Level Zero Health is building a continuous hormone monitoring medical device that could help millions of people. The company is attempting to invent a never-achieved technology by adapting FDA-approved needles used in continuous glucose monitoring devices. Level Zero’s approach is to build a sensor that detects and measures different hormones by scanning what’s known as aptamers. The first sensors they are working on detect progesterone, estrogen, cortisol and testosterone. Level Zero is hoping that the device will be used by healthcare providers for IVF treatments and low testosterone.
The sensors used in hormone monitoring devices take tiny, sporadic samples of interstitial fluid, which makes hormone monitoring a much harder task to accomplish. Level Zero is building a sensor that can detect the molecule density of a particular hormone by determining how much of it is binding to strands of aptamer DNA. Level Zero aims to create the device quickly and expects it to be prescribed by healthcare providers. The founders of Level Zero were inspired by hormone-testing home kits, which have wobbly results.
There are indications that Level Zero’s scientific approach is sound; scientists from the Department of Nanoscience at the University of North Carolina published a paper in 2016 documenting how they successfully used aptamers to measure progesterone. Level Zero has previously secured clinical partnerships with IVF clinics, and they are readying their device for two clinical studies in 2025.
There’s still a long way to go before Level Zero Health has a device on the market. However, the company roadmap is fast, with manufacturing engineering set to begin next year and clinical trials to be conducted in 2026.