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Cardiac Biotech Solutions Activates China Production Pipeline for MyCardia AT and Moves into Final NMPA Submission Phase
Cardiac Biotech Solutions Activates China Production Pipeline for MyCardia AT and Moves into Final NMPA Submission Phase.
About this update from Cardiac Biotech Solutions Inc.
[{"type":"text","content":"\r\n\r\n \r\n \r\n Cardiac Biotech Solutions Activates China Production Pipeline for MyCardia AT and Moves into Final NMPA Submission Phase\r\n \r\n \r\n\r\n\r\nCardiac Biotech Solutions Activates China Production Pipeline for MyCardia AT and Moves into Final NMPA Submission Phase\r\nRegulated manufacturing, hospital field trials, and regulatory filings now underway with Ebulent Medical in Shenzhen\r\n\r\n\r\n\r\n\r\n\r\nLAS VEGAS, Jan. 15, 2026 (GLOBE NEWSWIRE) -- 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 r...