Cardiac Biotech Solutions Activates China Production Pipeline for MyCardia AT and Moves into Final NMPA Submission Phase

Core Viewpoint - Cardiac Biotech Solutions, Inc. is advancing its entry into the Chinese market for its MyCardia AT cardiac event monitoring device through a partnership with Ebulent Medical, focusing on manufacturing and regulatory compliance [1][6]. Group 1: Manufacturing and Regulatory Activities - The company has initiated manufacturing and regulatory preparation activities in China via Ebulent Medical, a licensed NMPA medical device manufacturer [2]. - Printed circuit assemblies, components, and accessories for the MyCardia AT system have been delivered to Ebulent in Shenzhen, with a secure cloud-based data room established for manufacturing documentation [3]. - Ebulent has begun configuring its production line and is expected to complete an initial manufacturing run by the end of the month, with devices to be used in clinical field testing in hospitals [4][5]. Group 2: Clinical Trials and Market Strategy - The company’s existing clinical trial has surpassed five million prior patient procedures, which will support the in-hospital testing of the MyCardia AT device [4]. - Following successful validation in hospital use, Ebulent will register as the Chinese manufacturing partner with the NMPA, streamlining the regulatory approval process [5]. - The MyCardia AT device integrates wearable technology with cloud-based connectivity and mobile applications, creating a recurring revenue stream through a revenue-sharing model tailored to regional healthcare economics [7]. Group 3: Strategic Partnerships and Expansion - The partnership with Ebulent Medical enhances the company's access to a licensed manufacturing and regulatory infrastructure in China, which is crucial for achieving NMPA clearance [6]. - This initiative marks a significant milestone in the company's global expansion strategy, which includes recent regulatory approvals in Canada and distribution agreements in Central and South America [6].