Berlin-based femtech startup Inne is popping out of stealth to announce an €8 million (~$8.8M) Series A and provides the primary glimpse of a hormone-tracking subscription product for fertility-tracking and pure contraception that’s slated for launch in Q1 subsequent yr.
The Series A is led by led by Blossom Capital, with early Inne backer Monkfish Equity additionally taking part, together with various angel traders — together with Taavet Hinrikus, co-founder of TransferWise; Tom Stafford, managing associate at DST; and Trivago co-founder Rolf Schromgens.
Women’s well being apps have been having a tech-fuelled second in recent times, with the rise of a femtech class. There are actually all types of apps for monitoring durations and the menstrual cycle, akin to Clue and Flo.
Some additionally attempt to predict which days a girls is fertile and which they’re not — providing digital instruments to assist girls observe bodily alerts in the event that they’re following a pure household planning methodology of contraception, or certainly making an attempt to conceive a child.
Others — akin to Natural Cycles — have gone additional down that path, branding their method “digital contraception” and claiming higher sophistication vs conventional pure household planning by making use of studying algorithms to cycle knowledge augmented with further info (usually a every day physique temperature measurement). Although there has additionally been some controversy round aggressive and even deceptive advertising and marketing techniques focusing on younger girls.
A multi-month investigation by the medical machine regulator in Natural Cycles’ house market, instigated after various girls fell pregnant whereas utilizing its methodology, discovered charges of failure had been according to its small-print guarantees however concluded with the corporate agreeing to make clear the danger of the product failing.
At situation is that the notion of “digital contraception” might current as easy and easy — arriving in useful app type, typically boosted by a flotilla of seductive social media life-style adverts. Yet the fact for the consumer is the other of easy. Because in actual fact they’re personally taking up all the threat.
For these merchandise to work the consumer wants a excessive stage of dedication to stay at it, be constant and pay shut consideration to key particulars with the intention to obtain the promised price of safety.
Natural contraception can also be what Inne is touting, dangling one other attractive promise of hormone-free contraception — its web site calls the product “a tool of radical self-knowledge” and claims it “protect[s]… from invasive contraceptive methods”. It’s twist is it’s not utilizing temperature to trace fertility; its focus is on hormone-tracking as a fertility measure.
Inne says it’s developed a saliva-based check to measure hormone ranges, together with an in vitro diagnostic machine (pictured above) that permits knowledge to be extracted from the disposable checks at house and wirelessly logged within the companion app.
Founder Eirini Rapti describes the product as a “mini lab” — saying it’s small and moveable sufficient to slot in a pocket. Her staff has been doing the R&D on it since 2017, preferring, she says, to give attention to getting the biochemistry proper moderately than shouting about launching the startup. (It took in seed funding previous to this spherical however isn’t disclosing how a lot.)
At this stage Inne has utilized for and gained European certification as a medical machine. Though it’s not but been formally introduced.
The first product, a pure contraception for grownup girls — billed as finest fitted to girls aged 28-40, i.e. at a gentle relationship time-of-life — shall be launching in choose European markets (beginning in Scandinavia) subsequent yr, although initially as a closed beta type launch as they work on iterating the product primarily based on consumer suggestions.
“It basically has three parts,” Rapti says of the proposition. “It has a small reader… It has what we name a bit of mouth opening within the entrance. It at all times provides you a smile. That’s the {hardware} a part of it, so it acknowledges the depth of your hormones. And then there’s a disposable saliva check. You mainly acquire your saliva by placing it in your mouth for 30 seconds. And you then insert it within the reader and you then go about your day.
“The reader is connected to your phone, either via BlueTooth or wifi, depending on where you are taking the test daily… It takes the reading and it sends it over to your phone. In your phone you can do a couple of things. First of all you look at your hormonal data and you look at how those change throughout the menstrual cycle. So you can see how they grow, how they fall. What that means about your ovulation or your overall female health — like we measure progesterone; that tells you a lot about your lining etc. And then you can also track your fluids… We teach you how to track them, how to understand what they mean.”
As nicely as a contraception use-case, the fertility monitoring component naturally means it is also utilized by girls desirous to get pregnant.
“This product is not a tracker. We’re not looking to gather your data and then tell you next month what you should be feeling — at all,” she provides. “It’s extra designed to trace your hormones and inform you look that is essentially the most primary change that occurs in your physique and due to these adjustments you’ll really feel sure issues. So do you’re feeling them or not — and should you don’t, what does it imply? Or should you do what does it imply?
“It builds your own hormonal baseline — so you start measuring your hormones and we go okay so this is your baseline and now let’s look at things that go out of your baseline. And what do they mean?”
Of course the important thing query is how correct is a saliva-based check for hormones as a technique for predicting fertility? On this Rapti says Inne isn’t able to share knowledge in regards to the product’s efficacy — however claims will probably be publishing particulars of the varied research it carried out as a part of the CE marking course of within the subsequent few weeks.
“A couple more weeks and all the hardcore numbers will be out there,” she says.
