NHS-backed Accurable to launch sleep apnea testing device in the US

Following a successful launch in Europe, London-based medical device company Accurable is aiming to revolutionize sleep apnea diagnosis for Americans with the launch of its AcuPebble device for obstructive sleep apnea (OSA) diagnosis in the US.

The extremely patient-friendly device, which is already used by the NHS to improve upon the current time-consuming home sleep apnea diagnosis method, enables remote and efficient home sleep apnea testing, allowing for the early detection of this chronic condition, Allows for faster treatment and better management. ,

The AcuPebble device has received a new approval from the US Food and Drug Administration (FDA), and Acurable plans to launch the device in the US this summer.

OSA affects around 1.5 million adults in the UK and 25 million adults in the US, and repeatedly stop people from breathing while they sleep. If left untreated, it is linked to serious health conditions, including heart attack, diabetes and dementia.

Despite its prevalence, an estimated 85% of adults worldwide are not diagnosed and current testing procedures are complex and expensive. Currently, patients need to go to hospital to be trained to use the testing equipment, which involves using inconvenient wired sensors at home.

About 10-20% of these sleep tests have to be repeated because the sensors become dislodged or are not placed correctly by the patient. Once the results are available, a specialist needs to spend up to two hours manually interpreting the signals.

A more patient-friendly solution

The AcuPebble device provides a much cheaper, faster, safer, eco-friendly and patient-friendly solution. AcuPebble is the world’s first medical device capable of continuously and accurately extracting respiratory biomarkers, enabling automated diagnosis of OSA.

To use the device, the patient has to attach the sensor to the front of their neck before sleeping. The sensor transfers the signal to a mobile device, which uploads the data to a secure platform. A doctor then receives a report with a diagnosis.

Thanks to the ease of use, no patient training or healthcare professional involvement is required to explain how to use the device and very few tests have to be repeated (~1%).

This means that sleep testing can be significantly scaled up, saving time for both clinicians and patients. It also reduces the risk of infection by reducing the need for patients to visit the hospital.

The EU version of the device has been used by the NHS for the past two years as an established alternative to conventional testing procedures.

A study conducted at the Royal Free Hospital, a center of excellence in respiratory medicine in the UK, demonstrated the safety and effectiveness of Acupable against multi-channel polygraphy (94% positive predictive value, 98% negative predictive value, with positive and negative probability) performed. ratios greater than 10 and below 0.1, respectively). 100% of patients in this study successfully completed the test without any training or support.

Its FDA approved version of the device is customized to target very specific needs of the US healthcare system. This follows their recent €11M Series A funding round, which was tied to KHP Ventures, the first NHS-anchored venture fund in the UK.

The most recent FDA cleared device, the Acupable Ox 100, provides a complete sleep report, and a comprehensive set of channels, including, among others, heart rate and signal, activity, snoring, oxygen saturation, respiratory phase, and airflow .

In addition, the device is very comfortable to wear and allows the patient to have a completely natural, undisturbed sleep at home. This provides more reliable OSA diagnostic results and facilitates other clinically useful applications such as multi-night testing or monitoring the evolution of the condition.

This breakthrough patented technology comes after a decade of research by Accurable’s founder, Professor Esther Rodriguez Villegas, at the Wearable Technologies Lab at Imperial College London.

AcuPebble has been recognized as a breakthrough in respiratory therapy, winning some of the most respected awards in the industry. Accurable is predicting that it will grow its team by 300% this year as it expands its business in the US.

Rodriguez-Villegas says: “We already have a lot of interest from US physicians who believe this could be transformative for the millions of Americans who have undiagnosed sleep apnea, putting them at risk for other serious health conditions Is.

“Yet, accessing a diagnosis and diagnostic test has been inconvenient and inconvenient for patients for too long, and too time-consuming for physicians.

“The AcuPebble device is set to change that, making it much easier for patients to get tested and for doctors to access results, saving billions of dollars in the process.”

Sleep has long been an issue in both the UK and the US, with not only sleep apnea but simple day-to-day issues causing insomnia.

The issue of sleep deprivation has been addressed in the digital health sector for several years, exemplified by the 2019 roll-out of the Sleepio app in London, a cognitive behavioral therapy (CBT)-based program that can be accessed via Is. Smartphone or web.