Level Zero Health is working on a potentially life-changing hormone health device

Level Zero Health co-founders Ula Rustamova and Irene Jia are swinging for the fences. They are trying to invent a never-before-achieved technology that could help millions of people. If they succeed — and there are positive first indicators — they will create a medical device for constant hormone monitoring.

Such a device could do for hormone health what continuous blood glucose monitors (CGMs) did for diabetes health.

Hormones control almost every aspect of the body, from reproductive health to aging, and affect everything from energy levels to mood. “It’s all regulated by your hormones,” CEO Rustamova told TechCrunch. “Now we know how much they regulate your daily life.”

Zero levelwho spoke on the Startup Battlefield stage at Disrupt today, hopes to quickly build this device by adapting the FDA-approved needles used in CGM devices to continuously monitor hormones. This sentence is easy to write. This task is much more difficult because the sensors and even the science behind them are only now being developed. These needles take tiny, sporadic samples interstitial fluidor the fluid found in the spaces around the cells that flows out of the blood capillaries. Measuring glucose in this fluid for CGM devices is common science, but hormones? Not really. At least not yet.

Level Zero’s approach is to create a sensor that detects and measures different hormones by scanning so-called aptamers. These are single-stranded DNA molecules (ssDNA) “that specifically bind to target molecules and undergo reversible conformational changes that can be detected by electrochemical and optical methods,” explains CTO Jia. In other words, they are building a sensor that can detect the molecular density of a particular hormone by determining how much of it binds to aptamer DNA strands.

The first sensors they are working on detect progesterone, estrogen, cortisol and testosterone. They chose these hormones because it would allow their first devices to be used for two important needs: IVF and low testosterone. That’s a combined $30 billion in total addressable markets, according to the founders.

While Level Zero doesn’t plan for consumers to buy the devices directly — they’ll be prescribed by health care providers — they were inspired by home hormone testing kits. Such kits attempt to measure hormones in urine, sweat or saliva, but the results are shaky at best, says Rustamova, who uses the word “pseudoscience” to describe much of the home hormone test market. “The only possible accurate way to measure hormones is to take a drop of blood,” she tells TechCrunch.

But blood draws aren’t entirely helpful either, since they only measure hormone levels in that one slice of 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.

Strong early indicators

The company is less than a year old and has not published any peer-reviewed articles on the progress of its work. So the public can’t yet know if what they’re building will do what they hope it will. According to Rustamova, Level Zero is still keeping its technology close to patent sight vests.

However, there are signs that his scientific approach is sound. Scientists from the Department of Nanosciences at the University of North Carolina published an article in 2016 who documented how they successfully used aptamers to measure progesterone. by 2022, scientists in Hyderabad, Indiasuccessfully created a low-cost sensor.

The founders told TechCrunch that Level Zero has also assembled an impressive group of medical experts as advisors. They include Dr. Aaron Steyer, associate professor at Harvard University and medical director of the CCRM Boston Infertility Clinic; Dr. Kelly Walker, a urologist who works with Himes and is medical director of Posterity Health’s digital male fertility management platform; Dr. Joshua Klein, associate professor of obstetrics and gynecology at Mount Sinai School of Medicine; and biosensor engineer Roel Mingels.

As for the founders, Rustamova was one of those prodigy programmers. When she was 16, she won a contest sponsored by Microsoft that helped her create a portable posture correction device. After graduating with a degree in software engineering, she spent several years at Palantir until she wanted to start a company and joined Entrepreneur First, a program that helps people find their co-founders and ideas. There she met Jia.

“It was love at first sight for both of us,” Rustamova recalled. Gia was a ballerina as a teenager, dancing professionally before being injured. She returned to school to earn a master’s degree in industrial design, studying biomaterials and biosensors. She spent several years working on medical devices at Philips before joining Entrepreneur First.

After founding Level Zero, the co-founders were also accepted into the renowned HAX SOSV deep technology/hardware accelerator program. Among other benefits, HAX gives them access to lab equipment. They say they now have a prototype sensor that has reached a feasibility milestone by detecting progesterone in interstitial fluid at clinical levels.

There’s still a long way to go before Level Zero hits the market, but its roadmap is fast. In addition to the important device milestone, earlier this year the company secured a clinical partnership with IVF clinics in the US. They are preparing their device for two clinical trials in 2025 and will also start production next year. In 2026, the founders plan to conduct clinical trials and begin the FDA approval process.

“We spent an incredible amount of time talking to expert clinicians, researchers in fertility, perimenopause, PCOS (polycystic ovary syndrome) and others to make sure the data we provide is relevant,” Jia said. “We also believe that this is why some of the top names in fertility from Harvard, Mount Sinai and Hims have joined our team and continue to guide us.”