Cardiac Biotech Solutions Stock Price, News & Analysis

Cardiac Biotech Solutions, Inc. (CBSC) is a medical technology company focused on non-invasive ambulatory cardiac monitoring. The company is described in its public communications as a designer, manufacturer, and distributor of cardiac monitoring products and services that help physicians detect and manage abnormal heart rhythms in patients outside of traditional hospital settings.

Cardiac Biotech Solutions operates in the medicinal and botanical manufacturing industry within the broader manufacturing sector, with a specialization in cardiac event monitoring devices and related software platforms. Through its international subsidiaries and partners, the company states that it provides products and services in the ambulatory non-invasive cardiac monitoring space, combining electrocardiogram (EKG) devices, cloud-based acquisition software, and smartphone applications.

Core products and technology

The company highlights two flagship products in its disclosures: MyCardia AT and CardioHolter AT. MyCardia AT is described as a next-generation cardiac event monitoring device that is FDA-cleared and targeted for remote cardiac monitoring. It is designed as a lightweight, easy-to-wear device that supports flexible options for transmitting event recordings via iOS and Android smartphones, using the company’s MyCardia mobile applications and portal.

CardioHolter AT is the brand name used for the MyCardia AT device in Canada, where the company reports that the device has received a Medical Device License from Health Canada as a Class II medical device. According to Cardiac Biotech Solutions, the CardioHolter AT is tested and distributed through a manufacturing partner operating under an ISO 13485 quality management system.

Across its platforms, the company emphasizes the use of an AWS Cloud-based monitoring infrastructure and patient-facing mobile applications for iOS, Android, and WeChat. These tools are described as enabling patients to transmit recorded ECG data to physicians over standard telephone lines, cellular networks, or WiFi, with the goal of improving diagnostic accuracy and patient outcomes for those at risk of cardiac arrhythmias.

Clinical use and monitoring capabilities

Cardiac Biotech Solutions states that its MyCardia AT cardiac event monitor helps physicians detect, identify, and diagnose potential cardiac arrhythmias in patients with intermittent, transient symptoms over monitoring periods of up to 30 days. The device can also be used, according to company communications, as an in-office ECG screening device.

The company has reported extensive international clinical experience with its earlier myCam cardiac event monitor platform. It describes regulatory device and software trials beginning in hospitals across China and later expanding into Hong Kong and Macau, with millions of ECG patient interactions completed and a high reported performance rating. The MyCardia AT platform is presented as part of a broader effort to enhance remote cardiac monitoring and address the burden of cardiac disease by enabling earlier detection and treatment of rhythm disorders.

Business model and revenue approach

In its public announcements, Cardiac Biotech Solutions describes a business model that combines device sales with recurring revenue programs. The company reports that it sells cardiac event monitoring devices, such as MyCardia AT and CardioHolter AT, to distribution partners and healthcare-related organizations in various international markets.

In addition to upfront device sales, the company states that it has implemented a monthly rental program that generates recurring income once devices are deployed in hospitals and healthcare facilities. According to the company, these programs typically include access to the physical device, the AWS Cloud-based monitoring platform, and patient-facing mobile applications. Cardiac Biotech Solutions reports that revenue from these usage fees is shared between the company and its distributor partners, with fee structures and pricing tailored to each country’s healthcare economics and reimbursement environment.

International distribution and regulatory footprint

Cardiac Biotech Solutions describes a strategy of global commercialization for its cardiac event monitoring platforms. The company reports that regulatory clearance has been secured in the United States for its MyCardia AT device and that Health Canada has issued a Medical Device License for the CardioHolter AT in Canada. It also describes ongoing or planned regulatory submissions in China and other markets.

