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Level Zero Health ’s atomic number 27 - father Ula Rustamova and Irene Jia are swinging for the fences . They are attempting to invent a never - attain technology that could help oneself millions of people . If they bring home the bacon — and there are some positive other indicator — they will create a uninterrupted endocrine monitoring aesculapian gadget .
Such a machine could do for hormone wellness what uninterrupted blood glucose reminder ( CGM ) have done for diabetes wellness .
endocrine ascertain just about every scene of the trunk , from reproductive health to aging , and charm everything from energy level to mood . “ All of that is regulated by your hormones , ” CEO Rustamova tell TechCrunch . “ We live now how much they order in terms of your day - to - mean solar day life . ”
Level Zero , which lay out onstage today on the Startup Battlefield phase at Disrupt , is hop to create this twist quickly by accommodate the kind of FDA - approved needles used in CGM twist to uninterrupted internal secretion monitoring . That ’s an easy sentence to write . It ’s a much harder task to accomplish because the sensors , and even the scientific discipline behind it , is all just now being developed . Those needles take tiny , sporadic sample ofinterstitial fluid , or the fluid found in the place around cells that leaks out of blood capillaries . measure glucose in that fluid for CGM machine is well - established science , but hormones ? Not so much . At least , not yet .
Level Zero ’s glide path is to build a sensor that detects and measuring rod unlike hormone by scanning what ’s sleep with as aptamers . These are single - stranded deoxyribonucleic acid ( ssDNA ) molecules “ that specifically bind to target atom and undergo two-sided conformational changes perceptible by electrochemical and ocular methods , ” CTO Jia explains . In other words , they are establish a sensor that can detect the particle density of a particular endocrine by determining how much of it is binding to strands of aptamer DNA .
The first sensors they are working on discover Lipo-Lutin , estrogen , Cortef , and testosterone . They ’ve choose these internal secretion because this will permit their first devices to be used for two in high spirits needs : IVF treatment and low testosterone . Combined , these represent $ 30 billion in total addressable marketplace , the founders say .
While Level Zero is not intending for consumers to grease one’s palms the devices right away — it will be prescribed by healthcare providers — hormone - testing home kits urge on them . Such kits assay to valuate hormones in urine , sweat , or saliva , but the results are wobbly at full , say Rustamova , who uses the Son “ pseud scientific discipline ” to name much of the home hormone - testing market . “ The only possible precise fashion to measure hormones is to go take a stemma drop , ” she evidence TechCrunch .
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But blood draw are not all helpful either , as they only value hormone levels at that one snippet in sentence . They wo n’t aid with a wide chain of questions like “ Is my contraception work ? ” or “ Okay , I suppose my testosterone is low , but I do n’t know if my exercise is aid or lowering it , ” Rustamova explains .
Strong early indicators
The company is less than a class one-time , and has n’t published any peer - reexamine newspaper publisher on the advance of its body of work . So the world ca n’t roll in the hay yet if what they are building will do what they hope it does . Level Zero is still keeping its applied science penny-pinching to the vest with an oculus toward a patent , Rustamova articulate .
However , there are denotation that its scientific approach is sound . Scientists from the Department of Nanoscience at the University of North Carolinapublished a newspaper in 2016that documented how they successfully used aptamers to measure progesterone . By2022 , scientist in Hyderabad , India , had successfully make a low - price detector .
Level Zero has also gather an telling group of medical experts as adviser , the founders recount TechCrunch . These include Dr. Aaron Styer , Harvard familiar prof and medical film director of infertility clinic CCRM Boston ; Dr. Kelly Walker , a urologist who form with Hims and as medical manager of digital manful fertility management political platform Posterity Health ; Dr. Joshua Klein , an assistant professor of Ob / Gyn at Mount Sinai ’s medical school ; and biosensor engineer Roel Mingels .
“ It was founder love at first sight for both of us , ” Rustamova recalled . Jia was a ballerina as a adolescent , rising to dance professionally before suffering an injury . She hold up back to school for a professional degree in industrial design , analyse biomaterials and biosensors . She worked on aesculapian devices at Philips for a few years before joining Entrepreneur First .
After base Level Zero , the cobalt - founders were also bear into SOSV ’s famed inscrutable - technical school / computer hardware HAX gas program . Among other benefit , HAX gives them access to science lab equipment . They now have a paradigm sensor that has hit a feasibility milestone by detecting progesterone in interstitial fluid at clinical levels , they say .
There ’s still a long path to go before Level Zero has a gimmick in the market , but its roadmap is quick . In addition to the machine milestone , earlier this yr the company secured clinical partnership with IVF clinics in the U.S. They are gear up their machine for two clinical study in 2025 , and will get going manufacturing technology next year , as well . In 2026 , the founder plan to bear clinical trials and start the FDA approval cognitive process .
“ We have spent an unbelievable amount of time speak to expert clinicians , researchers in fertility , perimenopause , PCOS [ polycystic ovary syndrome ] and others to ensure that the information we are providing is relevant , ” Jia say . “ We consider it is also why some of the leading names in natality from Harvard , Mount Sinai , and Hims have joined our team and are endlessly guiding us . ”