Tonal triples its physical stores with Nordstrom partnership

Tonal, maker of the smart home fitness trainer, announced it is more than tripling the number of physical locations it sells devices in through a new partnership with Nordstrom.

Starting this month, Tonal will have 50-square-foot stations in the women’s activewear departments of at least 40 Nordstrom locations across the U.S., bringing the total number of Tonal physical locations to 60 by the end of 2021. Shoppers will be able to walk in or book appointments to try Tonal devices and purchase them through employees on-hand.

“As we looked to expand our retail footprint and strategy, we looked to the retail landscape, and we really feel like Nordstrom says ‘best-in-class’ — the department store is well-suited to succeed in a COVID and post-COVID world,” explained Christopher Stadler, Tonal’s CMO.

Tonal, which manufactures a wall-mounted device with a digital weight system that emulates various traditional gym stations, already operates 16 locations across the country with devices shoppers can try and work out to, with plans to open four additional showrooms later this year. But the partnership with Nordstrom, which expects overall sales growth of 25% in 2021, marks a first-of-its-kind for at-home fitness makers. Peloton, for instance, operates a larger network of dedicated showrooms in the U.S., Canada, Germany and the UK, but it has yet to partner with an outside retailer to display and demo its bikes and treadmills.

An example of Tonal’s placement at a Nordstrom in Walnut Creek. Photo via Tonal.

Tonal’s physical expansion arrives amid a boom in demand for at-home equipment during the pandemic. According to Stadler, sales of Tonal equipment surged 800% from December 2019 to December 2020, causing 10-12 week wait times for deliveries. Those delays are somewhat comparable to Peloton, which has also faced significant delivery wait times in recent months and currently reports 6-10 week delays — an issue Peloton CEO John Foley acknowledged and apologized for in a note to users.

Tonal, for its part, is working to address shipment delays. According to Stadler, the startup has significantly ramped up production of devices, increased employee headcount, and in some cases, now air-ships equipment from Taiwan to the U.S. to meet demand.

“We have seen extraordinary demand for Tonal, and we’re working aggressively around the clock to produce, deliver and install Tonals faster and faster,” says Stadler. “We’ve absolutely ramped up production, and all facets of the organization are rallying to deliver our customer orders as quickly as we can.”


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Clue gets FDA clearance to launch a digital contraceptive

Clue, an early pioneer in the femtech category with a well-regarded period-tracking app that’s used by around 13 million people, is getting ready to launch a digital contraceptive which will offer users a statistical prediction of ovulation as a birth control tool.

A US launch of Clue Birth Control is slated for “this year”. The team won’t be more specific on the date yet.

Pricing will be “premium” — but they’re also keeping the exact cost under wraps for now.

The Berlin-based company is today announcing that they’ve gained FDA clearance for the forthcoming product, clearing the way for a US launch in 2021.

Europe is the next region on their launch list but the necessary regulatory clearances mean the roll out will be gradual, going market by market.

The startup has also recently made a number of operational changes — including to the leadership of the company — to reflect becoming a medical-device grade regulated entity in the US.

The short version is that founder and CEO, Ida Tin, has moved up to become chairwoman of the board, while Audrey Tsang (who was leading product) and Carrie Walter (formerly general counsel), are now Clue’s co-CEOs.

TechCrunch chatted to all three women — along with Clue’s chief medical officer, Lynae Brayboy — to get the lowdown on its latest news.

Clue Birth Control

Clue is not the first to market with an app offering a statistical prediction of fertility but unlike first mover, Natural Cycles — which gained FDA clearance back in 2018 — its product, Clue Birth Control, is being billed as “all-digital”; aka it will work without the user needing to take their temperature daily.

There’s also no need to track other bodily changes (such as monitoring cervical fluid). The method is based on women inputting a single data point regularly: The start date of their period.

This means it looks like a major step up in ‘ease of use’ vs the earlier-to-market rival — which Clue has achieved within similar efficacy margins (see below).

Clue’s algorithmic prediction is based on Bayesian modelling — with the app displaying a high risk window across a number of days of the user’s cycle, during which having unprotected intercourse could result in the woman getting pregnant. It shows a window of low risk when the opposite is true.

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The length of these windows is likely to change as the user inputs more data, with the risk-window starting out longer and typically shrinking as the app becomes more personalized to their individual cycle data.

“Bayesian modelling has been used in medicine for a lot of different applications. What that does is it takes population data and it puts that population data into an algorithm — which is a mathematical model — and [that] basically borrows from what has been found in the population in terms of cycling and ovulation,” explains Brayboy, who was appointed as Clue’s first ever chief medical officer last summer.

“Before we had a fertile window [i.e. displayed in the Clue period-tacking app to illustrate the stages of a cycle] — which is not a reliable, nor is it a tested, model of contraception. So now we’re using a bayesian modelling concept,” she says. “It personalizes over time. So as the individual puts in their cycle day one then we’re able to personalize the window of their high risk days vs their low risk days.

“[The high risk window] will start out long… Usually it’ll be 16 days within the cycle — but it’ll shorten over time. It probably won’t shorten to more than nine days.”

For the product to work as a contraception, users must either abstain from sex on high risk days or use additional protection (such as condoms). That’s why it’s a more involved method than some established birth control alternatives (especially vs an IUD; intrauterine device). On low risk days Clue users are relying on the app’s statistical prediction of their (low) fertility risk to not get pregnant.

Clue says the product has been shown to be 92% effective at preventing unwanted pregnancy under ‘typical use’ and 97% effective under ‘perfect use’ — referencing the standard research terminology for measuring contraception effectiveness (the latter meaning the product is used exactly as instructed every time the woman has sex vs ‘typical’ use which accounts for some usage slip-ups).

What those percentages mean in practice is that under typical use, eight couples out of 100 would be predicted to get pregnant over a year of use of Clue’s digital birth control. While — in the perfect use scenario — the failure rate would be three out of 100 over a year’s use.

(For comparison, Natural Cycles says its product is 93% effective under typical use and 98% effective under perfect use; while — per the Guttmacher Institute‘s US study — the pill is 93% effective under typical use and 99% effective under perfect use; and male condoms are 87% effective under typical use vs 98% effective under perfect use.)

Clue isn’t disclosing how many users it’s expecting to sign up — but the length of time it’s taken to bring the product to market suggests it’s confident Clue Birth Control will find a sustainable user base. (It’s been quietly working on the development since at least 2019 — but will only say the product has been “a long time” in the works when we ask.)

The extra time Clue’s taken to bring its digital contraceptive to market does look like time well spent. The statistical method underlying Clue Birth Control has, for example, undergone rigorous pre-market clinical testing — via a prospective effectiveness trial which reported results back in 2019.

“It’s been in development for a long time because work like this and proving the efficacy of something like this takes a long time,” says Tsang. “From a product perspective as well we want to make sure that these are experiences [that are] easy to understand and that matches the safety and efficacy of this type of product. So that as well.

