Gameto Launches First U.S. Clinical Site for Patient Enrollment in Fertilo Study
Gameto, a clinical-stage biotechnology company at the forefront of developing cutting-edge iPSC (induced pluripotent stem cell)-based therapies to revolutionize fertility care, today announced an exciting milestone in its clinical development program. The Reproductive Fertility Center in Corona, California, led by renowned fertility specialist Dr. Daniel Williams, is now open for patient enrollment in Gameto’s first U.S. clinical study of Fertilo. This trial marks a significant advancement in Gameto’s efforts to bring Fertilo, an innovative platform designed to alleviate the challenges of ovarian stimulation during fertility treatment, to patients across the United States.
Fertilo is an investigational technology that aims to drastically reduce the burden of hormone injections typically required in traditional in vitro fertilization (IVF) procedures. By harnessing the power of engineered ovarian support cells, Fertilo promotes the maturation of a woman’s eggs outside of the body, thereby shortening or potentially eliminating the need for lengthy and invasive ovarian stimulation processes. This breakthrough could transform the landscape of fertility treatments, offering a more streamlined and less invasive approach to achieving successful pregnancies for women.
A Key Step Forward in Clinical Development
The launch of the clinical study at the Reproductive Fertility Center represents a pivotal moment in the development of Fertilo. As Gameto continues to expand its clinical trials, this site in California serves as the first of many that will open in the coming weeks across the U.S. The company anticipates the addition of more than a dozen clinical sites located in major fertility hubs throughout the country, including Florida, Texas, New York, and Connecticut. These new sites will play a crucial role in evaluating the efficacy and safety of Fertilo for women undergoing fertility treatments, allowing Gameto to broaden its clinical data and accelerate the path to regulatory approval.
“Opening our first U.S. clinical site for our pivotal study is a significant and exciting step forward for Gameto and the broader fertility care landscape,” said Dr. Dina Radenkovic, CEO and Co-Founder of Gameto. “Our partnership with Dr. Williams and his esteemed team at Reproductive Fertility Center is an essential collaboration in bringing an innovative new option to women. Fertilo has the potential to make fertility treatment faster, more efficient, and less invasive, which could significantly improve the overall patient experience.”
The Fertilo Study: A New Approach to Egg Maturation
The Fertilo clinical study will primarily focus on evaluating the ability of engineered ovarian support cells to effectively promote egg maturation ex vivo—outside the human body. The goal is to enable successful fertilization and embryo development after a much shorter period of ovarian stimulation compared to conventional methods. By minimizing or eliminating the need for prolonged hormone injections, Fertilo aims to provide a safer and more convenient alternative for women undergoing fertility treatments, whether they are pursuing in vitro fertilization (IVF) or seeking to preserve their fertility for future family planning.
Patients enrolled in the study will receive individualized care and monitoring at the Reproductive Fertility Center, one of Southern California’s most respected fertility clinics. With access to the latest advancements in reproductive medicine, participants will benefit from the expertise of Dr. Williams and his clinical team, including Dr. James P. Lin and Dr. Susan Nasab. These experienced specialists are dedicated to offering the highest standard of fertility care while contributing to the groundbreaking research behind Fertilo.
“We are thrilled to be the first clinical site in the U.S. to begin enrolling patients for this exciting and innovative study,” said Dr. Daniel Williams, Medical Director at Reproductive Fertility Center. “Our clinic has always been committed to providing patients with access to the latest advancements in reproductive medicine, and we believe that Fertilo could offer a safer and more accessible option for women who are seeking to preserve their fertility or start a family. With the expertise of our clinical team, we are proud to be at the forefront of this important research.”
Preliminary Data Demonstrating Fertilo’s Potential
Gameto’s promise in revolutionizing fertility treatment is further supported by promising preclinical data published in a preprint on medRxiv, showcasing Fertilo’s efficacy in promoting egg maturation. In their studies, the company demonstrated that Fertilo’s innovative approach significantly enhances the number of viable embryos produced, ultimately leading to dramatically improved pregnancy success rates.
In mini-stimulation (mini-stim) cycles, where Fertilo is used as a supplement to traditional IVF protocols, patients achieved an impressive 44% pregnancy rate per cycle after the first embryo transfer. This success rate is more than double the typical pregnancy success rate seen in conventional in vitro maturation (IVM) cycles, which stands at approximately 20%. Furthermore, patients who received Fertilo treatment had a greater number of viable embryos available for transfer, thus improving their chances of conception and pregnancy success.
These results highlight the potential of Fertilo to not only improve the overall fertility treatment process but also enhance the likelihood of a successful pregnancy for women undergoing IVF procedures. With Fertilo, Gameto is offering a promising new solution that may lead to shorter, less invasive treatment cycles, with a higher probability of achieving a successful pregnancy.
Expanding Access to Fertility Innovations
Gameto’s clinical trial rollout and the opening of additional sites are part of a broader effort to make Fertilo available to more women who face the challenges of traditional fertility treatments. As the company continues to expand its clinical trials and gather more data, it is expected that Fertilo could become a valuable tool in the fertility care toolbox for patients around the world.
Dr. Radenkovic emphasized that the mission of Gameto is to make fertility treatment more accessible, effective, and patient-friendly. “We know that fertility treatments can be physically and emotionally taxing, and our goal with Fertilo is to reduce the complexity and invasiveness of these procedures. By improving the way we approach ovarian stimulation, we hope to provide women with a faster, more convenient path to successful pregnancies.”
In addition to improving patient outcomes, the potential for Fertilo to reduce the financial burden of fertility treatments cannot be understated. IVF cycles are often expensive, and the costs of repeated hormone injections and the extended duration of ovarian stimulation can add to the financial strain faced by patients. Fertilo’s streamlined approach could lower treatment costs, making fertility care more accessible to a broader demographic of women, especially those in underserved communities or with limited financial resources.
A Bright Future for Fertility Treatment
The launch of the Fertilo clinical study at the Reproductive Fertility Center is just the beginning for Gameto. As the company prepares to open additional clinical sites across the U.S., it is also working closely with regulatory bodies to move the platform closer to approval and commercialization. With the backing of a world-class team of researchers, clinicians, and innovators, Gameto is poised to lead the charge in transforming the fertility care landscape.
“We are just at the beginning of what we hope will be a transformative journey in reproductive medicine,” Dr. Radenkovic concluded. “We look forward to working with our clinical partners, including Reproductive Fertility Center, to expand the reach of Fertilo and offer women a new, better way to approach fertility treatments. Our vision is clear—to make fertility care faster, easier, and less invasive for everyone who needs it.”
As Gameto continues its clinical development and refines its groundbreaking Fertilo platform, it is clear that the company’s innovative approach has the potential to reshape the future of fertility care, providing patients with a safer, more effective, and less burdensome way to achieve their family-building dreams.
