Self-monitoring and patient empowerment plays a pivotal role in the digital health revolution. 1. Global Initiative for
HealthUp / MySpiroo
Patient Focused, Digital Respiratory Disease Management System B E T T E R C O N T R O L OF A S T H M A A N D C O P D
www.myspiroo.com
Team
Challenge
•
Respiratory diseases are among top 4 1,2 causes of death
•
Up-to 80% of patients are underdiagnosed and sub-optimally treated3
•
Spirometry, the basic diagnostic method, is not accessible for home use and limited for many GPs3
1. Global Initiative for COPD, 2017 report; 2. WHO, 2017 report; 3. CHEST 2015; 148(4):971-985;
Opportunity •
Large market: • 550 million patients • 1 million HCPs • 80.000 patients in clinical trials / year
•
Exponential growth of smartphone use among patients and physicians
•
Self-monitoring and patient empowerment plays a pivotal role in the digital health revolution www.myspiroo.com www.myspiroo.com
Respiratory Disease Management System components Software/Service
Hardware
Data
AI Lung Diagnostics & Monitoring
Ambient Environment Monitoring
Comprehensive Cloud-based Data platform
Hospital grade spirometer
Web-based dashboard
Easy-to-use
Air quality compounds influencing asthma exacerbations
Instant data upload
Two versions: 1. Charging station for any mobile device 2. On-the-go, mobile device
All-in-one (treatment, diseases, living conditions, online consultations), for optimal disease management
2 Dedicated Smart Mobile Apps 2 PLAFTORMS Patient app (iOS&Android) Lung function diary Digital asthma action plan Instant data upload (cloud) ERS/GLI norms Doctor app (Android) Built-in diagnostic criteria Automated diagnostic pathways Multiple patient records
Decision Support & Predictive Algorithms AI system engine for personalised: exacerbation predictive models medication reminders drug titration Decision support algorithms for diagnosis of COPD Disease phenotyping
Product Design
Full spirometry FVC FEV1 FEV1/FVC PEF FEF 25, 50, 75 Flow-Volume curve
Heart Rate HR sensor SpO2 sensor www.myspiroo.com
Momentum “To become the Apple of respiratory care”
Dream
First Prototype
1st strategic partner
Seed Funding
2014
2015
2016
Idea & first sketches
R&D IT Development
Investment JPIF $1.1M
ISO & CE
FDA Submission
MySpiroo Production
Online Platform
BETA testing
Clinical Trial
COPD screening
2018
2017 • •
• •
Patent pending Registration as Class IIa Medical Device CE & ISO 13485 ATS/ERS criteria met
FDA submission
First serial production
•
• • •
Cloud-based data platform Doctor app Patient app Start first Clinical Trial
• • • •
•
First pharma partner Beta testing (MDs) COPD screening Meeting in Cupertino (Apple) First medical diagnosis
Problem: Asthma Team
Solution
Key challenge:
Daily collection of respiratory parameters & environmental data by companion devices in asthma management
Mainly Due to: • Poor therapy adherence stemming from inhaled corticosteroid (ICS) side effects
Patient app displays result and advises according to a personal asthma action plan that allows to titrate doses & reduce drug side effects
Frequent exacerbations
•
Delayed ICS dose titration based only on symptoms
•
No immediate access to healthcare professionals
•
Lack of modern tools for self management, “pen&paper” still dominate
Lung function and environmental data instantly available for a physician to prevent exacerbations
AI
Exponential growth of real-life health database allowing for AI learning and prediction modeling www.myspiroo.com
Home spirometry
Team
Methodology:
Steep learning curve to correct selfspirometry d
one by patient at home 100% 80%
Can the patient perform
self-spirometry independently at home?
