of Predicate (One Page) Summary of Specific Aims of Phase I Specific Aim 1: Train and evaluate an algorithm to detect pediatric asthma symptoms (cough and wheeze) on a low power, small form factor wearable device. Specifications: 90% sensitivity; false alarm rate: 1 cough episode/day or 1 wheeze episode/day. Evaluate algorithm against medical expert (physician) scoring using the two best available asthma scoring tools (AS: asthma score; PRAM: Pediatric Respiratory Assessment Measure).
Specific Aim 2 : Design and evaluate algorithm to detect lung function variability on a low power, small form factor wearable device. Specifications: Using respiratory signals from sensor patch, detect variations ? 10% in forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC). Evaluate algorithm against spirometry gold standard. Progress towards Specific Aims As of today, January 21, 2020, the work on the predicate NIH STTR award has not yet begun. The work related to this NIH STTR is anticipated to begin April 2020. Prior to submitting our NIH STTR application, significant work was completed to test the viability of collecting lung function using our wearable technology. We tested on over 20 patients in the hospital, and in this study we found a positive correlation between our measurements and those of spirometry. Our NIH STTR work will build upon this. Technical, administrative, or commercial challenges and how they?ve been addressed During our customer discovery so far, we have learned about the complexities of achieving reimbursement, even if we have identified applicable CPT codes. Realizing this challenge, we selected an initial customer that will not require reimbursement. Our initial customer will be respiratory clinical trials. From our interviews, we have learned that they have a strong unmet need, they are willing to pay a large amount, and we will be able to serve them earlier than other customer types. We hope to explore this further during this NIH I-Corps program. Brief intro to team members Principal Investigator: Justice Amoh, PhD, CTO of Clairways - Justice is a pioneer in embedded systems for stochastic modelling of physiological signals. His focus is on deep neural network models for detecting the onset of symptoms in respiratory diseases. C-Level Corporate Officer: Jeff Bemowski, MBA, CEO of Clairways - Jeff is experienced in product management, market research, and customer discovery for novel biomedical devices. He previously worked in product management for Endotronix, a Series C funded medical device company. Industry Expert: Bob Gatewood, VP Digital Health at Portal Instruments - Bob Gatewood is an experienced healthcare and digital health entrepreneur. Bob was one of the founding members of Athenahealth, which is now valued at over $5.5 billion. He has already worked through many of the challenges Clairways will have to overcome, so his perspective will be very valuable to our team. Additionally, Bob is well connected within the industry and will aid in connecting with 100 potential customers within the short timeline.
