For TidalSense, a Cambridge based, respiratory diagnostic technology company, 2024/25 has been a significant year in the organisations development – culminating in, EU regulatory approval for N-Tidal Diagnose, being commissioned by Suffolk and North East Essex Integrated Care System, and SBRI funding of £780,000.

Insight

Chronic Obstructive Pulmonary Disease (COPD) is a lung condition characterised by chronic respiratory symptoms associated with persistent and progressively worsening airflow obstruction. Approximately 1.4 million people aged 40 years or over in England have a diagnosis of COPD with an estimated two million remaining undiagnosed (1). COPD costs the NHS £1.9 billion annually (2).

The prevalence and severity of COPD increases with age and the earlier a diagnosis is made the better the long-term health outcomes. Diagnosis of COPD is the crucial first step in effective management of the disease – treatment slows the decline in lung function and reduces the chances of needing to attend hospital with an exacerbation.

Spirometry services, the current standard diagnostic test for the condition, have been under pressure for some time. Community spirometry was halted during the COVID-19 pandemic and has not recovered in many places across the UK, creating a substantial bottleneck and waiting list for this diagnostic test (3).

The need for specialist Association for Respiratory Technology and Physiology (ARTP) qualified clinicians to deliver spirometry tests limits the ability for the test to be delivered in a primary care setting, in turn, this increasing the burden on specialist or secondary care centres with patients who could otherwise be diagnosed in a community setting.

Intervention

N-Tidal Diagnose, a product of TidalSense, is a point of care diagnostic medical device (CE-marked class 2a regulated under EU MDR) that can be used to diagnose patients with COPD.

N-Tidal Diagnose performs real-time analysis of breath waveforms (a way clinicians measure and identify any issues with breathing) captured on the N-Tidal Handset, which contains an innovative fast-response carbon dioxide sensor embedded within a connected device. Using the handset requires only 75 seconds of normal relaxed breathing, as opposed to approximately 20 minutes for traditional spirometry approaches (4).

N-Tidal Diagnose then applies its AI diagnostic algorithms to the breath waveform to output the likelihood that the patient being tested has COPD. A diagnostic output is displayed for clinicians within five minutes of using the handset. A broad range of healthcare professionals, including healthcare assistants, can be trained to use this rapid and highly accurate point of care diagnostic test without the need for accreditation from the ARTP.

The device aims to significantly reduce the need for spirometry services, reducing diagnostic delays for patients, reducing overall service cost and lowering secondary care referrals in the process.

Over the past 24 months, within our Office for Life Sciences commission, Health Innovation East has supported colleagues at TidalSense with the commercialisation of N-Tidal Diagnose and crucial aspects of its early stage adoption into the NHS.

• Funding health economic analysis: Health innovation East commissioned an health economic analysis to determine the effectiveness, efficiency and value that N-Tidal Diagnose offers health and care decisions makers.
• Accessing expertise: The network of experts available to Health Innovation East proved a valuable source of advice across a range of topics including NHS contracting and VAT. We also supported the company’s DTAC submission.
• Connecting to respiratory innovators: One of the most telling ways we helped was by facilitating introductions to teams innovating respiratory care in the regions healthcare systems.
• Facilitating promotional opportunities: Featuring N-Tidal Diagnose at regional and national events offered a platform that contributed to widespread interest in N-Tidal diagnose among the region’s ICB’s.
• Supporting through commissioning process: including the technology’s real-world evaluation. All GP practices across Suffolk and North East Essex (SNEE) integrated care board (ICB) will now be able to choose to use N-Tidal Diagnose.

Impact

Over the last 12-months the TidalSense team made significant progress towards widespread adoption in the NHS

N-Tidal Diagnose received regulatory approval – CE-marked class 2a, under EU Medical Device regulations – showing it to be of it to be of exceptional effectiveness and quality. In the East of England, regulatory approval triggered SNEE integrated care system (ICS) to commission the technology in primary care, making N-Tidal Diagnose available should they elect to use it and its benefits, over traditional spirometry.

The innovation evidenced its contribution to the ‘shifts’ currently being pursued by the NHS. Relating to hospital to community, N-Tidal Diagnose is so easy to use it opens up the possibility of widespread community testing for COPD within primary care, reducing the need for hospital referrals for spirometry. Equally, primary care usual interpretation of spirometry is via a human. N-Tidal Diagnose uses AI to automate interpretation and output a straightforward likelihood of COPD, transitioning from analogue to digital

From existing evidence, including budget impact modelling, the device is likely to reduce the delay between the first time a patient presents with symptoms and when they receive a diagnosis of COPD and reduce the waiting lists of those currently referred for spirometry for COPD. It will also be easier for primary care services to use than spirometry, including requiring a shorter training period for staff and a shorter appointment time. Further, when compared with spirometry N-Tidal Diagnose enables allied healthcare professionals such as healthcare assistants to be able to effectively administer COPD diagnostic testing.

Next steps

In support of the company’s ambitions it was recently awarded SBRI funding of £780,000 to develop N-Tidal to diagnose asthma in children. Backing from a funder with such gravitas further proves the products potential as a scalable solution for highly accurate COPD diagnostic testing and its potential to be deployed across a range of primary care settings.

Next, alongside Health Innovation East’s real-world evaluation function, TidalSense will report on its development across SNEE ICS and seek implementation across the East of England, leveraging already keen interest from other ICB’s.

Having achieved that the team aims to establish AI algorithms for the diagnosis of other respiratory conditions.