January 27, 2023

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A Women’s Health Brand Takes Shape • Eureka News Now

Up until last year, healthcare funding continued to break previous records. But at least one very big hole remains in the industry. No one has created a broad, leading brand in women’s healthcare before, and that means opportunity.

Dina Radenkovic is among those who see this, and with her company Gameto, she specifically aims to build a massive healthcare business that will redefine reproductive health. Radenkovic, a bioinformatician with a medical degree from University College of London, is currently primarily focused on using cell engineering to shorten IVF cycles. But the bigger company she has in mind would one day make it possible for young women to freeze their eggs so easily and inexpensively that there would be little reason not to. Later, when some of these women turned to IVF, Gameto would help improve their chances of success at a price that wouldn’t break the bank. Even later, those same customers could turn to Gameto to prolong the life of their ovaries. Radenkovic’s thinking: women live longer; Your ovaries could and should function longer too.

It’s still early days for the New York startup, which currently only has one biologic in preclinical trials. There’s a good chance nothing of what she envisions will come to fruition. Still, investors like Insight Partners and Future Ventures like their vision and credentials.

They also like their New York and Spain-based team, including co-founder and chairman Martin Varsavsky, who has previously founded numerous companies including a WiFi connectivity company called FON and Prelude, a chain of fertility clinics owned by about a handful similar facilities that are now enrolling patients in Gameto’s studies. In fact, VCs have already funded Gameto with $40 million.

We first spoke to the company in January when it freshly secured its $20 million Series A round. Almost 12 months and an economic downturn later, we spoke to Radenkovic again about the progress Gameto has made – and some of the challenges it still has to overcome.

Last time we spoke you were very excited about the potential to delay or even eradicate menopause. But they’re now more focused on a biologic trying to improve IVF outcomes, which is a more crowded area. Why?

We know that every eighth couple suffers from infertility [in part] because we have this problem [with] Aging of the ovaries, as our ovaries age faster than the rest of the body. Women are born with a limited number of ova, and we lose them throughout life, and if we want to use them, we may not be able to use them anymore. We also know that although many couples suffer from infertility, only about 2% of babies are currently born through assisted reproductive technology. It’s one of the few industries that has seen a doubling or tripling in a very short time horizon. A good example is the UK, where egg freezing has increased tenfold in the last 10 years because the technology has gotten so much better; Until now we didn’t know how to freeze eggs without destroying them.

The technology wasn’t there, but it’s also expensive.

Yes, for women to freeze their eggs, they have to spend $15,000 to $20,000, with some variation between states and different jurisdictions around the world. They also require around two weeks of full-body hormone injections to stimulate and artificially stimulate the ovaries, which is both uncomfortable and comes with side effects ranging from nausea and bloating to potentially more serious side effects like ovarian hyperstimulation syndrome . So for this reason, even if the technology is used to freeze eggs [now works well], it currently accounts for about 7% of all IVF cycles in the US. So it’s still very small. We believe we can expand the market and allow more women to use this service.

They say the biologic you’re developing is different from IVF today in that patients using it only need to undergo hormonal stimulation for two to four days instead of two to four weeks. As?

We are a biotechnology cell engineering company. We started with a research sponsorship deal with George Church’s lab at Harvard Medical School. Our underlying technology allows us to transform stem cells into cells of the reproductive system. And we build that into the organoid model of the reproductive system. And from this we derive therapeutic biologics that occur in diseases of the reproductive system. Our first product, Fertilo, is a derivative of a genetically engineered cell line to support the ovaries and which allows us to add Fertilo to eggs in a tray in the embryology laboratory and support their maturation and improve their quality by mimicking a natural process which occurs in the ovary. Normally in our ovaries we have immature eggs and ovarian support cells that help egg maturation, so we try to mimic this natural process and thereby reduce the need for injections.

[Editor’s note: the IVF process as it’s designed today aims to stimulate the follicles in someone’s ovaries so that they produce and mature eggs in preparation for an egg collection procedure; Gameto thinks it can move this process outside of the body.]

