
Innovative Wearable Cardiac Monitor CHARM for Arrhythmia Detection
Introducing CHARM - Cardiac Heart Arrhythmia Monitor, a revolutionary finger-worn device for continuous cardiac monitoring with real-time arrhythmia detection capabilities. Designed to address the silent threat of Atrial Fibrillation, this miniature device offers advanced features like comprehensive monitoring, comfortable form factor, and AI-powered detection. Learn how CHARM aims to revolutionize the cardiac monitoring market with its cutting-edge technology.
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Presentation Transcript
Cardiodet Miniature Medical Device for Arrhythmia Detection Introducing CHARM - Cardiac Heart Arrhythmia Monitor 1
Cardiodet Executive Summary Innovative finger-worn device for continuous cardiac monitoring Real Time Arrhythmia detection (Atrial Fibrillation, Flutter) Successful initial clinical validation with exceptional accuracy metrics Targeting $11B+ global cardiac monitoring market Goals: final development, clinical trials, and FDA clearance 2
Cardiodet The Problem Atrial Fibrillation (AFib): A Silent Killer Atrial fibrillation affects 33.5 million people globally (~0.5% of population) Delayed detection leads to increased stroke risk, heart failure and complications Continuous and long-term data analysis is crucial for arrhythmia detection, otherwise arrhythmia episodes will not be detected Current monitoring solutions are bulky, inconvenient, or intermittent: Holters and ECG patches are inconvenient and their monitoring duration is limited Smartwatches and Smart rings provide sparse non-continuous monitoring 3
Cardiodet Our Solution: Innovative Wearable Device Comprehensive monitoring: AFib, Flutter, SpO2, and heart rate Continuous and unlimited duration monitoring Miniature comfortable ring-like form factor for patient compliance Advanced ML/AI algorithms for accurate real-time arrhythmia detection Seamless integration with smartphones and cloud platforms The physiological signals analysis results are transferred to the cloud for storage and sharing with physicians and health providers The combination of an affordable, convenient, wearable device with continuous, unlimited 24/7 medical grade, AI powered cardiac monitoring is a game changer 4
Cardiodet CHARM Technology Collecting Photoplethysmography (PPG) signals at high sampling rate Continuous signals analysis based on Machine Learning and AI edge algorithms Analysis results transmission to the patient s smartphone via Bluetooth, followed by further transmission to a secure cloud storage Patient s smartphone used for device control and clinical data visualization Share patient s data with physicians and health providers Efficient design for low power consumption and minimal data bandwidth 5
Cardiodet Clinical Validation Clinical study for evaluation of the CHARM device arrhythmia detection efficacy has been conducted in Shamir Medical Center: 16 subjects Total of 1498 recorded minutes 298 arrhythmia episodes (225 minutes) Sensitivity: 91% Legend: The figure shows an example of pacing-induced AF initiation and detection by the Specificity: 95% experimental device (Panel C). The detection is based solely on PPG signal recording (Panel A, ROC AUC: 0.97 top channel) and Lorentz plot analysis (Panel B). The bottom two channels of surface ECG and intracardiac CS catheter recording were exported from the recording system for algorithm training and validation purposes only. 6
Cardiodet Market Opportunity Global cardiac monitoring market: $11.2B (2023) CAGR: 6.2% (2023-2028) Demand for wearable health monitoring devices is growing rapidly due to increasing health awareness and the shift towards remote patient monitoring Target segments: High-risk cardiac patients and patients with other factors, such as age 60+, high blood pressure, obesity and diabetes Post-procedure clinical assessment Preventive health monitoring for early diagnosis Healthcare providers and hospitals 7
Cardiodet Regulatory Strategy FDA Classification: Class II medical device Clinical trial (based on final product) Predicate devices identification 510(k) submission Timeline to clearance: 12-18 months Similar process for CE approval 8
Cardiodet Development Roadmap Q1-Q2 2025: Final product optimization Manufacturing process development Q3-Q4 2025: Clinical trial execution FDA submission preparation Q1-Q2 2026: FDA clearance (estimated) Commercial launch preparation 9
Cardiodet Budget and Schedule Task $K 300 200 100 600 Duration (months) 6 - 8 4 - 6 Product Development Clinical Study FDA Submission Total 12 - 14 10
Cardiodet Revenue Model Device sales: Direct to healthcare providers Recurring revenue: Monthly subscription for monitoring services B2B partnerships with healthcare systems Insurance reimbursement strategy in development 11
Cardiodet Competition Comparison Device Type Implantable ECG Patch Holter Loop Recorder Smartwatch Smart ring Cardiodet Method Non-Invasive Medica grade ECG No Yes ECG Yes Yes ECG Yes Yes ECG Yes Yes ECG[1]/PPG Yes No ECG[1]/PPG Yes No PPG Yes Yes No[2] No[2] No[2] No[2] Continuous arrhythmia detection No No Yes No[3] 3 years No[3] few days No[3] 2 days No[3] 2 days Real Time arrhythmia detection Duration No Unlimited No Unlimited Yes Unlimited No[4] No Wrist $700 No[4] Yes Finger $400 Electrodes Small Footprint Location Price Internal Yes Chest $4K Yes No Chest $500 Yes No Chest $200 Yes No Chest $300 No Yes Finger $250 [1] sparse manually activated spot check (non-continuous) [2] suspiceous change of heart rate triggers recording [3] arrhythmia may be detected offline [4] comes with 1-lead electrodes for user activated spot check, does not increase footprint 12
Cardiodet Competitive Advantage Key differentiators: Continuous, accurate and unlimited monitoring capability Validated clinical accuracy Superior form factor offering convenience for user compliance Cost-effective compared to traditional diagnostic methods and wearable alternatives System cost reduction by: Embedded ML/AI analytics (instead of cloud-based computing) Efficient data transmission (requires low bandwidth) 13
Cardiodet Call to Action Investment opportunity to: Complete product development Execute clinical trials Achieve FDA/CE clearance Launch innovative cardiac monitoring solution Address growing global health need 14