“It takes a long time to make sure that we develop something that is also usability validated on that front and that we put that out with confidence and with an exact understanding of how well users will understand that.”

The ovulation prediction algorithm was put through a year-long, full-scale, representative (of the US population), independent clinical trial involving more than 700 women. This was conducted by researchers at the Institute for Reproductive Health (IRH) at Georgetown University in partnership with a third company, called Cycle Technologies — using a research app, called DOT (Dynamic Optimal Timing), for the purpose of the trial.

Clue says it acquired the assets of DOT — both the algorithm and the app — in summer 2019 and it’s that clinically validated technology which it’s implementing into its own app now, as Clue Birth Control.

“This was a ‘proper’, full scale clinical trial that was designed to be a clinical trial — rather than put a product out there, see if it works and collect the data,” says Walter. “This was done by academics. We then bought the algorithm and the app and we implemented the features of the app into Clue Birth Control which is a feature of Clue.”

“The clinical trial shows you both what the algorithm does and how the user interacts with the app. Because the algorithm is only part of the story — the main part is can a woman understand what’s going on, track and check and then act on the information,” she adds.

The FDA clearance process for Clue Birth Control involved scrutiny of the efficacy of the algorithm’s statistical predictions and also how Clue presents the information to users. So the whole package has been examined by the regulator. (To be clear the DOT app was not FDA cleared; rather Clue implemented that clinically tested algorithm in its own app and submitted the package for FDA clearance.)

“When you get FDA clearance as a medical device that is for a very specific product — you don’t then get to just take it away and tinker with it,” says Walter. “So I’m sure that there will be further iterations. This is iteration one of a new kind of birth control — but as of right now the thing that is going into our app is the thing that FDA saw and cleared. So the only piece… that we put significant creative work into was making sure that the usability interface is totally user tested and safe.”

Going forward, Clue’s business processes will be subject to ongoing regulatory scrutiny — a considerable switch for the startup that Tin describes as a “huge maturing process”.

“Another big part of the work that happened is to live and be a regulated company,” she tells TechCrunch. “That in itself is a very big change and a huge amount of work… So that’s another thing that has to happen. So one thing is what you put out in the market that users see but as a company you really have to operate in a completely new way — it’s a huge maturing process that we have gone through.”

“It feels like the baby can walk and talk and is actually more like a teenager and now it’s like leaving home — and I say you can do this!” she adds when asked what it feels like to see her femtech startup becoming FDA regulated.

Suitability

No method of contraception — except for abstinence — is 100% effective, of course. But just comparing the varying efficacy percentages of different contraception methods may not be super helpful given how personal birth control choices are.

A digital contraceptive certainly has a bunch of pros and cons that need to be considered. And Clue is being up front that its product is not suitable for everyone.

Top line: Clue says Clue Birth Control is only suitable for women, aged between 18-45, who have regular periods. (It also says: Users must also be able to track their period; check the app each day they have sex; and be prepared to use a condom or avoid sex that may result in pregnancy on high-risk days.)

Clearly there are various additional considerations beyond having a regular cycle that potential users should weigh up before signing up. Not least being comfortable with the stated degree of pregnancy risk.

That’s also true of all FABM (fertility awareness based methods) of birth control — including the old fashioned, non-digital/manual-tracking version (sometimes referred to as the rhythm or calendar method). But app-based products like Natural Cycles and Clue Birth Control are undoubtedly making FABM accessible to more women. Which means that communicating — and even enforcing — suitability is a key component of responsible product development in this category.

This is because the level of commitment and attention to detail required to act on changing fertility information makes FABM more complex than some birth control options. An IUD, for example, works without a woman needing to do anything once it’s been inserted. The pill is also more simplistic — in the sense that it only requires a woman to remember to take a tablet daily.

At the same time, it’s clear that hormonal contraception isn’t for everyone — or may not be accessible to everyone (Brayboy points to rising difficulty for US women specifically to access contraception as a relevant point here, for instance). And the convenience of an app-based form of personalised contraception has quickly convinced a new generation of women to try an alternative. (Natural Cycles’ reported some 1.5 million users worldwide last year.)

App-based convenience can invite missteps too, though. After its launch in Europe in 2017 Natural Cycles quickly attracted criticism over misleading and aggressive social media marketing. It was also investigated in Sweden after a hospital in its home market reported a number of unintended pregnancies from women who had been using the app. Although that probe confirmed the number of pregnancies was within the claimed margin of efficacy Natural Cycles agreed with the regulator to clarify the risk of its product failing.

So how digital birth control is presented is a vital consideration.

Clue doesn’t look like it’s taking any risks with how it communicates suitability for Clue Birth Control — prospective users have to go through an eligibility process which requires them to not just say they’re eligible but demonstrate eligibility by being able to provide key information, including about their own cycle.

If the user can’t show eligibility the app will “boot them out”, as Tsang puts it. She says they’ll also then be locked out for a period of time so they can’t just go back in and try different answers. While users whose cycle becomes too irregular for the product to work properly will similarly be prevented from continued use.

“There is a very detailed assessment process as soon as you try to sign up for Clue Birth Control,” she says. “It asks you a series of questions that really even in the questions themselves and how you answer — it’s like a question with a drop-down underneath it — even in how we’ve set those up it makes it so that users actually have to explicitly say that they are eligible. It’s not a true/false kind of situation. It’s ‘how are old are you’?… We ask these explicit questions so what that does is it actually draws the information out of the user in a way where we can be sure that they are actually eligible to use this feature as it is regulated to be used.”

“That process itself was scrutinized in detail by FDA,” adds Walter. “This is a device that you can use in the privacy of your phone — nobody else has to be involved in it — so it’s really important that that funnel is correct and so that is something that we talked about in a lot of detail.

“And one thing that you do need to be aware of is that you’re not going to be able to answer these questions unless you have some awareness of your cycle going in. Because you’ve got to know is your cycle typically this long or this long. What does your longest cycle look like? What’s your shortest cycle look like over the last 12 months?”

“The [FDA] clearance is related to the product as presented. The product — because it relies purely on one data input and statistical predictions — there’s obviously some level of… ‘irregularity’,” Walter adds. “If your periods are wildly unpredictable this isn’t going to work. What our science team says is… about 70-80% of currently cycling women fall within the bandwidth that could be covered by it.

“It’s 20-40 day cycles and 9 days or less of variation between them. So it’s not like you have to know to the day.”

“We know that it’s impossible to be perfect and so we make sure to tell people that typical use is 92% and so we don’t at all try to oversell ourselves. And that this is better than doing many things which are commonly done by users in the US,” says Brayboy.

“The pill and the IUD have very very defined risks,” she adds. “So we essentially explain that we are not as effective as those methods but our users potentially would have benefits because some of them cannot tolerate those methods for whatever reason.”

