UK medtech startup Acurable has gained FDA clearance for a novel wireless diagnostic device for remote detection of obstructive sleep apnea (OSA). A formal launch into the US market is slated to follow this summer. Its wearable is already being used by a number of hospitals in the UK (where it launched in 2021) and in the European Union, after obtaining local regulatory clearances in the region.
The startup, which was founded back in 2016, is the brainchild of Imperial College professor Esther Rodriguez-Villegas, director of the university’s Wearable Technologies Lab, who spent some 1.5 decades conducting research into using acoustic sensing for tracking respiratory biomarkers to diagnose cardiorespiratory conditions — work that underpins the commercial hardware.
The London-based startup raised an €11 million Series A round (~$11.8M) back in October with its eye on the US launch. Prior to that it received £1.8M (~$2.2M) in across three different grants from Innovate UK, a national body which supports product commercialization. Private investors in the medtech startup include Madrid-based Alma Mundi Ventures, London’s Kindred Capital and KHP Ventures, a healthcare-focused venture fund also in the UK which is a collaboration between two NHS Hospital Trusts (King’s College and Guy’s and St Thomas’) and King’s College London.
OSA refers to a chronic respiratory condition characterized by pauses in breathing caused by the person’s upper airway being obstructed during sleep. It’s thought to affect a small percentage of adults — around 1.5 million adults in the UK; and some 25M in the US (with many more people affected across the world) — and while not immediately life-threatening it can be linked to serious health implications since it can contribute to conditions such as cardiovascular disease, diabetes, dementia and even heart attacks, making treatment or management important.
Healthcare services often struggle to manage chronic conditions, given the expense of long term monitoring. But Rodriguez-Villegas explains that in the case of sleep apnea there is even a challenge for healthcare services to diagnose the condition — since traditional polysomnography tests are inconvenient and/or costly. (The patient is either asked to sleep overnight at a special center, where they’re fitted out with a bunch of wired sensors. Or else they are trained how to fit the various electrodes themselves at home, with the associated risk that the test will have to be repeated if sensors are incorrectly fitted or get detached during sleep.)
Acurable’s tiny, self-applied wearable has been designed to offer a far more patient-friendly (and cost effective way) for diagnosis of the condition — allowing for the testing to be both remote (in patients’ homes) and super simple so patients can self-administer it.
One early adopter of Acurable’s product — Dr Michael Harrison, a professor of surgery and pediatrics at the Children’s Hospital at UCSF — offers strong praise, writing in a supporting statement that the device has been “game-changing for our patients, as it is a much simpler and comfortable experience”, as well as talking up how it “enables clinicians to conduct multiple night studies at a time, improving patient outcomes by giving them a much speedier diagnosis”.
For her part, Rodriguez-Villegas says she saw a role for developing technologies to solve problems with a significant social impact by addressing healthcare bottlenecks associated with chronic (and often under-diagnosed) respiratory conditions, starting with sleep apnea. So the plan is for her startup to bring more wearables to market in future, for other respiratory conditions, such as COPD and asthma — all based on the core acoustic sensing IP developed for the first device.
“What I realised early on was that [chronic cardiorespiratory conditions] will not be something that could be solved if we continue with [traditional healthcare] processes — that it’s not a matter of pumping money into the system. Because there is also human resources. So you need the clinicians, the nurses, you need to understanding. So that’s where where my journey started with tech,” she tells TechCrunch. “Deciding how do we create techs that can solve the bottlenecks and make patients’ lives better?”
While core research underpinning the product has taken well over a decade, designing, prototyping and building the actual product took around six or seven years, according to Rodriguez-Villegas — so working on things like miniaturizing the hardware and designing a UX with high accessibility so it’s easy for patients of all ages (and tech abilities) to use which she says was a huge priority for her.
“The app is designed so that there is no room for a stress or failure,” she says, explaining how she pushed her design team to avoid assuming users would know how to navigate traditional software menu structures. “I had had to have lots of conversations with my UI people in the beginning because they couldn’t understand where it was coming from.”
A patient self administering the AcuPebble with guidance from the app (Photo credit: Acurable)
As for the hardware, the startup’s one-shot sensing device, which is called the AcuPebble, looks a bit like a coffee pod that’s been colored an Apple-esque shade of shiny white. So sleek and minimalist looking is it that it resembles some kind of consumer device, rather than a medical instrument, with no utility grey plastic or scary bundles of cables in sight.
This purist look is entirely by design — reflecting Acurable’s overarching mission to rethink a convoluted diagnostic bottleneck using sensor-driven automation.
Patients use the AcuPebble at home where it’s worn overnight stuck to the the skin of their neck (using a patented adhesive). It’s also a single-use medical device — gathering and uploading enough data across one night’s tracking of the sleeper’s breathing to produce a diagnosis. (So to borrow another piece of Apple lore, you could say it’s designed to ‘just work’.)
The kit works by using tiny