NEW YORK--(BUSINESS WIRE)--Gameto, a biotechnology company dedicated to advancing treatment option in women's health, announced today the world’s first live human birth using Fertilo, an ovarian support cell (OSC) technology that matures eggs outside the body. The delivery was conducted at Santa Isabel Clinic, in Lima, Peru.
With nearly half of the women in the US never reaching their maternity goals, there is an urgent need for innovation. Unlike traditional methods, which rely on 10-14 days of high-dose hormonal stimulation to mature eggs, Fertilo uses engineered, young ovarian support cells to recreate the natural egg maturation process in a laboratory setting. This process replaces 80% of hormone injections required with traditional IVF, and reduces the duration of treatment cycles to just three days, offering patients a more comfortable and less invasive experience.
“We are delighted to celebrate the world’s first live birth conceived using Fertilo,” said Dr. Dina Radenkovic, CEO and co-founder of Gameto. “By overcoming the major challenges of conventional IVF, such as long treatment cycles, significant side effects, and the emotional and physical strain, Fertilo provides a potentially faster, safer, and more accessible solution for families. This milestone marks a turning point in reproductive health and highlights the first application of iPSC technology in IVF and the immense potential of our technology.”
This is also the first demonstration of an end-to-end process by which a therapy developed from induced pluripotent stem cells (iPSC) has the potential to improve IVF outcomes and advance women’s health. Co-culturing immature eggs with Gameto’s proprietary OSCs has shown promising results to date, with the potential for higher rates of egg maturation and embryo formation.
“This breakthrough represents a historic milestone in reproductive medicine,” said Dr. Luis Guzmán, Lead at Pranor Labs & Science, who oversaw the Fertilo-enabled IVF cycle that enabled the first live birth. “The ability to mature eggs outside the body with minimal hormonal intervention significantly reduces risks such as ovarian hyperstimulation syndrome and alleviates the side effects caused by high hormone doses. Fertilo is a major advancement for women who cannot tolerate or do not want to undergo the burden of the traditional IVF protocol, bringing hope and new possibilities to a broader patient population.”
“The Fertilo method was the preferred option compared to traditional approaches. With fewer injections and a gentler, less invasive egg retrieval process, it gave me hope and reassurance during a deeply personal journey. Fertilo’s innovative approach made the physical experience easier and also lightened the emotional burden of many hormone injections. I am profoundly grateful to the Pranor Clinic and the Gameto team for their care and dedication in making my dream of having a family a reality,” said the mother of the first baby born through Fertilo.
By maturing eggs outside the body and minimizing hormonal stimulation, Gameto is improving outcomes and experiences for women utilizing assisted reproduction technology (ART). The result is a streamlined process that yields high-quality, mature eggs with similar efficacy to conventional IVF but in a fraction of the time and with potentially fewer complications.
Gameto is rapidly expanding the availability of Fertilo and has secured regulatory clearance in key markets such as Australia, Japan, Argentina, Paraguay, Mexico, and Peru. Recently, the company announced a strategic partnership with IVFAustralia, a leading IVF clinic chain and part of the Virtus Health group, one of the top five global providers of assisted reproductive services. In the U.S., the company is preparing for Phase 3 trials.
About Fertilo
Fertilo, Gameto's lead investigational program, is a solution derived from induced pluripotent stem cells (iPSC) and designed to mature eggs outside of the body as part of minimal hormonal stimulation cycles for in vitro fertilization and egg freezing. Gameto's goal in developing Fertilo is to make fertility treatments more convenient, safer, and accessible for a wider patient population. Fertilo has received different regulatory classifications in foreign jurisdictions, and after consultation with national regulators, has been cleared for commercialization in Australia and in large markets in Latin America.
About Gameto
Gameto is a biotechnology company developing novel treatment solutions for women's health, starting with infertility. Gameto brings together an experienced scientific management team with the vision and passion to develop a product suite to support women throughout their reproductive journeys. Gameto's lead program, Fertilo, aims to make IVF and egg freezing shorter, safer, and more accessible through reduced hormonal injections by maturing eggs outside of the body. Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and founder of one of North America's largest fertility networks Prelude Fertility, Martin Varsavsky, as Chairman. For more information, go to gametogen.com or follow us on Twitter and Instagram @gametogen and on LinkedIn.