“Unfortunately a lot of people do rely on coitus interruptus and a lot of people do rely on condoms which are great but you have to use condoms every single time in order to be effective. And so those individuals might really benefit from having some idea of where they are in their cycle and it’s not only some idea — it’s a rigorously looked at algorithm that they can use in the privacy of their home,” Brayboy goes on.

“It’s really getting difficult… for a lot of American women to actually access birth control. One because of job loss; two because of a recent supreme court ruling in 2020 about opting out of contraceptive coverage. And so this is something they can do in collaboration with their healthcare providers but they don’t have to go out to a pharmacy and hopefully people will see that it’s easy to use. It really is easy to use. You never [don’t] leave your phone at home so you can’t lose this contraception.”

Another major consideration for users of digital contraception is that unprotected sex offers no protection against STDs (sexually transmitted diseases) — rates of which have been increasing in the US in recent years.

Clue therefore recommends its product for women who are in stable relationships — and/or are getting regularly screened, along with their partner/s — i.e. rather than for those who don’t know the sexual history of the people they’re sleeping with.

“It was sort of a premise from the beginning that we only want people to use this product for whom it’s really truly a good product,” says Tin. “It’s like we’re building this product because we think many people will benefit from it and we’ve seen many people needing it and so that’s the core. We want to be helpful. We don’t want people to use it for whom it’s not a good solution. And that’s how we’ve built it.”

Asked who the ‘perfect/ideal’ user for Clue Birth Control, Brayboy puts it like this: “This is someone who — as I envisage as a physician — potentially wants to get pregnant in the next couple of years but is not ready and does not want to use hormonal birth control for whatever reason and is already using condoms.

“So this is someone who wants to not get pregnant just now but is preparing, is planning — and they don’t want something that’s long acting.”

She also points out that many of the most effective methods of contraception (“like the levonorgestrel IUD or the Mirena”, which are ~99.9%) have draw-backs too — in that they have to be placed and removed from the woman’s uterus. They may also, she suggests, have a long term effect on the endometrium.

“So [Clue Birth Control] is something where if you decide okay in the next few years you want to get pregnant you absolutely can stop [following the regime] and you can get pregnant. And you also have a better idea of your cycles at the same time — so it gives you that added benefit,” she adds. “Again, our indication’s 18-45 but a lot of people who are in their late 20s and 30s would be ideal candidates for this.”

Tin also points to the “staggering amount of unwanted pregnancies” in the US and around the world — noting that many women currently still don’t use any birth control, for whatever reason. So an app-based fertility prediction might be an alternative that works for them.

Brayboy notes that unintended pregnancy in the US is about 45% but can be as high as 69% in some ethnic groups, per figures from the American College of OBGYN.

“Unintended pregnancy is also hard to study because people don’t typically plan to become pregnant — and so it makes it difficult. But this [app-based FABM] is a way — also people could really think about how do I want to plan my family in the next couple of years? And so it really is a lovely way for people to start really thinking about becoming parents.”

The marketing for Clue Birth Control will reflect that it’s a “serious choice” people are making to opt for a digital birth control, per Tsang.

“We make sure that people understand that no form of birth control is 100% effective. And that this is a choice — and this is a serious choice that they make,” she says. “In our marketing we plan to help people make that choice — make a choice that’s right for them. And be transparent about the risks and how it works and what it means.”

“I would say that we don’t have huge plans to do social media and influencer marketing,” she adds. “But again we do have these standard operating procedures that make sure that we both speak about the labelling, we speak about our product in a way that reflects exactly what it is.”

Retooling to be regulated

The aforementioned changes to Clue’s leadership team are coupled with a wider retooling of its internal processes — reflective of its new status as a regulated company.

“Something that a lot of people aren’t aware of is that to be allowed to have a medical device on the market you have to operate a quality management system that covers your entire company. And as you know if you cover tech startups that’s not how tech startups tend to work!” says Walter. 

“Which is why it’s incredibly important if you’re going to use an app to make important life decisions about your health you want to make sure they’re building their product in a quality controlled way. And of course any app that you find out there on the market that is not a regulated medical device pretty much 100% will not be working in this way. And so one of the things that we had to do — and that we will be audited for once we have the product in the market — is to show that all of our processes, from design over software development, testing, user testing, all of these things are quality controlled every step of the way. So that’s the big change that we’ve gone through in the last two years.”

“It’s a really big change,” adds Tin. “And for us it’s been important to get the team along in a really good way — not lose who we are. We think of it as acquiring a new ninja skill — something new that we’re learning to do that we’re adding to who we are — so that we can still be user focused and maintain all the qualities that we care about and always have cared about but now doing it sort of at a higher level under this quality management system.

“I think it’s very well aligned with who we are because essentially a quality management system’s about quality and risk and care, essentially, for users — and we feel a lot of responsibility putting out a product that help people navigate really big, important things, like getting pregnant, not getting pregnant, so we feel good about making sure that our processes match that level of responsibility. So in that way it’s been easy to get the team along but I will say it’s been a huge amount of work.

“I don’t know how many thousands of pages of technical documentation that we have submitted etc. It’s really like a huge rehaul. So the fact that we can maintain still feeling like Clue while operating in a very new way I’m pretty happy about. Because we could also become very boring — big, corporate-ish — but that isn’t who we are and that’s important because of course we want to keep caring about users.”

For all the extra paperwork, Tsang says Clue’s mission as a company hasn’t — and isn’t — changing.

“It’s just very value-aligned. We’re here to put something out that’s high quality and where we have a clear procedure and clear processes for evaluating risk and mitigating risk. And that’s all completely values aligned with being a femtech company that empowers women to make healthy choices,” she says.

“Nobody is going to go out there and say well we play fast and loose with people’s health. Nobody wants to do that but it helps to have a third party watch you — and that’s what it means to be a regulated company. It means that there are democratically accountable government institutions looking over your shoulder and checking,” adds Walter.

“And I think if you’re looking at some of the criticism that femtech has come into recently — legitimately — because there are all kinds of apps out there that are completely unregulated, no one knows where they’re coming from, no one knows what their business models are, no one knows what they’re really doing. And this is a strong move in the opposite direction.

“We take the constraints that flow from that seriously… As Ida says we’re going to try not to lose our fun in the process.”

The team does also see wider opportunities flowing from being a regulated entity.

“I think this broadens our mission too,” says Brayboy. “Period tracking is really important in overall health but I think this allows individuals to use FABM in a modern way — and FABM itself can help individuals take in things in their cycles that might actually affect their fertility long term and also some diagnosis that might be important to speak with their physician about early, so they present to care early. So we hope to have that partnership with users and their healthcare providers.”

