Credit: Sebastian Kaulitzki / Getty Images / Science Photo Library
In his latest Netflix special, Love to Hate It, Malaysian actor and comedian Ronnie Chieng opens with a segment on in vitro fertilization (IVF). He spends a few minutes talking about how taxing it was giving his wife hormone injections—as well as mind-boggling given his, or any other person in his position’s, lack of medical training—and eventually goes on to talk about how his wife’s egg harvesting produced “all-star” numbers. But underneath the humorous bit lies something deeper—the intense stress experienced by people trying IVF and the limited progress that has been made in reproductive health.
Christian Kramme, PhD, chief scientific officer (CSO) at women’s health biotechnology company Gameto, told Inside Precision Medicine, “IVF is an old clinical practice—it’s been around for decades, and there are millions of babies and adults walking around as the product of IVF. But as it is today, IVF puts a huge amount of the burden on women, who must take injections to develop, retrieve, and fertilize eggs outside of the body.”
At Gameto, Kramme and his team are striving to enhance this challenging process, spearheaded by their Fertilo program, which utilizes lab-made “ovarian support cells” derived from human induced pluripotent stem cells (iPSCs) to mature oocytes outside the body, aiming to enhance both IVF and egg freezing. Last December, Gameto announced the world’s first live human birth using Fertilo, demonstrating that the platform worked, at least once. Now, Gameto has announced that it raised $44 million in a funding round to advance Fertilo through Phase III clinical trials and obtain regulatory approval.
“It’s nice to see that a company can raise money to innovate in infertility specifically—that’s not what a lot of other companies, Big Pharma, or really anyone has been trying to invest these resources into,” said Kramme. “I am hopeful that a program like ours will truly incentivize others to explore the infertility space and investigate new medicines that can enhance egg quality, as well as improve our handling of eggs and embryos.”
Kramme added, “There are not many new products in infertility, and Fertilo will be one of the few that is entering into a phase III trial as a new drug to actually get approved. That matters because infertility is not a United States problem; it’s a global problem, and it’s going to get worse.”
From petri dish to parenthood
Shortly after Gameto was co-founded by now CEO Dina Radenkovic, MBBS, and Martin Varsavsky, in 2021, the then stealth company first raised a seed funding round, which was placed into a research agreement with Harvard Medical School (HMS) to fund the core foundational work of the company. Radenkovic eventually met Kramme, who was then pursuing his PhD in George Church’s lab, using stem cells to study reproductive health.
“I was trying to build these ovarian organoid models and advance the science of stem cell engineering in the female reproductive anatomy,” said Kramme. “The sponsored research agreement between HMS and Gameto actually funded my PhD work.”
By 2022, stem cell biology in reproductive health had advanced to a point where Kramme and his colleagues could consistently create ovarian cell types from stem cells, which coincided with Kramme finishing his graduate work and contemplating his next steps. Fast-forward to today, and Kramme is leading Gameto’s scientific progress as CSO, where he has been spearheading Gameto’s work in the fertility program and the new menopause program, Ameno, as well as guiding the scientific aspects of clinical and preclinical manufacturing, along with regulatory affairs.
Kramme and Gameto are focusing on enhancing IVF-based fertility. As Kramme explained, the key determinants of IVF are whether it is possible to retrieve a sufficient number of eggs that are in an appropriate developmental state to fertilize and develop into healthy embryos capable of resulting in a baby. When eggs are retrieved in an immature state, they must be developed outside of the body via in vitro maturation (IVM).
To address the oocyte maturation aspect, Kramme, at Harvard and then at Gameto, zeroed in on a way to take iPSCs using three transcription factors and make critical cell types that surround an egg inside of the body, most notably granulosa-like cells, which Gameto calls ovarian support cells. The role of these ovarian support cells is twofold. First, they nurture the egg’s development by promoting its meiosis and ensuring its complete maturation; second, they mature eggs by providing steroids during the menstrual cycle. Enter Fertilo, an iPSC-derived ovarian support cell system that can mature eggs outside of the body in co-culture, readying them for fertilization and implantation.
“We’re trying to achieve people’s family-building goals and address infertility. The point of Fertilo is that a patient can use our medication to treat their eggs instead of using existing medications to treat their body. It’s an awesome use of cell-based medicine.”
Hugh S. Taylor, MD, professor and chair of the department of obstetrics, gynecology, and reproductive sciences at Yale School of Medicine and chief of obstetrics and gynecology at Yale New Haven Hospital, told Inside Precision Medicine, “The concept of in vitro maturation of a woman’s own eggs is not novel; however, the use of stem cells to help in the process is new. This may be an improvement and worth testing.”
Setting the bar for iPSCs
Making these ovarian support cells from iPSCs consistently potent and pure has been a major focus at Gameto. Because Fertilo is a cell-based medicine, Kramme said it would be a disaster if these therapies were inconsistent, difficult to manage, or impossible to ensure they are pure and effective, as this would hurt their success in treatment and product reliability. Subsequently, Gameto has invested significant effort in the manufacturing process to determine the exact methods needed to produce these therapies at a scale comparable to that of their cell therapy counterparts.
