London-based company Acurable is targeting summer 2023 to release its AcuPebble sleep apnoea testing device on the US market.

According to Acurable, the device has been tailored to the US healthcare system with the Ox100 model offering a diagnostic report compatible with the reimbursement guidelines in the US healthcare market.

The product has the potential to reduce the need for retesting and hospital visits. Studies at the London based Royal Free Hospital demonstrated that 100% of patients were able to complete the test without any training and assistance which is a milestone when compared to traditional devices used by the NHS. 

With an ageing population in the US and UK, the need for home testing devices is growing and driving innovation in the sleep apnoea space. Acurable has already locked in €11 million ($11.8 million) in Series A funding from NHS anchored venture fund, KHP Ventures. 

Currently North America holds the largest market share for sleep aponea products, with the US holding the largest contribution to the regional market. The AcuPebble device will only be available for purchase by healthcare professionals and partners in the US and it is closer to reaching consumers in Europe first.

Acurable co-CEO, Professor Esther Rodriguez-Villegas said the company is already receiving interest from US clinicians, who believe it can be transformational. “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,” said Rodriguez-Villegas.

Over the past two years the EU version of the device has been used by the NHS above traditional testing methods.

It is estimated that 1.5 million people suffer from obstructive sleep apnoea (OSA) in the UK and over 25 million in the US. Despite its prevalence, more than 85% of the worldwide population are reported to go undiagnosed with OSA due to the expense and practicality of current testing.

GlobalData expects the market to grow quickly, mainly due to the increasing population with OSA and growing awareness of the devices in the region of North America.

Risk factors such as obesity, aging, male gender, menopause, craniofacial abnormalities, upper airway anatomy, smoking, alcohol, and genetic predisposition, which contribute to more OSA cases and high obesity rate makes the US market more lucrative than other regions.