SpiroPRO™: Democratising COPD and Asthma Diagnosis

COPD and Asthma are major global challenges. There are more than 750 million patients globally. Countries have a huge economical burden of these diseases - in India, its estimated that the annual economical burden of COPD and Asthma is more than USD 20 Billion and in Europe more than USD 75 Billion. There are numerous research studies published which identify Misdiagnosis or Un-diagnosis or delayed diagnosis of COPD or Asthma is directly proportional to the the disease's economic burden, number of deaths, shortened lifespan, and poor quality of life. 

There is a huge unmet need for "Early and Precise" Diagnosis of COPD and Asthma.

While there are well defined strategy for diagnosis - such as Spirometry the practical use of such objective method is very limited. For example in India - only 20% of suspected Asthma or COPD patients are advised and offered to do Spirometry. These numbers are more or less similar across various countries - in Europe for example only 40% to 50% patients are advised and offered spirometry.

Briota is working on solving this problem of "making Spirometry - accessible, affordable and scalable across various patient groups".

To solve this problem - Briota is actually solving the root causes of Spirometry not being "main-stream" diagnosis practice - these root causes are:

1. You need a trained spirometry technician to conduct the Spirometry test (the ratio of technicians versus patients is heavily skewed)

2. The equipment is expensive to buy, to maintain, to calibrate

3. You need an expert doctor such as pulmonologist to interpret the Spirometry report

(the ratio of pulmonologists versus patients is heavily skewed)

Briota has built a simple handheld digital spirometer - SpiroPRO™. It's a IOT device which connects over bluetooth and cable to a PC, Laptop or a Mobile Phone. It has various unique features to help the healthcare worker conduct a high quality spirometry test with minimal training. Our device comes with an easy to use mobile app - NEHA (Nurse Educator Health Assistant) available in multiple languages - to help the healthcare worker conduct the test with a simple process and workflow. NEHA also uses a comprehensive algorithm to give real time feedback to the healthcare worker and also to the patient to enable them with a high quality of test. The system has 2 modes - 1 Minute Quick Screening Test and 20 Minute Full Spirometry Test. Both these modes come with a Machine Learning powered AI algorithm to read and interpret the results for accurate screening and diagnosis of COPD, Asthma, ILD, Long Covid, Post TB Lung issues etc.

Our solution also includes a complete workflow for doctors who can then refer to the diagnosis reports, patient history, confirm the diagnosis and select one of the many treatment plan templates to offer a well defined and structured treatment plan to patient. The treatment plan (for other than medicines) gives personalised recommendations for Diet and Breathing Exercises for each patient.

Our solution is serving those patients who do not get diagnosis and hence treatment for COPD and Asthma at an early stage. Especially those patients who can not afford to go to district hospitals or expensive private practices (in countries like India) for early diagnosis. In a country like India - full spirometry in a private hospital costs anywhere between Rs. 750 to Rs. 3000 and at district government hospital considering the logistics costs it's estimated that each Spirometry test costs Rs. 350. (US$5). Apart from costs the availability of Spirometry test is a huge constraint for rural population, tribal population and underprivileged sections of the society. With Briota's Spirometer - a normal healthcare worker such as ASHA worker can also perform the screening and then the full spirometry can be conducted at Primary Healthcare Center by the regular healthcare staff. Even spirometry could be conducted in health check up camps with diagnosis and treatment plan made available. Our calculations show that the complete spirometry test could be now offered for less than US$1 per patient. 

Early diagnosis means a lot to every patient but especially for the underserved - early diagnosis of COPD and Asthma means how long they could remain productive and reduce loss of wages or loss of school days. This also means the disease progression could be slower than in normal scenario. With slower disease progression, optimal disease control is a possibility which means less hospitalisation and reduced deaths.

I personally decided to get into solving this problem because I have seen the suffering an Asthma patient goes through due to incorrect and delayed diagnosis. My mother is Asthma patient for last 3 decades whereas she was diagnosed with Asthma only in the severe stage. For last 3 years me and my team are closely working with hospitals, ASHA workers, PHC doctors, General Practitioners, Government Agencies, Municipalities, schools, patient support organisations like PATH, Karma Healthcare etc. to enhance and develop our solution in the most robust fashion. Our solution was "redesigned" based on ground realities community health workers and PHC doctors faced during covid19 pandemic. Our mobile application and some part of algorithms (as our solution is for Lungs and Covid19 impacts lungs) was used during pandemic to help more than 40 thousand patients most of them from industrial labor colonies and slum areas. During this project - code named "SAVE - Screening Assisted Virtually and Early" we have got lot of insights about the difficulties experienced by healthcare staff in remote, semi-urban and factory settings in helping patients with early diagnosis and offering a treatment plan. Our team members are currently based in Pune, Bangalore, Hyderabad and Nagpur in India and Copenhagen, Denmark. We collate various standard practices, learnings and global innovations to constantly improve our methodologies, protocols and technologies. Denmark government has granted me a resident permit under Entprenuership Visa program to expand Briota presence in Denmark. I accepted this as it gives us an opportunity to validate our solutions in one of the most advanced - equitable health ecosystem of the world. I currently live in Denmark and also spend time in India with my team often.

Our solution - SpiroPRO™ is battlefield tested, regulatory approved and medically appreciated. Our efforts are recognised by BIRAC, Govt of India and we are incubated with AIC CCMB India and Healthtech Hub Copenhagen. We have also won various awards and recognitions for building innovative equitable health solutions from OPPI (Bayer Pharma), Qualcomm Design In India, AIM PRIME top 10 national innovations on health etc.

Our next challenge to solve is make it "scalable operationally in India and then at global level". The technology developed is scalable but we need to make sure that it reaches masses. The main goal for applying to Solve is to establish right partnerships and get the ecosystem support to take our solution to grassroots - not only in India but in other countries where affordable screening and diagnosis is desperately needed for COPD and Asthma. 

