of science-enabled family building, one that’s faster, safer and truly transformative,” said Dr. Dina Radenkovic, CEO and Co-Founder, Gameto. “It offers a better option for women, same-sex couples, and anyone planning to start or grow their family. We’ve built an end-to-end solution that puts patients first, reducing the physical and emotional burden of traditional IVF. We’re proud to be advancing a technology that reflects today’s families, and we look forward to expanding access to Fertilo in our U.S. pivotal study and globally.”

“These results validate the potential of iPSC-derived products to transform reproductive medicine. Fertilo demonstrated significantly higher egg maturation, fertilization, and euploid embryo rates, as well as real-world pregnancies and a live birth,” said Dr. Christian Kramme, Chief Scientific Officer, Gameto. “Fertilo offers a scalable, reliable solution that meets the needs of individuals and couples looking to build a family.”

Gameto is now currently enrolling participants in its pivotal U.S. Phase 3 clinical trial (NCT06858111) of Fertilo, a first-in-class iPSC-derived therapy. Individuals interested in joining the study can learn more at clinicaltrials.gov.

About Fertilo

Fertilo is Gameto’s ovarian support cell (OSC) product that matures eggs outside the body using iPSC-derived cells. By mimicking the natural ovarian environment in vitro, Fertilo enables replacement of ~80% of hormone injections and shortens IVF or egg freezing cycles from 10-14 days to just 2-3 days. This approach offers a potentially safer, less invasive alternative to traditional IVF, significantly reducing patient burden and the risk of ovarian hyperstimulation.

About Gameto

Gameto is a biotechnology company developing novel solutions for women's health, starting with infertility. Gameto brings together an experienced scientific management team with the vision and passion to develop a product suite to support women throughout their reproductive journeys. Gameto's lead program, Fertilo, aims to make IVF and egg freezing shorter, safer, and more accessible through reduced hormonal injections by maturing eggs outside of the body. Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and founder of one of North America's largest fertility networks Prelude Fertility, Martin Varsavsky, as Chairman. For more information, go to gametogen.com or follow us on Twitter and Instagram @gametogen and on LinkedIn.

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