“We don’t have plans to do [comparative studies with other types of contraception] but what I’d like to say is that we have a post-market surveillance plan and we’ll be doing studies with collaborators — we’ve already started to collaborate with academia before Clue Birth Control came out so it’s something that we’ll continue to do,” she also says. “What we’ll be doing in future is we’ll be going to clinical meetings, and presenting and allowing people to collaborate with us. And I think that’s really important that our doors are open for physician scientists and scientists and contraceptive researchers to continue to look at us. And we want to do that because we’re all about science — we’re based on science. And I came to Clue because of that mission.”

“For us it’s also an ability to keep doing more and more advanced things with the data, if you like,” adds Tin. “Which of course is important because people have many needs that if you are to answer them it has to be regulated. It’s right that they’re regulated. Now we learn how to operate as a regulated company — we are operating as a regulated company — that gives us an ability to keep meeting these needs that are deeper.”

Walter also emphasizes the competitive advantage of being a consumer app that’s subject to regulatory surveillance as a medical device — in a sea of unregulated apps.

“A really important thing is that if you look at your average health and fitness app or whatever, their main KPI is let’s get a tonne of users through the door and make money off them. And I’m not going to say we don’t want a tonne of users through the door and to be profitable — we do want that. But because we are regulated we also have this post-market surveillance obligation that we will be audited on. That’s a KPI now. That’s not a nice to have. And I think that’s a big difference. And that’s something that consumers should think about when they’re using an app — like what KPIs are those people working to.

“And you might want to ask yourself what other apps is that developer putting out? Do they have 15 gaming apps and one period tracker? And what’s their business model?”

“And who’s leading the company,” Brayboy chips in. “Look around this Zoom room you can see that we have all potentially had periods and continue to have them and so have had to make these decisions and so I think it puts us in a very unique position because we have a level of empathy and understanding that really comes from a personal space.

“And I wanted to say on the global health [potential] — I’m really excited about that. And that’s another of the reasons why I joined the company because I started my career in the Republic of Mali in West Africa and I saw how difficult it was for individuals to get contraception and a lot of things that are culturally pushed to people in those areas. And so this to me really represents an exciting prospect… I think there’s just limitless possibilities in other countries — we haven’t really thought about the cultural practices and the tendencies that people want to use something that is hormone free.”

Asked about the new co-CEO structure, Tin says it’s a natural continuation of the collaborative leadership style she encouraged at Clue.

“The big two things that Clue is going to care about is being a regulated company and building a sustainable business and I could’t think of two better people than Carrie and Audrey to mind these two parts of the business… We have had a very collaborative leadership style at Clue, always, because that’s how I like doing things — and it feels again also like an upgrade. Now two people get to do this in a pair and I think that’s a really great reflection of what I think is the future of leadership. So on that level it’s also an expression of who we are to choose to have co-CEOs.”

“We’re new at this but it’s been really fun the last couple of weeks but at the heart of it are these values of being disciplined about being transparent,” adds Tsang. “Being collaborative and being equal. And it allows us to hold each other accountable for all of those things which are at at the heart of Clue’s values. So I completely agree with Ida — I’d love to see more leadership look like this moving forward and I personally have been enjoying it quite a bit.”

“Who needs another ‘hero CEO’,” adds Walter. “My starting point was that every conversation I have is actually better when Audrey’s in it — so let’s make my head conversations that way. Let’s upgrade the thinking process to a dialogue. And I think once you accept that most decisions are better made in some form of collaboration — let’s get real, right; we’re not that much of a genius that all of us don’t ever need to talk to other people — so once we accept that then the only question is how do you collaborate?

“As Ida said, we’ve always had a pretty collaborative management team but actually we found that — it’s like in the arts. Where are the most productive, most creative collaborations — they’re in really tight micro teams. And so let’s put that at the heart. And of course there’s a management team and of course there are other expertise and having Lynae in the company is wonderful and having the science component, and data science component, and all of this expertise, but I really like this generative heart of two. This dialogue as being the decision making process. There’s no reason to me why that wouldn’t make us more bold and more thoughtful.”

“I want to second this and maybe it’s also worth saying that I founded Clue together with a bunch of great guys — one of them my life partner, and in a way we have, for many years, also been a very closed pair,” adds Tin. “And working on understanding equality and living from that place and now it’s, in a way, just an even more clear part of the structure. It’s like a good next step on something we’ve been learning about — basically since the beginning of Clue.”

 

Foresite Capital raises $969 million fund to invest in healthcare startups across all stages of growth

Health and life science specialist investment firm Foresite Capital has raised a new fund, its fifth to date, totally $969 million in commitments from LPs. This is the firm’s largest fund to date, and was oversubscribed relative to its original target according to fund CEO and founder Dr. Jim Tananbaum, who told me that while the fundraising process started out slow in the early months of the pandemic, it gained steam quickly starting around last fall and ultimately exceeded expectations.

This latest fund actually makes up two separate investment vehicles, Foresite Capital Fund V, and Foresite Capital Opportunity Fund V, but Tananbaum says that the money will be used to fuel investments in line with its existing approach, which includes companies ranging from early- to late-stage, and everything in between. Foresite’s approach is designed to help it be uniquely positioned to shepherd companies from founding (they also have a company-building incubator) all the way to public market exit – and even beyond. Tananbaum said that they’re also very interested in coming in later to startups they have have missed out on at earlier stages of their growth, however.

Image Credits: Foresite Capital

“We can also come into a later situation that’s competitive with a number of hedge funds, and bring something unique to the table, because we have all these value added resources that we used to start companies,” Tananbaum said. “So we have a competitive advantage for later stage deals, and we have a competitive advantage for early stage deals, by virtue of being able to function at a high level in the capital markets.”

Foresite’s other advantage, according to Tananbaum, is that it has long focused on the intersection of traditional tech business mechanics and biotech. That approach has especially paid off in recent years, he says, since the gap between the two continues to narrow.

“We’ve just had this enormous believe that technology, and tools and data science, machine learning, biotechnology, biology, and genetics – they are going to come together,” he told me. “There hasn’t been an organization out there that really speaks both languages well for entrepreneurs, and knows how to bring that diverse set of people together. So that’s what we specialized i,n and we have a lot of resources and a lot of cross-lingual resources, so that techies that can talk to biotechies, and biotechies can talk to techies.”

Foresite extended this approach to company formation with the creation of Foresite Labs, an incubation platform that it spun up in October 2019 to leverage this experience at the earliest possible stage of startup founding. It’s run by Dr. Vik Bajaj, who was previously co-founder and Chief Science Officer of Alphabet’s Verily health sciences enterprise.

“What’s going on, or last couple decades, is that the innovation cycles are getting faster and faster,” Tananbaum said. “So and then at some point, the people that are having the really big wins on the public side are saying, ‘Well, these really big wins are being driven by innovation, and by quality science, so let’s go a little bit more upstream on the quality science.'”

