Across the Middle East and North Africa there are an estimated 10.7 million cases of COPD, and nearly 90,000 annual deaths attributed to COPD, making it one of the leading causes of death and disability across the MENA region*.

Globally, access to quality respiratory diagnostics is poor, in part due to an historic lack of innovation in the field. At present it is estimated that at least half of the people who live with COPD remain undiagnosed.

TidalSense is on a mission to change this.

Based in Cambridge, UK, TidalSense has developed, and is ready to bring to market, a rapid, high accuracy and easy-to-use diagnostic test for COPD, which has potential to replace spirometry in primary and secondary care respiratory diagnostic pathways. N-Tidal Diagnose combines a novel, patented, and innovative fast-response CO2 sensor embedded within a connected, handheld and battery-operated handset (N-Tidal Handset), with AI algorithms that can sensitively detect changes in lung physiology consistent with obstructive respiratory diseases such as COPD and asthma (N-Tidal Diagnose software). The diagnostic software performs real-time geometric analysis of patient data to detect patterns of airway obstruction and remodelling consistent with COPD.

The N-Tidal Handset is regulated in the UK and EU, and N-Tidal Diagnose has been filed for EU MDR class 2a regulatory clearance with technical file auditing now complete. Certification is expected Q4 2024, which will bring the novel diagnostic technology to the UK and EU markets.

Designed with respiratory patients in mind, the N-Tidal handset requires just over one minute of regular tidal breathing through the mouth, following a one-minute warm-up period, making it non-technique-dependent, and easy for patients of all ages and co-morbidities to use. Data is automatically transferred from the N-Tidal Handsets via 4G to TidalSense’s regulated cloud platform and a diagnostic output is produced by the N-Tidal Diagnose software in just minutes. There is no requirement for Wi-Fi connectivity or Bluetooth. This reduces appointment times for patients from c. 40 minutes (for spirometry) down to just five minutes (for N-Tidal Diagnose), with a definitive outcome within that time period. The speed of testing and diagnosis enables a wide range of deployment contexts within screening programmes and diagnostic clinics. 

As part of the regulatory filing, TidalSense has validated that clinicians can be trained to use N-Tidal Diagnose in under 10 minutes, and the software can be safely operated by healthcare assistants, drastically reducing both training costs and people-related service delivery costs.

This development represents a revolution in respiratory medicine. The innovative approach to delivering a diagnostic outcome, without the need for highly trained specialists to administer the test, enables N-Tidal Diagnose to bring innovative, accurate, and rapid respiratory diagnostics to the full spectrum of healthcare settings. 

While COPD diagnostic software is the first to be brought to market by TidalSense, diagnostic technology for asthma and other cardiorespiratory conditions will be brought online over time from the same data stream on the N-Tidal Handset, thus giving clinicians a depth and breadth of diagnostic data previously unseen in a five-minute test. 

 *Feizi, H., Alizadeh, M., Nejadghaderi, S.A. et al. The burden of chronic obstructive pulmonary disease and its attributable risk factors in the Middle East and North Africa region, 1990–2019. Respir Res 23, 319 (2022). https://doi.org/10.1186/s12931-022-02242-z