The Feelix Platform

https://sonavilabs.com

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Which of the following categories best describes your solution?

Describe what makes your solution innovative.

The Feelix platform is an innovative solution that seeks to empower every clinician, and lay person with the ability to identify a potentially harmful disease. The devices are simple and effective, and we have studies that show implementation leads to higher accuracy and more appropriate treatments.

Our competitors are making strides to add electronic features to traditional stethoscopes, however, they lack the attention to acoustic quality, and the sophistication to deploy analytics directly onto the hardware. This allowed Sonavi Labs to create a device that anyone can use anywhere, empowering clinicians of all skill levels.

Feelix can bridge the gaps in access to timely diagnosis during a pandemic, by giving minimally trained community health workers an advantage in supporting the most vulnerable and traditionally under-resourced communities. Slowing the spread of a pandemic requires rapid deployment of healthcare workers and they need to be armed with advanced tools that can support rapid patient screening. If we are able to collect data now on COVID-19, we may be in a position the next time it spreads to catch it more quickly.

We are working to drive the cost of our hardware down so that we can afford to give them away. Feelix has the ability to impact millions of lives and if we can make the device more accessible, then we can not only make the technology better, we can make whole communities healthier.

Describe the core technology that powers your solution.

There are two proprietary algorithms embedded into each Feelix device that function in tandem to deliver diagnostic support in any environment.

The Feelix devices use an adaptive noise suppression algorithm to remove environmental noise from the stethoscope, producing much clearer and cleaner lung sounds of patients to medical professionals. With extended battery life, enhanced sound quality, and Bluetooth connectivity, the Feelix devices can empower anyone, anywhere with the ability to screen for potentially deadly pathogens, even while devices are connected to a centralized hub and data is monitored by physicians and researchers from a safe distance.

An artificial intelligence (AI) based classification algorithm analyzes the clean screenings to detect abnormal lung sounds with a 91% accuracy. This is intended to help diagnose respiratory conditions and to distinguish wheeze-related ailments such as asthma from crackle-sound respiratory conditions such as pneumonia. By embedding advanced analytics directly onto the Feelix hardware, we are able to create a standalone product that is highly functional without the aid of supportive apps, cellular phones or internet connectivity. This allows Feelix to provide decision support to minimally trained CHWs and other frontline health care providers.

When needed, our app and cloud system can be used to analyze lung sounds uploaded into an electronic health record, research database. Recordings can instantly shared with a consulting physician for additional confirmation.

Provide evidence that this technology works.

Our researchers have been working on this project for over 6 years at Johns Hopkins University. In that time, numerous publications have detailed the impact Computerized Lung Sound Analysis (CLSA) can have in low and middle income countries if deployed on a low-cost, easily scalable device.

Since founding the company, in 2017, we have developed partnerships to further validate and enhance the core technology to be more useful. We have an ongoing Tuberculosis study in Peru with FINDdx, which is intended to replicate the work we have done in Bangladesh to validate the classification algorithm on pneumonia. We have also received NIH funding from the Office of Minority Health and Health Disparities (OMHHD) to enhance our asthma management platform. Additionally, we have received funding from the National Heart, Lung and Blood Institute (NHLBI) to support COPD research.

It is because of our previous and current work that we are confident the Feelix platform can be a global diagnostic force and prevent millions from losing their life to a detectable disease. We estimate that with the funding provided in this MIT-SOLVE competition, we can deploy over 1,500 devices in different disease studies, to research COVID-19, carotid stenosis or other diseases, then train our algorithms detect these diseases in seconds. We aim to expose the technology to as much data and as many diseases as possible to save as many lives as possible.

Please select the technologies currently used in your solution:

• Artificial Intelligence / Machine Learning
• Imaging and Sensor Technology
• Internet of Things
• Software and Mobile Applications

What is your theory of change?

With a quick, easy and rapid solution that deploys real-time analytics we can multiply the capacity of the frontline, saving time and lives.

Our theory is very simple, in that if we empower frontline healthcare workers with advanced tools that rapidly and accurately detect diseases, then patients will be more likely to receive appropriate treatments, and thus better outcomes. Even further, we are developing population level analytics capabilities into our smart cloud to identify outbreaks before they spread. 

The organization and utilization of quality data has stifled researchers and frontline workers from optimizing practices and standardizing patient screenings. Our theory is that we can change the course of patient treatment by starting with the very first interaction then use data to intervene at the community level.

