AUSTIN, TX, USA I January 30, 2025 I Gameto, a clinical-stage biotech company developing iPSC-based therapies for women’s health, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Fertilo, to enable the launch of the first US-based Phase 3 clinical trial for an induced pluripotent stem cell (iPSC)-based therapy. This groundbreaking milestone highlights the potential of iPSC technology to address critical unmet needs in reproductive medicine.
Fertilo is Gameto’s ovarian support cell (OSC) technology, designed to mature eggs outside the body using iPSC-derived cells. 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 dish. This process replaces 80% of hormone injections required with traditional in vitro fertilization (IVF), and reduces the duration of treatment cycles to just 2-3 days, offering patients a more comfortable and less invasive experience. This also significantly reduces risks such as ovarian hyperstimulation syndrome and alleviates side effects caused by high-dose hormone treatments.
“FDA clearance to advance Fertilo into a Phase 3 trial is a significant milestone for Gameto, and a landmark moment in iPSC technology,” said Dr. Dina Radenkovic, CEO and Co-Founder, Gameto. “We are proud to be pioneers in this field, with technology that has the potential to transform reproductive medicine. I’d like to express my gratitude to our team, whose work is focused on empowering women by offering a solution that is less invasive and improves the IVF journey. Fertilo is a solution for both men and women from all walks of life, offering millions of people new possibilities for family building at a time when declining birth rates present a growing global challenge.”
The Phase 3 trial will evaluate the efficacy and safety of Fertilo in maturing healthy eggs outside of the body, yielding embryos and improving pregnancy rate assessed at 12 weeks of pregnancy, the primary efficacy endpoint for women undergoing assisted reproductive technologies. The Phase 3 study clearance follows the world’s first live human birth conceived using Fertilo technology, achieved at Santa Isabel Clinic in Lima, Peru, in December 2024.
Gameto will launch its Phase 3 clinical trial across 15 sites in the United States. The study will assess key outcomes, including embryo development, pregnancy rates (as a measure of efficacy), and maternal health and live birth rates (as safety endpoints). The protocol involves up to two days of hormonal injections stimulation, with up to two embryo transfers, and is open to couples struggling with infertility for at least one year. Participants who do not achieve pregnancy during the trial will be offered a voucher for a second attempt. The Phase 3 study will be a double-blind, randomized controlled trial to ensure robust data collection and analysis.
“Fertility clinics have been hoping for a solution that makes the journey towards parenthood shorter, safer and more likely,” said Martin Varsavsky, Co-Founder and Chairman, Gameto and Founder, Prelude Fertility, the largest network of IVF and fertility clinics in the United States and Canada. “Fertilo’s three-day IVF and egg freezing is the answer.”
“Gameto’s technology platform opens entirely new possibilities for addressing reproductive health challenges through cell engineering-inspired innovation,” said Dr. Christian Kramme, Chief Scientific Officer, Gameto. “With Fertilo, we’ve demonstrated the potential of iPSC-based therapies to redefine fertility care by targeting ovarian health at the cellular level. This milestone also highlights the power of iPSCs in regenerative medicine and our computational and cell engineering platform where we have broader applications including menopause and ovarian cancer.”
Gameto is pioneering the use of iPSC technology in fertility care, building on Shinya Yamanaka’s Nobel Prize-winning discovery of induced pluripotent stem cells, which revolutionized regenerative medicine. As the first company to apply this technology in a Phase 3 clinical trial, Fertilo enables new possibilities in improving patient outcomes to transform fertility treatment and advance the field of cell therapy.
In December 2024, Fertilo made history with the world’s first live human birth using its Fertilo technology. By co-culturing immature eggs with Fertilo’s proprietary ovarian support cells, Gameto recreated the natural egg maturation process in the laboratory, offering a faster, safer, and more accessible fertility solution.
Gameto is actively expanding the availability of Fertilo and has secured regulatory clearance in Australia, Japan, Argentina, Paraguay, Mexico, and Peru. The company also recently announced a strategic partnership with IVFAustralia, part of the Virtus Health group, to bring Fertilo to broader patient populations.
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.
