Level Zero Health, a medical device startup founded by women, is set to revolutionize hormone monitoring with its innovative continuous monitoring device. The company, which has been in operation for just over a year, has successfully completed an oversubscribed pre-seed funding round securing $6.9 million. Their mission is to eliminate the necessity for invasive blood draws while supporting research that may lead to new treatments for hormone-related conditions and innovative healthcare solutions like personalized hormone-based contraception.
Co-founder and CEO Ula Rustamova reflects, “One of our investors remarked on the differences between companies developing fundamental technologies and those merely wrapping their technologies. Our endeavor is about crafting something entirely new.” This statement came as Rustamova discussed the company’s progress since their last presentation at TechCrunch Disrupt during the Startup Battlefield competition last fall.
Rustamova elaborates, “Our ambition is to forge an entirely new market, akin to what CGMs [continuous glucose monitors] accomplished, which single-handedly established a multibillion-dollar sector. This represents a unique product category that we hope will motivate others to utilize our device and its data, sparking a wave of new companies and innovations over the coming decades.”
Step by Step Towards Innovation
Creating an entirely new product category is a time-intensive process, especially as a hardware startup focused on medical devices. Therefore, Level Zero Health recognizes that it will not instantaneously transform hormone monitoring methods.
In the interim, the team is developing a single-use product (shown above in prototype) they hope to secure prescription clearance for next year. This product aims to facilitate intermittent hormone testing for medical applications such as fertility treatments (IVF) and testosterone replacement therapy (TRT).
The current prototype features micro-needles designed to sample hormones just below the skin’s surface, capturing minute quantities for analysis.
This is a stepping stone toward their ultimate goal of launching a wearable device—tentatively scheduled for 2028—that continuously measures hormone levels like progesterone, estrogen, and testosterone through interstitial fluid, which surrounds human cells and acts as a conduit between blood and cells.
A continuous hormone monitoring device—and the valuable data it collects—could revolutionize our understanding of hormones in human biology, similar to how CGMs have reshaped diabetes management.
However, Level Zero Health is also focusing on building a business, initially adopting a B2B model to sell their technology within healthcare networks. The founders are actively working on two development tracks to expedite market entry while bridging the gap between their ambitious vision and current capabilities.
“We believe we have access to a reliable data source—interstitial fluid,” Rustamova explains. “This approach offers us a shorter-term product opportunity that we plan to launch first.”
Rustamova emphasizes the significance of continuous hormone monitoring, describing it as the “holy grail” of the future due to its seamless usability, enabling consistent readings. Nonetheless, she acknowledges that immediate market entry must respect existing medical protocols without undergoing considerable delays in data interpretation. Thus, the first device will function similarly to fingerstick blood tests, yet it will resemble a patch.
The prototype wearable is designed to consistently measure hormone levels throughout the day, providing a series of data points to deliver immediate insights for specific applications like IVF, where women typically need multiple blood draws to track hormonal fluctuations.
Rustamova mentions that the team aims to conclude clinical trials and secure approval for this single-use monitoring patch next year. The target is to obtain both U.S. FDA clearance and a CE marking for entry into the European healthcare market, without a clear preference for which may come first.
“This year, we aim to establish some correlation between the hormonal levels detected by our wearable patch and those measured through blood draws—that’s one of the assurances we want to deliver with the pre-seed funding,” she adds.
CTO and co-founder Irene Jia expresses the team’s aspiration to exhibit over 90% accuracy in correlation between their patch’s readings and traditional blood measurement methods.
Evaluating Risks and Rewards
As the conversation shifts to the differences between blood sampling and interstitial fluid detection, Rustamova highlights the varying medical risks associated with these techniques. She notes that while inaccurate blood glucose readings can result in severe health consequences for diabetics, hormone monitoring typically involves lower stakes.
“With glucose, incorrect readings or delays could have lethal repercussions… But hormone monitoring carries a different risk profile, where slight deviations might be tolerable,” she explains. “Of course, we aim for the highest possible correlation, but the inherent risks are distinct.” Additionally, she points out that fledgling CGM devices had lower accuracy compared to current offerings.
The idea is to continuously enhance accuracy, which could explain investors’ enthusiasm in this medtech startup’s initial funding round, perceiving the balance between potential rewards and risks as favorable.
Furthermore, Level Zero Health is not exclusively addressing issues pertinent to women’s health; monitoring male hormone levels is also integral to their business model. This aspect remains crucial, particularly considering that a significant portion of tech investors are men likely seeking to fund solutions reflecting their interests.
The pre-seed funding for Level Zero Health was spearheaded by European venture capital firm Redalpine, with contributions from HAX (SOSV), Entrepreneur First (EF), and various industry veterans. Notably, SOSV had previously inducted the startup into its deeptech/hardware HAX accelerator program, and Rustamova is also an alumnus of EF.
In a statement, Philip Kneis, investor at Redalpine and a board member of Level Zero Health, expressed excitement: “We accomplished significant advancements in blood pressure monitoring and now intend to replicate that success in hormone measurement. Continuous hormone tracking represents a critical breakthrough in diagnostics, and as foundational science transitions to practical applications, we are thrilled to support Level Zero Health in their endeavor to revolutionize hormone monitoring with their state-of-the-art biosensor—laying the groundwork for a new chapter in personalized health management.”
Compiled by Techarena.au.
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