Cloud DX (TSX-V:CDX, OTCQB:CDXFF) has announced new partner funding from the New Brunswick Health Research Foundation (NBHRF).
The company said that the funding will support ongoing clinical calibration and subsequent validation trials with the Cloud DX (TSX-V:CDX, OTCQB:CDXFF) Pulsewave 2.0 wrist-worn vital sign monitoring device.
"The NBHRF is proud of our continued support of industry," said Meaghan Seagrave, NBHRF CEO in a statement. "Building strong partnerships like the one with Cloud DX (TSX-V:CDX, OTCQB:CDXFF) 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."
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The NBHRF Strategic Initiative Grant will be matched two to one by Cloud DX (TSX-V:CDX, OTCQB:CDXFF) over three years to support the ongoing research and development led by Dr. Keith Brunt and Dr. Robert 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 company said.
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.
"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,” Brunt said in a statement. “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."
Cloud DX said that it 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 market needs in Canada and the United States, the company noted.
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.
Teskey, an interventional cardiologist with the Horizon Health Network, New Brunswick Heart Centre said: "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."
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