Cardiac Biotech Solutions, Inc. (OTCMKTS: CBSC) announced that its China partner Shenzhen Ebulent has commenced manufacturing line setup and regulatory filing preparation for the MyCardia AT cardiac event monitoring device, with initial production expected by end‑January 2026.
Contents
Partnership & Manufacturing Milestone
| Item | Detail |
|---|---|
| Partners | Cardiac Biotech Solutions (OTC: CBSC) & Shenzhen Ebulent (China) |
| Product | MyCardia AT cardiac event monitoring device |
| Scope | Manufacturing, assembly, verification, and NMPA regulatory filing |
| Production Start | January 2026 (line setup underway) |
| Initial Batch | Expected completion end‑January 2026 |
| Regulatory Path | Class II medical device NMPA registration (estimated 12‑month review) |
| Commercial Launch | Target Q1 2027 (pending approval) |
Product Profile
- Technology: Wearable cardiac event monitor with AI‑enhanced arrhythmia detection
- Key Features:
- 30‑day continuous monitoring with real‑time ECG transmission
- P‑wave analysis for atrial fibrillation (AFib) detection (98.5 % sensitivity)
- Waterproof design (IP67) for patient compliance
- Cloud‑based analytics platform with physician dashboard
- Competitive Edge: Lower cost vs. traditional Holter monitors; faster diagnosis (average 4.2 days vs. 14 days)
- Indications: AFib, atrial flutter, supraventricular tachycardia, syncope work‑up
Market Opportunity
| Parameter | 2026E | 2027E | 2028E |
|---|---|---|---|
| China Cardiac Monitoring Market | $1.8 billion | $2.3 billion | $2.9 billion |
| Wearable Event Monitor Segment | $280 million | $420 million | $650 million |
| Target Population (China) | 12 million AFib patients | 12.5 million | 13 million |
| MyCardia AT Market Share Target | 0 % | 5 % | 12 % |
| Estimated Device Price (¥) | – | ¥8,500 | ¥8,200 |
| China Revenue Forecast | – | ¥420 million | ¥1.18 billion |
- Reimbursement Pathway: Class II device eligible for provincial reimbursement; expected 65 % coverage in tier‑1/2 cities by 2028
- Distribution: Shenzhen Ebulent leverages 300‑hospital network; CBSC retains brand control and software licensing
- Unmet Need: Rural China has < 20 % penetration of cardiac monitoring; MyCardia AT’s cost advantage addresses accessibility gap
Competitive Landscape
| Company | Product | Stage (China) | Price (¥) | Key Differentiator |
|---|---|---|---|---|
| Cardiac Bio / Ebulent | MyCardia AT | Manufacturing (2026) | ¥8,500 (est.) | AI detection, 30‑day wear, IP67 |
| Medtronic | SEEQ | Marketed | ¥15,000 | 14‑day wear, limited AI |
| iRhythm | Zio Patch | Marketed (import) | ¥12,800 | 14‑day wear, cloud platform |
| Mawi AI | Mawi Band | Marketed | ¥6,500 | 7‑day wear, basic algorithm |
| Lepu Medical | CardioCare | Marketed | ¥9,200 | 24‑hour Holter, no extended wear |
Strategic Positioning
- Intellectual Property: 12 patents covering device design, AI algorithm, and cloud platform; NMPA filing expected Q2 2026
- Manufacturing Cost: Shenzhen Ebulent’s vertically integrated production targets COGS < ¥2,500 (70 % gross margin)
- Software‑as‑a‑Service: Recurring ¥800/year cloud subscription per patient; projected ¥96 million ARR by 2028
- Pipeline Expansion: CBSC developing MyCardia Pro with 12‑lead capability for acute coronary syndrome (ACS) detection; IND filing 2027
Forward-Looking Statements
This brief contains forward-looking statements regarding manufacturing timelines, NMPA approval, and revenue projections for MyCardia AT in China. Actual results may differ due to regulatory review delays, competitive responses, and market adoption rates.-Fineline Info & Tech
