Regulated manufacturing, hospital field trials, and regulatory filings now underway with Ebulent Medical in Shenzhen
LAS VEGAS, NV, January 15, 2026 – PRISM MediaWire (Press Release Service – Press Release Distribution) – Cardiac Biotech Solutions, Inc. (OTCID: CBSC) (“CBSC” or the “Company”), a designer, manufacturer and distributor of non-invasive ambulatory cardiac monitoring products, today provided an update on the execution of its China market entry plan for its MyCardia AT cardiac event monitoring device.
The Company has formally initiated manufacturing and regulatory preparation activities in China through its contract manufacturing and regulatory partner Ebulent Medical (Shenzhen) Ltd., a licensed National Medical Products Administration (NMPA) medical device manufacturer.
CBSC has recently delivered printed circuit assemblies, components, and accessories for the MyCardia AT system to Ebulent in Shenzhen. A secure cloud-based data room containing the full manufacturing package, including bills of materials, assembly instructions, validation software, testing protocols, and packaging documentation, has been activated and is being used by Ebulent to build its NMPA-compliant manufacturing file and Device History File (DHF).
Ebulent has also begun configuring its production line and post-assembly validation stations for the MyCardia AT and is scheduled to complete an initial manufacturing run by month-end. As required to complete the NMPA approval process, these devices will be placed into active hospital accounts in China for in-hospital clinical field testing, building on the Company’s existing clinical trial which recently topped five million prior patient procedures.
Following this final successful device validation in hospital use, Ebulent will register as CBSC’s Chinese manufacturing partner with the NMPA, and since Ebulent is already an NMPA-approved medical device manufacturer, the registration formality is expected to be a filing-based process. CBSC, Ebulent, and CBSC’s Chinese clinical partners will then submit the final regulatory dossier to the NMPA advisory board for commercial clearance of the MyCardia AT device in China.
“This partnership gives us direct access to a fully licensed Chinese medical-device manufacturing and regulatory infrastructure. 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.”
Charles Martin, Chief Executive Officer of CBSC.
This China initiative represents another significant milestone in the Company’s mission to provide state-of-the-art cardiac monitoring solutions worldwide and builds on its recent international expansion including regulatory approval in Canada, and exclusive distribution agreements in Central and South America.
The MyCardia AT integrates lightweight, easy-to-use wearable technology with AWS Cloud-based connectivity and mobile applications for iOS, Android, and WeChat, and produces a recurring revenue stream for the Company through a revenue-sharing model which varies by market reflecting regional healthcare economics and reimbursement practices.
As additional new developments occur, Cardiac Biotech Solutions, Inc. will make timely announcements through press releases and regulatory filings to keep its shareholders, industry participants, and the public markets informed.
About Cardiac Biotech Solutions, Inc.
Cardiac Biotech Solutions, Inc., through its international subsidiaries, provides innovative products and services in the ambulatory non-invasive cardiac monitoring space. Our electrocardiogram (EKG) devices, interactive cloud-based acquisition software, and smartphone apps for both iOS and Android platforms provide improved compliance for patients at risk of abnormal heart rhythms, as well as more accurate information for physicians.
About Ebulent Medical (Shenzhen) Ltd.
Ebulent Medical (Shenzhen) Ltd., through its Shenzhen and Huizhou facilities, provides comprehensive contract development, regulatory, and manufacturing services for medical device companies. Its integrated R&D, quality systems, regulatory registration support, and advanced production capabilities enable the design, validation, and commercial manufacture of regulated medical devices for the Chinese and global healthcare markets.
Company Contact Information:
Telephone: (888) 225-0870
Investor Inquiries: investor@cardiacbiotech.com
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Source: Cardiac Biotech Solutions, Inc.
