Biotech gears up for potential Fertilo approval while accelerating development of menopause-targeting therapies.
Women’s health biotech Gameto has secured $44 million in Series C financing to advance its work in stem cell–derived therapies for reproductive health. The company says the funding will allow it to complete its Phase 3 trial of its infertility program Fertilo and prepare for regulatory approval filings, reportedly making it the first induced pluripotent stem cell therapy to reach late-stage development in the reproductive health field.
While Gameto’s primary focus is clearly on infertility, longevity watchers will be interested to know that the new capital also supports the company’s ongoing focus on menopause through its Ameno program. The program, which recently received a $10 million, two-year award from ARPA-H, aims to address the multitude of health challenges that affect women beyond their reproductive years. Menopause, expected to impact more than a billion women worldwide by 2025, is associated with symptoms and long-term health risks ranging from osteoporosis and cardiovascular disease to cognitive decline.
Ameno is built on the premise that the adverse effects of menopause need not be an inevitable consequence of aging ovaries. CEO Dr Dina Radenkovic Turner, who co-founded the company alongside Martin Varsavsky, founder of one of North America’s largest fertility clinic networks, told us that the program is a key component of the company’s mission to improve women’s healthspan across all life stages.
“Menopause brings both short-term and long-term health challenges, with 8 out of 10 women experiencing acute vasomotor symptoms and many facing chronic mental, sexual, and physical health issues over time,” she explained, adding that Gameto is working towards bringing products to the clinic and engaging with regulators on potential pathways.
The Ameno program includes an implantable cell therapy designed to restore ovarian hormone production by responding to natural signals from the brain and ovaries, aiming to maintain hormonal balance in a way that mirrors physiological function. The strategy is intended not only to alleviate acute symptoms such as hot flashes, sleep disruption and sexual dysfunction, but also to reduce the risk of chronic conditions linked to hormonal decline. The company is also developing a next-generation vaginal ring designed to deliver cyclical hormone patterns that more closely replicate the body’s natural rhythms, with plans to enter Phase 1 trials in the near future.
“We believe a more physiological and dynamic hormone replacement approach could help delay conditions like osteoporosis, heart disease, vaginal dryness, painful intercourse or urination, and potentially even dementia, which research suggests may be linked to hormonal changes such as elevated FSH,” Radenkovic told us. “We are excited about advancing treatments that could give women more years in better health, feeling good.”
Gameto’s research builds on its AI-powered in vitro organoid platform, which models the female reproductive system to accelerate drug discovery, disease modeling and safety testing. The company’s platform, initially developed in the lab of Harvard Medical School professor George Church, underpins both Fertilo and Ameno.
The latest round, which brings the total funding raised by Gameto to $127 million, was led by Overwater Ventures, with participation from a range of institutional and strategic investors.
“We believe Gameto has the potential to drive the biggest transformation in women’s health since the birth control pill,” said Overwater founder Kristina Simmons, who revealed Gameto was the firm’s largest investment to date. “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.”
