Heart of the Dragon: MyCardia AT's Bid for China's Medical Market

LAS VEGAS, NV – January 15, 2026 – Cardiac Biotech Solutions, Inc. (OTCID: CBSC) has initiated a critical push into the vast Chinese healthcare market, activating its production pipeline for the MyCardia AT cardiac event monitor and moving into the final phase of its submission to the National Medical Products Administration (NMPA). This strategic move, executed in partnership with a licensed local manufacturer, positions the small-cap American company to compete for a share of China's rapidly expanding, multi-billion-dollar cardiac device sector.

The Las Vegas-based firm announced today that it has begun manufacturing and regulatory preparations through its partner, Ebulent Medical (Shenzhen) Ltd. This collaboration is pivotal, providing CBSC with an established foothold and a clear path through China's notoriously complex regulatory environment.

A Strategic Path Through the Regulatory Labyrinth

For any foreign medical device company, gaining access to China is a formidable challenge, often involving a multi-year process of navigating the NMPA's stringent requirements. Cardiac Biotech Solutions is attempting to streamline this journey by embedding its operations within a trusted local entity. Ebulent Medical is not just a contract manufacturer; it is an NMPA-licensed and ISO 13485-certified firm with deep experience in local regulatory affairs, quality systems, and advanced production.

CBSC has delivered core components, including printed circuit assemblies for the MyCardia AT system, to Ebulent's Shenzhen facility. Concurrently, a secure cloud-based data room containing the device's entire manufacturing blueprint—from bills of materials to validation software and testing protocols—has been activated. This allows Ebulent to build the NMPA-compliant Device History File (DHF) necessary for regulatory approval.

Ebulent has already begun configuring its production lines and is scheduled to complete an initial manufacturing run of the MyCardia AT devices by the end of this month. These locally produced units will then undergo a crucial final step: in-hospital clinical field testing within China. This validation builds upon the device's existing clinical trial data, which already includes over five million patient procedures.

“This partnership gives us direct access to a fully licensed Chinese medical-device manufacturing and regulatory infrastructure,” said Charles Martin, Chief Executive Officer of CBSC, in a statement. “We believe that Ebulent’s scale, quality systems, and regulatory standing significantly strengthen our ability to achieve NMPA clearance and commercialize MyCardia AT in China.”

Once the in-hospital validation is successfully completed, the final regulatory dossier will be submitted to the NMPA advisory board for commercial clearance. The existing NMPA license held by Ebulent is expected to make its registration as CBSC's official Chinese manufacturing partner a straightforward filing process, potentially shaving significant time off the typical approval timeline, which can stretch from 16 to 36 months for similar medical devices.

Tapping into a Burgeoning Multi-Billion Dollar Market

The strategic importance of this move is underscored by the sheer scale of the market opportunity. China's cardiac monitoring device market, valued at over $2.9 billion in 2023, is projected to exceed $4.2 billion by 2030. The ambulatory monitoring segment, where MyCardia AT competes, is growing even faster, with forecasts predicting it will reach over $775 million by 2030, expanding at a compound annual growth rate of nearly 12%.

This explosive growth is fueled by powerful demographic and public health trends. China's aging population, with over 350 million people expected to be over 65 by 2030, combined with the rising prevalence of cardiovascular diseases (CVDs), creates an immense and urgent need for effective diagnostic tools. The Chinese government has responded with ambitious initiatives like “Healthy China 2030,” which prioritizes remote patient monitoring for chronic conditions and aims to expand telemedicine networks that already connect over 80,000 medical institutions.

By entering this market, Cardiac Biotech Solutions will face established domestic giants like Mindray Medical and international powerhouses such as Philips and GE Healthcare. However, the company is betting that its technology offers key differentiators tailored to the needs of modern Chinese healthcare.

Differentiated Technology for a Digital-First Nation

The MyCardia AT is a lightweight, wearable monitor designed for continuous, non-invasive ECG monitoring for up to 30 days. Its core innovation lies in a proprietary auto-trigger algorithm that can automatically detect and record asymptomatic cardiac events like atrial fibrillation, tachycardia, and bradycardia—arrhythmias that patients may not feel and which often go undiagnosed.

Crucially, the system is built on a modern digital platform. It utilizes AWS Cloud connectivity and is supported by mobile applications for iOS and Android. In a move that demonstrates keen market awareness, the platform also integrates with WeChat, China's ubiquitous super-app. This integration allows patients to easily manage their monitoring and transmit data, leveraging a digital ecosystem that is second nature to hundreds of millions of Chinese citizens and aligns perfectly with the nation's push towards digital health and telemedicine.

Furthermore, the company operates on a recurring revenue model, which can lower the initial capital expenditure for hospitals and clinics, making the technology more accessible. This combination of advanced clinical capability, user-friendly design, and a business model suited for scalable deployment gives MyCardia AT a unique value proposition as it prepares to enter the competitive landscape.

A Global Ambition with a Chinese Keystone

The China initiative is not an isolated venture but the cornerstone of a broader international expansion strategy for Cardiac Biotech Solutions. The company, which trades on the OTC markets with a market capitalization of just over $8 million, has been methodically building its global footprint. In recent months, it secured a Health Canada license for its device and signed exclusive distribution agreements covering several countries in Central and South America.

For a company of its size, a successful launch in China could be transformative, unlocking a revenue stream that would dwarf its current figures. The final steps—successful in-hospital validation and the subsequent submission of the regulatory dossier—are now the primary focus. With production lines firing up in Shenzhen, Cardiac Biotech Solutions is on the cusp of potentially turning its global ambition into a tangible and significant commercial reality.