Level Zero Health, a female-founded medical device startup that’s aiming to break new ground by developing a device for continuous hormone monitoring, has closed an oversubscribed $6.9 million pre-seed funding round despite being only a little over a year old. The startup wants to do away with the need for invasive blood draws and support research which could lead to new treatments for conditions linked to hormone imbalances or even new healthcare innovations, such as individual dosing for hormone-based contraception.

“One of our investors told us there are companies who build fundamental technologies and there are companies who build wrappers around that technology; you guys are creating new technology here,” says co-founder and CEO Ula Rustamova, discussing the company’s development since we last check in with them last fall when they presented on stage at TechCrunch Disrupt as part of the Startup Battlefield competition.

“The goal is to create a whole new market out of this, right? The same way CGMs [continuous glucose monitors] did. They literally, out of nothing, created a multi-billion dollar market,” she goes on. “This is, by definition, a whole new product category of its own — that hopefully will inspire people to use the device and the data to create a lot of companies on top of that and have a ripple effect in the next few decades.”

Building a whole new product category of any stripe can take time. Factor in this being a hardware startup, and a medical device to boot, it’s clear Level Zero Health isn’t going to be able to serve up a paradigm shift in how hormones are monitored overnight.

This is why the team is also working on a stepping stone single-use product (pictured above in prototype form), which they hope to get cleared for prescription use next year — to support intermittent hormone testing associated with medical use cases such as fertility (IVF) and low testosterone (TRT).

The current prototype wearable contains tiny needles that allow it to take samples to detect trace amounts of hormones.

This is a step towards the hormone monitoring wearable they ultimately hope to bring to market — tentatively slated for 2028 — that’s able to pull a continuous measure of things like progesterone, estrogen and testosterone from the wearer’s interstitial fluid. (That is fluid that fills the 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 hormone monitoring device — or, rather, the data it picks up — could play a transformative role in boosting scientific understanding of the roles hormones play in human biology — much like CGMs have transformed diabetes management (and more besides).

But Level Zero Health is also building a business — initially a B2B business, aiming to sell technology into healthcare provider networks — so the founders are working on twin product development tracks to shorten time-to-market and bridge the gap between the big bang mission and what’s currently possible.

“We think that we have this source of truth that we can tap into — which is interstitial fluid,” Rustamova tells TechCrunch. “And we think that there’s an immediate, shorter term product here that we should launch first.

“The idea is that continuous [hormone monitoring] … is the holy grail — that is the future — because it makes sense, in a way because it’s again frictionless, you can put it on, and you can sort of get really consistent measurements. But also we understand that, today, we need to enter the market in a way where we would not try to change the protocol — and not have a seven-year research question of ‘let’s try and interpret this data’ — so our first device is actually similar to finger stick devices, but it’s also a patch.”

The prototype wearable is able to take measurements throughout the day when worn — extracting a series of data points with the goal of “delivering value immediately” for use-cases such as IVF, where a woman might otherwise need to have multiple blood draws to monitor hormone levels.

Rustamova says the team hopes to have concluded clinical trials and secured clearance for this single-use intermittent monitoring patch next year — with eyes on obtaining approval both from the U.S. regulator, the FDA, and a CE marking to allow them to sell into European healthcare markets (she says they’re not sure which may come first).

“Hopefully, this year we want to show some level of correlation [between levels of hormones the wearable patch can detect and levels detected via a blood draw] — that’s the promise I want to deliver with the pre-seed money,” she adds.

CTO and co-founder, Irene Jia, tells us the team’s goal is to be able to demonstrate a 90%+ correlation with what their patch can pick up compared to measuring hormone levels via a blood draw.

Although later on — when we’re discussing the delay between blood-based readings and detection via interstitial fluid — Rustamova chimes in to underscore the difference in medical risk between CGMs and hormone monitoring. She points out that the risk for someone with diabetes (i.e., if blood glucose readings are delayed or off) is likely to be extremely high, whereas hormone monitoring is typically not that high stakes.

“For glucose, you have potential lethal consequences of giving a wrong reading or having that delay… [but when it comes to hormone monitoring] the risk of having a slight deviation or sort of correlation not being as tight,” she tells us. “Obviously, we’re going to try and correlate as much as possible — but … there’s this very different risk profile here.” She also noted that the first CGMs to market had a lower correlation with blood readings than these devices now do.

The suggestion is the team’s goal is to keep raising the bar on accuracy. Which — perhaps — hints at the reason investors have been keen to pile into this medtech startup’s early round — with the potential rewards vs. risks being skewed in a positive direction.

The other — doubtless — helpful factor here is that Level Zero Health isn’t solely focused on women’s health issues; monitoring male hormones is a core piece of the initial business plan. (And it remains the case that most tech investors are still men placing bets on solving problems that speak to their interests.)

Level Zero Health’s pre-seed funding round was led by European VC, redalpine. HAX (SOSV), Entrepreneur First (EF), and industry experts also contributed to the round — with SOSV having previously accepted the startup onto its deeptech/hardware HAX accelerator program, and Rustamova also being an EF alum.

Commenting in a statement, Philip Kneis, investor at redalpine and a Level Zero Health board member, said: “We did it for blood pressure and will do it again for hormones. Continuous hormone measurement is one of the holy grails of diagnostics, and as fundamental science transitions to engineering, we couldn’t be more excited to back Level Zero Health in their mission to transform hormone tracking with their novel biosensor — paving the way for a new era of personalized health management.”