Stage Zero Wellbeing co-founders Ula Rustamova and Irene Jia are fighting for it. They are trying to invent a never-before-realized technology that could help millions of people. If they are successful, and there are some positive early indicators, they will create a continuous hormone monitoring medical device.
Such a device could do for hormonal health what continuous blood glucose monitors (CGMs) have done for diabetes health.
Hormones control nearly every aspect of the body, from reproductive health to aging, and influence everything from energy level to mood. “All of that is regulated by hormones,” CEO Rustamova told TechCrunch. “Now we know how much they regulate in terms of their daily lives.”
Level Zero, which debuted today on the Startup Battlefield stage at Disrupt, hopes to create this device quickly by adapting the type of FDA-approved needles used in CGM devices to continuous hormone monitoring. That's an easy sentence to write. It's a much more difficult task to accomplish because the sensors, and even the science behind them, are just being developed. These needles take tiny, sporadic samples of interstitial fluid, or the fluid in the spaces around cells that leaks from blood capillaries. Measuring glucose in that liquid for CGM devices is well-established science, but hormones? Not so much. At least not yet.
Stage Zero's approach is to build a sensor that detects and measures different hormones by scanning what are known as aptamers. These are single-stranded DNA (ssDNA) molecules “that specifically bind to target molecules and undergo reversible conformational changes detectable by electrochemical and optical methods,” explains CTO Jia. In other words, they are building a sensor that can detect the molecular density of a specific hormone by determining how much of it binds to strands of DNA aptamer.
The first sensors they are working on detect progesterone, estrogen, cortisol and testosterone. They have chosen these hormones because they will allow their first devices to be used for two important needs: IVF treatments and low testosterone levels. Combined, these represent $30 billion in total addressable markets, the founders say.
While Stage Zero does not intend for consumers to purchase the devices directly (they will be prescribed by healthcare providers), they were inspired by the at-home hormone testing kits. These 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 at-home hormone testing market. . “The only possible and accurate way to measure hormones is to take a drop of blood,” he tells TechCrunch.
But blood draws are not entirely useful either, since they only measure hormone levels in that fragment over time. They won't help with a wide range of questions like “Is my birth control working?” or “Okay, I think my testosterone is low, but I don't know if my exercise helps or scales it back,” 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 know yet if what they are building will work as they expect. Stage Zero is still keeping its technology secret with an eye toward a patent, Rustamova says.
However, there are signs that its scientific approach is sound. Scientists from the Department of Nanoscience at the University of North Carolina published a paper in 2016 that documented how they successfully used aptamers to measure progesterone. By 2022, scientists in Hyderabad, India had successfully created a low-cost sensor.
Stage Zero has also assembled an impressive group of medical experts as advisors, the founders tell TechCrunch. They include Dr. Aaron Styer, associate professor at Harvard and medical director of the CCRM Boston infertility clinic; Dr. Kelly Walker, a urologist with Hims and medical director of digital male fertility management platform Posterity Wellbeing; Dr. Joshua Klein, assistant professor of Obstetrics and Gynecology at Mount Sinai School of Medicine; and biosensors engineer Roel Mingels.
As for the founders, Rustamova was one of those prodigy programmers. She won a contest sponsored by Microsoft when she was 16, which led her to help create a wearable posture-correcting device. After graduating in software engineering, he spent several years at Palantir, until he wanted to start a company and joined Entrepreneur First, a program that helps people find both their co-founders and a concept. There he met Jia.
“For both of us it was a founding love at first sight,” Rustamova recalls. Jia was a dancer as a teenager and went on to dance professionally before suffering an injury. He returned to school to earn a master's degree in industrial design, studying biomaterials and biosensors. He worked in medical devices at Philips for a few years before joining Entrepreneur First.
After founding Stage Zero, the co-founders were also accepted into SOSV's famous {hardware} and deep tech HAX accelerator program. Among other benefits, HAX gives them access to laboratory equipment. They now have a prototype sensor that has reached a feasibility milestone by detecting progesterone in interstitial fluid at clinical levels, they say.
There's still a long way to go before Stage Zero has a device on the market, but its roadmap is fast. In addition to the device milestone, earlier this year the company secured clinical partnerships with IVF clinics in the US. They are preparing their device for two clinical studies in 2025 and will also begin engineering manufacturing next year. In 2026, the founders plan to conduct clinical trials and begin FDA approval processes.
“We've spent an incredible amount of time talking to medical experts, researchers in fertility, perimenopause, polycystic ovary syndrome. [polycystic ovary syndrome] and others to make sure the data we provide is relevant,” Jia said. “We believe it is also why some of the leading names in fertility from Harvard, Mount Sinai and Hims have joined our team and continually guide us.”
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