A healthcare brand for women begins to take shape

Until last year, healthcare funding continued to shatter previous records. But there remains at least one very big hole in the industry. No one has yet created a broad, leading women’s healthcare brand, and that spells opportunity.

Dina Radenkovic is among those who see it, and at her company, Gameto, she specifically wants to build a massive healthcare business that redefines reproductive health. A bioinformatics researcher who has a medical degree from the University College of London, Radenkovic is primarily focused right now on using cell engineering to make IVF cycles shorter. But the bigger company she has in mind would one day enable young women to so easily and affordably freeze their eggs that there would be little reason not to do this. Later, if some of these same women turned to IVF, Gameto would help improve their odds of success at a price that doesn’t break the bank. Even later still, these same customers might turn to Gameto to extend the life of their ovaries. Radenkovic’s thinking: women are living longer; their ovaries could and should be functioning longer, too.

It’s early days for the New York-based startup, which has just one biologic in pre-clinical trials right now. There’s a good chance that none of what she is imagining will come to fruition. Still, investors like Insight Partners and Future Ventures like her vision and her credentials.

They also like her New York- and Spain-based team, including 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 roughly a handful of similar outfits that are now enrolling patients in Gameto’s trials. In fact, VCs have already funded Gameto to the tune of $40 million.

We first talked with the company back in January, when it had newly secured its $20 million Series A round. Nearly 12 months and an economic downturn later, we talked again with Radenkovic about the progress Gameto has made — and some of the challenges it has yet to overcome.

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

DR: We know that one in eight couples suffer from infertility [in part] because we do have this problem [with] ovarian aging in that our ovaries age faster than the rest of the body. Women are born with a finite number of eggs, and we keep losing them throughout life, and by the time we want to use them, we may not be able to. We also know that even though many couples experience infertility, only around 2% of babies are born through assisted reproduction technology right now. It’s one of the few industries where you could see double or triple in a very short time horizon. A good example is the United Kingdom, where egg freezing has increased tenfold in 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 wasn’t there but it’s also expensive.

Yes, for women to freeze their eggs they need to dedicate $15,000 to $20,000, with some variance across states and different jurisdictions globally. They also need around two weeks of hormonal injections that are given to the whole body in order 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 like ovarian hyperstimulation syndrome. So for that reason, even though egg freezing technology [now works well], it accounts for about 7% of total IVF cycles in the U.S. right now. So it’s still very small. We think we can widen the market and allow more women to use this service.

You say the biologic you’re developing is different than IVF as it exists today, that patients using it need to undergo just two to four days of hormonal stimulation versus two to four weeks. How?

We are a cell engineering biotechnology company. We started with a sponsor research agreement with George Church‘s lab at Harvard Medical School. Our underlying technology allows 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 therapeutics biologics that occur for the disease of the reproductive system. Our first product, Fertilo, is a derivative of an engineered ovarian supporting cell line, and what that allows us to do is to add Fertilo to eggs in a dish in the embryology lab and aid their maturation and improve their quality by mimicking a natural process that occurs in the ovary. Normally, in our ovaries, we have immature eggs and ovarian supporting cells that help egg maturation, 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’re maturing eggs and mature eggs are essentially viable, good eggs that are more likely to [develop into] healthy embryos and healthy babies. So certainly, by improving maturation, you also improve the quality of eggs. And we’ve been doing really extensive analysis, both from an imaging and sequencing [standpoint], to show that it’s not just the maturity but also the quality of these eggs that are improved in the process.

You talk about opening up the market, meaning your process could prove more affordable. How?

A lot of the cost is around the injection medications. A lot of it is around ultrasounds and blood tests, right? Women are medicalized throughout this process, but if you could potentially 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] medications. You can make it a lot more convenient, shorter and cheaper. And that is what we hope to do. Our mission is really around access as well as efficacy and convenience.

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

We’ve recruited over 120 women in our studies. And we’re seeing that firstly, our product is non toxic, and secondly, that it does aid egg maturation. So we’re hoping to complete our preclinical data by the end of the year. And then certainly what will be the next step is to see if this translates into live births, so there’s still work to be done. We’re not making any judgments yet. We’re doing the science slowly. But the data that we’re getting so far is promising, and it certainly shows that there is some good science here . . . in that we are seeing increased egg maturation.

What do you think it’s going to take for women to think about freezing their eggs as something that should be done routinely?¬†

We need to make it cheap and convenient. When it comes to egg freezing today, it is often a decision on the balance of risk and benefit. So you could imagine a 28-year-old, living in New York, and she has saved $20,000 and has 10 days of paid time off, and she’s thinking whether to use it to go on holiday with her friends, or use those same resources to inject herself at home and become bloated and have to explain to people why she’s freezing her eggs — [people who might ask] if there’s something wrong with her or why she’s delaying having children. There’s a lot of potential judgment.

But let’s say we do end up showing that the [minimal] injections procotol works. Now imagine a world where you come in [to a clinic for your egg extraction] for one day, and that’s it. You can go back to work. You don’t need to mess up your whole body. You can even repeat [the process] two or three times until you get enough eggs. And then you have a monthly subscription where your eggs are frozen as a security policy, because so many things can happen, from taking a medicine or an accident or cancer or just deciding that you want to have a second or third child later, when you’re 38. I mean, we’re living longer by two years every decade but the age at which we lose our fertility has not really been extended since the introduction of medical records.

Speaking of women living longer, you and I had talked earlier this year about a different biologic — Ameno — you wanted to develop for women to essentially push out menopause from the time when most women experience it currently. Are you still working on this?

Right now, we’re really focused on bringing Fertilo from the clinic into the market. We made a first prototype for Ameno but given that we’re a small company and we started getting really promising data for Fertilo, our current team is really focused on infertility at the moment.

It’s a matter of prioritization. IVF is, I feel, really the best first place to start women’s health, though I could talk for probably way too long about all the things that need to be addressed. Like, seriously, when you go and look at women’s health medicines, there’s pretty much nothing. A lot of it is just pure hormonal-based. There are many things to be addressed 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 in the IVF clinic. . . But menopause and fertility are very closely interlinked, 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 woman’s body and that first we experience infertility and very shortly afterwards is this whole concept of perimenopause and menopause¬† . . .

By providing treatments, you could have a more continuous healthcare program that starts with women when they’re young, telling them about things like egg freezing, then they come back for IVF if they ever want to access that service, and then very shortly afterwards, they get support around perimenopause and menopause. You really are following women through the trajectory of ovarian aging, which is essentially the right way if you think about biology, and not the current service delivery.