CB Scientific, Inc. (CBSC) and Shenzhen Pump Medical Co., Ltd. Announce Cooperative Manufacturing Agreement for Chinese Market

Rhea-AI Summary

CB Scientific, Inc. (CBSC) has announced a manufacturing partnership with Shenzhen Pump Medical Co., Ltd. to produce its myCam cardiac monitoring device and related software in China. This agreement recognizes Shenzhen Pump as the official manufacturer, compliant with local regulatory standards. CBSC's myCam has demonstrated high performance with over 2.1 million patient interactions and a 99+% efficiency rate in trials. The collaboration aims to expedite the regulatory approval process by the National Medical Products Administration (NMPA).

Positive

• Partnership with Shenzhen Pump Medical enhances manufacturing capabilities for myCam in China.
• myCam device exhibits proven effectiveness with over 2.1 million patient interactions since 2019.
• 99+% efficiency rating in clinical evaluations strengthens the product's market potential.

Negative

• None.

Shenzhen Pump Medical Co. Ltd. to formally become the recognized manufacturer of record for CBSC's myCam device, cloud-based software, and smartphone app in China.

SHENZHEN, CHINA and ESCONDIDO, CA / ACCESSWIRE / August 23, 2022 / CB Scientific. Inc. (OTCQB:CBSC) ("CBSC" or the "Company"), a designer, manufacturer and distributor of non-invasive ambulatory cardiac monitoring products and services, is pleased to announce that it has entered into a cooperative manufacturing agreement (CMA) with Shenzhen Pump Medical Co., Ltd. (Shenzhen Pump), a privately held, well-established medical device manufacturer, developer and distributor of cardiovascular medical equipment and devices based in Shenzhen, Nanshan, China.

Under the terms of the CMA, Shenzhen Pump will formally be recognized as the qualified manufacturer of record in China for the Company's innovative myCam cardiac event monitor, interactive cloud-based acquisition software, and the associated We Chat smartphone app. As a certified ISO 13485, and Quality Systems Regulations compliant device manufacturer in that country, Shenzhen Pump fulfills the manufacturing regulatory requirements of the National Medical Products Administration (NMPA - formally China's FDA) medical device regulatory approval process for the Company's myCam device in China.

"I am extremely excited to welcome Shenzhen Pump as our manufacturing partner in China," said Charles Martin, Chief Executive Officer of CB Scientific, Inc. "They have a reputation of manufacturing excellence in that country which we believe will facilitate completion of the final regulatory approval process steps necessary to be awarded a clearance to market from the NMPA for the myCam device in the Chinese market."

While timing of the overall product approval process was temporarily hindered by the COVID-19 pandemic, CBSC was able to continue accruing significant market effectiveness data. Since 2019, the Company's successful onsite field evaluation trial for myCam includes over 2.1 million patient interactions, with a 99+% efficiency performance rating, located at 46 different hospitals in Ningbo, Shenzhen, Dongguan, and Guangzhou, China.

CBSC plans to immediately commence collaboration with Shenzhen Pump to prepare their facility for myCam device manufacturing, deployment of a new Chinese cloud-based software portal for validation, test and support purposes, as well as development of an enhanced WeChat smartphone app to seamlessly function with the newly manufactured devices. Subsequent to a successful NMPA audit confirming Shenzhen Pump meets requisite manufacturing standards, a limited number of pre-production myCam devices will be placed with existing hospital evaluation locations for final validation performance testing.

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 Shenzhen Pump Medical Co., Ltd.

Shenzhen Pump Medical System Co., Ltd. is a high-tech manufacturing company, founded in January 2007. Shenzhen Pump Medical System Co. Ltd. is a unique developer, manufacturer and distributor of medical equipment and devices based in China focusing on cardiovascular diagnostic system such as Handheld Single-Channel ECG EKG Monitors, Blood Pressure Monitors, Digital Thermometers, and DVT prevention systems.

Shenzhen Pump Medical System Co. Ltd. is ISO 13485 certified and Quality System Regulations (QSR) compliant. Shenzhen Pump has established a partnership with medical professionals such as the Affiliated Hospital of Sun Yat Sen and the Affiliated Hospital of Nan Fang from the research and development, concept design, clinical trial, product realization all the way through the sales of the devices.

Company Contact Information:
Area C, 2^nd Floor, Building 15
No. 1008, Songbai Road, Nanshan District
518108 Shenzhen, PEOPLE'S REPUBLIC OF CHINA
Website: www.bpumpmedical.com
Telephone: (86)-755-26717079
Email: sales06@bpump.com.cn

About CB Scientific, Inc.
CB Scientific, Inc., through its domestic and international subsidiaries, provides innovative products and services in the ambulatory non-invasive cardiac monitoring space. Our FDA and CE cleared 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: Robert Hesse - dorchco.bh@gmail.com
Follow CBSC: Twitter, 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 source version on accesswire.com:
https://www.accesswire.com/713170/CB-Scientific-Inc-CBSC-and-Shenzhen-PumpMedical-Co-Ltd-AnnounceCooperativeManufacturingAgreementfor-Chinese-Market

FAQ

What is the significance of CBSC's agreement with Shenzhen Pump Medical?

The agreement allows Shenzhen Pump to manufacture CBSC's myCam device in compliance with Chinese regulations, facilitating market entry.

How effective is the myCam device based on clinical trials?

The myCam device has been involved in over 2.1 million patient interactions, achieving a performance efficiency rating of over 99%.

What regulatory body is involved in approving CBSC's myCam device for the Chinese market?

The National Medical Products Administration (NMPA) is responsible for the regulatory approval of CBSC's myCam device in China.

When was the partnership between CBSC and Shenzhen Pump Medical announced?

The partnership was announced on August 23, 2022.

What are the next steps for CBSC following the partnership with Shenzhen Pump?

CBSC plans to collaborate with Shenzhen Pump to prepare for manufacturing and regulatory audits, followed by pre-production testing of the myCam device.