We know that one of the major challenges caused by the shortage of healthcare professionals is an over-reliance on World Health Organization (WHO) guidelines, which are notorious for leading to the over-administration of antibiotics. Anti-microbial resistance is on the rise and will cost health systems countless resources and is a detriment to patient outcomes. Early data from some of our recent studies show that by implementing the Feelix platform, the accuracy of community health workers to identify pneumonia increased by 22%. If we model this out across diseases like Tuberculosis and even COVID-19, not only will we save countless resources by limiting the need for traditional wet diagnostics or x-rays, but we can also save millions of lives.

Sonavi’s approach is automated and removes the need for human interpretation of respiratory sounds. Our plan is to evolve the way diseases are detected and managed by using simple, universally accessible tools. Patients will have access to tools that are just as intelligent and powerful as the clinicians, but simple enough for them to understand.

We believe that every choice in healthcare has a consequence, and AI will be the key to ensuring the critical choices of frontline healthcare workers are more informed, objective and accurate. Further, we hope our population level analytics will help health systems and governments make more informed choices to protect citizens.

Select the key characteristics of your target population.

• Infants
• Children & Adolescents
• Elderly
• Rural
• Poor
• Low-Income
• Refugees & Internally Displaced Persons
• Minorities & Previously Excluded Populations

Which of the UN Sustainable Development Goals does your solution address?

• 3. Good Health and Well-Being
• 11. Sustainable Cities and Communities

In which countries do you currently operate?

• Bangladesh
• Belgium
• Nigeria
• Peru
• United States

In which countries will you be operating within the next year?

• Azerbaijan
• Bangladesh
• Belgium
• Canada
• South Korea
• Nigeria
• Peru
• Qatar
• Saudi Arabia
• South Africa
• Turkey
• United Arab Emirates
• United States

How many people does your solution currently serve? How many will it serve in one year? In five years?

Since founding the company in 2017, we have launched over 150 devices into 5 different countries, including the US, Belgium, Nigeria, Peru, and Bangladesh. Community health workers have screened over 10,000 patients in total and we are excited about the opportunity to scale our platform to touch millions of lives in the next five years.

It is difficult to pinpoint the exact amount of patients screened by Feelix devices, but if we assume the 150 devices are with community health workers who screen an average of 2,000 patients per year, we can estimate that this year, we will screen approximately 300,000 patients. Studies show that even confirmed diagnosis using a radiographic chest x-ray range in accuracy of 47% - 75%, while the Feelix devices consistently benchmark above 90%.

If we continue to scale our distribution at the current rate, which is at a rate of 3x increase in the number of devices being distributed each year, in the next year, we will distribute between 3,000 and 5,000 devices, screening between 6 and 10 million patients.

In 5 years, we hope that we will have made the hardware extremely affordable and accessible, such that we will have distributed between 500,000 and 1,000,000 devices through distribution and research partnerships. In the event of the next pandemic, we believe that Feelix devices can screen billions of potential patients.

What are your goals within the next year and within the next five years?

Completing the regulatory process is a top priority for us, and we have already begun the process with the FDA. Within the next year we plan to complete the regulatory process for our hardware and classification algorithms. We have decoupled our hardware from the software for the FDA submission in order to reduce the complexity of the review and minimize the likelihood of complications. The classification algorithm will be submitted following the approval of the Class II 510(k) hardware, and we will simultaneously submit the combined hardware and software application to receive CE marking from the appropriate notifying bodies. Completing both regulatory processes in the next year will enable broad distribution of our platform.

In the next five years, we plan to complete the regulatory processes for other major markets to scale the Feelix platform even further. Countries like Brazil do not abide by FDA or CE marking but offer significant opportunities for our solution. With the launch of an @Home version to support patients, even those in remote communities, and a wearable device, we plan to dramatically strengthen the lines of communication between patients and their healthcare providers. Easing the burden on disease management will have a drastic impact on the communities most devastated by chronic respiratory conditions.

What barriers currently exist for you to accomplish your goals in the next year and in the next five years?

Disparate regulatory processes are certainly going to present a challenge as we aim to engage ministries of health around the world. We expect to encounter widely varied reactions from government agencies and consumers as we understand different markets have different priorities and motivations.

We are currently building relationships with the US Commercial service agency as well as distributors on the ground, who will help guide us through regulatory bodies. The US Commercial Service has also provided due diligence reporting at a very nominal fee, to ensure that our interests are being protected as we engage international agencies.

