Level Zero Health Secures $6.9M to Revolutionize Hormone Testing with Wearable MedTech Solutions

Level Zero Health, an innovative medical device startup founded by women, is on a mission to revolutionize hormone monitoring with its groundbreaking continuous hormone monitoring device. Recently, the company successfully closed an oversubscribed pre-seed funding round of $6.9 million, reflecting strong investor confidence in their vision despite being only a year old.

Transforming Hormone Monitoring

Level Zero Health aims to eliminate the need for invasive blood draws while advancing research that could lead to innovative treatments for hormone-related conditions. The founders believe their device could eventually enable personalized healthcare solutions, such as tailored dosing for hormone-based contraceptives.

Investor Insights

Co-founder and CEO Ula Rustamova expressed her excitement about the journey of Level Zero Health since their last appearance at TechCrunch Disrupt. She stated, “One of our investors told us there are companies who build fundamental technologies and companies who build wrappers around that technology; you guys are creating new technology here.”

Creating a New Market

The startup aspires to create a new market similar to how continuous glucose monitors (CGMs) established a multi-billion dollar industry. Rustamova emphasized, “This is, by definition, a whole new product category of its own.”

Step-by-Step Development

Building a new product category, particularly in the medical device sector, is a lengthy process. To address immediate market needs, Level Zero Health is developing a single-use product aimed at facilitating intermittent hormone testing for conditions like fertility (IVF) and low testosterone (TRT).

• The current prototype features tiny needles for sampling hormones just beneath the skin.
• The long-term goal is a wearable device capable of continuous hormone measurement from interstitial fluid.
• This device aims to track hormones such as progesterone, estrogen, and testosterone.

The Impact of Continuous Monitoring

A continuous hormone monitoring device could significantly enhance scientific understanding of hormone roles in human biology. Much like CGMs have transformed diabetes management, Level Zero Health aims to bridge the gap between current healthcare practices and advanced hormone monitoring.

Business Development Strategy

Initially focusing on a B2B model, Level Zero Health is committed to developing products that meet the immediate needs of healthcare providers while paving the way for future innovations. Rustamova explained, “We think that we have this source of truth that we can tap into — which is interstitial fluid.”

Clinical Trials and Market Entry

The team is currently preparing to conduct clinical trials for their single-use intermittent monitoring patch, targeting regulatory approvals from the FDA and obtaining a CE marking for the European market. Rustamova hopes to demonstrate a correlation between hormone levels detected by their patch and traditional blood draws.

Accuracy and Safety

Level Zero Health is aiming for a correlation accuracy of over 90% compared to blood tests. Rustamova noted the difference in medical risk between glucose monitoring and hormone tracking, emphasizing that while glucose levels have immediate health implications, hormone deviations tend to be less critical.

Funding and Future Prospects

The recent funding round was led by redalpine, with contributions from HAX (SOSV) and other industry experts. Philip Kneis, an investor at redalpine, commented on the potential of continuous hormone measurement, stating, “We couldn’t be more excited to back Level Zero Health in their mission to transform hormone tracking with their novel biosensor.”

As Level Zero Health continues to innovate and develop its hormone monitoring device, the startup is poised to make significant contributions to personalized health management. For more insights into advancements in medical technology, visit our medical technology news section.