Level Zero Health, a female-founded medical device startup, has successfully closed an oversubscribed $6.9 million pre-seed funding round to develop a revolutionary wearable device for continuous hormone monitoring. The startup, which is barely over a year old, is poised to break new ground in the healthcare industry by eliminating the need for invasive blood draws and supporting research that could lead to new treatments for conditions linked to hormone imbalances.

The device, which is still in development, aims to provide a continuous measure of hormones such as progesterone, estrogen, and testosterone from the wearer's interstitial fluid. This innovation has the potential to transform scientific understanding of the roles hormones play in human biology, much like continuous glucose monitors (CGMs) have transformed diabetes management. According to co-founder and CEO Ula Rustamova, the goal is to create a whole new market out of this technology, inspiring other companies to build upon it and creating a ripple effect in the next few decades.

To achieve this ambitious goal, the team is working on a stepping stone single-use product, which they hope to get cleared for prescription use next year. This prototype wearable contains tiny needles that allow it to take samples just under the skin to detect trace amounts of hormones. The device is designed to support intermittent hormone testing associated with medical use cases such as fertility (IVF) and low testosterone (TRT).

Rustamova emphasized that building a whole new product category takes time, especially for a hardware startup in the medical device space. However, the team is committed to shortening time-to-market and bridging the gap between their big-bang mission and what's currently possible. They are working on twin product development tracks, with the first device being similar to finger stick devices but with a patch-like design.

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. 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 from both the U.S. regulator, the FDA, and a CE marking to allow them to sell into European healthcare markets.

Rustamova noted that the team's goal is to demonstrate a 90%+ correlation between levels of hormones the wearable patch can detect and levels detected via a blood draw. She also highlighted the difference in medical risk between CGMs and hormone monitoring, pointing out that the risk for someone with diabetes is likely to be extremely high, whereas hormone monitoring is typically not that high stakes.

The pre-seed funding round was led by European VC, redalpine, with HAX (SOSV), Entrepreneur First (EF), and industry experts also contributing to the round. Philip Kneis, investor at redalpine and a Level Zero Health board member, expressed his excitement about backing the startup in their mission to transform hormone tracking with their novel biosensor, paving the way for a new era of personalized health management.

Level Zero Health's innovative approach and ambitious goals have captured the attention of investors, who see the potential rewards vs. risks being skewed in a positive direction. The startup's focus on both women's and men's health issues, as well as its commitment to accuracy and precision, make it an attractive prospect for those looking to make a significant impact in the healthcare industry.

As the startup continues to develop its revolutionary device, it's clear that Level Zero Health is poised to make a significant impact on the healthcare industry, transforming hormone tracking and personalized health management for years to come.