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“ One of our investors state us there are companies who build underlying technologies and there are caller who build wrapper around that engineering ; you guys are creating Modern applied science here , ” says co - founding father and CEO Ula Rustamova , discuss the companionship ’s development since we last hold in with themlast fallwhen they presented onstage at TechCrunch Disrupt as part of the Startup Battlefield competition .
“ The goal is to create a whole new marketplace out of this , correct ? The same way CGMs [ continuous glucose varan ] did . They literally , out of nothing , make a multibillion - dollar market , ” she go on . “ This is , by definition , a whole new mathematical product category of its own — that hopefully will urge masses to use the gimmick and the datum to create a lot of company on top of that and have a ripple result in the next few X . ”
Step by step
Building a whole new product category of any stripe can take prison term . agent in this being a hardware startup , and a medical gadget to the boot , it ’s clear Level Zero Health is n’t going to be able to serve up a paradigm shift in how internal secretion are monitored overnight .
This is why the team is also working on a stepping stone single - utilization product ( pictured above in prototype form ) , which they hope to get cleared for prescription medicine function next year — to bear out intermittent hormone examination associate with medical use subject such as fertility ( IVF ) and low testosterone ( TRT ) .
The current paradigm wearable contains tiny needles that allow it to take samples just under the cutis to notice trace total of hormones .
This is a step toward the hormone monitoring wearable they ultimately hope to bring to mart — tentatively slat for 2028 — that ’s able to pull a uninterrupted measure of things like progesterone , estrogen , and testosterone from the wearer ’s interstitial fluid . ( That is fluid that fulfill the space around cell , acting as an intermediary between descent plasm and cells — hence why biochemical compounds in the rake can also be find in interstitial fluid . )
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A continuous internal secretion monitoring twist — or , rather , the data it picks up — could dally a transformative role in boosting scientific understanding of the use hormones meet in human biology — much like CGMs have transformed diabetes direction ( and more besides ) .
But Level Zero Health is also building a business — initially a B2B stage business , take aim to trade technology into health care provider networks — so the founders are do work on duplicate product ontogenesis tracks to foreshorten meter - to - market and bridge the interruption between the big bang mission and what ’s presently possible .
“ We think that we have this source of Sojourner Truth that we can knock into — which is interstitial fluid , ” Rustamova tells TechCrunch . “ And we think that there ’s an immediate , short - term intersection here that we should found first .
“ The idea is that uninterrupted [ internal secretion monitoring ] … is the holy Sangraal — that is the future — because it makes sense , in a way because it ’s again frictionless , you may put it on , and you may sort of get really uniform measuring . But also we understand that , today , we postulate to enrol the market in a way where we would not taste to change the protocol — and not have a seven - year enquiry motion of ‘ let ’s try and understand this data point ’ — so our first equipment is really similar to finger stick devices , but it ’s also a patch . ”
The prototype wearable is capable to take mensuration throughout the day when worn — draw out a serial of information points with the goal of “ delivering value right away ” for use cases such as IVF , where a woman might otherwise need to have multiple roue line to supervise hormone levels .
Rustamova pronounce the team hopes to have concluded clinical trial and secured clearance for this single - use intermittent monitoring patch next year — with eye on obtaining blessing both from the U.S. governor , the FDA , and a CE stigmatize to allow them to sell into European healthcare market ( she order they ’re not certain which may come first ) .
“ Hopefully , this year we desire to show some level of correlation [ between levels of hormone the wearable patch can discover and grade detected via a rake attraction ] — that ’s the hope I want to deliver with the pre - seed money , ” she contribute .
CTO and co - founder Irene Jia tells us the team ’s finish is to be able-bodied to demonstrate a 90%+ correlation with what their patch can pick up compared to measuring hormone levels via a blood draw .
Risk vs. reward
Although afterward on — when we ’re discussing the holdup between blood - base readings and detection via interstitial fluid — Rustamova chimes in to underscore the difference of opinion in aesculapian risk between CGMs and hormone monitoring . She points out that the peril for someone with diabetes ( i.e. , if blood glucose reading are detain or off ) is likely to be super mellow , whereas hormone monitoring is typically not that in high spirits stake .
“ For glucose , you have possible deadly issue of giving a untimely version or having that time lag … [ but when it comes to hormone monitoring ] the peril of get a slim deviation or sort of correlation not being as tight , ” she tell us . “ Obviously , we ’re buy the farm to stress and correlate as much as possible — but … there ’s this very different risk profile here . ” She also noted that the first CGMs to mart had a lower correlativity with blood readings than these devices now do .
The suggestion is the team ’s goal is to keep raising the bar on accuracy . Which — perhaps — hint at the reason investors have been keen to pile into this medtech inauguration ’s former round — with the possible advantage versus risks being skewed in a overconfident direction .
The other — doubtless — helpful element here is that Level Zero Health is n’t solely focused on woman ’s health issues ; monitoring manlike endocrine is a core slice of the initial line programme . ( And it remains the example that most tech investors are still men put bets on solving problem that talk to their pastime . )
Level Zero Health ’s pre - seed financial backing circle was direct by European VC Redalpine . HAX ( SOSV ) , Entrepreneur First ( EF ) , and industry experts also chip in to the daily round — with SOSV having previously take the inauguration onto its deeptech / computer hardware HAX accelerator program , and Rustamova also being an EF alum .
Commenting in a instruction , Philip Kneis , investor at Redalpine and a Level Zero Health display panel appendage , said : “ We did it for blood pressure and will do it again for hormones . uninterrupted endocrine measurement is one of the holy grails of diagnostics , and as primal skill transitions to technology , we could n’t be more delirious to back Level Zero Health in their mission to transform endocrine trailing with their novel biosensor — paving the way for a new era of personalized health direction . ”
