Ula Rustamova and Irene Jia, co-founders of Level Zero Health, advocate that position. They are inventing previously unrealized technology that can help millions of people. If they are successful, and there are some positive early indicators, medical devices that continuously monitor hormones will be developed.
Such devices could have the same benefits for hormonal health that continuous glucose monitors (CGMs) have had for diabetic health.
Hormones control nearly every aspect of your body, from reproductive health to aging, and influence everything from your energy levels to your mood. “All of this is controlled by hormones,” CEO Rustamova told TechCrunch. “We now know how much they regulate your daily life.”
Level Zero, which presented on Disrupt's Startup Battlefield stage today, hopes to quickly create this device by adapting the FDA-approved needles used in CGM devices for continuous hormone monitoring. It's an easy sentence to write. Achieving this is a much more difficult challenge as the sensors and even the science behind them are all currently under development. These needles take small, sporadic samples of interstitial fluid, the fluid in the spaces around cells that leaks from capillaries. Measuring glucose in fluids with CGM devices is a well-established science, but what about hormones? There aren't that many. At least not yet.
Level Zero's approach is to build sensors that detect and measure different hormones by scanning for what are known as aptamers. These are single-stranded DNA (ssDNA) molecules that “bind specifically to target molecules and undergo reversible structural 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 measuring how much of it is bound to an aptamer DNA strand.
The first sensor they are working on detects progesterone, estrogen, cortisol, and testosterone. They chose these hormones because it would allow their first device to be used for two high needs: IVF treatment and low testosterone. Together, the founders say the total addressable market is worth $30 billion.
Although Level Zero is not intended for consumers to purchase the device directly, but rather to be prescribed by a healthcare provider, the home kit for hormone testing has inspired consumers. Although such kits attempt to measure hormones in urine, sweat, and saliva, Rustamova, who uses the word “pseudoscience” to describe much of the home hormone testing market, says, “At best, the results are poor. It's unstable.” “The only accurate way to measure hormones is to go get blood drawn,” she told TechCrunch.
However, a blood draw is completely useless as it only measures hormone levels at that moment. They won't answer broad questions like “Is my birth control effective?” “Well, I think my testosterone is low, but I don't know if exercise is helping it or lowering it,” Rustamova explains.
Level Zero Health co-founders Ula Rustamova and Irene Jia Image credit: Level Zero Health
strong early indicators
The company is less than a year old and has yet to publish a peer-reviewed paper on the progress of its efforts. Therefore, the public still does not know whether what they are building will have the desired effect. Rustamova said Level Zero continues to perfect its technology with the goal of patenting it.
But there are signs that the scientific approach is sound. Scientists from the University of North Carolina's Department of Nanoscience published a paper in 2016 documenting how they successfully measured progesterone using an aptamer. By 2022, scientists in Hyderabad, India, have successfully created a low-cost sensor.
Level Zero has also assembled an impressive group of medical experts as advisors, its founders told TechCrunch. These include Dr. Aaron Steyer, associate professor at Harvard University and medical director of fertility clinic CCRM Boston; Dr. Kelly Walker is a urologist who works with Hims and is the medical director of Posterity Health, a digital male fertility management platform. Dr. Joshua Klein, assistant professor of obstetrics and gynecology at Mount Sinai School of Medicine. and biosensor engineer Roel Mingels.
As for the founders, Rustamova was one of the genius programmers. At the age of 16, she won a contest sponsored by Microsoft, which led her to work on developing wearable posture correction devices. After earning a degree in software engineering, she spent a few years at Palantir, but itching to start a company, she joined Entrepreneur First, a program that helps find both co-founders and ideas. I did. There she met Gia.
“For both of us, it was love at first sight for the founders,” Rustamova recalls. Gia was a ballerina in her teens and started dancing professionally, but suffered an injury. She went back to school for a master's degree in industrial design, studying biomaterials and biosensors. Before joining Entrepreneur First, she spent several years working in medical device development at Philips.
After founding Level Zero, the co-founders were also accepted into SOSV's prestigious Deep Technology/Hardware HAX Accelerator Program. HAX provides access to lab equipment, among other benefits. They say they have now completed a prototype sensor that has reached the feasibility milestone of detecting progesterone in interstitial fluid at clinical levels.
Level Zero still has a long way to go to bring its devices to market, but its roadmap is fast. In addition to the device milestone, the company secured a clinical partnership with an IVF clinic in the United States earlier this year. They are preparing the device for two clinical studies in 2025, and plan to begin manufacturing engineering next year. In 2026, the founders plan to conduct clinical trials and begin the FDA approval process.
“We have spent an incredible amount of time speaking with clinicians and researchers who are experts in fertility, menopause, and PCOS. [polycystic ovary syndrome] This is to ensure that the data we provide is relevant,” Jia said. “We believe that is also why some of the biggest names in the fertility field from Harvard, Mount Sinai, and Hims have joined our team and continue to mentor us.”