The major driving force behind our optimization efforts will be resources and data collection partners. While we have been able to secure a substantial amount of grant funding, each clinical trial is limited to a single disease. We need the support of private and public health systems to fund validation studies and pilot programs, which will help to eliminate bias from our data as well as providing distribution opportunities international markets.

How do you plan to overcome these barriers?

Our current price per unit would create a barrier for LMIC markets, however, we have identified a pathway to increase the capabilities of our device while reducing the cost. Current clinical studies are providing data that will enable our researchers to enhance the capabilities of the classification algorithm. 

In parallel, we intend to conduct engineering work to optimize the device for cost and power through hardware redesign and software optimization to decrease the manufacturing costs of the device by half while improving algorithm design.

Countries like India present significant opportunities for data collection but the average consumer in the market cannot bear the cost at current. This is why we are also actively seeking partnerships with global health organizations, impact funds, and community health initiatives who are seeking diagnostic equipment to support frontline workers. Organizations like the Gates Foundation and our partners at Johnson and Johnson, among others will be able to provide funding to supply devices in areas of high need and low resource.

What type of organization is your solution team?

How many people work on your solution team?

Sonavi Labs has 4 full-time staff members that comprise the executive leadership team. One executive member is a part-time employee of the company.

There are two contracting firms that provide manufacturing, assembly and distribution services.

We have two additional contractors that provide technical support. One is focused on web development services, while the other is focused on software engineering support.

How many years have you worked on your solution?

6

Why are you and your team well-positioned to deliver this solution?

The Sonavi Labs team has come together serendipitously with the experience, skills and network needed transform this company from a university research project into a global health company. With over 300 patents, 4 PhD’s, and decades of business development experience, including multiple successful exits, the Sonavi Labs team has already made tremendous strides in bringing the technology to market and making the company a leader in the digital healthcare frontier.

Ellington West is a business development expert and left a senior director role in a national healthcare organization to co-found Sonavi Labs. She has over 10 years of experience in leadership, business, and market research.

Ian McLane is the inventor of the Feelix technology, and is completing a Phd in the Hopkins School of Engineering with a concentration on machine learning, mechanical engineering and signal processing

Dr. Ilene Busch-Vishniac is an acoustics expert and holds 9 patents for her work in acoustical physics. Dr. Busch-Vishniac holds a PhD from MIT and is the former Dean of the Hopkins School of Engineering and President of Saskatchewan University.

In a very short time the leadership team has been able to complete regulatory testing for the inaugural product line, built relationships with global healthcare organizations, secured significant grant funding and won numerous competitions and innovation challenges.

What organizations do you currently partner with, if any? How are you working with them?

Sonavi Labs is currently a part of the Johnson and Johnson Innovation, JLABS program. This opportunity is exposing Sonavi Labs to researchers within the J&J network, in addition to providing resources to help us grow and scale the company. J&J is working to support our research as a leader in the Tuberculosis space, we have been connected with leaders of the Global Public Health initiative.

We have begun a pilot program with the INOVA Fairfax Lung Transplant team. The Feelix device is being used to support patients in their post-operative care, which requires numerous follow-up visits. Many of these patients travel several hours each way to visit with care teams for a 15 to 20 minute visit. Physicians have the ability to customize notifications and device parameters, recognizing that everyone's base line is different. Their goal is to more deeply understand patient trends while avoiding excessive alerts.

Sonavi Labs has also partnered with LifeBridge Health system in Baltimore, MD to develop additional clinical trials and pilot programs that prove the impact of remote monitoring solutions in managing chronic diseases.

Additionally, we have partnered with the mHealth Lab at the Bangladesh University of Technology to use our classification algorithms to identify cardiovascular abnormalities. This partnership is being supported by the TIGER IT Foundation following our win in the MIT-SOLVE TIGER Challenge.

What is your business model?

We believe that solving global health challenges will require additional partnerships and funding from various sources. Our mission is to do well as a company, through strategic business model and a holistic approach that offers solutions to the entire healthcare ecosystem. We have identified B2G, B2B and B2C opportunities for device sales, subscription services, and data analytics contracts.

Feelix, FeelixPro and Feelix@Home devices will be distributed at varied price points, while maintaining healthy margins to support wide sweeping data collection initiatives, and further enhancement of the classification algorithms. Bulk contracts will be sought with non-profits and global health  organizations. We estimate significant profits through reimbursement plans in high-income markets where the FeelixPro and Feelix@Home platforms will support patients with chronic conditions like asthma and COPD.

