Strados Labs

Real World Monitoring of Cough and Wheeze

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Inspiration

Strados Labs' RESP® Biosensor was developed by an asthma patient concerned by the lack of objective remote monitoring of his respiratory symptoms.

Chronic respiratory diseases such as COPD and Asthma affect more than 300 million people and are among the top causes of death worldwide, with 30 day readmissions for COPD often exceeding 20%. Symptoms such as coughing, wheezing and shortness of breath are early warning signs of exacerbations but there are currently no effective ways for objectively monitoring these symptoms.

Respiratory clinical trials for new therapies, which are among the most expensive to run, also lack adequate technologies for objectively measuring improvement in these symptoms in daily life.

What it does

The RESP Biosensor is a FDA-cleared remote monitoring technology that allows for more effective respiratory disease management from hospital to home. Our wearable device remotely and continuously captures lung sounds, similar to a stethoscope, allowing clinicians to monitor changes in patients' respiratory status including coughing, wheezing, crackles as well as vitals such as respiratory rate and heart rate. Respiratory data captured by our device sync wirelessly to our proprietary cloud software platform designed to collect and process lung sound data with over 100,000 validated lung sound events and 10 million breaths captured. Our CoughCheck™ and WheezeCheck™ machine learning algorithms allow for accurate and efficient detection of cough and wheeze events, leading to faster reporting and data turnaround for care teams.

Research suggests that the RESP Biosensor has the potential to detect exacerbations earlier than standard of care such as pulse oximeters. It is also more objective than patient e-diaries, thus offering a more effective tool to remotely monitor patients.

The technology is also used in life sciences to measure drug treatment response in phase I - IV clinical trials and demonstrate efficacy.

Compared to traditional cough monitors in clinical trials, the RESP Biosensor greatly accelerates and streamlines cough trials. The device wirelessly syncs data to the cloud as compared to traditional devices which require a connected cable; this feature can lead to weeks saved in reviewing subject cough results. Our technology also allows for weekly adherence reports, revealing that a subject isn't following protocol. Because every subject matters in clinical trials, this alone can save thousands of dollars and improve subject retention. Our device is also capable of capturing a much wider range of data (wheezing, crackles, respiratory rate) compared to traditional cough monitors.

How we built it

The technology was developed by an Asthma patient Nick Delmonico in partnership with a physician. After initial prototypes were developed, the founder Nick brought on med tech veterans and engineers Richard Powers and Jason Kroh who were on the team that developed the CardioMEMS Heart Failure Management System (sold to Abbott for ~$500 million).

Challenges we ran into

To expand commercially into health systems, we need to cross another regulatory clearance hurdle that requires more data on the patients such as worsening symptoms, rehospitalizations, how often they are experiencing these symptoms, efficacy of the treatment, and other factors. Without this additional regulatory clearance, it would be very difficult to expand so it is definitely a barrier to entry.

All of our revenue to date has coming from working with pharmaceutical clinical trials, which is an easier buying process and requires way fewer barriers to entry.

What we learned

One of the biggest lessons learned is that a skilled and experienced team is paramount to any company’s success. I know that it's always the thing that sounds cliche, but you need people who have the skill set to build something from zero to one, and the interest and passion for it. Getting experience working with people with technical backgrounds is critical. We can't imagine not having the guidance of our co-founder who came from med tech and had a successful exit. We are learning a great deal together.

What's next for Strados Labs

Some things that have been going on at our company during the period have included: 1) a clinical trial to validate our device in children to prepare for a FDA pediatric submission 2) enhancements to our wheeze detection algorithm to prepare for a FDA submission 3) adapting our device for military applications. I

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