TidalSense Raises €16.6M to Accelerate Global Expansion

The big picture: TidalSense (formerly Cambridge Respiratory Innovations), a Cambridge-based AI-powered respiratory diagnostic company, announced a €16.6 million ($19 million) funding round to accelerate commercialisation in the UK and support globalisation of its technology, including to the USA.

Why it matters:

• Persistent Neglect: Respiratory disease affects one in five people and COPD is the UK’s third biggest cause of death, often overshadowed by other conditions despite its significant prevalence and cost to healthcare systems.
• Diagnosis Backlog: Over 600,000 people in the UK are currently waiting for a formal COPD diagnosis, with more than half of NHS regions lacking the capacity to meet current demand for traditional spirometry testing.
• Outdated Methods: Current spirometry, a test invented in the 1800s, requires forceful exhalation and specialist training, creating a barrier to timely and accessible diagnosis, particularly in lower-income and minority communities.

How it works:

• AI-Driven Diagnostics: TidalSense builds diagnostic and monitoring solutions for respiratory medicine using its novel patented N-Tidal sensor technology.
• Simplified Testing: The N-Tidal Diagnose device requires patients to breathe normally into a handheld unit for just 75 seconds, capturing a CO₂ waveform (capnogram).
• Accessible & Accurate: AI models analyze the capnogram to detect COPD, with any healthcare professional trainable in 10 minutes. The models, trained on over 2.5 million patient breaths, achieved over 90% diagnostic accuracy in post-market validation.

The catch: While N-Tidal Diagnose has secured a CE mark and is expanding within the NHS, achieving widespread adoption in new, complex markets like the USA will require navigating stringent regulatory landscapes, securing favorable reimbursement policies, and overcoming inertia from established diagnostic practices and equipment. Competition from existing diagnostic providers and other emerging AI health solutions also presents a significant challenge to market penetration.