(Primary End-Point)
•
46 patients completed follow-up
•
Follow-up: 21 days
•
Efficacy primary end-point, at least 3 correct examinations within a week of follow-up
2%
n=46 pts
Outcome:
60%
40%
20%
0% 1 3 5 7 9 11 13 15 17 19 21 Follow-up (days)
Unpublished data from home self-spirometry trial
•
1680 days of patient follow-up
•
4878 measurements in 1204 exams
•
4,1 measurement per exam
•
Short and steep learning curve
•
98% of patients are able to perform good quality self-spirometry at home
98%
No
Yes
n=1204
www.myspiroo.com
Problem: Chronic Obstructive Team Pulmonary Disease (COPD)
Solution
Key challenges:
Screening questionnaire to identify individuals with high risk of COPD
Large underdiagnosis makes COPD the 4th leading cause of death Diagnosed
n=30,100
Underdiagnosed
100 75
72
50 25 0
28 Spain
65
69
91
75
80
86
82
16
18
Brasil
Canada
50
35
31
25
20
China
Germany
Poland
UK
9 Turkey
50
USA
Spirometry with bronchodilation tests followed by automated result interpretation and decision support at GP’s office
Mainly due to: •
Lack of active spirometry screening at primary care facilities
•
Difficult diagnostic pathways involving complicated calculations and algorithms
*Global Initiative for COPD, 2017 report; **WHO, 2017 report; ***CHEST 2015; 148(4):971-985
Instant upload of the diagnostic report to EHR or print out for medical records
www.myspiroo.com www.myspiroo.com
COPD screening Pilot - preliminary results
Team
Screened patients for lung
obstruction Underdiagnosed Diagnosed (n = 215) 100%
75%
75% 50%
25%
25% 0%
Poland
}
Methodology:
Underdiagnosed 100%
31 %
75%
Diagnosed
•
21 participating GPs
•
21 MySpiroo distributed
•
3 weeks active testing
52%
Outcome:
69 %
50%
25%
Obturation No obturation
48%
0%
Poland
•
215 screened patients
•
66 newly diagnosed obstructions
•
Cost of pilot: 5K EUR / 9 weeks
•
Cost of one newly diagnosed patient: 25 EUR
www.myspiroo.com
Supported by International Team Scientific Advisory Board
Professor Sebastian Johnston, Imperial College, London, UK Professor Norbert Krug, Institute for Toxic. and Experimental Med., Hannover, Germany Professor Adnan Custovic, Imperial College, London, UK Professor Tim Harrison, University of Nottingham , UK Dr. Andrei Malinovschi, Uppsala University, Sweden Dr. Rene Aalbers, University of Groningen, The Netherlands Prof. Piotr Boros, Institute of Pulmonary Disease and Tuberculosis, Warsaw, Poland Dr Maciej Kupczyk, Medical University, Lodz, Poland Dr. Piotr Dąbrowiecki, WIM, Warsaw, Poland
www.myspiroo.com
Source of revenues Team • • •
• • •
• • •
B2C Device sale to patients and doctors Platform subscription Up-selling
COPD screening with Pharma Clinical trials with CROs Data base access
Total available market
Target market
•
•
> 550 million patients > 1 million Family doctors*
•
> 10 million Family doctors
•
•
80k patients / year in clinical trials > 6.5 million patients**
•
•
•
> 6.5 million patients** > 100k GP doctors*
B2B
Big data analysis / behavioural models Pharma and med-tech Big data integrators Insurers/healthcare payers
•
Data access & reports on >6.5 million patients and > 1 million doctors
•
•
> 900k* GP doctors 40k patients / year in clinical trials > 6.5 million patients**
Data access & reports on >6.5 million patients and > 1 million doctors
www.myspiroo.com www.myspiroo.com
MySpiroo growth strategy Team Time frame
0 - 12 months
13-60 months
Strategic objective
To prove MySpiroo marketability and confirm the business model
Paradigm shift in respiratory disease management (asthma&COPD)
Focus areas
Enrollment into clinical trials (CT) with CROs COPD screening with Pharma (3 EU countries) First asthma patients enrolled by HCPs
Delivering clinical outcomes Expanding sales via the selected channels Building consumer data base Building predictive algorithms and add-on services
Deliverables
MySpiroo used in key drug CTs 3 pilot project with Pharma for COPD screening Min. of 300 paying users with asthma
A large data base of patients (> 10.000) Predictive algorithms Disease management ecosystem (SaaS)
www.myspiroo.com www.myspiroo.com
MySpiroo vs. Competitors - summary
Area
Function
MySpiroo
Spirobank
Micro Diary
Spirotube
Nuvoair
GoSpiro
WING
Full spirometry Performance Low-flow accuracy Disposable turbines only
No need for calibration
Software
Disposable turbines only
Separate, customisable apps for MDs & patients COPD /asthma
diagnostic module Apps for iOS & Android Instant data upload to telehealth platform Digital asthma plan Digital spirometry assistant (coach) Charging
Stand alone device
NFC
USB
USB
USB
Cable
USB
Cable
User experience Affordable price (
