https://innovateuk.blog.gov.uk/2017/03/27/breath-taking-technology-innovating-respiratory-measurement/

Breath-taking technology – innovating respiratory measurement

Hundreds of millions of people globally suffer from chronic respiratory conditions like asthma and chronic obstructive pulmonary disease (COPD).  Currently there are no personal respiratory monitors which measure actual respiratory performance.  It sounds amazing, but it is a fact!  Quite often the treatment is based on the question, “How do I feel at the moment?”

Measuring respiratory conditions consistently and automatically

Cambridge Respiratory Innovations, N-Tidal C in use
Cambridge Respiratory Innovations, N-Tidal C in use

Whilst exploring this massive opportunity, we came across research from the 1990s which showed that the way our lungs exhale carbon dioxide indicates whether we have a respiratory condition such as asthma or COPD.  However, the researchers noted that it was difficult to measure consistently and that automated analysis was also complex.

We’d identified both the challenge and the business opportunity we should tackle, so in 2013 we formed Cambridge Respiratory Innovations Limited (CRiL).

Photonics for health

It was obvious that we didn’t have all of the expertise internally to develop the solution - so we formed a consortium with:

  • Gas Sensing Solutions Limited (GSS - world leaders in CO2 sensors)
  • Wideblue Limited (product and medical device design specialists)

Together, we were awarded an Innovate UK “Photonics for Health” grant to develop a low-cost, accurate, reliable sensor to measure CO2 in respiration.  We could start our journey.

Balancing commercial and technological development

Our Innovate UK funds helped us to develop our innovative low-cost LED-based sensor - the key to measuring the carbon dioxide.

Within months of starting the sensor development, awarded us a contract for a feasibility study COPD.  This ensured that we focused earlier on the commercialisation needs:

  • stakeholder research
  • user needs
  • market needs
  • market opportunity

This is very important since most new medical devices take five years and at least £5 million investment to be licensed.

Meanwhile, the Innovate UK programme, to develop our unique medical CO2 sensor, was progressing to plan.  We became confident that we could overcome the accuracy issues with other medical CO2 sensors, enabling us to develop a low-cost self-care personal respiratory monitor.

Hurdles and hoops

Our SBRI contract required us to develop an advanced prototype of a based on our new sensor.  It quickly became clear that we had other hurdles to jump and hoops to pass through on our journey, all relating to the regulatory requirements for developing a medical device. We:

  • needed to trial our device, now called the N-Tidal C
  • about defining and monitoring a clinical study within the NHS
  • also made sure that our IP was totally owned by the company when both Wideblue and GSS became shareholders in CRiL

De-risking our technology

By the middle of 2016, we had successfully completed our first clinical study, the COPD Breathing Record Study. The 30 COPD patients in the clinical study delivered over 50,000 breaths so we had to develop the way to in bulk.  We had always known that our solution had to be automated so that we could ultimately provide warnings of a deterioration in a user’s respiratory condition.

Even with this volume of data, we knew that we were still nowhere near the end.  We had just finished the start.  The medical community, commercial partners and investors would want more evidence, more analysis, more technology and more proof!

Around this time, like many R&D-based companies, we needed to make it through the “funding gap” to de-risk our potentially transformational technology.

Extending our technology to other cardio-respiratory conditions

Analysis of the data demonstrated that our innovative CO2 sensor and our N-Tidal monitor had the capability of predicting a COPD exacerbation by 48 hours or more.  This would allow sufficient time for a doctor to intervene and prevent an avoidable, unpleasant and costly hospitalisation.

Fantastic news, “pats on the back” all round but no let-up in our effort.  We knew that we had to keep peddling hard for more of our journey.

We have recently been awarded a second Innovate UK grant, so we are now starting to research the use of our technology in other cardio-respiratory conditions – asthma, congestive heart failure, pneumonia and cystic fibrosis.

We are also collecting more research with COPD patients.  We believe that our N-Tidal monitors will help people with a range of respiratory conditions to:

  • improve their self-care
  • increase their quality of life
  • predict respiratory attacks
  • minimise avoidable hospitalisations
  • lower the cost of care

We still have some way to go.  With such a large global problem, we continue to network with the commercial partners to help us unlock this market, delivering real benefits to patients and other healthcare stakeholders.

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