Stage Zero Well being’s co-founders Ula Rustamova and Irene Jia are swinging for the fences. They’re trying to invent a never-achieved expertise that might assist tens of millions of individuals. In the event that they succeed — and there are some constructive early indicators — they are going to create a steady hormone monitoring medical system.
Such a tool may do for hormone well being what steady blood glucose screens (CGM) have executed for diabetes well being.
Hormones management nearly each facet of the physique, from reproductive well being to getting older, and affect every part from vitality degree to temper. “All of that’s regulated by your hormones,” CEO Rustamova informed TechCrunch. “We all know now how a lot they regulate by way of your day-to-day life.”
Stage Zero, which introduced onstage at this time on the Startup Battlefield stage at Disrupt, is hoping to create this system shortly by adapting the type of FDA-approved needles utilized in CGM gadgets to steady hormone monitoring. That’s a simple sentence to jot down. It’s a a lot tougher job to perform as a result of the sensors, and even the science behind it, is all simply now being developed. These needles take tiny, sporadic samples of interstitial fluid, or the fluid discovered within the areas round cells that leaks out of blood capillaries. Measuring glucose in that fluid for CGM gadgets is well-established science, however hormones? Not a lot. At the least, not but.
Stage Zero’s method is to construct a sensor that detects and measures completely different hormones by scanning what’s often known as aptamers. These are single-stranded DNA (ssDNA) molecules “that particularly bind to focus on molecules and bear reversible conformational modifications detectable by electrochemical and optical strategies,” CTO Jia explains. In different phrases, they’re constructing a sensor that may detect the molecule density of a selected hormone by figuring out how a lot of it’s binding to strands of aptamer DNA.
The primary sensors they’re engaged on detect progesterone, estrogen, cortisol, and testosterone. They’ve chosen these hormones as a result of it will permit their first gadgets for use for 2 excessive wants: IVF therapies and low testosterone. Mixed, these signify $30 billion in complete addressable markets, the founders say.
Whereas Stage Zero is just not intending for customers to purchase the gadgets instantly — will probably be prescribed by healthcare suppliers — hormone-testing residence kits impressed them. Such kits try and measure hormones in urine, sweat, or saliva, however the outcomes are wobbly at greatest, says Rustamova, who makes use of the phrase “pseudo science” to explain a lot of the house hormone-testing market. “The one attainable correct method to measure hormones is to go take a blood drop,” she tells TechCrunch.
However blood attracts are usually not wholly useful both, as they solely measure hormone ranges at that one snippet in time. They received’t assist with a variety of questions like “Is my contraception working?” or “Okay, I believe my testosterone is low, however I don’t know if my train helps or reducing it,” Rustamova explains.
Robust early indicators
The corporate is lower than a 12 months outdated, and hasn’t revealed any peer-reviewed papers on the progress of its work. So the general public can’t know but if what they’re constructing will do what they hope it does. Stage Zero continues to be maintaining its expertise near the vest with a watch towards a patent, Rustamova says.
Nonetheless, there are indications that its scientific method is sound. Scientists from the Division of Nanoscience on the College of North Carolina revealed a paper in 2016 that documented how they efficiently used aptamers to measure progesterone. By 2022, scientists in Hyderabad, India, had efficiently created a low-cost sensor.
Stage Zero has additionally assembled a formidable group of medical specialists as advisors, the founders inform TechCrunch. These embody Dr. Aaron Styer, Harvard affiliate 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 administration platform Posterity Well being; Dr. Joshua Klein, an assistant professor of Ob/Gyn at Mount Sinai’s medical faculty; and biosensor engineer Roel Mingels.
As for the founders, Rustamova was a type of wunderkind programmers. She received a Microsoft-sponsored competitors when she was 16 that led her to assist create a wearable posture-correcting system. After her software program engineering diploma, she spent a number of years at Palantir, till she itched to discovered an organization and joined Entrepreneur First, a program that helps individuals discover each their co-founders and an concept. That’s the place she met Jia.
“It was founder love at first sight for each of us,” Rustamova recalled. Jia was a ballerina as a teen, rising to bop professionally earlier than struggling an harm. She went again to high school for a masters diploma in industrial design, learning biomaterials and biosensors. She labored on medical gadgets at Philips for a number of years earlier than becoming a member of Entrepreneur First.
After founding Stage Zero, the co-founders have been additionally accepted into SOSV’s famed deep-tech/{hardware} HAX accelerator program. Amongst different advantages, HAX offers them entry to lab gear. They now have a prototype sensor that has hit a feasibility milestone by detecting progesterone in interstitial fluid at scientific ranges, they are saying.
There’s nonetheless an extended method to go earlier than Stage Zero has a tool out there, however its roadmap is quick. Along with the system milestone, earlier this 12 months the corporate secured scientific partnerships with IVF clinics within the U.S. They’re readying their system for 2 scientific research in 2025, and can begin manufacturing engineering subsequent 12 months, as nicely. In 2026, the founders plan to conduct scientific trials and start the FDA approval processes.
“Now we have spent an unbelievable period of time chatting with knowledgeable clinicians, researchers in fertility, perimenopause, PCOS [polycystic ovary syndrome] and others to guarantee that the information we’re offering is related,” Jia stated. “We consider it’s also why a few of the main names in fertility from Harvard, Mount Sinai, and Hims have joined our group and are repeatedly guiding us.”
