Gameto is a biotechnology company that is developing therapies using stem cells for reproductive health. The company recently raised $44 million in a Series C financing round, led by Overwater Ventures, with support from several investors, including Insight Partners, RA Capital, and Two Sigma Ventures.
With this funding, Gameto has raised a total of $127 million. This demonstrates the potential of their work and the rapid progress they are making in clinical development. The new funding will help Gameto complete the ongoing Phase 3 trial for its main program, Fertilo, and seek regulatory approvals worldwide.
Fertilo is already approved for use in several countries outside the U.S. and is currently available in clinics in Peru, Mexico, and Australia. It has also received approvals in Japan, India, Singapore, Guatemala, Argentina, the Dominican Republic, and Paraguay. To date, five babies have been born using Fertilo, and over 20 pregnancies have been reported.
Fertilo is a leading treatment for infertility and is the first therapy developed from induced pluripotent stem cells (iPSCs) to reach late-stage clinical development in the U.S. This is a significant milestone, especially since Shinya Yamanaka won the Nobel Prize in 2012 for his pioneering work on iPSCs. Gameto’s technology is changing how we approach reproductive care, potentially moving us away from traditional IVF and egg freezing towards new therapies for the ovaries and delaying menopause.
Fertilo enhances the maturation of eggs for IVF. It utilizes engineered ovarian support cells derived from induced pluripotent stem cells (iPSCs) to mature eggs outside the body. This reduces the usual two weeks of daily hormone injections to just 2-3 days.
The Phase 3 trial for Fertilo is the first study to randomly assign patients and include a control group for evaluating egg maturation outside the body. The trial will take place at up to 20 sites in the U.S., including Shady Grove Fertility, the largest fertility clinic chain in the country. It will also expand to other prominent centers, such as Columbia University and Prelude Fertility, a large clinic network. Gameto expects to have preliminary results from this trial in late 2026, assessing both the safety and effectiveness of Fertilo. This could help them bring the product to market amid declining birth rates and growing demand for fertility services.
In addition to Fertilo, Gameto is working on treatments for menopause through its Ameno program, which recently received funding from the Advanced Research Projects Agency for Health (ARPA-H). This program includes an implantable therapy to restore ovarian hormone production and a new vaginal ring that mimics natural hormone release patterns.
Gameto aims to start Phase 1 clinical trials for the vaginal ring soon. Their technology is based on an AI-powered organoid platform that models the female reproductive system for drug discovery and safety testing, helping to speed up the development of therapies for women.
KEY QUOTES:
“This is a defining moment for Gameto and for our broader mission of advancing women’s and family health. With this fundraising round we are now positioned to complete our robust Phase 3 trial of Fertilo and evaluate its safety and efficacy across leading U.S. study sites. Fertilo In Vitro Research Study and Trial (FIRST)1 is the first randomized, controlled, double-blind trial to evaluate the maturation of eggs outside the body in the U.S., despite this technique’s decades of clinical use, as well as the first to explore stem cell technology in IVF. This funding enables us to advance and expand our pipeline of next-generation therapeutics and solidify our position as an emerging biopharma innovator in a field that remains deeply underserved, underresearched, and ripe for modernization.”
Dr. Dina Radenkovic Turner, CEO and co-founder of Gameto
“We believe Gameto has the potential to drive the biggest transformation in women’s health since the birth control pill. We have yet to see another company with the rare combination of determination, breakthrough science, and the potential to create a strong consumer brand in biotech. At Overwater, we invest in category-defining technology, and few areas of healthcare are more overdue for reinvention than female biology itself. The implications and impact go far beyond reproduction. This is why we’ve written our largest check to date.”
Kristina Simmons, Founder and Managing Partner at Overwater Ventures
“As someone who has built fertility clinic networks around the world, I know firsthand how urgently patients and physicians need better tools. Fertilo has the potential to transform IVF, making it faster, safer, and more accessible to patients. This financing round marks a major step toward realizing that vision.”
Martin Varsavsky, co-founder & Chairman of Gameto and founder of Inception Prelude, the largest fertility clinic chain in North America (U.S. and Canada)
