附近上门

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鈥檚 a problem a lot of health devices suffer from. , a partner at health-focused VC firm , reiterated one early piece of advice she learned as a VC: 鈥淒iagnostics that don’t change medical intervention鈥� don’t actually deserve to exist.鈥�

鈥淚t 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,鈥� 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

, 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鈥檚 device considers nine different diagnostic measurements ranging from an individual鈥檚 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.

鈥淏ecause it’s a bracelet, we can feed those data points in a much more convenient fashion,鈥� Ava鈥檚 President and Co-Founder, Lea Von Bidder said. 鈥淪o 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.鈥�

The company鈥檚 convenience-driven approach has raised in venture capital funding from investors.

As for Ava鈥檚 ability to actually influence conception, Von Bidder told 附近上门 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 鈥渁n average of 5.3 fertile days per cycle鈥� with that metric changing depending on the regularity of a user鈥檚 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, aims to bring medical-grade, scientific analysis to women鈥檚 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.

鈥�43 percent of women right now take more than three months to conceive,鈥� Kang told 附近上门 News. 鈥淭here is no really convenient but also accurate information provider that can guide them and help them through this process.鈥�

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鈥檚 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鈥檚 block-panel analysis.

鈥淭he only thing that you can do to make this data really meaningful is to track something first that is medical-grade,鈥� Kang told 附近上门 News. 鈥淭he only thing that鈥檚 medical-grade in fertility is your hormone level.鈥�

But what makes this tracker different than any other urine-based, Target-purchased ovulation tracker? Kang told 附近上门 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 鈥渙vulating鈥� or 鈥渘ot ovulating鈥� 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.

鈥淗olding consumer products up to a clinical impacts and clinical evidence frame, in fact, is not just me being an overly demanding healthcare VC,鈥� Samuels told 附近上门 News. 鈥淚 think it also turns out the clinical impact correlates ultimately with revenue and profitability.鈥�

However, pressure from tech-focused VCs to bring products to market and pursue exponential growth can potentially hinder that process.

鈥淭ech investors have a harder time with a business plan that says, 鈥榃ait until you get rigorous clinical data before you launch into the market鈥�,鈥� 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.