Level Zero Health, a pioneering medical device company led by women, has secured $6.9 million in pre-seed funding. Their ambitious goal is to develop a revolutionary wearable device that enables continuous hormone monitoring, eliminating the need for invasive blood draws.
This device aims to transform the understanding of hormone dynamics in the human body, potentially leading to breakthroughs in treating conditions associated with hormone imbalances. It could also pave the way for personalized dosage of hormone-based contraceptives.
CEO Ula Rustamova emphasizes the groundbreaking nature of their technology, which focuses on creating a new product category altogether. She compares it to the impact of continuous glucose monitors (CGMs), which have transformed diabetes management.
Recognizing the challenges of developing a comprehensive wearable solution, Level Zero Health is adopting a phased approach. They are initially introducing a single-use wearable designed for intermittent hormone testing in medical settings, such as fertility treatments and testosterone replacement therapy.
The wearable prototype features tiny needles that extract samples from just beneath the skin, detecting trace amounts of hormones. This device is expected to receive clearance for prescription use next year.
Ultimately, the company aspires to develop a continuous hormone monitoring wearable that measures levels of progesterone, estrogen, and testosterone from interstitial fluid. This fluid, which surrounds cells, contains biochemical compounds that can be detected in blood.
Level Zero Health’s approach balances innovation with practicality. They understand the need to enter the market with a device that aligns with current clinical protocols. The initial patch device will resemble finger stick devices but with the added convenience of a patch.
Clinical trials for the intermittent monitoring patch are underway, with the goal of demonstrating a 90%+ correlation with blood test results. The team aims to secure FDA approval and a CE marking for European markets.
Investors have shown great interest in Level Zero Health’s potential, recognizing the positive risk-to-reward balance of their technology. The company’s focus on both women’s and men’s health is another contributing factor.
With support from redalpine, HAX (SOSV), Entrepreneur First (EF), and industry experts, Level Zero Health is poised to revolutionize the field of hormone monitoring, empowering individuals with a deeper understanding of their health and potentially leading to transformative treatments.
Original source: Read the full article on TechCrunch
