A lot of companies claim to track your cycle, but that rarely provides enough clinical insight into your individual ability to conceive.
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It’s a problem a lot of health devices suffer from. Camille Samuels, a partner at health-focused VC firm Venrock, reiterated one early piece of advice she learned as a VC: “Diagnostics that don’t change medical intervention… don’t actually deserve to exist.”
“It may be used briefly because it’s fun to know your temperature and your heart rate, but it’s not going to be used in a scalable way,” Samuels said.
But there are companies in the fertility space that aim to give women and doctors the information they need to improve the chances of conception. And two notable startups are catching on to that trend.
Comfortable, Passive Diagnostic Tracking
Ava, a Switzerland and San Francisco-based company founded in 2014, has developed a wearable that uses non-invasive sensor technology to detect and track various body measurements that are affected by cycle changes and ovulation.
Ava’s device considers nine different diagnostic measurements ranging from an individual’s skin temperature and resting pulse rate to perfusion (blood flow), heat loss, and sleep. Using those measurements, an algorithm detects variations that may correlate with cycle changes.
“Because it’s a bracelet, we can feed those data points in a much more convenient fashion,” Ava’s President and Co-Founder, Lea Von Bidder said. “So you don’t have to get up at the same time [to take your temperature and] you don’t have to pee on something. That allows us to detect [and] give you an early first indicator of your fertile window.”
The company’s convenience-driven approach has raised $42.3 million in venture capital funding from investors.
As for Ava’s ability to actually influence conception, Von Bidder told Crunchbase News the company has conducted five clinical trials with its Food and Drug Administration (FDA) and CE-approved device. Its largest, 400-person clinical trial is currently in process. Ava claims 89 percent accuracy in detecting “an average of 5.3 fertile days per cycle” with that metric changing depending on the regularity of a user’s cycle.
Ava targets women who are just beginning their fertility journeys, and who are still in their first year of trying to conceive. However, many women do not have regular cycles, or they have other individual factors that might lead to decreased fertility.
In that case, more accessible, lab-based methods may be needed. And a new startup, Mira, believes it has the tech and the data to bring such a product to market.
Lab In A Pod
Founded in July 2015 by Sylvia Kang and her former classmates, Mira aims to bring medical-grade, scientific analysis to women’s smartphones with its palm-sized hormone tracking device. For those unfamiliar, Luteinizing Hormone (LH) is the hormone level that infertility doctors test when analyzing female and male fertility. LH is at its peak during ovulation.
“43 percent of women right now take more than three months to conceive,” Kang told Crunchbase News. “There is no really convenient but also accurate information provider that can guide them and help them through this process.”
With Mira, women are supplied with wands for urine samples along with a Mira analyzer, which looks a bit like an egg. They can insert the wand into the analyzer, which detects and measures LH hormone levels and syncs with the Mira app. As the app gathers more data, machine learning technology charts and predicts an individual’s fertility window.
According to the company, the technology, which is FDA and CE approved, was also clinically tested against 400 hospital patient urine samples. It was found to produce LH-level results that were 99 percent accurate when compared to the hospital’s block-panel analysis.
“The only thing that you can do to make this data really meaningful is to track something first that is medical-grade,” Kang told Crunchbase News. “The only thing that’s medical-grade in fertility is your hormone level.”
But what makes this tracker different than any other urine-based, Target-purchased ovulation tracker? Kang told Crunchbase News that at-home tests produce a result based on a hard threshold. In other words, the Target test and its equivalents only shows a woman whether she is “ovulating” or “not ovulating” based on a standard LH level. Mira, on the other hand, allows women to view exact readings and formulate an individual ovulation curve.
The company, which has raised a total of $4.3 million, is shipping in the U.S. next month and Europe soon after. The company will also launch in China by the beginning of next year. In the future, Mira plans to expand into other trackable verticals like tests related to chronic illnesses. Further, Kang said that improved access to data could help doctors and practitioners learn more about female fertility.
Actionable Insights[bctt tweet=”Holding consumer products up to a clinical impacts and clinical evidence frame, in fact, is not just me being an overly demanding healthcare VC.” username=”CamiSamuelsVC”]
Though Ava and Mira approach the consumer fertility market differently, one thing they have both attempted to do is provide individuals with actionable insights. And while Ava might have a bit further to go on the clinical research front, both startups have claimed to make that a centerpiece of their platforms.
That clinically-driven approach is one that Samuels believes is central to long-lasting success for consumer health tech companies.
“Holding consumer products up to a clinical impacts and clinical evidence frame, in fact, is not just me being an overly demanding healthcare VC,” Samuels told Crunchbase News. “I think it also turns out the clinical impact correlates ultimately with revenue and profitability.”
However, pressure from tech-focused VCs to bring products to market and pursue exponential growth can potentially hinder that process.
“Tech investors have a harder time with a business plan that says, ‘Wait until you get rigorous clinical data before you launch into the market’,” Samuels explained.
However, as more consumer health tech companies aim to strike a balance between ensuring clinical efficacy and providing their customers with actionable insights into the state of their health, patients may feel more empowered in their health journeys. Beyond the consumer, the collection of health data on a big data scale may further inform medical practices and shape the process of medical care more generally.