Can you make eggs more viable with your technology? Or is an egg’s viability predetermined?

Well, we mature eggs and mature eggs are essentially viable, good eggs more likely [develop into] healthy embryos and healthy babies. So, by improving ripening, you are surely improving the quality of the eggs as well. And we did really extensive analysis, both from imaging and from sequencing [standpoint]to show that not only the maturity but also the quality of these eggs is thereby improved.

You talk about opening up marketing, which means your process could prove more affordable. As?

Much of the cost is for the injection medications. A lot revolves around ultrasounds and blood tests, right? Women are being medicalized during this process, but if you could possibly change this protocol by eliminating injections or reducing them to the bare minimum of injections that the patient needs, you could reduce clinic visits, you could reduce the need for [expensive] medication. You can do it much more conveniently, shorter and cheaper. And that’s what we hope to do. Our mission is truly about access, effectiveness and convenience.

What do your preclinical study data tell you and how many women have participated in these studies so far?

We recruited over 120 women for our studies. And we see that firstly our product is non-toxic and secondly it supports egg maturation. Therefore, we hope to complete our preclinical data by the end of the year. And then surely the next step will be to see if that leads to live births, so there’s still work to be done. We’re not making judgments yet. We do science slowly. But the data we’ve received so far is promising and certainly shows that there is some good science here. . . that we see increased egg maturation.

What do you think it takes for women to consider egg freezing routine?

We have to make it cheap and convenient. When it comes to egg freezing today, it is often a choice between risk and benefit. So you can imagine a 28-year-old living in New York, with $20,000 in savings and 10 days of paid time off, and she’s debating whether to take it on vacation with her friends or use the same resources at home squirting and getting bloated and having to explain to people why she freezes her balls – [people who might ask] if there is something wrong with her or why she is delaying having children. There is a lot of possible judgment.

But suppose we end up showing that the [minimal] Injection protocol works. Now imagine a world you are going into [to a clinic for your egg extraction] for one day and that’s it. You can go back to work. You don’t have to mess up your whole body. You can even repeat [the process] two or three times until you have enough eggs. And then you have a monthly subscription that freezes your eggs as a safety guideline because so many things can happen, from taking a drug or an accident or cancer or just deciding you want a second or third child later on, we do are 38. I mean, we live two more years every ten years, but the age at which we lose our fertility hasn’t really been extended since the introduction of medical records.

Speaking of longer-lived women, earlier this year you and I talked about another biologic — Ameno — that you wanted to develop for women to essentially postpone menopause from when most women are currently experiencing it. Are you still working on it?

Right now we are really focused on getting Fertilo out of the clinic. We made an initial prototype for Ameno, but since we’re a small company and we’ve started to get really promising data for Fertilo, our current team is really focused on infertility at the moment.

It’s a matter of prioritization. IVF really is the best first place to start in women’s health in my opinion, although I could probably talk way too long about all the things that need to be addressed. Seriously, if you look at medicine for women’s health, there’s pretty much nothing. Much of this is purely hormonal. There are many things to address here. And we certainly have that platform technology [to do that].

The reason IVF is so good is because it is always done in a bowl, so we were able to test our product in a bowl very quickly and then take that bowl from our lab to the IVF clinic lab. . . But menopause and fertility are very closely linked, right? These are all ovarian aging phenotypes. If you look at almost a trajectory of ovarian function, we know that the ovaries age faster than the rest of the woman’s body and that we experience infertility first and very shortly after that this whole concept of perimenopause and menopause. . .

By offering treatments, you could have a more ongoing health program that starts with women when they are young, tells them things like egg freezing, then they come back for IVF if they ever want to access that service, and then very shortly thereafter, they receive support around perimenopause and menopause. They really do follow women through the trajectory of ovarian aging, which is essentially the right path if you think in terms of biology and not current performance.