NEWS OUT-
CB Scientific, Inc. (CBSC) and Shenzhen Pump Medical Co., Ltd. Announce Cooperative Manufacturing Agreement for Chinese Market
Press Release | 08/23/2022
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.
