Stage Zero Well being co-founders Ula Rustamova and Irene Jia swing for the fences. They’re making an attempt to invent an unrealized expertise that might assist hundreds of thousands of individuals. In the event that they succeed—and there are some early optimistic indicators—they may create a medical gadget for steady hormone monitoring.
Such a tool might do for hormonal well being what steady blood glucose displays (CGMs) have executed for diabetes well being.
Hormones management nearly each facet of the physique, from reproductive well being to getting older, and affect every little thing from power ranges to temper. “All of that is regulated by your hormones,” CEO Rustamova informed TechCrunch. “We now understand how a lot it regulates when it comes to your each day life.”
Stage Zero, which was introduced on the Startup Battlefield stage at Disrupt at the moment, hopes to shortly create this gadget by adapting the kind of FDA-approved needles utilized in CGM units to steady hormone monitoring. It’s a simple sentence to write down. It's a way more tough activity to perform as a result of the sensors, and even the science behind them, are simply now being developed. These needles take tiny, sporadic samples of interstitial fluid, or the fluid discovered within the areas round cells that leak from blood capillaries. Measuring glucose in that fluid for CGM units is effectively established science, however hormones? Not a lot. No less than not but.
Stage Zero's strategy is to construct a sensor that detects and measures completely different hormones by scanning what are referred to as aptamers. These are single-stranded DNA (ssDNA) molecules “that bind particularly to focus on molecules and endure reversible conformational modifications detectable by electrochemical and optical strategies,” explains CTO Jia. In different phrases, they’re constructing a sensor that may detect the molecular density of a specific hormone, figuring out how a lot of it binds to aptamer DNA strands.
The primary sensors they’re engaged on detect progesterone, estrogen, cortisol and testosterone. They selected these hormones as a result of it’ll enable their first units for use for 2 huge wants: IVF remedies and low testosterone. Mixed, these characterize $30 billion in complete addressable markets, the founders say.
Though Stage Zero doesn't intend for shoppers to purchase the units outright — they are going to be prescribed by healthcare suppliers — the hormone testing kits impressed them. Such kits try and measure hormones in urine, sweat or saliva, however the outcomes are unreliable at greatest, says Rustamova, who makes use of the phrase “pseudoscience” to explain a lot of the house hormone testing market. “The one correct means attainable to measure hormones is to take a drop of blood,” she tells TechCrunch.
However blood attracts aren't completely helpful both, as a result of they solely measure hormone ranges at that fraction in time. They received't assist with a variety of questions like “Is my contraception working?” or “Okay, I feel my testosterone is low, however I don't know if my train helps it or decreasing it,” Rustamova explains.
Robust early indicators
The corporate is lower than a yr previous and has not revealed any peer-reviewed work on the progress of its work. So the general public can't but know if what they're constructing will do what they hope. Stage Zero continues to be holding its expertise near the vest, with a watch towards a patent, Rustamova says.
Nevertheless, there are indications that his scientific strategy is sound. Scientists within the Division of Nanoscience on the College of North Carolina revealed a paper in 2016 documenting how they efficiently used aptamers to measure progesterone. By 2022, scientists in Hyderabad, India have efficiently created a low-cost sensor.
Stage Zero has additionally assembled a powerful group of medical consultants as advisors, the founders inform TechCrunch. They embody Dr. Aaron Styer, Harvard Affiliate Professor and Medical Director of the CCRM Boston Infertility Clinic; Dr. Kelly Walker, a urologist who works with Hims and as medical director of digital male fertility administration platform Posterity Well being; Dr. Joshua Klein, Assistant Professor of Ob/Gyn at Mount Sinai College of Drugs; and biosensor engineer Roel Mingels.
As for the founders, Rustamova was a type of superior programmers. She received a contest sponsored by Microsoft when she was 16, which led her to assist create a posture-correcting gadget. After her software program engineering diploma, she spent a number of years at Palantir till she wished to start out an organization and joined Entrepreneur First, a program that helps individuals discover each their co-founders and an concept. There he met Jia.
“It was love at first sight for each of us,” Rustamova recalled. Jia was a teenage ballerina rising as much as dance professionally earlier than struggling an harm. He returned to highschool for a grasp's diploma in industrial design, finding out biomaterials and biosensors. He labored for a number of years in medical units at Philips earlier than becoming a member of Entrepreneur First.
After founding Stage Zero, the co-founders had been additionally accepted into SOSV's well-known HAX deep-tech/hardware accelerator program. Amongst different advantages, HAX offers them entry to laboratory tools. They now have a prototype sensor that has reached a feasibility stage by detecting progesterone in interstitial fluid at medical ranges, they are saying.
There's nonetheless an extended strategy to go earlier than Stage Zero has a tool available on the market, however the roadmap is quick. Along with the gadget milestone, earlier this yr the corporate secured medical partnerships with IVF clinics within the US. They’re making ready their gadget for 2 medical trials in 2025 and can start engineering subsequent yr as effectively. In 2026, the founders plan to conduct medical trials and start FDA approval processes.
“I spent an unbelievable period of time speaking to knowledgeable clinicians, fertility researchers, perimenopause, PCOS [polycystic ovary syndrome] and others to ensure the info we offer is related,” Jia stated. “We consider that is additionally why a few of the high names in fertility from Harvard, Mount Sinai and Hims have joined our crew and proceed to information us.”