“They’re probably the best cell therapies that are mass-manufactured,” said Kramme. “CAR T therapies don’t even begin to achieve the kind of scale that an infertility treatment works on. I mean, we don’t talk about dosing tens of thousands of patients. We consider what it would take to dose millions of patients eventually.”
This mindset of treating the masses was crucial for Gameto to accomplish something with Fertilo that no other group had achieved in the field of iPSCs—entering an iPSC-derived therapy into a Phase III clinical trial in the United States. Kramme thinks that this is due in large part to the struggle to define purity and to standardize iPSC-derived therapies.
“It’s difficult to show someone, like the FDA, that your process is sufficiently mature to control,” said Kramme. “We invented the cell type, developed the process that assured the FDA that we can do this at a commercial and clinical grade, and made a product that can appeal to the masses and treat infertility. I think a lot of eyes are looking to us. The definition of what makes an iPSC GMP is defined by our product. It’s the first time that the FDA has been able to look at somebody’s program and say, yes, this is good manufacturing practice for an iPSC.”
Considering the company is hardly four years old, the achievement is remarkable, an effort Kramme said was the result of an extraordinary amount of work from the Gameto team and the necessary resources. In that time, Gameto’s processes have been experiencing significant growth in both the scale and speed of our development.
“We’re trying to push the envelope and show a success case for cell-based medicine and iPSC-derived cell therapy,” said Kramme. “I hope that people see that there are companies that are still winning in [the fertility] space, that are raising funds, that are doing good clinical medicine with this and continue to be interested in the investment, because obviously this money is to take Fertilo over the finish line and into the commercial kind of mass-manufactured space.”
With their Series C announcement, Gameto has secured the necessary funding to advance Fertilo through a Phase III clinical trial and submit an application for approval. The phase III trial, which is open for enrollment, will be a double-blind randomized clinical trial with two arms of 250 patients each: Fertilo versus the gold standard that exists for maturing eggs outside of the body.
“IVF treatments are not cheap, and neither are Phase III clinical trials, because you are paying for a significant amount of systematic control and treatments for these patients,” said Kramme. “This funding and the funding that we’ve raised to date are being deployed to drive our recruitment, form this phase three study, and get all of the remaining commercialization ready—the actual manufacturing, the demonstration of the process, and the GMP control, all prepared so that in the United States, our product will be approved using what’s called the BLA pathway or Biologic Licensing Application. So really, this funding gets us all the way to submission of a BLA.”
Kramme added that the Series C funding will also help Gameto align its strategy in both the U.S. and the E.U., where Fertilo is recognized as an advanced therapy medicinal product (ATMP). Gameto plans to bring Fertilo to market in both jurisdictions over the next few years in order to take a more widespread and global approach to commercialization.
Unpausing menopause
If Fertilo clears its final clinical hurdle, it could mark a turning point for IVF—shifting egg maturation from an arduous, body-wide process to a precise, lab-based treatment and potentially broadening access to millions of people worldwide. Yet Gameto’s ambitions don’t stop at fertility. With Ameno, the company is applying the same iPSC-derived ovarian support cell platform to menopause, aiming to restore hormonal balance and transform a once-inevitable life stage into a manageable, gradual transition for women’s physical and emotional health.
According to Yale’s Taylor, Fertilo isn’t even the crown jewel of Gameto; rather, he believes that lies in the Ameno program, in which iPSC-derived ovarian support cells can undergo in vitro follicle formation and dynamically secrete therapeutically relevant levels of key hormones. “The big breakthrough that they are also developing is the ability to make eggs themselves from stem cells,” said Taylor. “That would potentially revolutionize reproduction. One could make large quantities of eggs at any age.”
In January 2025, Gameto recently received a $10 million award from the ARPA-H Sprint for Women’s Health program to support its Ameno program. Gameto’s early studies have shown that their iPSC-derived ovarian support cells can undergo in vitro follicle formation and dynamically secrete therapeutically relevant levels of key hormones. Utilizing the OSCs, Gameto aims to develop a cell therapy that makes the onset of menopause slow and gradual, no longer an abrupt and inevitable milestone but something we can manage and modify with medical intervention.
“Our company is also still trying to develop new medicines for the menopause program,” said Kramme. “This will require ongoing interest, continuous innovation, and further investment. Hopefully, people will recognize the success here and consider what the future might look like as well.”
Gameto’s Fertilo and Ameno programs hint at a future where reproductive medicine is not only more effective but also more humane—addressing the full arc of women’s reproductive health with therapies born from the lab yet designed for real life. By pushing the boundaries of cell-based medicine, Gameto isn’t just modernizing decades-old practices; it’s reimagining what’s possible from puberty to post-menopause.