That has combined with shorter and shorter healthcare product development cycles, he added, aided by general improvements in technology. Tananbaum pointed out that when he began Foresite in 2011, even, the time horizons for returns on healthcare investments were significantly longer, and at the outside edge of the tolerances of venture economics. Now, however, they’re much closer to those found in the general tech startup ecosystem, even in the case of fundamental scientific breakthroughs.

CAMBRIDGE – DECEMBER 1: Stephanie Chandler, Relay Therapeutics Office Manager, demonstrates how she and her fellow co-workers at the company administer their own COVID tests inside the COVID testing room at Relay Therapeutics in Cambridge, MA on Dec. 1, 2021. The cancer treatment development company converted its coat room into a room where employees get tested once a week. All 100+employees have been back in the office as a result of regular testing. Relay is a Foresite portfolio company. (Photo by Jessica Rinaldi/The Boston Globe via Getty Images)

“Basically, you’re seeing people now really look at biotech in general, in the same kind of way that you would look at a tech company,” he said. “There are these tech metrics that now also apply in biotech, about adoption velocity, other other things that may not exactly equate to immediate revenue, but give you all the core material that usually works over time.”

Overall, Foresite’s investment thesis focuses on funding companies in three areas – therapeutics at the clinical stage, infrastructure focused on automation and data generation, and what Tananbaum calls “individualized care.” All three are part of a continuum in the tech-enabled healthcare end state that he envisions, ultimately resulting “a world where we’re able to, at the individual level, help someone understand what their predispositions are to disease development.” That, Tananbaum suggests, will result in a transformation of this kind of targeted care into an everyday consumer experience – in the same way tech in general has taken previously specialist functions and abilities, and made them generally available to the public at large.

Eat this, not that, exercise now; new personalized software predicts and helps prevents blood sugar spikes

Not everyone has Type 2 diabetes, the disease that causes chronically high blood sugar levels, but many do. Around 9% of Americans are afflicted, and another 30% are at risk of developing it.

Enter software by January AI, a four-year-old, subscription-based startup that in November began providing personalized nutritional and activity-related suggestions to its customers based on a combination of food-related data the company has spent the last three years painstakingly amassing, as well as each person’s unique profile, which it gleans based on how an individual reacts to certain foods over the first four days of using the software.

Why the need for personalization? Because believe it or not, people can react very differently to every single food, from rice to salad dressing.

The tech may sound mundane but it’s eye-opening, promises cofounder and CEO Nosheen Hashemi and her cofounder, Michael Snyder, a genetics professor at Stanford who has focused on diabetes and pre-diabetes for years.

Investors apparently agree, too. Felicis Ventures just led a $21 million Series A investment in the company, joined by HAND Capital and Salesforce founder Marc Benioff. (Earlier investors include Ame Cloud Ventures, SignalFire, YouTube cofounder Steve Chen, and Sunshine cofounder Marissa Mayer, among others.) Says Felicis founder Aydin Senkut, “While other companies have made headway in understanding biometric sensor data—from heart rate and glucose monitors, for example—January AI has made progress in analyzing and predicting the effects of food consumption itself [which is] key to addressing chronic disease.”

We talked with Hashemi and Snyder this afternoon to learn more. Below is part of our chat, edited for length and clarity.

TC: What have you built?

NH: We’ve built a multiomic platform where we take data from different sources and predict people’s glycemic response, allowing them to consider their choices before they make them. We pull in data from heart rate monitors and continuous glucose monitors and a 1,000-person clinical study and an atlas of 16 million foods for which, using machine learning, we have derived nutritional values and created nutritional labeling [that didn’t exist previously].

[The idea is to] predict for [customers] what their glycemic response is going to be to any food in our database after just four days of training. They don’t actually have to eat the food to know whether they should eat it or not; our product tells them what their response is going to be.

TC: So glucose monitoring existed previously, but this is predictive. Why is this important?

NH: We want to bring the joy back to eating and remove the guilt. We can predict, for example, how long you’d have to walk after eating any food in our database in order to keep your blood sugar at the right level. Knowing what “is” isn’t enough; we want to tell you what to do about it. If you’re thinking about fried chicken and a shake, we can tell you: you’re going to have to walk 46 minutes afterward to maintain a healthy [blood sugar] range. Would you like to do the uptime for that? No? Then maybe [eat the chicken and shake] on a Saturday.

TC: This is subscription software that works with other wearables and that costs $488 for three months.

NH: That’s retail price, but we have an introductory offer of $288.

TC: Are you at all concerned that people will use the product, get a sense of what they could be doing differently, then end their subscription?

NH: No. Pregnancy changes [one’s profile], age changes it. People travel and they aren’t always eating the same things. . .

MS: I’ve been wearing [continuous glucose monitoring] wearables for seven years and I still learn stuff. You suddenly realize that every time you eat white rice, you spike through the roof, for example. That’s true for many people. But we are also offering a year-long subscription soon because we do know that people slip sometimes [only to be reminded] later that these boosters are very valuable.

TC: How does it work practically? Say I’m at a restaurant and I’m in the mood for pizza but I don’t know which one to order.

NH: You can compare curve over curve to see which is healthier. You can see how much you’ll have to walk [depending on the toppings].

TC: Do I need to speak all of these toppings into my smart phone?

NH: January scans barcodes, it also understands photos. It also has manual entry, and it takes voice [commands].

TC: Are you doing anything else with this massive food database that you’ve aggregated and that you’re enriching with your own data? 

NH: We will definitely not sell personal information.

TC: Not even aggregated data? Because it does sound like a useful database . . .

MS: We’re not 23andMe; that’s really not the goal.

TC: You mentioned that rice can cause someone’s blood sugar to soar, which is surprising. What are some of the things that might surprise people about what your software can show them? 

NH: The way people’s glycemic response is so different, not just between by Connie and Mike, but also for Connie and Connie. If you eat nine days in a row, your glycemic response could be different each of those nine days because of how much you slept or how much thinking you did the day before or how much fiber was in your body and whether you ate before bedtime.

Activity before eating and activity after eating is important. Fiber is important. It’s the most under overlooked intervention in the American diet. Our ancestral diets featured 150 grams of fiber a day; the average American diet today includes 15 grams of fiber. A lot of health issues can be traced to a lack of fiber.

TC: It seems like coaching would be helpful in concert with your app. Is there a coaching component?

NH: We don’t offer a coaching component today, but we’re in talks with several coaching solutions as we speak, to be the AI partner to them.

TC: Who else are you partnering with? Healthcare companies? Employers that can offer this as a benefit?

NH: We are selling to direct to consumers, but we’ve already had a pharma customer for two years. Pharma companies are very interested in working with us because we are able to use lifestyle as a biomarker. We essentially give them [anonymized] visibility into someone’s lifestyle for a period of two weeks or however long they want to run the program for so they can gain insights as to whether the therapeutic is working because of the person’s lifestyle or in spite of a person’s lifestyle. Pharma companies are very interested in working with us because they can potentially get answers in a trial phase faster and even reduce the number of subjects they need.

