Zero level of health banks $ 6.9 million to prove that portable medtech can eliminate the constraint of hormonal tests

Zero healthA startup of medical devices based on women who aims to innovate by developing a device for continuous hormonal surveillance, ended a funding tour of $ 6.9 million overcomed, despite a little more than a year. The startup wants to remove the need for invasive blood samples and support research that could lead to new treatments for conditions related to hormonal imbalances or even new health care innovations, such as individual dosage for contraception based on hormones.

“One of our investors told us that there were companies that build fundamental technologies and that there are companies that build packaging around this technology; You create new technologies here, ”explains the co-founder and CEO Ula Rustamova, discussing the development of the company since our last recording with them Last Fall When they presented on stage at Techcrunch Disrupt as part of the Startup battlefield competition.

“The objective is to create a whole new market from it, right? In the same way CGMS [continuous glucose monitors] did. They have literally, by nothing, created a market of several billion dollars, “she continues. “It is, by definition, a whole new category of products that are specific to it – which, hopefully, will inspire people to use the device and data to create many companies in addition to that and have a effect of ‘Training in the coming decades. “

Step by step

Building a whole new category of products from any band can take time. The fact that it is a hardware startup and a medical device to start, it is clear that zero level health will not be able to serve a paradigm change in the way hormones are monitored during the night.

This is why the team also works on a single -use product of springboard (illustrated above in prototype form), which it hopes to be erased for prescription use next year – to support intermittent hormonal tests medical use cases such as fertility (IVF) and low testosterone (TRT).

The current portable prototype contains tiny needles which allow it to take samples just under the skin to detect traces of hormones.

This is a step towards portable hormonal surveillance which they finally hope to put on the market – temporarily planned for 2028 – which is capable of drawing a continuous measure of things such as progesterone, estrogen and testosterone of liquid bearer’s interstitial. (It is fluid that fills spaces around cells, acting as an intermediary between blood plasma and cells – hence why biochemical compounds in the blood can also be detected in interstitial fluid.)

A continuous hormonal surveillance device – or, rather, the data he picks up – could play a transforming role in the increase in scientific understanding of the roles played in human biology – just as CGMs have transformed diabetes management (And more and more).

But Level Zero Health also create a company – initially a B2B company, aimed at selling technology in health care providers networks – the founders therefore work on twin product development tracks to shorten the marketing time and fill the ‘Gap between the Big Bang mission and what is currently possible.

“We believe that we have this source of truth in which we can exploit – which is an interstitial liquid,” Rustamova told Techcrunch. “And we think there is an immediate and shorter product here that we have to launch first.

“The idea is that continuous [hormone monitoring] … Is the holy grail – it is the future – because it makes sense, in a way because it is again without friction, you can put it, and you can somehow obtain really coherent measurements . But we also understand that today we must enter the market in a way where we would not try to modify the protocol – and not have a question of research of seven years of “try to interpret these Data ” – So our first device is actually similar to finger stick devices, but it is also a patch. »»

The portable prototype is capable of taking measures throughout the day when worn – extract a series of data points in order to “provide a value immediately” for use cases such as IVF, where A woman could otherwise need to have several blood samples to monitor hormone levels.

Rustamova says that the team hopes to have concluded clinical trials and ensured the authorization of this intermittent surveillance patch for single use next year – with eyes on obtaining the approval of the American regulator, the FDA and CE marking to enable them to sell in European market health care (she says they don’t know what could come first).

“I hope this year we want to show a certain level of correlation [between levels of hormones the wearable patch can detect and levels detected via a blood draw] “This is the promise I mean with the pre-series money,” she adds.

CTO and co-founder, Irene JIA, tells us that the team’s objective is to be able to demonstrate a correlation of 90% + with what their patch can pick up compared to the measurement of hormones via a blood sample .

RISK VS Reward

Although later – when we discuss the delay between blood readings and detection via interstitial fluid – Rustamova CARILLONS to underline the difference in medical risk between CGMS and hormone surveillance. She emphasizes that the risk for a person with diabetes (that is, if the readings of blood sugar are delayed or deactivated) is probably extremely high, while hormone surveillance is generally not high issues .

“For glucose, you have potential fatal consequences to give a bad reading or have this delay … [but when it comes to hormone monitoring] The risk of having a slight deviation or a kind of correlation is not as tight, ”she tells us. “Obviously, we will try to correlate as much as possible – but … there is this very different risk profile here.” She also noted that the first CGMs to market had a lower correlation with the blood readings than these devices.

The suggestion is that the team’s goal is to continue to increase the bar on precision. This – perhaps – alludes to the reason why investors wanted to accumulate in the beginning of the start of this Medtech startup – with the potential awards compared to biased risks in a positive direction.

The other – no doubt – a useful factor here is that zero level health is not only focused on women’s health problems; Monitoring male hormones is a central element of the initial business plan. (And there remains the case that most technological investors are still men who place betting on problem solving that talk about their interests.)

The Pre-Grève financing tour of the Zero Health level was led by the European VC, Redalpine. HAX (SOSV), Entrepreneur First (EF) and industry experts have also contributed to the Tour – SOSV having already accepted the startup on its Deeptech / Hax Accelerator program, and Rustamova also being a former EF.

Commenting in a press release, Philip Kneis, Redalpine investor and a member of Zero Health Board, said: “We did it for blood pressure and we will refer it to hormones. The measurement of continuous hormones is one of the saintly diagnostics, and as fundamental science goes to engineering, we could not be more excited to support zero health in their mission to transform the follow-up of hormones With their new biocaptor – opening the way to a new era of personalized health management. »»