How AcuPebble is changing the face of sleep apnoea diagnosis – Med-Tech Innovation

Ian Bolland spoke to Emilio Sanz-Pereiras, co-CEO and COO from Acurable to discuss the company’s award-winning technology, the potential for technology in the sleep apnoea market and its plans following a funding round. 

Acurable was originally called AcuPebble – the name of its technology developed to tackle the challenges of sleep apnoea. Sanz-Pereiras explains that the technology took the company’s founder Professor Esther Rodriguez-Villegas almost two decades to develop, and was this year recognised with the 2022 Med-Tech Innovation Award in the Connected Health category. 

The research started when she was approached to help solve the problem of Sudden Unexpected Death in Epilepsy (SUDEP), where patients die due to seizures during which they stop breathing. These patients needed close monitoring, however breathing is one of the most complex bio signals to monitor, so available devices were large and cumbersome. 

Sanz-Pereiras explains: “On the journey to try to develop a system to monitor central apnoea events in epileptic patients at risk of seizure, Esther discovered a lot of things around physiological biomarkers.”

“Esther worked from the bottom up, figuring out which of all the sensor modalities had the theoretical limit that would allow her to get to this level of accuracy when measuring breathing. And the only one meeting all the requirements was acoustic sensing; which now forms the core of our technology after ten years of research.”

Some of the biggest technical challenges included dealing with interference such as background noise and artefacts, which are other biological noises that can pollute and corrupt the signal. This signal contains a lot of useful physiological information, but with all these artefacts it becomes extremely complex to analyse – something nobody had done until now. 

During the 20 years that passed the technology matured with research at Imperial College and then at Acurable, and sleep apnoea was identified as a key focus area as it affects approximately 1 billion adults worldwide. 

Acurable’s first product AcuPebble is the first medical device to be authorised by regulators for the automated diagnosis of obstructive sleep apnoea at home. To summarise what the product offers, it is a multi-use rechargeable sensor which is stuck to the base of neck against the windpipe to collect cardio-respiratory signals. It extracts respiratory and cardiac data and transmits this information wirelessly to a mobile device. 

Algorithms then interpret this data and reports are sent to clinicians who can make a diagnostic decision without the patient needing to visit a sleep clinic, which have long waiting lists and require extensive training. AcuPebble provides a real solution for health services in which resources are increasingly stretched and waiting times to continue to rise. 

“Hospitals just send us a list of the patients they want to test. We send an AcuPebble device to the patients’ home, they do the test, and the report is automatically sent to the doctor who decides what to do with the patient. So, a doctor spends, 10-15 minutes per patient instead of 2-3 hours.”

As companies increasingly grapple with the challenge of sustainability, Sanz-Pereiras highlights the green credentials of the product. 

“The sensor is rechargeable; we are very careful about sustainability and really making sure that we have the lowest carbon footprint possible. This is very rare in medical devices. Some don’t care and their business model is often based on disposable parts being thrown away all the time, so they need to buy more.”

The product is already live in several NHS Trusts with the company keen to develop the credibility of the device within medical circles before contemplating making it more consumer focused. 

“We are really working on multiple fronts within the NHS to rethink pathways, to rethink the way the whole system works for a sleep test. We are continuing to build further medical credibility with more research, with the ultimate aim being that we will get to a point where consumers can request a test themselves and their HCP will trust this data without having to repeat the whole pathway.”

In a recent funding round, the company raised €11 million to scale up its offer in Europe and the United States.

“We began with the UK and Spain, and now we want to open four more markets in Western Europe and then the US. We have 510(k) approval, so, we will enter the US market next year. In parallel we are also developing further applications for AcuPebble’s acoustic sensing technology in other respiratory conditions.”

The potential for AcuPebble is not just for measuring sleep apnoea as Sanz-Pereiras listed several other areas and highlighted the usability of Bluetooth-related devices.

“As we build more markets into the system, it becomes clinically useful in additional cardiac and respiratory conditions. So, we are working with different hospitals and different clinicians to really build a product that they need.

“Often when creating wireless devices, you sacrifice some accuracy to make the product more usable, which is acceptable for long-term monitoring when you only want to see trends. However, if you need to monitor patients for a serious respiratory event you need to be confident in the accuracy. This is where we come in. Developing accurate technology verified against the gold standard that can really have a profound impact on the way things are monitored in hospital and at home.”