Level Zero Health Secures $6.9M for Wearable Hormone Testing

Level Zero Health Secures $6.9 Million Pre-Seed Funding

Level Zero Health, a medical device startup founded by women, has successfully completed an oversubscribed pre-seed funding round, raising $6.9 million. This achievement comes despite the company being just over a year old.

The company is focused on pioneering a new device for continuous hormone monitoring. Their aim is to eliminate the necessity for traditional, invasive blood tests.

Supporting Research and Innovation

Level Zero Health intends to facilitate research that could unlock novel treatments for conditions associated with hormone imbalances. This includes potential advancements in healthcare, like personalized dosing strategies for hormone-based contraceptives.

Co-founder and CEO, Ula Rustamova, shared an investor’s perspective: the company isn’t simply refining existing technology, but rather forging entirely new technological pathways.

A New Market Category

Rustamova highlighted the company’s progress since their presentation at TechCrunch Disrupt’s Startup Battlefield competition last autumn.

The vision is to establish a completely new market, mirroring the impact of continuous glucose monitors (CGMs). CGMs successfully generated a multibillion-dollar market from a previously unmet need.

“This represents, fundamentally, a distinct and novel product category,” Rustamova stated.

Ripple Effect and Future Growth

The company anticipates that their device and the resulting data will inspire the creation of numerous businesses. They hope to see a cascading effect of innovation over the coming decades.

Ultimately, Level Zero Health seeks to empower individuals to utilize the device and its data, fostering a wave of new companies and advancements in the field.

A Phased Approach to Hormone Monitoring

Developing an entirely new product category requires significant time and effort. Considering this is a hardware startup focused on a medical device, Level Zero Health recognizes that a revolutionary shift in hormone monitoring won't happen immediately.

Therefore, the company is concurrently developing a single-use, stepping-stone product – currently in the prototype phase – with the aim of securing prescription clearance next year. This will facilitate intermittent hormone testing for medical applications like fertility treatments (IVF) and low testosterone therapy (TRT).

Prototype Technology

The present wearable prototype utilizes minuscule needles to obtain samples from just beneath the skin, enabling the detection of even trace amounts of hormones.

This represents an incremental advancement towards their ultimate goal: a wearable device capable of continuous hormone monitoring, tentatively planned for release in 2028. This device will measure levels of progesterone, estrogen, and testosterone from the wearer’s interstitial fluid.

Interstitial fluid, which occupies the spaces surrounding cells, serves as a medium between blood plasma and cells. Consequently, biochemical compounds present in blood can also be identified within interstitial fluid.

Potential Impact of Continuous Monitoring

A device providing continuous hormone monitoring – and the resulting data – has the potential to significantly enhance scientific understanding of the roles hormones play in human biology. This parallels the transformative impact of Continuous Glucose Monitors (CGMs) on diabetes management and beyond.

However, Level Zero Health is also focused on building a sustainable business. Initially, they intend to operate as a B2B entity, selling their technology to healthcare provider networks. To accelerate market entry and bridge the gap between their ambitious long-term vision and current feasibility, the founders are pursuing dual product development paths.

“We believe we’ve identified a valuable data source – interstitial fluid,” explains Rustamova to TechCrunch. “And we see an immediate, shorter-term product opportunity that we should prioritize.”

Balancing Innovation and Practicality

“While continuous hormone monitoring represents the ultimate objective – the ‘holy grail’ – due to its convenience and consistent measurements, we acknowledge the need to enter the market strategically. We aim to avoid a lengthy, seven-year research undertaking focused solely on data interpretation.

Therefore, our initial device will function similarly to traditional finger-stick methods, but in a patch format.”

The prototype wearable can collect measurements throughout the day, generating a series of data points designed to “deliver value immediately” for applications such as IVF, where women currently require multiple blood draws to monitor hormone levels.

Regulatory Approvals and Future Plans

Rustamova states the team anticipates completing clinical trials and obtaining regulatory clearance for this single-use, intermittent monitoring patch next year. They are pursuing approval from both the U.S. Food and Drug Administration (FDA) and a CE marking for sales in European healthcare markets, though the order of attainment remains uncertain.

“Our priority this year is to demonstrate a strong correlation between hormone levels detected by the wearable patch and those measured through a standard blood draw,” she adds.

Correlation Goals

Irene Jia, CTO and co-founder, indicates the team’s objective is to achieve a 90% or higher correlation between the patch’s readings and traditional blood draw hormone level measurements.

Risk Assessment and Potential Gains

A distinction in medical risk between continuous glucose monitors (CGMs) and hormone monitoring is highlighted by Rustamova, particularly concerning the time lag between blood-based and interstitial fluid readings.

She explains that inaccurate or delayed blood glucose measurements can carry significant, even life-threatening, consequences for individuals with diabetes. Conversely, inaccuracies in hormone monitoring generally present a lower level of immediate risk.

“The potential for critical errors exists with glucose monitoring due to the severity of the condition,” she states. “However, hormone monitoring tolerates a degree of deviation or imperfect correlation more readily.” The team aims for high correlation, but acknowledges the differing risk profiles.

Rustamova also points out that early CGMs exhibited lower correlation with blood glucose readings than current models, demonstrating a continuous drive for improved accuracy.

This commitment to enhancing precision likely contributes to investor enthusiasm for Level Zero Health, suggesting a favorable balance between potential rewards and inherent risks.

Furthermore, the company’s business strategy extends beyond women’s health, incorporating the monitoring of male hormones. This broader focus may appeal to the predominantly male demographic of tech investors, who often prioritize solutions addressing their own interests.

Investment and Backing

Level Zero Health’s initial funding round was spearheaded by European venture capital firm Redalpine. Additional contributions came from HAX (SOSV), Entrepreneur First (EF), and various industry specialists.

SOSV had previously provided support through its deeptech/hardware accelerator, HAX, and Rustamova is also an alumna of the Entrepreneur First program.

Philip Kneis, an investor at Redalpine and a member of Level Zero Health’s board, commented: “Similar to the advancements made in blood pressure monitoring, we anticipate a revolution in hormone measurement.”

He continued, “Continuous hormone measurement represents a significant diagnostic goal, and we are thrilled to support Level Zero Health’s innovative biosensor technology, which promises to transform hormone tracking and usher in a new era of personalized healthcare.”

• Continuous hormone measurement is seen as a key advancement in diagnostics.
• Level Zero Health’s novel biosensor is expected to revolutionize hormone tracking.
• The company aims to enable a new era of personalized health management.