The Landmark Approval: CardioHolter AT Enters Canada
Securing a national medical device license is the crucible for any MedTech innovator, marking the transition from development to commercial reality. For Cardiac Biotech Solutions, this milestone has now been decisively achieved in Canada.
CBSC announced it has been issued a Medical Device License (MDL) by Health Canada for its MyCardia AT device. This approval allows for the immediate import and distribution of the monitor, which will be marketed in Canada under the new brand name CardioHolter AT.
This market entry is anchored by a key partnership with Your Heart Protector Corp. of Calgary, Alberta, which has been named the exclusive Canadian distributor. The collaboration ensures that the CardioHolter AT will have an established and expert channel to reach healthcare providers nationwide.
“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. 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.” — Elmer N. Johnson, co-owner of Your Heart Protector Corp.
This regulatory green light now puts the spotlight on the innovative technology at the heart of the CardioHolter AT and its specific design for the Canadian landscape.
A Closer Look: How the CardioHolter AT Empowers Patients and Doctors
Modern healthcare increasingly demands medical technology that is not only powerful but also patient-friendly and adaptable to diverse environments. The CardioHolter AT is engineered to meet these needs, offering a combination of sophisticated monitoring capabilities and practical, user-focused design. Its core features directly address the challenges of remote care, particularly in a country as geographically expansive as Canada.
The device’s key technological differentiators include:
• Versatile Connectivity: The monitor can transmit recorded ECG data using standard landline telephone connections as well as modern cellular and WiFi networks. This flexibility is crucial for ensuring reliable data transmission for patients in Canada’s remote communities, where internet access may be inconsistent.
• Patient-Centric Design: As a lightweight and easy-to-use wearable, the device is engineered for patient comfort and compliance, ensuring that monitoring protocols can be followed with minimal disruption to daily life.
• Integrated Digital Platform: The CardioHolter AT connects to a secure, AWS Cloud-based platform. This ecosystem is supported by mobile applications for iOS, Android, and WeChat, creating a seamless and accessible system for both patients and physicians to transmit, review, and manage cardiac data.
These features are strategically aligned with the demands of the Canadian healthcare system, a point emphasized by CBSC’s leadership.
“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. The CardioHolter AT is designed to meet that need… This technology empowers physicians to achieve better patient outcomes, improved diagnoses, and enhanced quality of life regardless of a patient’s location.” — Charles Martin, Chief Executive Officer of CBSC.
This powerful technology is backed by a robust business strategy designed to ensure a successful and sustainable launch in the Canadian market.
The Strategy for Success: Partnerships, Sales, and Sustainable Growth
An innovative product is only as strong as the commercial strategy behind it. CBSC’s Canadian launch is underpinned by a robust three-pillar strategy designed for immediate impact and long-term, sustainable revenue growth.
The Health Canada approval has already yielded a significant commercial result, with exclusive distributor Your Heart Protector Corp. placing an initial order for CardioHolter AT devices totaling $375,000 USD. The delivery is scheduled to begin with the first 1,000 units upon completion of production, with the remainder of the order to be fulfilled within 90 to 120 days.
To ensure long-term growth, CBSC has structured a two-pronged revenue model:
1. Direct Device Sales: This stream generates upfront revenue from the initial sale of CardioHolter AT units to distributors and healthcare facilities, providing immediate capital and establishing the device’s presence in the market.
2. Recurring Rental Program: The company has also implemented a sustainable rental program that generates recurring monthly income. These fees cover the use of the device, access to the AWS Cloud platform, and the associated mobile apps. Revenue from these usage fees is shared between CBSC and its distribution partners, and is strategically priced based on the specific healthcare economics and reimbursement models of each country, ensuring a sustainable and adaptable model for global growth.
Underpinning this entire operation is the critical partnership with Nasiff Associates, Inc., which serves as the manufacturing, testing, and distribution partner. Nasiff is a Health Canada-licensed establishment operating under a certified ISO 13485 Quality Management System—a certification that de-risks the supply chain and assures Canadian healthcare providers of the highest manufacturing and quality standards for Class II medical devices.
The successful execution of this strategy in Canada serves as a powerful template for the company’s broader international ambitions.
Beyond Borders: CBSC’s Expanding Global Footprint
The approval in Canada is not a standalone achievement but a key milestone in Cardiac Biotech Solutions’ broader global commercialization strategy. The company is methodically working to make its state-of-the-art cardiac monitoring technology available to patients and physicians worldwide, navigating complex regulatory landscapes to establish a truly international presence.
CBSC’s current international regulatory status includes:
• United States: Regulatory clearance secured.
• Canada: Medical Device License secured.
• China: Submission currently progressing.
This strategic, multi-market approach underscores the company’s overarching mission to deliver best-in-class cardiac monitoring solutions worldwide. With commercial operations now established in North America’s two largest markets, CBSC is not only demonstrating significant momentum, but also executing a clear and methodical strategy to deliver long-term value to its shareholders and improve patient outcomes on a global scale.
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.
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