So we’re excited about pharma. We are also very interested in working with employers, with coaching solutions, and ultimately, with payers [like insurance companies].

Pfizer-BioNTech’s COVID-19 vaccine just got a lot easier to transport and distribute

The COVID-19 vaccine developed by Pfizer and BioNTech now has less stringent and extreme transportation requirements than it debuted with. Originally, the mRNA-based vaccine had to be maintained at ultra-low temperatures throughout the transportation chain in order to remain viable – between -76°F and -112°F. New stability data collected by Pfizer and BioNTech, which has been submitted to the U.S. Food and Drug Administration (FDA) for review, allow it to be stored at temps between 5°F and -13°F – ranges available in standard medical freezers found in most clinics and care facilities.

The vaccine should remain stable for up to two weeks at that temperature, which vastly improves the flexibility of its options for transportation, and last-mile storage in preparation for administration to patients. To date, the vaccine has relied largely on existing “cold-chain” infrastructure to be in place in order for it to be able to reach the areas where it’s being used to inoculate patients. That limitation hasn’t been in place for Moderna’s vaccine, which is stable at even higher, standard refrigerator temperatures for up to a month.

This development is just one example of how work continues on the vaccines that are already being deployed under emergency approvals by health regulators across the U.S. and elsewhere in the world. Pfizer and BioNTech say they’re working on bringing those storage temp requirements down even further, so they could potentially approach the standard set by the Moderna jab.

Taken together with another fresh development, study results from Israeli researchers that found just one shot of the ordinarily two-shot Pfizer-BioNTech vaccine could be as high as 85 percent effective on its own, this is a major development for global inoculation programs. The new requirements open up participation to a whole host of potential new players in supporting delivery and distribution – including ride-hailing and on-demand delivery players with large networks like Amazon, which has offered the President Biden’s administration its support, and Uber, which is already teamed up with Moderna on vaccine education programs.

This also opens the door for participation from a range of startups and smaller companies in both the logistics and the care delivery space that don’t have the scale or the specialized equipment to be able to offer extreme ‘cold-chain’ storage. Technical barriers have been a blocker for some who have been looking for ways to assist, but lacked the necessary hardware and expertise to do so effectively.

Toronto’s UHN launches a study to see if Apple Watch can spot worsening heart failure

A new study underway at Toronto’s University Health Network (UHN), a group of working research hospitals in the city, could shift our approach to treatment in an area of growing concern in human health. The study, led by Dr. Heather Ross, will investigate whether the Apple Watch can provide early warnings about potentially worsening health for patients following incidents of heart failure.

The study, which is aiming to eventually span around 200 patients, and which already has a number of participants enrolled spanning ages from 25 to 90, and various demographics, will use the Apple Watch Series 6 and its onboard sensors to monitor signals including heart rate, blood oxygen, general activity levels, overall performance during a six minute walk test and more. Researchers led by Ross will compare this data to measurements taken from the more formal clinical tests currently used by physicians to monitor the recovery of heart failure patients during routine, periodic check-ups.

The hope is that Ross and her team will be able to identify correlations between signs they’re seeing from the Apple Watch data, and the information gathered from the proven medical diagnostic and monitoring equipment. If they can verify that the Apple Watch accurately reflects what’s happening with a heart failure patient’s health, it has tremendous potential for treatment and care.

“In the US, there are about six-and-a-half million adults with heart failure,” Ross told me in an interview. “About one in five people in North America over the age of 40 will develop heart failure. And the average life expectancy [following heart failure] is still measured at around 2.1 years, at a tremendous impact to quality of life.”

The stats point to heart failure as a “growing epidemic,” says Ross, at a cost of some “$30 billion a year at present in the U.S.” to the healthcare system. A significant portion of that cost can come from the care required when conditions worsen due to preventable causes – ones that can be avoided by changes in patient behavior, if only implemented at the right time. Ross told me that currently, the paradigm of care for heat failure patients is “episodic” – meaning it happens in three- or six-month intervals, when patients go into a physician’s office or clinic for a bevy of tests using expensive equipment that must be monitored by a trained professional, like a nurse practitioner.

“If you think about the paradigm to a certain degree, we’ve kind of got it backwards,” Ross said. “So in our thinking, the idea really is how do we provide a continuous style monitoring of patients in a relatively unobtrusive way that will allow us to detect a change in a patient status before they end up actually coming into hospital. So this is where the opportunity with Apple is tremendous.”

Ross said that current estimates suggest nearly 50% of hospitalizations could be avoided altogether through steps taken by patients including better self-care, like adhering to prescribed medicinal regimens, accurate symptom monitoring, monitoring dietary intake and more. Apple Vice President of Health Dr. Sumbul Desai echoed the sentiment that proactivity is one of the key ingredients to better standards of care, and better long-term outcomes.

“A lot of health, in the world of medicine, has been focused on reactive responses to situations,” she said in an interview. “The idea to get a little more proactive in the way we think about our own health is really empowering and we’re really excited about where that could take us. We think starting with these studies to really ground us in the science is critical but, really, the potential for it is something that we look forward to tackling.”

Desai, has led Apple’s Health initiatives for just under four years, and also spent much of her career prior to that at Stanford (where she remains an associate professor) working on both the academic and clinical side. She knows first-hand the value of continuous care, and said that this study is representative of the potential the company sees in Apple Watch’s role in the daily health of individuals.

“The ability to have that snapshot of an individual as they’re living their everyday life is extremely useful,” she said. “As a physician, part of your conversation is ‘tell me what’s going on when you’re not in the clinic.’ To be able to have some of that data at your fingertips and have that part of your conversation really enhances your engagement with your patients as well. We believe that can provide insight in ways that has not been done before and we’re really excited to see what more we’re learning in this specific realm but we already hearing from both users and physicians how valuable that is.”

Both Ross and Desai highlighted the value of Apple Watch as a consumer-friendly device that’s easy to set up and learn, and that serves a number of different purposes beyond health and fitness, as being key ingredients to its potential in a continuous care paradigm.

“We really believe that people should be able to play a more active role in managing their well-being and Apple Watch in particular, we find to be — and are really proud of — a powerful health and wellness tool because the same device that you can connect with loved ones and check messages also supports safety, motivates you to stay healthy by moving more and provides important information on your overall wellness,” Desai said.

“This is a powerful health care tool bundled into a device that people just love for all the reasons Sumbul has said,” Ross added. “But this is a powerful diagnostic tool, too. So it is that consumer platform that I think will make this potentially an unstoppable tool, if we can evaluate it properly, which we’re doing in this partnership.”

