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CB Scientific Inc. (CBSC) Formally Launches Next Generation MyCardia AT Cardiac Monitor

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CB Scientific Inc. (CBSC) has officially launched its next generation MyCardia AT cardiac monitor in partnership with contract manufacturer Datrix, This FDA-cleared device is designed for the company's international distribution network in SE Asia, Hong Kong, and Macau.

The MyCardia AT offers an improved patient monitoring experience with its lightweight, easy-to-wear design and flexible options to transmit event recordings via iOS or Android smartphones using the MyCardia app. The device helps physicians detect cardiac arrhythmias in patients with intermittent symptoms during a 30-day monitoring period, addressing a critical health concern as ischemic heart disease deaths have increased from 2.7 million to 9.1 million since 2000.

CBSC is strategically enhancing its cardiac monitoring portfolio by integrating the device with its existing AWS Cloud-based MyCardia portal and smartphone applications. Distributors in Malaysia, Singapore, Thailand, Indonesia, Hong Kong, and Macau will begin registering the device with regulatory agencies, with plans to expand to China and Canada pending regulatory approvals.

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Positive

  • FDA-cleared MyCardia AT cardiac monitor launched for international markets
  • Device integrates with existing AWS Cloud-based MyCardia portal and smartphone apps
  • Established distribution network in SE Asia, Hong Kong, and Macau
  • Expansion plans for China and Canada markets in progress
  • Addresses growing cardiac disease market (ischemic heart disease deaths increased from 2.7M to 9.1M since 2000)

Negative

  • Pending regulatory approvals required before sales can begin in target markets
  • Additional regulatory hurdles with China's NMPA still ahead
  • No immediate revenue impact until regulatory approvals are secured

News Market Reaction

+14.10%
1 alert
+14.10% News Effect

On the day this news was published, CBSC gained 14.10%, reflecting a significant positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

LAS VEGAS, NV / ACCESS Newswire / February 25, 2025 / CB Scientific, Inc. (OTC PINK:CBSC) ("CBSC" or the "Company"), a designer, manufacturer and distributor of non-invasive ambulatory cardiac monitoring products, announced today that the Company, in partnership with its contract manufacturer Datrix, LLC, is launching its next generation MyCardia AT cardiac event monitor targeted for use with our international distribution network in SE Asia, Hong Kong, and Macau. The newly branded MyCardia AT device is FDA-cleared and is designed to provide an improved patient remote cardiac monitoring experience with its lightweight, easy-to-wear design, including flexible and convenient options to transmit event recordings over an iOS or Android smartphone and utilizing our MyCardia Apple, Google or WeChat app.

The MyCardia AT cardiac event monitor helps physicians detect, identify, and diagnose potential cardiac arrhythmias in patients with intermittent transient symptoms closer to the time that they occur up to a 30-day monitoring period. Early detection and treatment of cardiac rhythm disorders helps to significantly reduce the burden of cardiac disease which can damage the heart and may even lead to an increased risk of stroke and death. According to the World Health Organization, since 2000 the largest increase in deaths is from ischemic heart disease which multiplied from 2.7 million to 9.1 million, and in 2021 accounted for 13% of the world's total deaths. The MyCardia AT device can also be used as an in-office ECG screening device.

The Company is strategically enhancing its remote cardiac monitoring portfolio with the launch of the MyCardia AT device. This initiative aims to leverage the strength of our established brand name to drive recognition, streamline our product ecosystem, and reinforce our market presence. The MyCardia AT marketing strategy involves seamlessly integrating with our existing AWS Cloud-based MyCardia portal and the widely adopted MyCardia iOS and Android smartphone applications, with the goal of ensuring a cohesive and optimized user experience on a global scale.

Our established distributors in Malaysia, Singapore, Thailand, Indonesia, Hong Kong, and Macau will now begin registering the MyCardia AT device with their respective regulatory agencies for import approval. Upon completion, the MyCardia AT device will begin shipping at that time and be widely available throughout these respective markets going forward. Additionally next step regulatory submission work will immediately resume for the MyCardia AT towards the approval of our representative Chinese manufacturing partner Shenzhen Pump. The Company will also continue working directly with representatives from the National Medical Products Administration (NMPA) in China towards the completion of clearance to market approval for our device into that market. Regulatory submission will also begin with our Canadian distributor Your Heart Protector Corp. towards clearance to market acceptance throughout Canada.

As additional new developments occur, CB Scientific, Inc. plans to make timely announcements through press releases and regulatory filings to keep its shareholders, industry participants, and the public markets informed.

About CB Scientific, Inc.

CB Scientific, Inc., through its international subsidiaries, provides innovative products and services in the ambulatory non-invasive cardiac monitoring space. Our electrocardiogram (EKG) devices, interactive cloud-based acquisition software, and smartphone apps for both iOS and Android platforms provide improved compliance for patients at risk of abnormal heart rhythms, as well as more accurate information for physicians.

Company Contact Information:

Telephone: (888) 225-0870
Email: General Inquiries: info@cbscientificinc.com
Investor Inquiries: investor@cbscientificinc.com
Follow CBSC: X, Facebook, Instagram, LinkedIn, YouTube, and Newsletter

This information disclosure may contain forward-looking statements covered within the meaning of the Private Securities Litigation Act of 1995. These forward-looking statements relate to, among other things, plans and timing for the introduction or enhancement of our services and products, statements about future market conditions, supply and demand conditions, and other expectations, intentions, and plans contained in this press release that are not historical fact and involve risks and uncertainties. Our expectations regarding future revenues depend upon our ability to develop and supply products and services that we may not produce today and that meet defined specifications. When used in this press release, the words "plan," "expect," "believe," and similar expressions generally identify forward-looking statements. These statements reflect our current expectations. They are subject to a number of risks and uncertainties, including, but not limited to, changes in technology and changes in pervasive markets. This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties, including, without limitation, the ability to obtain financing and regulatory and shareholder approval for anticipated actions.

SOURCE: CB Scientific, Inc.



View the original press release on ACCESS Newswire

FAQ

What is the new product launched by CB Scientific Inc. (CBSC)?

CB Scientific (CBSC) has launched the next generation MyCardia AT cardiac event monitor, an FDA-cleared device designed for remote cardiac monitoring with a 30-day monitoring period.

Which markets will CBSC's MyCardia AT cardiac monitor be available in?

The MyCardia AT will initially target SE Asia, Hong Kong, and Macau, with plans to expand to China and Canada pending regulatory approvals.

How does the MyCardia AT cardiac monitor work with smartphones?

The MyCardia AT transmits cardiac event recordings over iOS or Android smartphones using the MyCardia app, which is available on Apple, Google, or WeChat platforms.

What is the monitoring period for CBSC's MyCardia AT cardiac device?

The MyCardia AT cardiac monitor can detect potential cardiac arrhythmias during a 30-day monitoring period.

What regulatory approvals does CBSC need for the MyCardia AT device?

CBSC's distributors must register the device with regulatory agencies in Malaysia, Singapore, Thailand, Indonesia, Hong Kong, and Macau. Additional approvals are being pursued with China's NMPA and Canadian authorities.
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