The New Brunswick Health Research Foundation (NBHRF) partners with Cloud DX to fund Calibration and Validation research of its patented Pulsewave 2.0, a Non-Invasive Vital Sign Monitoring Device

News in Summary

• NBHRF is providing $131,902 to the New Brunswick research team for ongoing research of the clinical evaluation of the wrist-worn vital sign monitoring device, Pulsewave 2.0
• Cloud DX commits to R&D investment for clinical calibration and subsequent validation of a wrist-worn non-invasive health monitoring device to be conducted at the Horizon Health Network, Saint John Regional Hospital (SJRH)
• The NBHRF supports, facilitates, and promotes innovative health research in New Brunswick, Canada
• Research findings and data will be used for Health Canada licensing and FDA clearance of Cloud DX's next-generation Pulsewave 2.0, on its path to market as the only wrist cuff to accurately measure pulse rate, blood pressure, and respiratory rate in both home and clinical settings

KITCHENER, ON / ACCESSWIRE / January 13, 2022 / Cloud DX (TSXV:CDX)(OTCQB:CDXFF), Cloud DX announces new partner funding from the New Brunswick Health Research Foundation (NBHRF). This funding will support ongoing clinical calibration and subsequent validation trials with the Cloud DX Pulsewave 2.0 wrist-worn vital sign monitoring device.

The NBHRF Strategic Initiative Grant will be matched two to one by Cloud DX over three years to support the ongoing research and development led by Dr. Brunt and Dr. Teskey and their teams at Cardiovascular Research New Brunswick (CVR NB), Dalhousie Medicine New Brunswick (DMNB), University of New Brunswick (UNB) and the IMPART investigator team. The research will be conducted with the Department of Cardiology at the New Brunswick Heart Center at the Saint John Regional Hospital (SJRH), part of the Horizon Health Network.

Lead researcher & Translational Scientist, Dr. Keith Brunt states: "We are pleased to provide ongoing best-in-class R&D support to the development of medical technology innovations. We are committed to ensuring informed-decision making clinically is built upon strong evidence, validated intellectual property that is peer-reviewed and aligned with regulatory expectations for medical devices. Our prior clinical research with an earlier version of the device, was published in the Journal of Medical Internet Research, and key to the initial development of proprietary algorithms for the Pulsewave 2.0 device."

Dr. Robert Teskey, an Interventional Cardiologist with the Horizon Health Network, New Brunswick Heart Centre added that "Clinically accurate vital sign monitoring at home is essential for our cardiac patients. This funding will support the ongoing clinical calibration and validation of the Cloud DX, Inc. Pulsewave 2.0, the non-invasive vital sign monitoring device."

Cloud DX is in the process of clinically calibrating the PAD-2A device in preparation for subsequent clinical validation with the ISO 2020_AMD 1 universal protocol in order to submit the validation data to Health Canada and the FDA for licensing and clearance, respectively. This will satisfy the federal regulatory requirements in order to serve the market needs in Canada and the United States.

As with its other devices, Cloud DX will include the Pulsewave 2.0 device in its Connected Health™ virtual care and remote patient monitoring solution upon clinical validation by the research team and subsequent licensing and clearance by the federal regulatory agencies.

"Cloud DX deeply appreciates this financial support for our research partners Horizon Health, University of New Brunswick, and Dalhousie Medicine NB", stated Robert Kaul, Cloud DX CEO and Founder. "By funding the clinical studies required to achieve Health Canada licensing and FDA clearance, organizations like the NBHRF play an integral role in helping Canadian companies produce medical devices at home here in Canada and export our technological expertise around the world."

"The NBHRF is proud of our continued support of industry," said Meaghan Seagrave, NBHRF CEO. "Building strong partnerships like the one with Cloud DX enables us to maximize the impact of our work. We are able to support the best health research for New Brunswick solutions to New Brunswick health challenges."

"It is exciting to see the research being conducted within our health authority," said Barry Strack, Regional Director of Research Services at Horizon Health Network, "Having strong partners in the ecosystem make New Brunswick an attractive place to work and live for physicians and health researchers and provides our patients with opportunities to be involved in clinical studies that may improve their health and well-being."

About the Horizon Health Network

The Horizon Health Network is one of two health authorities in the province of New Brunswick. Cardiovascular Research New Brunswick (CVR-NB) is the clinical research division of the New Brunswick Heart Centre at the Saint John Regional Hospital. The New Brunswick Heart Centre provides cardiac treatment and care for the provinces of New Brunswick and Prince Edward Island.

About the NBHRF

The NBHRF is a not-for-profit organization that co-ordinates, supports and promotes health research in New Brunswick. Their vision is a healthy population, a high performing health system and a vibrant knowledge economy through health research and innovation. NBHRF is governed by a board of 15 directors comprised of key stakeholders from the health research community in New Brunswick.

About Cloud DX

Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health ^TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to manage chronic disease virtually, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and one of "Canada's Ten Most Prominent Telehealth Providers." In 2021, Cloud DX became an exclusive partner of Medtronic Canada.

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For media inquiries please contact:

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SOURCE: Cloud DX Inc.