FDA Clears Acurable’s Sleep Apnea Testing Device

Following a successful launch in Europe, London-based medical device company Acurable is releasing its AcuPebble device for Obstructive Sleep Apnoea (OSA) diagnosis in the United States.
 
The patient-friendly device, already used by the National Health Service to improve the time-consuming home sleep apnoea diagnosis method, makes remote and efficient home sleep apnoea testing possible by allowing for earlier detection, faster treatment, and better management of this chronic condition. The AcuPebble device has been cleared by the U.S. Food and Drug Administration (FDA).
 
OSA affects around 1.5 million U.K. adults and 25 million U.S. adults, and causes people to repeatedly stop breathing while asleep. If left untreated, OSA is associated with serious health conditions, including heart attacks, diabetes, and dementia. Despite its prevalence, an estimated 85% of adults worldwide are undiagnosed, as the current testing process is complex and expensive. Currently, patients need to visit a hospital to be trained to use the testing equipment, which involves using a set of uncomfortable wired sensors at home. About 10% to 20% of these sleep tests must be repeated because sensors get detached 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.
 
The AcuPebble device offers a much cheaper, faster, safer, environmentally friendly and patient friendly solution. Acurable touts AcuPebble as the world’s first medical device that can extract respiratory biomarkers continuously and accurately, enabling automated diagnosis of OSA. To use the device, a patient simply attaches a sensor onto the front of their neck before going to sleep. The sensor transfers the signals to a mobile device, which uploads the data to a secure platform. A doctor then receives a report with a diagnosis. No patient training or healthcare professional involvement is needed to explain how to use the device and very few tests have to be repeated (~1%). 
 
The EU version of the device has been used by the NHS as an established alternative to traditional testing processes for the past two years.
 
A study conducted at the Royal Free Hospital, a center of excellence in respiratory medicine in the United Kingdom, demonstrated the safety and effectiveness of AcuPebble against multi-channel polygraphy (94% positive predictive value, 98% negative predictive value, with positive and negative likelihood ratios over 10 and below 0.1, respectively). In this study 100% of patients completed the test successfully without training or assistance beforehand.
 
The FDA-cleared version of its device is adapted to target the very specific needs of the U.S. healthcare system. This follows an €11M Series A funding round, which was joined by KHP Ventures, the first NHS-anchored venture fund in the U.K.
 
The most recent FDA cleared device, AcuPebble Ox100, provides a complete sleep report, and offers a comprehensive set of channels including, amongst others, heart rate and signals, activity, snoring, oxygen saturation, respiratory phases and airflow. Moreover, the device is very comfortable to wear and allows the patient to have a fully natural, unconstrained, sleep at home. This provides more reliable OSA diagnostic results and facilitates other clinically useful applications such as multi-night testing or monitoring of the evolution of the condition.
 
This breakthrough patented technology grew from a decade of research by Acurable’s founder, Professor Esther Rodriguez Villegas, at the Wearable Technologies Lab at Imperial College London.
 
Acurable is predicting it will grow its team by 300% this year as it expands its U.S. footprint. “Launching our device in the U.S. is a major milestone for Acurable as we set our sights on AcuPebble becoming the gold standard and market leader for at-home sleep testing. We have already had a lot of interest from U.S. clinicians, who believe it can be transformational for the millions of Americans who have undiagnosed sleep apnoea, putting them at risk of other serious health conditions,” Acurable Co-CEO/Founder Professor Esther Rodriguez-Villegas, inventor of the AcuPebble technology, said. “Yet accessing a diagnosis and the diagnostic test itself has for too long been uncomfortable and inconvenient for patients, and far too time-consuming for clinicians. The AcuPebble device is set to change that, by making it far simpler for patients to get tested and for doctors to access the results, saving billions of dollars in the process.”
 
California-based Magnap has used the AcuPebble device in a sleep apnoea clinical trial at the University of California San Francisco.
 
“The AcuPebble has been game-changing for our patients, as it is a much simpler and comfortable experience,” said Dr. Michael Harrison, founder of Magnap and professor of surgery and pediatrics at the Children’s Hospital at UCSF for more than 20 years.  
“It enables clinicians to conduct multiple night studies at a time, improving patient outcomes by giving them a much speedier diagnosis. This will make an enormous difference to the lives of millions of Americans who have undiagnosed sleep apnoea.”
 
Acurable creates accurate and user-friendly wearable medical devices intended to be used by patients at home. Its patented technology enables for the first time the automated diagnosis and management of respiratory conditions at home. Its first product, AcuPebble SA100, is the first wearable medical device to obtain the CE mark for the automated diagnosis of obstructive sleep apnoea at home. Acurable is backed by investors from Alma Mundi Ventures and Kindred Capital.