Gameto, a US-based biotech company focused on reproductive health, has raised US$44 million in a series C funding round led by Overwater Ventures, bringing its total funding to US$127 million.

The new funding will be used to complete a phase 3 trial for Gameto’s lead therapy, Fertilo, which uses stem cell-derived ovarian support cells to mature eggs outside the body for IVF.

The Fertilo trial, enrolling patients at up to 20 US sites, including Shady Grove Fertility, is the first randomized, controlled, double-blind study of ex vivo egg maturation in the US.

Fertilo is already in use in clinics in Peru, Mexico, and Australia, and has regulatory clearance in several other countries, according to the company.

Gameto is also working on therapies for menopause under its Ameno program, which recently received funding from the Advanced Research Projects Agency for Health (ARPA-H).

An interim readout from the Fertilo phase 3 trial is expected in late 2026.

🔗 Source: Gameto

🧠 Food for thought

1️⃣ Stem cell breakthrough marks major milestone in reproductive medicine’s decades-long evolution

Gameto’s Fertilo represents a significant technological leap in a field that has seen incremental improvements since IVF’s inception in 1978.

While over 8 million IVF babies have been born globally since Louise Brown’s birth in 1978, the core process has remained largely unchanged for decades1.

The introduction of key techniques like ICSI in 1992 revolutionized male infertility treatment, but Gameto’s approach using induced pluripotent stem cells addresses a different challenge, reducing the intensive hormone stimulation that patients must endure2.

This marks the first iPSC-derived therapy to reach late-stage clinical trials in the United States, occurring more than a decade after Shinya Yamanaka won the Nobel Prize for iPSC technology in 2012.

The significance lies in potentially transforming the patient experience from two weeks of daily hormone injections to just 2-3 days, addressing one of IVF’s most burdensome aspects that has persisted throughout the technology’s 47-year history.

2️⃣ Substantial funding reflects growing market opportunity amid declining birth rates

Gameto’s $127 million in total funding comes as the assisted reproductive technology market experiences rapid growth alongside concerning demographic trends.