In-vitro fertilization (IVF), a procedure responsible for millions of births since its inception in 1978, has revolutionized reproductive medicine. However, the conventional IVF process, while effective, presents several challenges for patients. The procedure involves a lengthy period of hormone injections, often lasting ten to fourteen days, to stimulate egg maturation. These injections can lead to unpleasant side effects such as bloating, nausea, vomiting, and even ovarian hyperstimulation syndrome. Furthermore, the success rate of egg retrieval is not guaranteed, requiring many patients to undergo multiple cycles, adding to the physical, emotional, and financial burden. The cost per cycle can range from $3,000 to $5,000 in the U.S., making IVF inaccessible for many individuals and couples. This arduous and expensive process underscores the need for innovation in reproductive technology.
Recognizing the shortcomings of traditional IVF, Dina Radenkovic, a physician with experience in fertility health, co-founded Gameto in 2021 with serial entrepreneur Martin Varsavsky. Their shared vision was to develop a less invasive, less painful, and more accessible IVF process. Gameto’s approach leverages cell engineering technology to mature eggs outside the mother’s body, significantly reducing the duration and intensity of hormone injections. This innovation was inspired by research conducted at a Harvard Wyss Institute lab, which demonstrated the potential of maturing eggs in a synthetic ovary environment. The result of this research and development is Fertilio, Gameto’s flagship product, which aims to transform the IVF landscape.
Fertilio streamlines the IVF process by shortening the injection period to just two or three days, followed by the extraction of immature eggs. These eggs are then placed in a dish designed to mimic the function of an ovary, allowing them to mature outside the body. This method drastically reduces the need for hormone injections by approximately 80%, mitigating the associated side effects and discomfort. Beyond the improvement in patient experience, Fertilio also offers economic advantages by reducing the overall cost of IVF treatment. The shorter injection period translates to lower medication costs and potentially fewer clinic visits, making the procedure more accessible to a wider range of patients. This accessibility is particularly crucial for individuals who face financial constraints or geographical barriers to accessing fertility treatments.
The development of Fertilio involved rigorous testing and clinical trials to ensure the safety and efficacy of the technology. These trials have yielded positive results, leading to regulatory approval in six countries, including Australia, Mexico, Argentina, and Peru. Gameto is actively working on expanding its reach to Japan and Paraguay through partnerships with local clinics. The company’s success is further evidenced by the birth of the first baby conceived using Fertilio in Peru, a momentous milestone that validates the potential of this innovative approach. With several ongoing pregnancies, including a set of twins, utilizing Fertilio, Gameto is demonstrating its ability to make a tangible impact on the lives of individuals and families seeking fertility solutions.
Gameto’s progress has attracted significant attention from investors, resulting in $73 million in funding. This financial backing reflects growing recognition of the unmet needs in the fertility market, which is estimated to be worth $25 billion globally. The increasing age at which people are starting families, coupled with the limitations of traditional IVF, has created a demand for more effective and accessible reproductive technologies. Gameto’s innovative approach positions the company to address this growing need and disrupt the existing IVF market. The company’s strategy involves forging partnerships with established fertility clinics, like IVFAustralia, to expand its reach and generate revenue. These partnerships provide access to a wider patient base and contribute to the growth and sustainability of Gameto’s business model.
While Fertilio is making strides globally, Gameto is also focused on entering the U.S. market. The company is currently preparing for Phase 3 clinical trials, slated to begin in 2025, with the goal of securing FDA approval. This expansion into the U.S. represents a significant opportunity for Gameto to further its mission of making IVF more accessible and less burdensome. Radenkovic’s determination to blend scientific innovation with sound business practices underscores Gameto’s commitment to creating a positive impact within the healthcare industry. The company’s success in developing and commercializing Fertilio demonstrates the potential for scientific breakthroughs to transform medical practices and improve the lives of patients worldwide. The ongoing development and expansion of Fertilio hold the promise of reshaping the future of IVF and expanding access to fertility treatments for individuals and couples globally.
