Biotech Startup Gameto Pushes Boundaries With Fertilo IVF Innovation

Gameto, a New York–based biotechnology company, is gaining global attention for its pioneering fertility technology, Fertilo, which aims to make in-vitro fertilisation (IVF) and related reproductive treatments less invasive, shorter, and more accessible than conventional methods. The company’s work has already yielded multiple pregnancies and live births worldwide, and it is now advancing clinical research in the United States and other major markets.

Fertilo is based on a novel application of induced pluripotent stem cell (iPSC) technology to engineer ovarian support cells (OSCs) that mature human eggs outside the body — replicating the natural ovarian environment in a laboratory setting. This method significantly reduces the need for high-dose hormone injections typically required in standard IVF cycles, cutting down the usual two-week hormone stimulation phase to just a few days.

In December 2024, Gameto announced the world’s first live human birth achieved with the Fertilo procedure at a fertility clinic in Lima, Peru — a milestone that has drawn strong interest from patients and researchers alike. The procedure reportedly lowers the physical burden associated with conventional IVF, such as frequent injections and the risk of ovarian hyperstimulation syndrome, while maintaining promising pregnancy outcomes.

Since that landmark birth, Fertilo has been used in clinics in countries including Peru, Mexico, and Australia, where over 20 pregnancies and several births have been recorded. Most recently, Gameto highlighted the first Australian pregnancy using the technology in a pilot study involving a patient with polycystic ovary syndrome (PCOS), underscoring the potential appeal of less physically demanding fertility treatments for patients who have struggled with traditional IVF.

Gameto’s efforts in the U.S. are progressing rapidly. The company raised $44 million in Series C funding in 2025 to complete its ongoing Phase 3 clinical trial of Fertilo and pursue regulatory approvals in major jurisdictions, including the United States. The trial, designed to evaluate the safety and effectiveness of the OSC-based approach, is enrolling patients at multiple fertility centers across the country.

Regulators have already granted FDA clearance for the investigational phase of the Fertilo program, a key step that allows the technology to be studied in controlled clinical settings. If successful, this could make Fertilo the first new assisted reproductive therapy in decades to reach widespread adoption in the U.S. market.

Despite the excitement, experts stress that large-scale clinical validation is still needed to fully understand long-term outcomes and safety. Conventional IVF, introduced in the late 1970s, has become a standard of care worldwide, and innovative alternatives must undergo rigorous testing before being widely adopted by clinicians and patients.

Gameto’s co-founder and CEO, Dr. Dina Radenkovic, has emphasised the company’s mission to make fertility care more humane and accessible, saying the technology could “transform reproductive medicine” by reducing the physical, emotional, and financial burdens historically associated with infertility treatments.

As the Fertilo Phase 3 trial continues and early data from international use accumulates, the company’s progress highlights a broader push within biotech to address long-standing challenges in women’s health — and to rethink how complex biological processes like egg maturation can be supported outside the human body.