Case Study

MyBreathPrint® with Vocxi Health Inc 

An end-to-end digital solution for early disease detection
 

As we breathe, each exhaled breath is filled with thousands of chemical byproducts called volatile organic compounds (VOCs). These VOCs vaporize and are in gas form at room temperature. Their concentrations and sensor response patterns in the breath — called MyBreathPrint® — can inform clinicians about our health. For over half a century, scientists have been studying VOCs using very large, sophisticated equipment — proving to the world that VOCs in the breath can be related to diseases in the body. Now, for the first time, VOCs can be sensed and measured by a small handheld device.

This device platform — called MyBreathPrint® — has been invented by Vocxi Health. In coordination with S3 Connected Health, MyBreathPrint® is a connected medical device and integrated system that delivers a robust digital health solution for earlier disease detection. 
Vocxi_Header_image
Vocxi_device_v3

 

Initially, MyBreathPrint® is intended to detect VOCs related to early and late-stage lung cancer(s) and to supplement traditionally invasive and lengthy diagnostic processes such as x-rays, biopsies, and scans. This digital health solution is undergoing clinical studies in the USA, with opportunities to scale to detect other disease states and operate across additional territories. It will first be rolled out to healthcare providers for clinical use, with future applications to include remote use and at-home use cases.

Why start with early lung cancer detection?

It can be difficult to determine whether a nodule on the lungs is cancerous. There's no easy way to get an answer, and patients must endure a lengthy monitoring process involving a low-dose CT scan every three months. Patients are referred for a biopsy when measurable nodule growth is detected. 

Most of the time, the nodule isn't cancerous, so undergoing what can be an invasive surgical procedure is ill-advised unless the risk of lung cancer is relatively high. Although early diagnosis is in the patient's best interest, it can often take months or years for lung cancer to be confirmed. For those with cancerous nodules (about four percent of those with nodules in their lungs), this can mean detecting the disease in its later stages, making it harder to treat.

leading_cause_of_cancer_death_v6

It is the leading cause of cancer death globally
An estimated 238,340 people were diagnosed with cancer in the US in 2023. [1]

Untitled design (5)

Survivability is 10 times higher with early detection
A late-stage lung cancer diagnosis decreases 5-year survivability to only 5%. [2]

lungs_v4

Lung cancer costs the US economy $50B annually
It costs over $13B to the US directly and more than $36B in lost productivity. [3]

The project scope
Vocxi Health believes an easy-to-use, non-invasive device will increase early detection, ultimately saving many lives while reducing associated costs.

Vocxi Health approached S3 Connected Health in 2022, shortly after becoming an independent company. With eight years of research and development behind them, the Vocxi team had created a prototype that could use BreathPrints® to classify lung cancer but needed to evolve it into a robust reliable solution that could be launched in the market and scaled effectively.  

Though functional, it was a desktop device, about the size of a small kitchen appliance. The vision was for a sleeker, patient-friendly breath analyzer connecting to a mobile app and a user-friendly platform, allowing clinicians and patients unprecedented access to BreathPrint® results that could help save lives with a real-time, highly accurate, non-invasive procedure.  

 

Key challenges

How it works
Breath

Making breath analysis accessible 

MyBreathPrint® is redefining breath analysis technology, referred to as human breath intelligence, and creating an affordable, accessible, connected solution that is easily used to diagnose disease states. It is designed to be used with normal breathing, at normal breath temperature and humidity levels, so patients don’t need to be in a controlled environment to get highly accurate results.

 
science

The science behind MyBreathPrint®  

Although breath analysis has been used in other devices, what’s novel about MyBreathPrint® is that it uses the convergence of graphene-based sensors, novel chemistry and machine learning.  The patented sensor array interacts with VOCs and creates sensor capacitance changes. The changes create digital patterns — called BreathPrints® — that can be captured and analyzed.
Graphene has quantum mechanical properties. It is 1000 times more sensitive than traditional electronic sensors. Most electrical sensors are sensitive at the parts per million level, and MyBreathPrint® operates at the parts per billion level.

Making Vocxi Health’s vision a reality  

"It’s hard to predict the future in this space, and we’re learning every day, but we are partnering with some really strong companies, such as S3 Connected Health, and we’ll depend on our global team to help navigate our journey over the next few years."

 

Randy Schiestl, Chief Operating Officer Vocxi Health

Randy Schiestl

Key responsibilities

Developing an initial prototype
Developing a portable solution for market launch and roll-out
Building an end-to-end roadmap to help transition MyBreathPrint® to market
Developing an initial prototype
  • Shrinking the form factor into a highly portable analyzer connected to a conventional breathing mask so clinicians can easily use it to create additional information for clinicians where there is a high suspicion of lung cancer.
  • Engineering the chemical, electrical, and mechanical aspects of the design to create an integrated solution meeting functional, clinical, and operational requirements. 
Developing a portable solution for market launch and roll-out
  • Creating a viable, fast, efficient, and non-invasive design while meeting rigorous medical standards. 
  • Identifying a cost-effective manufacturing scheme to build prototypes with scalability to support larger quantities.
  • Designing the solution efficiently to leverage power available through the mobile phone.
Building an end-to-end roadmap to help transition MyBreathPrint® to market
  • Enabling the Vocxi Health global team to develop a connected digital health solution from the initial prototype and confidently negotiate all stages of development, including clinical studies, market development, manufacturing, and potential future expansion into other disease areas and geographies. 
  • Leveraging the Affinial digital health platform: Facilitated plans for future development, including potential expansion into other disease areas, geographies, and digital health services.

