Statement of Work
Proposal Number: MTEC-20-12-COVID-19_Diagnostics-046
Organization: Sibel Inc.
Title: ICU-Grade Wearable Sensors with (b) (4)Pre- and Very Early Symptomatic COVID-19 Infection (b) (4).

to Diagnose and Detect

Introduction/Background
COVID-19 is a highly contagious respiratory infection that ranges from asymptomaticpresentation to fatal, progressive pneumonia. The continued lag in availability of COVID-19
laboratory testing necessitates the need for (b) (4). Early symptoms ofCOVID-19 infections are predictable: fever, cough, shortness of breath, and hypoxia measured
by pulse oximetry. Unfortunately, the most popular wearables are unable to measure any ofthese parameters. Clinical signs such as skin rashes on the toes and patient-reported
symptoms such as a loss of smell have been identified as signatures of early infection.
Currently, there is a lack wearable diagnostic systems that capture sufficient objective andsubjective data specific to COVID-19 for pre and early symptomatic detection.
(b) (4)is a next generation wearable monitoring system that offers ICU-grade measurement
parameters and novel respiratory biomarkers specifically relevant to COVID-19. The core(b) (4)We hypothesize that the ANNETM One system is one of the mostcomprehensive wearable monitoring platforms commercially available providing rich, ICU-grade
physiological inputs that will serve as the basis for predictive algorithms to detect pre and early
COVID-19 infection.
Scope/Project ObjectiveTask
1

Goals / Objectives
(b) (4).
Second, we will automate calculation of vital
signs to reflect compensatory reserve, anearlier and more sensitive marker ofdecompensation.
Third, we will deploy a daily symptom
survey on our mobile tablet specific toCOVID-19 symptoms not captured by oursensors (e.g. appearance of characteristic
skin findings or loss of taste/smell withindependent prognostic value).

Major Milestone / Deliverables
Deliverable: (b) (4)2A

We will

Deliverables: final clinical trial report from(nurses, physicians,first to final patient enrollment.
close contacts of COVID+ individuals)
leveraging (b) (4)existing
monitoring, surveillance, and testing
infrastructure for 3 months continuously. A
power analysis is detailed later on with eachsubject generating ~2,000 hours of data with an
expected 48 positive cases.

2B

We will review our survey and physiologicalresults from our sensor and app for positive
and negative tests via the medical record andcompare them to healthy controls to train
machine learning algorithms.

Deliverables: Predictive algorithms forearly COVID-19 infection.

3A

We will

Deliverables: (b) (4)(b) (4)(b) (4)

where we
will enable low cost and accurate patientmonitoring by pararescuemen, during en routecare, and in military treatment facilities.
3B

This will be validated by human testing in (b) (4)(n=20) subjects withthe (b) (4)to demonstratesensor performance, data quality, and userreported comfort.

Deliverables: demonstration of system’s
applicability in a military context

4Sibel is an FDA-registered, ISO-13485 medical
device manufacturer with an established North
American only supply chain. We have thecurrent capability to produce (b) (4)monthly. However, we will establish a clear
production plan and vet domestic vendors thatcan enable higher scale production (b) (4)within 15 days of EUA.
increase scalability

Deliverable: high scale domestic
manufacturing plan

5Obtain FDA feedback in a Q-Sub meeting
followed by EUA within 9 months

Deliverable: FDA EUA

Requirements
The overall objective of the program is to obtain FDA EUA for the (b) (4)for pre and early symptomatic detection of COVID-19 infection.
The key needs are listed here:

Key Needs
1. Designed for pre-detection and early-detection of infection and pathogenic response.
2. Continuous wearable functionality with low user burden with a single device is preferable.
3. Easily interpretable data by non-technical personnel. The data should be easily saved,transmitted, and shared securely in a HIPAA compliant manner.
4. Operates and stored:
5. Physiological signatures yield predictive algorithms that are verified by subsequent
antibody/molecular measurements.
6. Established manufacturing capability for the platform on a large scale.
7. FDA EUA within 9 months of start of the program.
(b) (4)

Our sub-objectives and scope are summarized below.
Objective Aim 1: Design, validate, and rapidly develop a COVID-19 specific analytics
platform and accompany mobile application. We will expand beyond our current abilities todisplay and calculate core vital signs to include advanced metrics of physiologicalrespiratory-specific digital biomarkers (e.g. cough count, cough intensity, respiratory effort),
compensatory reserve (e.g. heart rate response to physical activity stressors), , and a
COVID-19 specific psychometric survey for patient reported symptoms to improve the ability
to generate predictive algorithms. This will serve as the basis for a new software platform
acting as a medical device that will be submitted to the FDA for EUA.
Objective Aim 2: Conduct a single-arm, open-label observational study of at least n=322
subjects at high-risk of contracting COVID-19 at (b) (4)wearing our sensor
continuously in order to establish predictive algorithms of asymptomatic and early
symptomatic infection confirmed by subsequent antibody / molecular assays.
Objective Aim 3A: To establish strong military relevancy, this RPP will also support
integration of our soft, flexible family of sensors (b) (4)platform via a software development kit (SDK).
Objective Aim 3B: We will then conduct a single-arm, pilot study of n=20 pararescuemen
during en route care, and in military treatment facilities with this integrated (b) (4)(b) (4).
Objective Aim 4: Establish and validate a high volume manufacturing plan that extends ourability to increase production to at least (b) (4)monthly with a focus on domesticvendors.

Deliverables







Deliverables
for iOS and Android(b) (4)Clinical report on patient enrollment, adherence, and enrollment
Finalized predictive algorithm model and performance criteria
Demonstrated MVP and test report for (b) (4)mobile application
Updated cost and lead time estimates in the context of a high volume manufacturing plan
FDA EUA within 9 months of project startMilestone Payment Schedule
MTEC
Significant Event
Milestone #1
Kickoff meeting with DOD to review GANTT
chart with project plan.
2
IRB modification submitted
3
Mobile and Algorithm Package for COVID-19
Completed
4First Patient Recruited
5
Quarterly Report 1 (July-September)
6
Quarterly Report 2 (October-December)
7
Final Data Report
8
EUA Submitted
9
Final Report
TotalDue Date
7/31/2020

ProgramFunds$(b) (4)(b) (4)

8/15/2020
9/15/2020$(b) (4)$(b) (4)$(b) (4)$(b) (4)9/30/2020
10/25/2020
1/25/2021
4/15/2021
4/30/2021
4/30/2021

Shipping Provisions
The shipping address for all matters:(b) (4), (b) (6)$(b) (4)Sibel Cost
Share(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)$(b) (4)$(b) (4)$(b) (4)$(b) (4)(b) (4)(b) (4)$2,396,958.00 $(b) (4)