The company has announced distribution relationships in several regions:

• Canada: An exclusive distribution arrangement with Your Heart Protector Corp., a Canadian distributor of remote diagnostic testing medical devices and lab services technologies. Cardiac Biotech Solutions reports that Your Heart Protector has placed an initial order for CardioHolter AT devices and plans to deploy them across Canadian healthcare settings.
• Central and South America: A distribution agreement with Noventis Medical, granting exclusive rights to distribute CBSC’s products in Costa Rica, Panama, Colombia, and Argentina. The company reports that Noventis Medical has committed to a multi-year contract value and has placed an initial purchase order for MyCardia AT devices.
• Southeast Asia, Hong Kong, and Macau: The company states that it works with an international distribution network in markets including Malaysia, Singapore, Thailand, Indonesia, Hong Kong, and Macau, where distributors are responsible for registering the MyCardia AT device with local regulatory agencies for import approval.
• China: Cardiac Biotech Solutions has described collaborations with Chinese manufacturing and regulatory partners, including Shenzhen-based entities, to support regulatory trials and submissions to the National Medical Products Administration (NMPA). The company reports that hospital-based clinical field testing and regulatory dossier preparation are part of its China market entry plan for MyCardia AT.

Manufacturing and partnerships

The company’s disclosures highlight the use of contract manufacturing and regulatory partners in multiple regions. For example, Cardiac Biotech Solutions reports working with Datrix, LLC as a contract manufacturer for its MyCardia AT device, and with Nasiff Associates in Canada as a manufacturing and distribution partner that operates under Health Canada licensing and ISO 13485 standards.

In China, the company states that it collaborates with Ebulent Medical (Shenzhen) Ltd., a licensed NMPA medical device manufacturer, to initiate manufacturing and regulatory preparation activities for MyCardia AT. Cardiac Biotech Solutions reports that it has delivered printed circuit assemblies, components, and accessories to Ebulent and that a secure cloud-based data room has been established to share manufacturing documentation, validation software, and testing protocols. Ebulent is described as configuring production lines and validation stations for MyCardia AT and preparing to support clinical field testing and regulatory submissions to the NMPA.

Corporate evolution and trading status

The company has communicated several corporate milestones in its recent history. It previously operated under the name CB Scientific, Inc. and announced that shareholders approved a name change to Cardiac Biotech Solutions, Inc. at an annual meeting. The company later reported that the name change became effective following review by the Financial Industry Regulatory Authority (FINRA), while retaining the ticker symbol CBSC.

Cardiac Biotech Solutions has also disclosed changes in its trading venue. It announced a voluntary delisting of its common stock from the OTCQB Venture Market, stating that its shares would continue to trade on the OTC Pink Open Market. The company described this decision as a measure to preserve capital while continuing to pursue its business plan, with the possibility of seeking an uplisting to a national exchange at a later time, subject to conditions it deems appropriate.

Research, trials, and technology development

In addition to its commercial devices, Cardiac Biotech Solutions has discussed ongoing regulatory and clinical programs. It reported submitting a 510(k) application to the U.S. Food and Drug Administration (FDA) for its myCam cardiac event monitor and described responding to updated FDA guidance on common emitters and cybersecurity by modifying device components and conducting additional testing. The company has indicated that it used the FDA’s pre-submission and eStar processes in connection with its regulatory efforts.

The company has also referenced a potential technology opportunity involving intellectual property referred to as Xnode, associated with Freedom Cardio, LLC. Cardiac Biotech Solutions describes a letter of intent and draft asset purchase agreement that could enable future acquisition of this technology, subject to board approval and definitive terms. It has indicated that it has funded certain development expenditures for the Xnode technology in exchange for reserving future exclusivity rights and has expressed an expectation that such technology could be applied across ambulatory cardiac monitoring modalities and other medical monitoring contexts.

Position within the healthcare ecosystem

Cardiac Biotech Solutions positions its products as tools for cardiologists and other healthcare providers who prescribe ambulatory cardiac monitoring. The company notes that its devices are used in hospitals, physician offices, telehealth settings, and home-based medical services through its partners. It emphasizes that its platforms are intended to improve patient compliance, provide more accurate information for physicians, and support earlier diagnosis of cardiac rhythm disorders, with the broader aim of improving patient outcomes and quality of life.

According to the company’s communications, its strategy includes combining regulatory-cleared devices, cloud-based data platforms, and international distribution relationships to expand access to remote cardiac monitoring in multiple regions, including North America, Latin America, and parts of Asia.