Gameto

This year, on International Women’s Day, join us at #SXSW for a panel discussion that brings together founders, investors and advocates who are making a change in the women’s health space. The panel will take place at the conference held in Austin, Texas on Saturday, March 8th from 2:30-3:30pm local time. We hope to see you there! Dina Radenkovic Turner, Chelsea M.R. Hirschhorn, Maneesh Jain, Olivia Sterns Walton, Frida, Mirvie, Ingeborg Investments https://lnkd.in/gTSsPRBn

Have you heard? The official #SXSW schedule has been announced! Gameto’s CEO & Co-founder, Dina Radenkovic Turner, will be speaking on a panel at this year’s conference. ‘Transforming Women’s Health: From Pain to Progress” features panelists who are transforming the women’s health field through groundbreaking technologies, innovative investments, and paradigm-shifting policies. Dina will be joined by Mirvie’s Maneesh Jain, Ingeborg Investments’ Olivia Sterns Walton, and Frida’s Chelsea M.R. Hirschhorn. We look forward to an exciting discussion between this dynamic group! More details here: https://lnkd.in/gTSsPRBn

Thanks Ashlee Vance from Core Memory for speaking with our CEO & Co-Founder, Dr. Dina Radenkovic Turner, about Gameto’s work advancing iPSC technology in fertility treatment. #Fertilo is the first iPSC-based therapy to enter Phase 3 trials. It matures eggs outside the body using lab-grown ovarian cells, reducing hormonal injection time from two weeks to just a few days. Already approved in several countries, with numerous ongoing pregnancies and a baby born with the technology last year. Dr. Radenkovic, a physician and biotech innovator, has also raised $73M in venture funding to pioneer new applications of iPSC, with Fertilo leading the way. Listen to the full interview here: https://lnkd.in/d2WKcBhy

?? Big news for reproductive medicine! ?? Gameto’s Fertilo just became the first-ever iPSC-based therapy to enter a U.S. Phase 3 clinical trial after FDA IND clearance! This is a game-changing moment for fertility care - #Fertilo enables egg maturation outside the body, reducing hormone injections by ~80% and cutting IVF treatment time from weeks to just 2-3 days. This milestone follows the world’s first baby born with Fertilo in December 2024. We’re thrilled to bring this innovation to patients across the U.S. with a 15-site Phase 3 trial. Sharing our press release here: https://lnkd.in/ebrJ4PUq Stay tuned for more info and updates! #Women’sHealth #FertilityInnovation #IVF #iPSCs

#Fertility startup Gameto has permission from the FDA to begin first-of-its-kind Phase 3 study of stem cell therapy for #IVF. The startup is using #iPSC-dervied ovarian support cells (based on technology from Harvard geneticist George Church's lab) to mature eggs in a lab dish. CEO Dina Radenkovic Turner tells me it could be an easier and safer alternative than the grueling hormoen treatments typically used prior to egg collection in IVF. Read more in my exclusive story for Endpoints News: https://lnkd.in/e4-hnZNg

? Pioneering a New Era in Fertility Treatment ? We’re thrilled to announce that Gameto has received FDA clearance to launch our Phase 3 clinical trial for Fertilo - the first iPSC-based therapy to enter this stage since Shinya Yamanaka’s Nobel Prize-winning discovery of induced pluripotent stem cells (iPSCs). This milestone represents a transformative step in our mission to revolutionize #reproductive medicine and improve the #IVF experience. What makes this even more special? Our small but mighty team. ?? This achievement didn’t come easy - it took countless hours, unwavering determination, and #teamwork. Every member of our team poured their heart and soul into this, and this FDA clearance is a testament to their brilliance and passion for transforming #fertility treatment. Why Fertilo Matters: ?? Built on Nobel Prize-winning technology, Fertilo uses iPSC-derived ovarian support cells (OSCs) to mature eggs outside the body, reducing hormone injections by 80% and shortening IVF treatment cycles from 10-14 days to just 2-3 days. ?? Potential to disrupt a multibillion-dollar injection market that has remained unchanged since IVF’s inception, replacing an outdated, difficult process with an innovative, patient-first solution. ?? A safer, less invasive approach - minimizing risks like ovarian hyperstimulation syndrome and reducing the harsh side effects of high-dose hormone treatments. Our Phase 3 trial will launch soon across 15 sites in the U.S., evaluating key outcomes such as embryo development, pregnancy rates, maternal health, and live birth outcomes. Patients struggling with infertility for at least a year will be eligible, with follow-up support for those who do not achieve pregnancy initially. This milestone follows another historic achievement: the world’s first live human birth using Fertilo technology, which took place in December 2024 (https://lnkd.in/euN3Bg_2). Now, with FDA clearance for our Phase 3 study, we are excited to bring a faster, safer, and more accessible fertility solution to families worldwide. ?? The future of fertility is here. Stay tuned for trial updates and site locations across our channels. Read the Endpoints News article: https://lnkd.in/eGi3MxC3 #IVF #iPSC #Gameto #ClinicalTrials #WomensHealth #ReproductiveMedicine