In phrases of the way it works usually the hormone measurement is “a combination of a biochemical reaction and the read out of it”, as she places it — with the check itself being pure chemistry however algorithms then being utilized to interpret the hormonal studying, looping in different alerts such because the consumer’s cycle size, age and the time of day of the check.
She claims the biochemical hormone check the product depends on as its baseline for predicting fertility relies on related rules to straightforward being pregnant checks — akin to those who contain peeing on a keep on with get a binary ‘pregnant’ or ‘not pregnant’ end result. “We are focused on specifically fertility hormones,” she says.
“Our device is a medical device. It’s CE-certified in Europe and to do that you have to do all kinds of verification and performance evaluation studies. They will be published pretty soon. I cannot tell you too much in detail but to develop something like that we had to do verification studies, performance evaluation studies, so all of that is done.”
While it developed and “validated” the method in-house, Rapti notes that it additionally labored with various exterior diagnostic corporations to “optimize” the check.
“The science behind it is pretty straightforward,” she provides. “Your hormones behave in a specific way — they go from a low to a high to a low again, and what you’re looking for is building that trend… What we are building is an individual curve per user. The starting and the ending point in terms of values can be different but it is the same across the cycle for one user.”
“When you enter a field like biochemistry as an outsider a lot of the academics will tell you about the incredible things you could do in the future. And there are plenty,” she provides. “But I think what has made a difference to us is we always had this manufacturability in mind. So if you ask me there’s plenty of ways you can detect hormones that are spectacular but need about ten years of development let alone being able to manufacture it at scale. So it was important to me to find a technology that would allow us to do it effectively, repeatedly but also manufacture it at a low cost — so not reinventing the whole wheel.”
Rapti says Inne is controlling for variability within the testing course of by controlling when customers take the measurement (though that’s clearly indirectly inside its management, even when it might probably ship an in-app reminder); controlling how a lot saliva is extracted per check; and controlling how a lot of the pattern is examined — saying “that’s all done mechanically; you don’t do that”.
“The beauty about hormones is they do not get influenced by lack of sleep, they do not get influenced by getting out of your bed — and this is the reason why I wanted to opt to actually measure them,” she provides, saying she got here up with the thought for the product as a consumer of pure contraception looking for a greater expertise. (Rapti is just not herself skilled in medical or life sciences.)
“When I started the company I was using the temperature method [of natural contraception] and I thought it cannot be that I have to take this measurement from my bed otherwise my measurement’s invalid,” she provides.
However there are different forms of utilization restrictions Inne customers might want to observe with the intention to keep away from negatively affecting the hormonal measurements.
Firstly they have to take the check in the identical time window every time — both within the morning or the night however sticking to a kind of decisions for good.
They additionally want to stay to every day testing for at the least a full menstrual cycle. Plus there are particular days within the month when testing will at all times be important, per Rapti, whilst she suggests a “learning element” would possibly enable for the odd missed check day in a while, i.e. as soon as sufficient knowledge has been inputted.
Users additionally must keep away from ingesting and consuming for 30 minutes earlier than taking the check. She additional specifies this half hour pre-test restriction consists of not having oral intercourse — “because that also affects the measurements”.
“There’s a few indications around it,” she concedes, including: “The product is super easy to use but it is not for women who want to not think ever about contraception or their bodies. I believe that for these women the IUD would be the perfect solution because they never have to think about it. This product is for women who consciously do not want to take hormones and don’t want invasive devices — either because they’ve been in pain or they’re interested in being natural and not taking hormones.”
At this stage Inne hasn’t carried out any comparative research vs established contraception strategies such because the capsule. So until or till it does customers received’t be capable to assess the relative threat of falling pregnant whereas utilizing it in opposition to extra tried and examined contraception strategies.
Rapti says the plan is to run extra medical research within the coming yr, helped by the brand new funding. But these shall be extra centered on what further insights will be extracted from the check to feed the product proposition — moderately than on additional efficacy (or any comparative) checks.
They’ve additionally began the method of making use of for FDA certification to have the ability to enter the US market in future.
Beyond pure contraception and fertility monitoring, Inne is considering wider purposes for its method to hormone monitoring — akin to offering girls with details about the menopause, primarily based on long term monitoring of their hormone ranges. Or to assist handle situations akin to endometriosis, which is among the areas the place it needs to do additional analysis.
The intent is to be the other of binary, she suggests, by offering grownup girls with a flexible software to assist them get nearer to and perceive adjustments of their our bodies for a variety of particular person wants and functions.
“I want to shift the way people perceive our female bodies to be binary,” she provides. “Our bodies are not binary, they change around the month. So maybe this month you want to avoid getting pregnant and maybe next month you actually want to get pregnant. It’s the same body that you need to understand to help you do that.”
Commenting on the Series A in a supporting assertion, Louise Samet, associate at Blossom Capital, mentioned: “Inne has a winning combination of scientific validity plus usability that can enable women to better understand their bodies at all stages in their lives. What really impressed us is the team’s meticulous focus on design and easy-of-use together with the scientific validity and clear ambition to impact women all over the world.”