Subscription services will be offered to these patients to benefit from longitudinal analysis. We have predictive analytics algorithms and a health-privacy compliant cloud system that aggregates patient data and provides a useful tool to clinicians.

The cloud also offers an opportunity to capitalize on data analytics services provided to health systems, payers and government organizations. We plan to use population level data to help better evaluate the spread of diseases and where to best allocate resources.

Do you primarily provide products or services directly to individuals, or to other organizations?

What is your path to financial sustainability?

We plan on pursuing every possible avenue toward achieving financial stability. Our business model includes multiple revenue streams, but as a research company, we will continue to pursue grant funding in addition to venture funding to help scale our solution.

We will continue applying for grant funding to support research and further enhancements of our classification algorithm and patient monitoring platform. We have so far been very successful in applying for NIH funding, and hope that our research will yield results that warrant continued funding. We have also identified grant opportunities with USAID, the US military and other institutions that are seeking to invest in and deploy novel innovations.

We will pursue venture funding to help us scale the company. VC's will provide the institutional support we will need as entrepreneurs to ensure that we are maximizing capacity and filling in operational gaps where needed. Leveraging VC networks will enable us to build a sustainable infrastructure and acquire top talent.

We will also generate revenue through device sales, subscription services and data analytics contracts. Our model includes multiple streams of revenue which include government contracts, bulk device orders for health systems, community organizations and insurance organizations.

Why are you applying to Solve?

Sonavi Labs has submitted numerous applications to MIT-SOLVE because we believe in the value of collaboration and using technology to tackle some of the world's most pressing challenges.

Winning the TIGER IT challenge in Bangladesh has had a significant impact on our company, and will allow us to deploy another 1,000 devices in the country, where pneumonia is the leading cause of death in children under 5. We hope to continue strengthening our relationship with SOLVE to ensure Feelix is even more widely deployed.

Our team is rich with business and academic leaders who value the commitment SOLVE has made to enabling and empowering startups, entrepreneurs and innovators. Dr. Ilene Busch-Vishniac, our Chief Innovation Officer and Interim Chief Operations Officer, received her PhD from MIT, and went on to become the first, and only, woman to serve as Dean of the Hopkins School of Engineering.

Becoming a SOLVE challenge winner has already helped us to secure additional investments and supports research that will rapidly enhance the Feelix platform. Our goals include reducing costs and funding from MIT-SOLVE will help us do that as well as getting devices into the hands of the people that need them most. 

In which of the following areas do you most need partners or support?

• Product/service distribution
• Funding and revenue model
• Board members or advisors
• Marketing, media, and exposure

Please explain in more detail here.

We hope to continue building partnerships with research institutions, pharmaceutical companies, health systems and public health agencies.

Research collaborations are always warranted as we believe that by feeding our classification algorithm more data, we can train it to detect and differentiate even more diseases in more body systems. 

We are seeking partners to deploy devices into research trials as well as on the frontline with community health workers. Deploying our platform is not going to be an easy task.  Despite the universal design of our device, we need people on the ground with familiarity in the regions to help with training and ongoing support.

Not only is the Feelix hardware capable of impacting millions of lives on the ground, but as we collect more and more data, we will be able to provide useful population level data to help health systems and government agencies allocate resources and capital more efficiently.

What organizations would you like to partner with, and how would you like to partner with them?

The TATA Center - Richard Fletcher and Christian Infante

- The TATA Center at MIT seeks to create affordable pulmonary disease diagnostic tools. We would be happy to collaborate on research and implementation projects with the TATA center.

Access Afya - Melissa Menke

- This mobile screening solution would be a great partner to support pediatric patients in rural and under-resourced communities. We hope to build this functionality into our supportive app.

Blue Sky Analytics - Abhilasha Purwar 

- Uses AI to provide air quality and emissions data, which would be important for supporting predictive analytics for chronic respiratory diseases patients. We aim to incorporate this data into our base station in order to provide predictive support to chronic disease patients.

Ada Health - Hila Azadzoy

- AI powered digital decision support platform for community health workers would be a powerful tool to incorporate into the Feelix community health worker program.

E-Heza - Wendy Leonard

- A low-cost, quality driven health record for families in low-income countries would be a great partner to ensure patients in remote and rural communities have access to longitudinal trend data to better manage chronic respiratory diseases.