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A women’s care brand begins to take shape • londonbusinessblog.com

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Until last year, healthcare funding continued to shatter previous records. But there remains at least one very large gap in the industry. No one has created a broad, leading brand for women’s healthcare until now, and that’s an opportunity.

Dina Radenkovic is one of those who see it, and by her company, Gameto, she specifically wants to build a massive healthcare company that redefines reproductive health. Radenkovic, a bioinformatics researcher with a medical degree from the University College of London, is currently focusing primarily on using cell engineering to shorten IVF cycles. But the larger company she envisions would one day allow young women to freeze their eggs so easily and affordably that there would be little reason not to. If some of these women turned to IVF later on, Gameto would help increase their chances of success at a price that wouldn’t break the bank. Later still, those same customers can turn to Gameto to extend the life of their ovaries. Radenkovic’s line of thought: women live longer; their ovaries could and should function longer as well.

It’s early days for the New York-based startup, which currently has only one biologic drug in preclinical trials. Chances are, none of what she imagines will come true. Still, investors such as Insight Partners and Future Ventures value her vision and her credentials.

They also love her New York and Spain-based team, which includes co-founder and chairman Martin Varsavsky, who has previously launched numerous companies, including a Wi-Fi connectivity company called FON, and Prelude, a chain of fertility clinics that is among the about a handful of similar outfits now enrolling patients in Gameto’s trials. In fact, VCs have already funded Gameto to the tune of $40 million.

We first spoke to the company in January when it recently closed its $20 million Series A round. Nearly 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.

TC: When we last spoke, you were very excited about the potential to delay or even eradicate menopause. But you’re now more focused on a biologic that’s trying to improve IVF outcomes, which is a busier area. Why?

DR: We know that one in eight couples suffers from infertility [in part] because we have this problem [with] ovarian aging due to our ovaries aging faster than the rest of the body. Women are born with a finite number of eggs, and we keep losing them throughout our lives, and by the time we want to use them, we may not be able to. We also know that while many couples experience infertility, only about 2% of babies are currently born through assisted reproductive technology. It is one of the few sectors where you can see a doubling or tripling in a very short time. A good example is the UK, where egg freezing has increased tenfold over the last 10 years because the technology has gotten so much better; previously we didn’t know how to freeze eggs without destroying them.

The technology was not there, but it is also expensive.

Yes, if women want to freeze their eggs, they will have to spend $15,000 to $20,000, with some variation between states and different jurisdictions worldwide. They also require about two weeks of hormonal injections that are given to the entire body to stimulate and artificially stimulate the ovaries, which is both inconvenient and carries side effects from nausea and bloating to potentially more serious side effects such as ovarian hyperstimulation syndrome. So for that reason also egg freezing technology [now works well], it currently accounts for about 7% of total IVF cycles in the US. So it’s still very small. We think we can broaden the market and let more women enjoy this service.

You say that the biologic you are developing is different from IVF as it exists today in that patients using it only need to undergo hormonal stimulation for two to four days instead of two to four weeks. How?

We are a biotechnology company in the field of cell engineering. We started a research sponsorship agreement with George church‘s lab at Harvard Medical School. Our underlying technology enables us to convert stem cells into cells of the reproductive system. And we build that into the organoid model of the reproductive system. And we use it to derive therapeutic biologics that occur in reproductive system disease. Our first product, Fertilo, is a derivative of an engineered ovarian support cell line, which allows us to add Fertilo to eggs in a shell in the embryology lab and promote their maturation and improve their quality through a natural process after to mimic that happens in the ovary. Normally, in our ovaries, we have immature eggs and ovarian support cells that help the eggs mature, so we try to mimic that 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 the viability of an egg predetermined?

Well, we are maturing eggs and mature eggs are essentially viable, good eggs that are more likely [develop into] healthy embryos and healthy babies. So certainly, by improving the maturation, you also improve the quality of the eggs. And we’ve done really extensive analysis, both of an imaging and sequencing [standpoint]to show that not only the ripeness but also the quality of these eggs is improved.

You talk about opening up the marketing which means your process could turn out to be more affordable. How?

A lot of the costs are around the injection drugs. A lot of it is about ultrasound and blood work, right? Women are being medicalized throughout this process, but if you could potentially change this protocol by eliminating injections or reducing to the bare minimum of injections that the patient needs, you could reduce clinic visits, you could reduce the need for [expensive] medicines. You can make it a lot more convenient, shorter and cheaper. And that’s what we hope to do. Our mission is really about access, effectiveness and convenience.

What do your preclinical trial data tell you, and how many women have participated in these trials to date?

We recruited more than 120 women into our studies. And we see that, firstly, our product is non-toxic, and secondly, it helps egg maturation. So we hope to complete our preclinical data by the end of the year. And then the next step is definitely to see if that translates into live births, so there’s still work to be done. We are not making any statements yet. We do science slowly. But the data we’re getting so far is promising, and it certainly shows there’s some good science here. . . in the sense that we are seeing increased maturation of eggs.

What do you think it takes for women to think that freezing their eggs is something that should be done routinely?

We need to make it cheap and easy. When it comes to egg freezing these days, it’s often a risk-benefit decision. Imagine a 28-year-old living in New York, and she has $20,000 in savings and has 10 days of paid leave, and she’s thinking about whether she’ll use it to go on vacation with her friends, or to use those same resources. inject herself at home and get bloated and have to explain to people why she freezes her eggs – [people who might ask] if there is something wrong with her or why she is delaying having children. There is a lot of potential judgment.

But let’s say we finally show that the [minimal] injections procotol works. Now imagine a world that you enter [to a clinic for your egg extraction] for a 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 where your eggs are frozen for safety reasons, because so much can happen, from taking medicine or an accident or cancer or just deciding you want a second or third child later, when you’re 38. I mean, we live two years longer every decade, but the age at which we lose our fertility hasn’t really been extended since the introduction of medical records.

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

At the moment we are really focused on bringing Fertilo to the market from the clinic. We’ve done an initial prototype for Ameno, but given that we’re a small company and we started to get some promising data for Fertilo, our current team is really focused on infertility right now.

It’s a matter of prioritizing. IVF is, I think, really the best first place to start women’s health, although I could probably talk way too long about all the things that need to be addressed. Like, seriously, when you start looking at women’s health drugs, there’s pretty much nothing there. A lot of it is just purely hormone based. There are many things to address here. And we certainly have this platform technology [to do that].

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

By offering treatments, you could have a more ongoing health care program that starts with women when they’re young, tells them about things like egg freezing, then they come back for IVF if they ever want to access that service, and then very shortly after, they receive support around perimenopause and menopause. You really follow women through the trajectory of ovarian aging, which is essentially the right way to go when you think about biology, not current services.

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