    • Providing system architecture, connectivity and gateway for a cloud-based solution.
    • Hosting the custom mobile and web applications.
    • Ensuring regulatory best practices are met for HIPAA, cyber-security, and QMS.  
  • Partitioning information into PHI (personal health information) and non-PHI elements. Advising on best practices to easily and effectively demonstrate compliance at the device, phone, and cloud levels.

 

The platform: Building on existing capabilities with Affinial  

One of the significant challenges of making their medical device accessible is ensuring a seamless user experience and facilitating future expansion into other disease areas. Affinial from S3 Connected Health addresses this challenge by enabling MyBreathPrint® to enhance its existing capabilities, tailoring the user experience and solution to meet the specific requirements of the medical device, clinical use cases, and end-user requirements. This results in a faster rollout by incorporating a tried and tested platform rather than starting from scratch to build the user experience. 

Affinial enables the creation of custom mobile and web applications, allowing MyBreathPrint® to offer a personalized and intuitive user interface for users. It's also designed to meet regulatory best practices, including compliance with HIPAA, cybersecurity standards, and Quality Management Systems (QMS).  

"The Affinial platform has accelerated our ability to develop the fully integrated MyBreathPrint® solution."

 

Randy Schiestl, Chief Operating Officer Vocxi Health

Randy Schiestl

Leveraging the Affinial digital health platform has facilitated plans for future development, including potential expansion into other disease areas, geographies, and digital health services. Affinial provides a comprehensive system architecture, connectivity, and gateway for a cloud-based solution that collects, stores, and processes the test data, ensuring that MyBreathPrint® can scale effectively as adoption increases. 

By leveraging Affinial's system architecture, connectivity, custom application development, and regulatory compliance, MyBreathPrint® can focus on delivering innovative health solutions without the burden of building a digital health platform from the ground up.

"The device alone would have been an incredible journey, but the work we’re engaged in with Vocxi Health goes much further. They’ve taken full advantage of our end-to-end digital health capabilities, from developing a connected medical device to providing a comprehensive digital health platform."

 

Bill Betten, Director of Medtech Solutions S3 Connected Health

Bill Betten Medtech S3 Connected Health
Results: Successful clinical studies and plans for clinical trials
S3 Connected Health and Vocxi Health are working closely to bring this integrated and fully connected system from feasibility studies to well-structured clinical trials.   
Results to date
Process improvements for clinicians to date
Outcome improvements for patients to date:
Results to date
  • Reduced form factor to create a portable, integrated, connected solution that delivers, real-time, accurate results for clinicians and patients.
  • Delivered a solution that leverages technologies of a breath analyzer, mobile phone, digital platform, and web connectivity.
  • Completed multiple feasibility studies with active engagement in on-going clinical studies to demonstrate effectiveness and maturity of this integrated platform.
Process improvements for clinicians to date
  • No lab is needed as it only requires the BreathPrint®, enabling patient health insights faster and cheaper, using a less complex procedure.
  • Handheld device form factor, so no extra space is needed for bulky and expensive equipment in the clinics.
  • Immediate results rather than waiting weeks or even months for results.
  • Secure management of sensitive data that meets regulatory requirements.
Outcome improvements for patients to date:
  • Non-invasive: Promoting patient comfort and care with lower risk of invasive infections.
  • Accurate: With parts per billion sensitivity, the technology can detect VOCs in breath and, using machine learning, generate a BreathPrint®.
  • No waiting: Clinicians receive and can share results much faster (within minutes), and patients don’t have long, frustrating wait-times for information.
  • Early detection: Accuracy, accessibility, and low cost allow it to detect earlier-stage lung cancer.
  • Increase survival: Lung cancer is more survivable when caught in the early stages, improving long-term health outcomes.
  • Cost-effective testing: Overall lower projected healthcare cost.

[1] American Cancer Society. 2023. “Cancer Facts and Figures 2023 | Special Section: Lung Cancer”. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2023/2023-cff-special-section-lung-cancer.pdf.

[2] Cancer Research UK. 2024. “Survival for Lung Cancer”. https://www.cancerresearchuk.org/about-cancer/lung-cancer/survival#:~:text=Stage%204,more%20after%20they%27re%20diagnosed

[3] Vocxi Health Inc. 2024. “The Breath Solution”. https://vocxihealth.com/the-breath-solution/

 

Images courtesy of Vocxi Health 

Learn more about digital health solutions for chronic disease management

Read More

NEWSLETTER

Sign up to our newsletter and marketing communications to be the first to receive our latest news, events and resources. You may unsubscribe from these communications any time. For more information, check out our Privacy Policy. 

Copyright © 2016 - 2024 Silicon & Software Systems Ltd.