What You Should Know:
– Gameto, a clinical-stage biotechnology company focused on reproductive health secures $44M in Series C funding, bringing its total capital raised to a leading $127M.
– The funding, led by Overwater Ventures with participation from multiple investors including Insight Partners and RA Capital, will support the completion of the ongoing Phase 3 trial for its lead program, Fertilo.
Fertilo: A Paradigm Shift in IVF
Fertilo is a novel therapy designed to mature eggs outside the body, fundamentally changing the IVF process. The therapy uses engineered ovarian support cells (OSCs) derived from induced pluripotent stem cells (iPSCs). This technology shortens the standard ovarian stimulation protocol from two weeks of daily hormone injections to just 2-3 days.
Fertilo is already cleared for commercial use in several countries outside the U.S. and is currently available in clinics in Peru, Mexico, and Australia. To date, five babies have been born using the therapy, and over 20 pregnancies have been recorded. The ongoing Fertilo In Vitro Research Study and Trial (FIRST) will be the first randomized, controlled, double-blind trial in the U.S. to evaluate the maturation of eggs outside the body and the first to explore stem cell technology in IVF.
Expanding the Pipeline Beyond Fertility
Beyond its lead program, Gameto is also developing therapies for menopause through its Ameno program. This program recently received funding from the Advanced Research Projects Agency for Health (ARPA-H) as part of the White House Initiative on Women’s Health Research. The Ameno program includes an implantable cell therapy to restore ovarian hormone production and a next-generation vaginal ring. Gameto hopes to bring the vaginal ring to Phase 1 clinical trials in the near future. The company’s technology is built on an AI-powered in vitro organoid platform of the female reproductive system, which is used for disease modeling, drug discovery, and safety testing. This platform is designed to improve and accelerate the development of therapeutics for women.
“This is a defining moment for Gameto and for our broader mission of advancing women’s and family health,” said Dr. Dina Radenkovic Turner, CEO and co-founder of Gameto. She noted that the funding will enable the company to complete the robust Phase 3 trial and evaluate Fertilo’s safety and efficacy across up to 20 U.S. study sites, including Shady Grove Fertility and Prelude Fertility.