The study, which is targeting 200 participants as mentioned, and enrolling more every day, will span three months of active monitoring, followed by a two-year follow up to investigate the data collected relative to patient outcomes. All data collected is stored in a fully encrypted form (Ross pointed to Apple’s privacy track record as another benefit of having it as a partner) and anyone taking part can opt-out at any point during the course of the research.

Even once the results are in, it’ll just be the first step in a larger process of validation, but Ross said that the hope is to ultimately “to improve access and equitable care,” by changing the fundamental approach to how we think about heart failure and treatment.

Jamaica’s immigration website exposed thousands of travelers’ data

A security lapse by a Jamaican government contractor has exposed immigration records and COVID-19 test results for hundreds of thousands of travelers who visited the island over the past year.

The Jamaican government contracted Amber Group to build the JamCOVID19 website and app, which the government uses to publish daily coronavirus figures and allows residents to self-report their symptoms. The contractor also built the website to pre-approve travel applications to visit the island during the pandemic, a process that requires travelers to upload a negative COVID-19 test result before they board their flight if they come from high-risk countries, including the United States.

But a cloud storage server storing those uploaded documents was left unprotected and without a password, and was publicly spilling out files onto the open web.

Many of the victims whose information was found on the exposed server are Americans.

The data is now secure after TechCrunch contacted Amber Group’s chief executive Dushyant Savadia, who did not comment when reached prior to publication.

The storage server, hosted on Amazon Web Services, was set to public. It’s not known for how long the data was unprotected, but contained more than 70,000 negative COVID-19 lab results, over 425,000 immigration documents authorizing travel to the island — which included the traveler’s name, date of birth and passport numbers — and over 250,000 quarantine orders dating back to June 2020, when Jamaica reopened its borders to visitors after the pandemic’s first wave. The server also contained more than 440,000 images of travelers’ signatures.

Two U.S. travelers whose lab results were among the exposed data told TechCrunch that they uploaded their COVID-19 results through the Visit Jamaica website before their travel. Once lab results are processed, travelers receive a travel authorization that they must present before boarding their flight.

Both of these documents, as well as quarantine orders that require visitors to shelter in place and several passports, were on the exposed storage server.

Travelers who are staying outside Jamaica’s so-called “resilient corridor,” a zone that covers a large portion of the island’s population, are told to install the app built by Amber Group that tracks their location and is tracked by the Ministry of Health to ensure visitors stay within the corridor. The app also requires that travelers record short “check-in” videos with a daily code sent by the government, along with their name and any symptoms.

The server exposed more than 1.1 million of those daily updating check-in videos.

An airport information flyer given to travelers arriving in Jamaica. Travelers may be required to install the JamCOVID19 app to allow the government to monitor their location and to require video check-ins. (Image: Jamaican government)

The server also contained dozens of daily timestamped spreadsheets named “PICA,” likely for the Jamaican passport, immigration and citizenship agency, but these were restricted by access permissions. But the permissions on the storage server were set so that anyone had full control of the files inside, such as allowing them to be downloaded or deleted altogether. (TechCrunch did neither, as doing so would be unlawful.)

Stephen Davidson, a spokesperson for the Jamaican Ministry of Health, did not comment when reached, or say if the government planned to inform travelers of the security lapse.

Savadia founded Amber Group in 2015 and soon launched its vehicle-tracking system, Amber Connect.

According to one report, Amber’s Savadia said the company developed JamCOVID19 “within three days” and made it available to the Jamaican government in large part for free. The contractor is billing other countries, including Grenada and the British Virgin Islands, for similar implementations, and is said to be looking for other government customers outside the Caribbean.

Savadia would not say what measures his company put in place to protect the data of paying governments.

Jamaica has recorded at least 19,300 coronavirus cases on the island to date, and more than 370 deaths.


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Certific, a health tech startup from the founder of TransferWise, aims to be the rails for certified home testing

Certific, a health tech startup co-founded by TransferWise’s Taavet Hinrikus, is breaking cover today with the launch of what it claims is the first “certified” remote COVID-19 testing service.

The British-Estonian company is using techniques borrowed from the worlds of fintech and telemedicine, including asking users to film themselves while taking the at-home test, in a bold attempt to solve remote testing’s adherence and trust problem.

Initially targeting private individuals and businesses in the U.K., with other markets to follow, tests can be ordered online and are carried out remotely with the promise of a certified result the following day for PCR tests and in under 90 minutes for antigen tests.

More broadly, the Certific app and user journey is designed to increase trust in remote testing and ensure that self-performed tests reach the same standard as those carried out in a clinical setting.

“When the pandemic hit, we started toying around with the first finger prick tests to see if you have antibodies, and thinking, ‘hey, is there a way to make use of these to help the world along,’ ” Hinrikus told me during an interview earlier this week. “[But] then it turned out that these kind of antibody tests, and the end immunity, was a very unclear concept. And so we kind of put it on hold, but we kept on thinking about what better things we can do to make testing more trustworthy and easier”.

Then late last year he and Certific’s other co-founders — physician Dr. Jack Kreindler and CEO Liis Narusk — realised that there were things “that we can and should be doing to come up with a more democratised way of medical testing, and apply this to the pandemic”.

Hinrikus doesn’t quite say it, but as the founder of TransferWise and a prolific angel investor, including backing Estonian verification platform Veriff, there’s little doubt that Certific is partly inspired by the authentication techniques that have gained prominence in fintech, such as video selfies used to onboard new customers at digital banks. In addition, medical director Kreindler has experience with anti-doping in close-combat sports.

Coupled with more traditional identity checks, the Certific app asks you to film yourself while you take the test. The recording and test result is securely uploaded to Certific and checked by a qualified physician to ensure you have adhered to the manufacturer’s instructions properly. A medical certification containing the test result is then delivered back to the app. PCR tests cost £64, and the soon to be available rapid antigen tests will be sold in 12-packs for £249 (making the price of a single antigen test £20.75).

But how easy would it be to cheat the test and therefore fake a result? “That’s one thing we definitely are very, very focused on solving,” says Certific CEO Narusk. “Our experience in all the anti-fraud and anti-cheat areas means that we went far and beyond to make sure that you can’t actually tamper with the process. So when you record the video, and after you have recorded the video, it is checked by our test verification officers who make sure that you haven’t moved the tests away from the screen”.

In addition, Certific ensures that the test you have used is actually the test that you ordered and contains the same unique ID, and that you are the person who was supposed to do the test.

That in itself isn’t entirely fraud proof, and Hinrikus clarifies that Certific is initially focusing on ensuring that a test is carried out medically correctly. He says that a higher-priced tier will be offered at a later stage with enhanced video verification, such as a live operator acting as a witness.

This could be particularly useful for businesses, such as live events or travel, where there could be incentives for individuals to cheat and where operators may be required to prove to insurance companies or government authorities that they are COVID-19 safe.