IVF may be an incredible feat of science, but the patient journey has seen little change since the first IVF baby was born in 1978. Women still endure a difficult process of injections, monitoring, and immense emotional, physical, and financial strain. For the majority, it takes multiple cycles to achieve success. Kristen V. Brown captures these challenges in her recent article for The Atlantic, opening up about her own egg freezing experience and highlighting the difficulties so many women who go through the process face. A study done in the UK reported that out of patients who access assisted reproductive technology (ART) the vast majority of respondents (84%) felt that having treatment affected their day-to-day work, 58% felt concerned that treatment would affect their career prospects, and 36% felt their career was actually damaged as a result [Payne, 2022]. At Gameto, we're committed to transforming this journey. Fertilo, our iPSC-derived ovarian support cell (OSC) solution, is designed to make fertility treatments faster, less invasive, and more accessible for patients by reducing the need for the harmful injections. Last year, we celebrated a major milestone: the first live birth using our technology. Full story linked here: https://lnkd.in/e2XfqkS5 Dina Radenkovic Turner Pietro Bortoletto Boston IVF

Yesterday, we published another paper about ovarian cell development detailing some of the core science behind our induced pluripotent stem cell (iPSC)-derived product, Fertilo, in #EBMOReports. The study identifies transcription factors that differentiate iPSCs into induced oogonia-like cells (iOLCs) and human primordial germ cell-like cells (hPGCLC), which share strong similarities with these types of cells derived in vivo and in vitro. Congratulations to the whole team who worked hard on this publication! Read the full paper here: https://lnkd.in/ee4geDWa

Gameto CSO Christian Kramme, PhD spoke with the Cure. team about our recent first live birth news, Advanced Research Projects Agency for Health (ARPA-H) award, and more. “I've always been interested in making a difference in patients' lives and not just practicing cool, fun science. It's inspiring to follow the trajectory of a project full circle, from start to finish, such as our first birth. I think young scientists today might be thinking, am I going to be a professor in academia or will I work in biotech or big pharma? But incredible science can occur on both paths.” - Christian Kramme Read more at the article here: https://lnkd.in/dfvNqVy2

This week, Gameto presented at the JP Morgan Healthcare Conference, in front of investors, pharma companies and other healthcare innovators. Our CEO and co-founder, Dina Radenkovic Turner, took the stage to share more about our mission to redefine women’s health through cutting-edge science, and our upcoming milestones in 2025. Key Highlights: ?? The first live human birth resulting from Gameto’s iPSC-derived product Fertilo ?? Our commercial partnership with fertility clinic network IVF Australia of the Virtus Health Group ?? Our $10M award from Advanced Research Projects Agency for Health (ARPA-H)’s Sprint for Women’s Health Initiative to accelerate the development of our menopause program We also had an engaging Q&A discussion, following the presentation, joined by Gameto’s Co-founder and Chairman, Martin Varsavsky, and our Chief Scientific Officer, Christian Kramme, PhD. We look forward to sharing more exciting updates this year, and thank all of our partners, supporters, and our amazing team who made this possible!