SOURCE: Gameto
Post Views: 119
AUSTIN, TX, USA I January 30, 2025 I Gameto, a clinical-stage biotech company developing iPSC-based therapies for women’s health, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Fertilo, to enable the launch of the first US-based Phase 3 clinical trial for an induced pluripotent stem cell (iPSC)-based therapy. This groundbreaking milestone highlights the potential of iPSC technology to address critical unmet needs in reproductive medicine.
Fertilo is Gameto’s ovarian support cell (OSC) technology, designed to mature eggs outside the body using iPSC-derived cells. 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 dish. This process replaces 80% of hormone injections required with traditional in vitro fertilization (IVF), and reduces the duration of treatment cycles to just 2-3 days, offering patients a more comfortable and less invasive experience. This also significantly reduces risks such as ovarian hyperstimulation syndrome and alleviates side effects caused by high-dose hormone treatments.
“FDA clearance to advance Fertilo into a Phase 3 trial is a significant milestone for Gameto, and a landmark moment in iPSC technology,” said Dr. Dina Radenkovic, CEO and Co-Founder, Gameto. “We are proud to be pioneers in this field, with technology that has the potential to transform reproductive medicine. I’d like to express my gratitude to our team, whose work is focused on empowering women by offering a solution that is less invasive and improves the IVF journey. Fertilo is a solution for both men and women from all walks of life, offering millions of people new possibilities for family building at a time when declining birth rates present a growing global challenge.”
The Phase 3 trial will evaluate the efficacy and safety of Fertilo in maturing healthy eggs outside of the body, yielding embryos and improving pregnancy rate assessed at 12 weeks of pregnancy, the primary efficacy endpoint for women undergoing assisted reproductive technologies. The Phase 3 study clearance follows the world’s first live human birth conceived using Fertilo technology, achieved at Santa Isabel Clinic in Lima, Peru, in December 2024.
Gameto will launch its Phase 3 clinical trial across 15 sites in the United States. The study will assess key outcomes, including embryo development, pregnancy rates (as a measure of efficacy), and maternal health and live birth rates (as safety endpoints). The protocol involves up to two days of hormonal injections stimulation, with up to two embryo transfers, and is open to couples struggling with infertility for at least one year. Participants who do not achieve pregnancy during the trial will be offered a voucher for a second attempt. The Phase 3 study will be a double-blind, randomized controlled trial to ensure robust data collection and analysis.
“Fertility clinics have been hoping for a solution that makes the journey towards parenthood shorter, safer and more likely,” said Martin Varsavsky, Co-Founder and Chairman, Gameto and Founder, Prelude Fertility, the largest network of IVF and fertility clinics in the United States and Canada. “Fertilo’s three-day IVF and egg freezing is the answer.”
“Gameto’s technology platform opens entirely new possibilities for addressing reproductive health challenges through cell engineering-inspired innovation,” said Dr. Christian Kramme, Chief Scientific Officer, Gameto. “With Fertilo, we’ve demonstrated the potential of iPSC-based therapies to redefine fertility care by targeting ovarian health at the cellular level. This milestone also highlights the power of iPSCs in regenerative medicine and our computational and cell engineering platform where we have broader applications including menopause and ovarian cancer.”
Gameto is pioneering the use of iPSC technology in fertility care, building on Shinya Yamanaka’s Nobel Prize-winning discovery of induced pluripotent stem cells, which revolutionized regenerative medicine. As the first company to apply this technology in a Phase 3 clinical trial, Fertilo enables new possibilities in improving patient outcomes to transform fertility treatment and advance the field of cell therapy.
In December 2024, Fertilo made history with the world’s first live human birth using its Fertilo technology. By co-culturing immature eggs with Fertilo’s proprietary ovarian support cells, Gameto recreated the natural egg maturation process in the laboratory, offering a faster, safer, and more accessible fertility solution.
Gameto is actively expanding the availability of Fertilo and has secured regulatory clearance in Australia, Japan, Argentina, Paraguay, Mexico, and Peru. The company also recently announced a strategic partnership with IVFAustralia, part of the Virtus Health group, to bring Fertilo to broader patient populations.
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.
SOURCE: Gameto
Post Views: 119