Kreindler, Certific’s medical director, contrasts this with key workers that are currently permitted by U.K. authorities to carry out coronavirus home-testing without any additional verification, but who aren’t nearly as likely to want to fake a result.

“If you think about it, those public servants are not at a great disadvantage if they test positive, because they still get paid. So there’s less of an incentive to cheat. And the challenge comes where you are doing point of care testing in an environment where there actually is some incentive or a big disadvantage [to testing positive]”.

Kreindler also says it’s not just about individuals and that Certific has worked with academics in Estonia, North America and in the U.K. to develop a computational risk model for mass testing for “super spreader” environments, such as large events. People will not only be able to take a test at home before attending, but a risk model that continually learns and takes into account “democratised decentralised testing” and an understanding of vaccination and immunity, could enable further mitigations to be put in place to make sure there’s no net spread of the virus back into the community. “That’s very core to our thinking going forward,” he says. “It’s not just about certifying testing, it’s also about certifying crowds”.

Zooming out even further — and beyond the current coronavirus pandemic — Certific has been built to be entirely test agnostic. Combining speed, convenience, adherence and trust, the company aims to be the rails on which existing and future home tests can run (my words, not theirs). In the future, this could span testing for sexually transmitted diseases (SDIs) to anti-doping tests in sports. And, of course, new types of COVID-19 tests as they come on stream.

Notable Health seeks to improve COVID-19 vaccine administration through intelligent automation

Efficient and cost-effective vaccine distribution remains one of the biggest challenges of 2021, so it’s no surprise that startup Notable Health wants to use their automation platform to help. Initially started to help address the nearly $250 billion annual administrative costs in healthcare, Notable Health launched in 2017 to use automation to replace time-consuming and repetitive simple tasks in health industry admin. In early January of this year, they announced plans to use that technology as a way to help manage vaccine distribution.

“As a physician, I saw firsthand that with any patient encounter, there are 90 steps or touchpoints that need to occur,” said Notable Health medical director Muthu Alagappan in an interview. “It’s our hypothesis that the vast majority of those points can be automated.”

Notable Health’s core technology is a platform that uses robotic process automation (RPA), natural language processing (NLP), and machine learning to find eligible patients for the COVID-19 vaccine. Combined with data provided by hospital systems’ electronic health records, the platform helps those qualified to receive the vaccine set up appointments and guides them to other relevant educational resources.

“By leveraging intelligent automation to identify, outreach, educate and triage patients, health systems can develop efficient and equitable vaccine distribution workflows,” said Notable Health strategic advisor and Biden Transition COVID-19 Advisory Board Member Dr. Ezekiel Emanuel, in a press release.

Making vaccine appointments has been especially difficult for older Americans, many of whom have reportedly struggled with navigating scheduling websites. Alagappan sees that as a design problem. “Technology often gets a bad reputation, because it’s hampered by the many bad technology experiences that are out there,” he said.

Instead, he thinks Notable Health has kept the user in mind through a more simplified approach, asking users only for basic and easy-to-remember information through a text message link. “It’s that emphasis on user-centric design that I think has allowed us to still have really good engagement rates even with older populations,” he said.

While the startup’s platform will likely help hospitals and health systems develop a more efficient approach to vaccinations, its use of RPA and NLP holds promise for future optimization in healthcare. Leaders of similar technology in other industries have already gone on to have multi-billion dollar valuations, and continue to attract investors’ interest.

Artificial intelligence is expected to grow in healthcare over the next several years, but Alagappan argues that combining that with other, more readily available intelligent technologies is also an important step towards improved care. “When we say intelligent automation, we’re really referring to the marriage of two concepts: artificial intelligence—which is knowing what to do—and robotic process automation—which is knowing how to do it,” he said. That dual approach is what he says allows Notable Health to bypass administrative bottlenecks in healthcare, instructing bots to carry out those tasks in an efficient and adaptable way.

So far, Notable Health has worked with several hospital systems across multiple states in using their platform for vaccine distribution and scheduling, and are now using the platform to reach out to tens of thousands of patients per day.

Wyndly aims to bring allergy drops to the masses

Chronic allergy sufferers know well the daily discomfort of seasonal allergies and environmental allergies. They also likely know about allergy shots — the treatment that requires you to go into an office to get shots on a weekly or monthly basis. But there is a lesser-known treatment, allergy drops, that requires a bit less effort. Wyndly, a startup participating in Y Combinator’s current batch, aims to make allergy drops more accessible to people.

Before the pandemic, Dr. Manan Shah, an otolaryngologist (an ear, nose, throat doctor), would have his patients come in for an evaluation and then prescribe them personalized allergy drops to train their immune system to fight off allergy triggers.  When the COVID-19 pandemic hit, Shah, began treating his patients suffering from allergies via telemedicine. That went well so Dr. Shah and his cousin, Aakash Shah, took their idea to Y Combinator. They showed their idea was working well in Denver, Colorado but wanted help taking it nationwide.

Through Wyndly, Dr. Shah can conduct both allergy testing and treatment via telemedicine. Unlike allergy shots, allergy drops can be taken at home. Wyndly aims to treat environmental allergies, like cats, dogs, dust mites, mold, pollen, trees, grasses and weeds.

“Most people don’t realize there is this other option,” Dr. Shah said. “I think most people think the only option for allergies are shots or taking antihistamines every day. we educate people there is this wonderful therapy and we can make it available to you in the most convenient way.”

Wyndly works by first evaluating a patient’s allergies. Patients can either submit a recent allergy test to Wyndly, or take Wyndly’s at-home finger prick test. Next, Wyndly prepares personalized allergy drops for the patient and sends a vial to the patient’s home. Then, at some point during the day, patients take five drops under the tongue. Dr. Shah said most patients see a decrease in their symptoms after taking these drops daily for six months.

Wyndly costs $99 per month for allergy drop treatment, which could come out to around $594 in total, if a patient takes them for six months. If you become a patient, the allergy test costs $0 but if you don’t become a patient, the test costs $200.

While allergy drops are easy to take, there’s a caveat. Insurance companies typically do not cover the cost of the treatment, while they generally do for allergy shots. But Wyndly says it aims to be the same cost as what someone would pay for insurance-covered allergy shots plus co-pays.

It’s also worth noting that these allergy drops are not approved by the Food and Drug Administration. While they are made using the same medications that are FDA-approved for allergy shots, the compounded medication is not itself approved and regulated by the FDA, Dr. Shah said.

Down the road, Wyndly may look to treat food allergies but Shah says there’s not enough data about its safety.

“I just want to see a little more research and for the field to reach a consensus on safety,” Shah said. “We hope to do food in the future if it ends up being proven to be really effective.”

Wyndly is has been in Y Combinator for a little over a month now and has been slowly expanding its offerings. Through partnerships with physicians, Wyndly is able to offer its services in 38 states throughout the country. By the end of 2022, Wyndly hopes to be in all 50 states.