TORONTO, July 25, 2013 /CNW/ - Biosign Technologies Inc. (TSXV: BIO) ("Biosign" or the "Company") announced the completion of a Memorandum of Understanding with Health + Life Science New Brunswick Inc. ("HLSNB") to participate in the "Biosign Critical Care Validation Project" ("CCV Project"), an equal-stake private-public co-operative project between Biosign, HLSNB, the New Brunswick Health Research Foundation ("NBHRF") and the University of New Brunswick, Saint John ("UNB") (together, "CCV Project partners").
The CCV Project will begin by comparing and validating the performance of the Biosign Pulsewave™ Health Monitor in a clinical setting by examining the non-invasive Biosign system against current clinical standards of invasive measurement for intra-arterial pressures in up to 50 patients. The CCV Project partners will engage an independent third-party investigator team, led by Keith Brunt PhD, Cardiovascular Translational Scientist & Adjunct Professor, University of New Brunswick and Sohrab Lutchmedial MD, FRCPC, Interventional Cardiologist & Director of the New Brunswick Heart Centre Research Initiative. This independent team is uniquely equipped to practice "Translational Medicine", the process of transitioning science into medical practice. CTO Christian Sleight & Medical Director Dr. Sonny Kohli will manage Biosign contributions to the Project.
Phase One of the CCV Project will determine the precision & accuracy delivered by the Pulsewave™ system when compared to direct arterial pressure analysis during routine cardiac catheterization procedures. If, as expected, the device performs within acceptable clinical guidelines, further Phases will determine the optimal deployment of the device to serve physicians and patients. Traditionally, non-invasive instruments and procedures improve quality of care and patient outcomes at a reduced cost to the health care system, and at a reduced risk to the patient.
Phase Two of the Project will test the Pulsewave™ system as a clinical tool, documenting improvements in care resulting from the substitution of Pulsewave™ readings for arterial catheterization, including reductions in risk, patient acceptance, physician engagement and medical outcomes. Future Phases are proposed to validate the ability of the Pulsewave™ system to non-invasively measure average breathing rate (ABR); to validate the "Pulse Wave Anomaly Score" in the detection of atrial fibrillation (AFIB); to measure augmentation index (AI), pulsewave velocity (PWV), Pulse Wave Transit Time (PWTT) and therefore arterial stiffness; to validate Pulse Pressure Variation (as a marker of fluid responsiveness in patients breathing on ventilators the ICU); to detect changes in the concentrations of certain molecules in the bloodstream; and to detect the effects of certain medications on the pulse wave, including adverse effects from drug interactions. In addition to, or in combination with, these investigations, the CCV Project partners propose to test and validate the performance of newer versions of the Pulsewave™ system to be introduced by Biosign.
Funding for Phase One of the CCV Project will consist of contributions from HLSNB (1/3), The New Brunswick Health Research Foundation (1/3) and Biosign (1/3, a portion of which will include "in kind" contributions). The total budget for Phase One is up to $180,000 CAD. To fund Phase Two of the CCV Project the partners have agreed to jointly apply to the Canadian Institutes of Health Research (CIHR) for a Federal Proof of Principal (POP-1) Grant of up to $165,000. The partners agreed to jointly complete the competitive grant application by the application deadline of September 3rd, 2013. The CCV Project partners will execute contractual agreements between HLSNB and Biosign, and then with NBHRF on an expedited schedule. It is the intention of the partners to begin Phase One of the CCV Project in the third quarter of 2013.
The CCV Project reflects a recent commitment by Biosign to conduct research, market testing and sales in the Province of New Brunswick. Earlier in 2013 the Company opened a satellite office in Saint John NB, and has plans to add additional administrative, engineering, distribution, sales, and IT/customer support service positions within the Province. New Brunswick offers a diverse consumer population, a bilingual employee base and is ideally situated for North American, European and South Asian product distribution. New Brunswick also has an enviable record of information technology (IT) support and development.
The Biosign Pulsewave™ Monitor is an end-to-end solution for non-invasive monitoring, analysis and reporting of health data. The Pulsewave™ inflatable cuff painlessly captures the pulse waveform from the subject's radial artery and Biosign software transmits this signal to secure servers in the Cloud. Proprietary algorithms analyze the data in seconds in order to generate reports that include blood pressure, heart beat anomalies and other vital sign measurements. Pulsewave™ is the only health monitor available over-the-counter that shows users the actual heart beating - live, in real-time. In addition, online Pulsewave™ analysis and reporting tools give patients and healthcare providers secure access to current and historical health information. Innovative features of the Pulsewave™ system are patent-pending. Pulsewave™ is manufactured by Biosign under strict ISO 9001 / ISO 13485 Quality Management Standards, and is approved by Health Canada, cleared by the US FDA and (in Europe) carries the CE-Mark.