We are looking at the COPD or Asthma diagnosis problem with a holistic approach. Based on our research and practical experience on the field, we have realised that its not sufficient to just "build a cheaper device". Of course we built a cheaper device with minimal R&D dollar costs - many of our senior team members are working at 1/10th of their market or previous employment salary costs as they want to be part of the change. But beyond affordability, our approach is to make the test "of Acceptable quality" with minimal or no involvement of spirometry technicians and pulmonologists. Our approach of using technology to solve the challenge of using most expensive resources (spirometry technicians and pulmonologists) is unique. We also collected lot of data and built Indian Demographic Lung Scale based on pre-approved research accepted at American Thoracic Society (earlier lung scale used in India was Asian lung scale) for better accuracy. Now we are providing this lung scale to other spirometry manufacturers. We have also adopted a Hardware Diagnostic approach for our Software Platform. This means our software for Point of Care Screening and Clinical Diagnosis can be easily integrated with other Spirometry devices. 

Spirometry has some limitations - especially since its effort based manoeuvre, it's not very easy for children below 12 years of age and for elderly suffering with other chronic ailments to undergo spirometry. Hence we started expanding our scope to include Impulse Oscilometry. We are now working with Qualcomm to build a portable Impulse Oscilometry device with Qualcomm chip and our software. In summary, we are expanding our canvas by making our technology available to other players and industry big players in the market.

Our screening and diagnostic solution SpiroPRO fits in our Clinical Decision Support System platform SiA™ - Systematic Intervention Agent which uses power of NO Contact AI to democratise not only diagnosis but management of Asthma and COPD.

Next Year Goals:

• Conduct more than 50 thousand Spirometry tests in partnership with various agencies and organisations such as PATH
• Make NEHA mobile app for conducting the tests available in additional 6 Indian languages and 5 European languages

Next 5 Year Goals:

• Get FDA, CE and other regulatory approvals for a global launch
• Make spirometry and impulse oscilometry available at the grassroots - primary healthcare centers, ASHA workers, labour colonies, remote and tribal villages, semi-urban areas, schools
• Help more 1 million patients improve their lung health globally

1. How many health workers - midwives, nurses, PHC staff can use our technology to do screening and diagnosis of Lung Health patients with efficiency 

2. Slowing down Disease Progression - Aim is to have average 10%+ increase in LHI™ of patient  - Lung Health Index (LHI™) is a comprehensive scale designed by Briota referring to various objective parameters used by pulmonologists while monitoring disease progression

3. Cost of medicine over 12 months, any reduction in ER visits, any reduction in Hospitalisation and Deaths

4. How many patients could be managed at Primary Care versus Speciality Care

5. Increased lifespan for COPD and Asthma patients

We are looking at the unmet need of misdiagnosis and un-diagnosis of asthma and COPD at primary care level. While designing the solution we have worked with a holistic approach. We worked closely with primary care staff, spirometry technicians, senior pulmonologists and most importantly patients of various backgrounds to understand why "measuring air" should be that difficult. We have done a thorough process analysis through surveys, feedback, group discussions, pilots to understand and design the optimal process of using Spirometry in the field environment. We have done multiple pilots, user studies and clinical validations with incubation support from AIC CCMB and BIRAC with research being published and discussed in various peer reviewed conferences and journals. We follow an agile approach in development which also includes feedback collection and correction in iterations. Our solution has stabilised after continuous improvement and correction process of 4 years. While we are happy with what we have designed and developed, we are open for critical feedback and evaluation and thats where we are now establishing ourselves in Denmark to get the right validation and endorsement for global scale and also working closely with HealthTechHub network in Copenhagen. This has also given us an opportunity to present to US networks such as Texas Medical Center. In short, our theory of change is simple - don't build the solution simply with a white board, instead do it in iterations, on the field and be humble to accept critical feedback and inputs from the people who will actually use it.

We use No Contact AI, Data Science, Machine Learning, IOT, Mobile Application and EDGE technology in our solution. Our software solution is hardware agnostic which means it works with our own properietary hardware and also with 3rd party hardware available in the open market. We have applied for 3 patents to protect our technology. We are currently building SDK and API for our software to allow a wider range of hardware providers use our Machine Learning and AI algorithms for achieving high level accuracy in early diagnosis of Asthma and COPD.

We have done multiple user studies, pilots and clinical studies.

• Clinical Validation completed  on “Clinical Validation of Novel Smartphone-Based Spirometer for Measurement of Obstructive Diseases” published in Indian Journal Of Respiratory Care - Article Link – https://cutt.ly/IDSgqjq

Video for Product Promo for Asthma patients:

Video for overall product offering:

Our team in India is led by our India business CEO - Ms. Aditi Pais and more than 60% staff is women team members.

We offer our Screening and Diagnostic Services in B2B2C and B2G2C model. We have 2 models included in our pricing plans -

1. Device for Sale - used in Government Tenders, GeM Portal - Direct Procurement by Government agencies in India etc. Our MRP for device is USD 500.

2. QtyBasedTests - used for selling to PHCs, Hospitals, NGOs, Factories etc. We offer qty based discounts. Our average price per full test is US$1. 

We are a for profit impact venture. Our revenue streams include following:

1. Direct sales to Government, Organisations, Hospitals, NGOs etc

2. Collaboration projects with Pharma companies

3. Soft money for R&D

4. Private Investment - Angels, VCs

We have received Government of India research and development related grants and subsidies totalling USD 120K and a sanction of grant and loan (not availed for strategic reasons) for USD 250K. We have already done 3 paid projects with Municipality of Mumbai and Hindalco Industries.