Level Zero Health co-founders Ula Rustamova and Irene Jia are swinging for the fences. They are attempting to create a never-achieved technology that will help millions of people. If they succeed — and there are some positive early indicators — they will make a continuous hormone monitoring medical device.

Such a device could do for hormone health what continuous blood glucose monitors (CGM) have done for diabetes health.

Hormones control almost everything in the body, from reproductive health to aging, and influence everything from energy level to mood. "All of that is regulated by your hormones," CEO Rustamova told TechCrunch. "We know now how much they regulate in terms of your day-to-day life."

Level Zero is speaking at Disrupt today on the Startup Battlefield stage, envisioning a future where this device comes pretty damn soon by using type to FDA-approved needles deployed by CGM devices used with continuous hormone monitoring. This is a cake take, so it's definitely one of those things that is harder put-together just because all its development-the sensors and also just the science-be are yet in its early beginnings. Those needles sample small, irregular amounts of interstitial fluid, or fluid around cells that leaks from the blood capillaries. The science behind the measurement of glucose in the fluid for CGM systems is solid; hormones aren't nearly as well-developed.

At least not yet.

Level Zero aims to develop a sensor detecting and measuring different hormones through the scanning of what are known as aptamers. According to CTO Jia, these are ssDNA molecules "that specifically bind to target molecules and undergo reversible conformational changes detectable by electrochemical and optical methods." That is, they're constructing a sensor that could sense the density of the molecule of a particular hormone by knowing how much it is binding to strands of aptamer DNA.

The first sensors they're building detect progesterone, estrogen, cortisol, and testosterone. They selected the hormones because this way their first devices will serve not one but two high-needs applications: IVF treatment and low testosterone. Cumulatively, these serve the $30 billion markets they say.

While Level Zero is not for consumers to buy the devices directly - it will be prescribed by healthcare providers - hormone-testing home kits inspired them. Such kits attempt to measure hormones in urine, sweat, or saliva, but the results are wobbly at best, says Rustamova, who uses the word "pseudo science" to describe much of the home hormone-testing market. "The only possible accurate way to measure hormones is to go take a blood drop," she tells TechCrunch.

But blood draws aren't entirely helpful, either, because they measure hormone levels at only that one snippet in time. They won't help with a wide range of questions like "Is my contraception working?" or "Okay, I think my testosterone is low, but I don't know if my exercise is helping or lowering it," Rustamova explains.

Early strong indicators
It's less than a year old, and hasn't published any peer-reviewed papers on the progress of its work. So the public can't know yet if what they are building will do what they hope it does. Level Zero is still keeping its technology close to the vest with an eye toward a patent, Rustamova says.

Still, its scientific approach sounds valid. In 2016, scientists from the Department of Nanoscience at the University of North Carolina published a paper showing they had successfully applied aptamers to measure progesterone. By 2022, scientists in Hyderabad, India, successfully made a low-cost sensor.

In rounding out what the founders consider an exceptional group of medical experts acting as advisors to Level Zero, there's Dr. Aaron Styer, Harvard University associate professor and director of the fertility clinic called CCRM Boston; medical director for Hims  and working on their digital male fertility management platform Posterity Health; Mount Sinai's medical school's assistant professor in Ob/Gyn Dr. Joshua Klein; and Roel Mingels, who comes from being a biosensor engineer.

In other words, one of her fellow co-founders was a wunderkind programmer who won a competition held by Microsoft at 16; this led her to developing a wearable posture-correcting device. A number of years spent with Palantir later, where she worked as an engineering leader, she reached out for a startup when her desire to create her company began to burn intensely enough inside of her to bring that feeling to Entrepreneur First -- a program which helped someone in search of their cofounder to find them. ".

"It was founder love at first sight for both of us," said Rustamova. Jia was a ballerina as a teenager, going professional before injury forced her out of dance. She headed back to school for a masters degree in industrial design, learning about biomaterials and biosensors. She worked on medical devices at Philips for a few years before joining Entrepreneur First.

Also joining the accelerator is SOSV's famous deep-tech/hardware HAX program, which gives access to lab equipment. They now have a prototype sensor that hit a feasibility milestone by detecting progesterone in interstitial fluid at clinical levels, according to them.
There's still much more for Level Zero before a device hits the market, but its roadmap goes pretty fast. Along with the device milestone, earlier this year the company secured clinical partnerships with IVF clinics in the U.S. They are readying their device for two clinical studies in 2025 and will start manufacturing engineering next year, as well. In 2026, the founders plan to run clinical trials and begin the FDA approval processes.

We've spent an unbelievable amount of time talking to expert clinicians, researchers in fertility, perimenopause, PCOS, and others just to make sure that the data we are providing is relevant," said Jia. "We also believe that's why some of the biggest names in fertility from Harvard, Mount Sinai, and Hims have joined our team and continue to guide us.".