CCV Project Partner Comments:
Biosign CEO Robert Kaul: "The CCV Project is an important next step for Biosign. Currently our Pulsewave™ Health Monitor is correlated to produce accurate results when compared to a typical arm-cuff blood pressure meter. Once Phase One of the CCV Project is completed we will immediately update our Health Canada and FDA filings to reflect a useful new correlation, namely arterial blood pressure measurement. The resulting clinical-grade product will open up important new markets for our technology around the world."
Biosign Medical Director Dr. Sonny Kohli: "As Medical Director for Biosign, I am encouraged by the creation of the CCV Project partnership. Although Pulsewave™ has been extensively tested prior to Health Canada approval and FDA clearance, we are always working on additional validation for our technology. By calibrating our Cloud Diagnostics™ readings to arterial pressures we intend to match our results correlation to the ultimate "gold standard" in blood pressure measurement. This in turn will extend the envelope of our system's effectiveness into acute hospital settings, allowing Biosign to further deliver on our mission of improving health outcomes while lowering costs."
Dr. Sohrab Lutchmedial, Interventional Cardiologist & Director of the New Brunswick Heart Centre Research Initiative, is an independent lead investigator on the CCV Project: "The Biosign Pulsewave™ system has the potential to significantly impact the evaluation and treatment of acute care cardiac patients in a hospital setting - there hasn't been a fundamental change in how health care practitioners measure vital signs for decades, but the Biosign platform may offer just that. I'm pleased to be part of the team evaluating this exciting technology."
About Health & Life Science New Brunswick Inc:
The New Brunswick provincial government established Health + Life Science New Brunswick to attract new investment in scientific research and to create jobs in the life sciences sector across New Brunswick. The Province provided initial funding. The founding members of Health + Life Science New Brunswick are the Horizon Health Network, the University of New Brunswick Saint John, Dalhousie Medicine New Brunswick and the New Brunswick Community College, actively supported by Enterprise Saint John, the Saint John Regional Hospital Foundation and the Saint John Board of Trade.
About New Brunswick Health Research Foundation:
The New Brunswick Health Research Foundation (NBHRF) was created in July 2008 with a mandate to co-ordinate, support and promote health research in New Brunswick. Their vision is a healthy and prosperous New Brunswick through excellence in health research and innovation. Their mission is to provide leadership and support to build health research capacity, improve the health of Canadians and advance the knowledge economy. The NBHRF is an independent organization governed by a board of directors comprised of key stakeholders from the health research community in New Brunswick. Provincial funding is provided by Business New Brunswick.
About Biosign Technologies Inc:
Biosign Technologies Inc. (TSXV: BIO) provides automated, software enabled health information solutions including the Pulsewave™ Health Monitor and the Healthanywhere™ Patient monitoring / self-care platform. The Company's Pulsewave™ Health Monitor solution enables Pulse data collection for cardiovascular clinical decision support and self-care, while its Healthanywhere™ solution offers industry-leading remote patient monitoring and patient centred care management. The Company also offers a number of cardiovascular screening programs for consumers under its Heart Friendly™ brand, including Heart Friendly™ Practice, Heart Friendly™ Dentist, and Heart Friendly™ Fitness. For more information on Biosign, please visit www.biosign.com
This release contains forward-looking statements. Forward-looking statements, without limitation, may contain the words believes, expects, anticipates, estimates, intends, plans, or similar expressions. Forward-looking statements are not guarantees of future performance. They involve risks, uncertainties and assumptions and Biosign's actual results could differ materially from those anticipated. Forward looking statements are based on the opinions and estimates of management at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. In the context of any forward-looking information please refer to risk factors detailed in, as well as other information contained in the company's filings with Canadian securities regulators (www.sedar.com).
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SOURCE: Biosign Technologies Inc.
For further information:
Contact Information for Biosign:
Chief Executive Officer
Biosign Technologies Inc
Phone: (416) 218-9800 ext. 201
Contact Information for Health & Life Science New Brunswick:
Ms Joan Creighton
Health & Life Science New Brunswick Inc
Contact Information for New Brunswick Health Research Foundation:
Dr Bruno Battistini
Chief Executive Officer
New Brunswick Health research Foundation