Cardiac Biotech Solutions, Inc. Secures Health Canada License for MyCardia AT Device, Now Branded as CardioHolter AT

LAS VEGAS, Sept. 25, 2025 (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 announced that its MyCardia AT device has been issued a Medical Device License (MDL) by Health Canada and is now approved for import into Canada, effective immediately. The device, rebranded as the CardioHolter AT, will be tested and distributed through CBSC's manufacturing partner, Nasiff Associates, located in Central Square, NY. Nasiff Associates is a Health Canada-licensed establishment operating under a certified ISO 13485 Quality Management System (QMS) that complies with Health Canada standards for Class II medical devices.

CBSC’s exclusive Canadian distributor, Your Heart Protector Corp. (Calgary, Alberta), has placed an initial order for CardioHolter AT devices totaling $375,000 USD. Delivery of the first 1,000 devices will occur upon completion of production (currently underway), with the balance scheduled for shipment within 90–120 days.

In addition to revenue from device sales, CBSC has implemented a monthly rental program that provides recurring income whenever devices are deployed in hospitals and healthcare facilities. The program fees include access to the device, the AWS Cloud-based monitoring platform, and patient-facing mobile applications. Revenue from these usage fees is shared between CBSC and its distributor partners, with pricing tailored to each country’s healthcare economics and reimbursement environment.

“With Canada’s vast geography and many remote communities, there is a critical need for flexible, easy-to-use monitoring solutions that extend beyond major metropolitan areas,” said Charles Martin, Chief Executive Officer of CBSC. “The CardioHolter AT is designed to meet that need. Whether using standard landline telephone connections or newer cellular and WiFi-enabled technologies, patients can reliably transmit recorded ECG data to their physicians for timely review and diagnosis. This technology empowers physicians to achieve better patient outcomes, improved diagnoses, and enhanced quality of life regardless of a patient’s location.”

“Our company is proud to have received licensing approval from Health Canada for the CardioHolter AT device, and we look forward to launching our services in Canada,” said Elmer N. Johnson, co-owner of Your Heart Protector Corp. “We are excited to help bring this innovative device to the Canadian market, as it represents a significant advancement in remote monitoring that will provide physicians greater ability to detect, diagnose, and treat irregular heart rhythms earlier, ultimately leading to better patient outcomes.”

The Company continues to advance the global commercialization of its MyCardia AT cardiac event monitoring platform, which integrates lightweight, easy-to-use wearable technology with AWS Cloud-based connectivity and mobile applications for iOS, Android, and WeChat. With regulatory clearance already secured in the United States and Canada, and an additional submission progressing in China, CBSC’s mission is to deliver state-of-the-art cardiac monitoring solutions worldwide.

About Cardiac Biotech Solutions, Inc.

Cardiac Biotech Solutions, Inc. (CBSC) is a medical technology company dedicated to developing and commercializing advanced cardiac monitoring solutions. The Company’s flagship products, the MyCardia AT and CardioHolter AT, are next-generation cardiac event monitoring devices supported by secure, cloud-based data platforms and patient engagement tools.

About Your Heart Protector Corp.

Your Heart Protector Corp., headquartered in Calgary, Alberta, Canada, is a distributor of remote diagnostic testing medical devices and lab services technologies throughout Canada. The company specializes in innovative patient complaint, ambulatory cardiac monitoring solutions for the detection of abnormal heart rhythm reviewed by physicians in an effort to provide early diagnosis, better outcomes, and overall improved quality of life for patients.

About Nasiff Associates, Inc.

Nasiff Associates, Inc. is a medical technology company committed to providing Diagnostic PC Based ECG Solutions to Healthcare Professionals. Leading Innovation of PC Based ECG Systems used in hospitals, offices, telehealth and home-based medical services, delivering Healthcare Providers with Superior Diagnostic Computer Cardiograph Solutions. Supported by an All-American sales and support team, the Nasiff brand offers available human sales and technical support when you need it. Find uncompromised value and accurate diagnostics with Nasiff CardioCard Systems.

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.

Company Contact Information:
Telephone: (888) 225-0870
Investor Inquiries: investor@cardiacbiotech.com
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