Cardiac Bio Solutions Launches MyCardia AT China Production with Shenzhen Ebulent

Cardiac Bio Solutions Launches MyCardia AT China Production with Shenzhen Ebulent

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.

Partnership & Manufacturing Milestone

ItemDetail
PartnersCardiac Biotech Solutions (OTC: CBSC) & Shenzhen Ebulent (China)
ProductMyCardia AT cardiac event monitoring device
ScopeManufacturing, assembly, verification, and NMPA regulatory filing
Production StartJanuary 2026 (line setup underway)
Initial BatchExpected completion end‑January 2026
Regulatory PathClass II medical device NMPA registration (estimated 12‑month review)
Commercial LaunchTarget 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

Parameter2026E2027E2028E
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 patients12.5 million13 million
MyCardia AT Market Share Target0 %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

CompanyProductStage (China)Price (¥)Key Differentiator
Cardiac Bio / EbulentMyCardia ATManufacturing (2026)¥8,500 (est.)AI detection, 30‑day wear, IP67
MedtronicSEEQMarketed¥15,00014‑day wear, limited AI
iRhythmZio PatchMarketed (import)¥12,80014‑day wear, cloud platform
Mawi AIMawi BandMarketed¥6,5007‑day wear, basic algorithm
Lepu MedicalCardioCareMarketed¥9,20024‑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