Level Zero Health’s co-founders Ula Rustamova and Irene Jia are swinging for the fences. They are attempting to invent a never-achieved technology that could help millions of people. If they succeed — and there are some positive early indicators — they will create 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 just about every aspect of the body, from reproductive health to aging, and influence everything from energy level to mood. âAll of that is regulated by your hormones,â CEO Rustamova told TechCrunch. âWe know now how much they regulate in terms of your day-to-day life.â
Level Zero, which presented onstage today on the Startup Battlefield stage at Disrupt, is hoping to create this device quickly by adapting the kind of FDA-approved needles used in CGM devices to continuous hormone monitoring. Thatâs an easy sentence to write. Itâs a much harder task to accomplish because the sensors, and even the science behind it, is all just now being developed. Those needles take tiny, sporadic samples of interstitial fluid, or the fluid found in the spaces around cells that leaks out of blood capillaries. Measuring glucose in that fluid for CGM devices is well-established science, but hormones? Not so much. At least, not yet.
Level Zeroâs approach is to build a sensor that detects and measures different hormones by scanning whatâs known as aptamers. These are single-stranded DNA (ssDNA) molecules âthat specifically bind to target molecules and undergo reversible conformational changes detectable by electrochemical and optical methods,â CTO Jia explains. In other words, they are 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.
The first sensors they are working on detect progesterone, estrogen, cortisol, and testosterone. Theyâve chosen these hormones because this will allow their first devices to be used for two high needs: IVF treatments and low testosterone. Combined, these represent $30 billion in total addressable markets, the founders say.
While Level Zero is not intending 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 âpseudo scienceâ to describe much of the home hormone-testing market. âThe only possible accurate way to measure hormones is to go take a blood drop,â she tells TechCrunch.
But blood draws are not wholly helpful either, as they only measure hormone levels at that one snippet in time. They wonât help with a wide range of questions like âIs my contraception working?â or âOkay, I think my testosterone is low, but I don’t know if my exercise is helping or lowering it,â Rustamova explains.
The company is less than a year old, and hasnât 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.
However, there are indications 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.
Level Zero has also assembled an impressive group of medical experts as advisors, the founders tell TechCrunch. These include Dr. Aaron Styer, Harvard associate professor and medical director of infertility clinic CCRM Boston; Dr. Kelly Walker, a urologist who works with Hims and as medical director of digital male fertility management platform Posterity Health; Dr. Joshua Klein, an assistant professor of Ob/Gyn at Mount Sinaiâs medical school; and biosensor engineer Roel Mingels.
As for the founders, Rustamova was one of those wunderkind programmers. She won a Microsoft-sponsored competition when she was 16 that led her to help create a wearable posture-correcting device. After her software engineering degree, she spent several years at Palantir, until she itched to found a company and joined Entrepreneur First, a program that helps people find both their co-founders and an idea. Thatâs where she met Jia.
âIt was founder love at first sight for both of us,â Rustamova recalled. Jia was a ballerina as a teen, rising to dance professionally before suffering an injury. She went back to school for a masters degree in industrial design, studying biomaterials and biosensors. She worked on medical devices at Philips for a few years before joining Entrepreneur First.
After founding Level Zero, the co-founders were also accepted into SOSVâs famed deep-tech/hardware HAX accelerator program. Among other benefits, HAX gives them access to lab equipment. They now have a prototype sensor that has hit a feasibility milestone by detecting progesterone in interstitial fluid at clinical levels, they say.
Thereâs still a long way to go before Level Zero has a device in 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 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 conduct clinical trials and begin the FDA approval processes.
âWe have spent an incredible amount of time speaking to expert clinicians, researchers in fertility, perimenopause, PCOS [polycystic ovary syndrome] and others to make sure that the data we are providing is relevant,â Jia said. âWe believe it is also why some of the leading names in fertility from Harvard, Mount Sinai, and Hims have joined our team and are continuously guiding us.â
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