TORONTO, Ontario, September 11, 2018 – CellAegis Devices Inc. (“CellAegis” or the “Company”), a commercial-stage medical device company advancing innovative, non-invasive, safe and cost-effective solutions for acute and chronic cardiovascular conditions, today announced completion of patient enrollment in a large scale, investigator sponsored study (“FIRST”) to evaluate the clinical and economic benefits of Remote Ischemic Conditioning (“RIC”) therapy in the treatment of patients presenting with ST-segment-elevation myocardial infarction (“STEMI”) heart attacks, as delivered by CellAegis’ autoRIC® device.
Sponsored by William Osler Health System, FIRST will examine clinical outcomes and costs of treatment for 1,800 STEMI heart attack patients receiving RIC , as delivered by CellAegis’ autoRIC® device (https://cellaegis.com/products/), therapy as compared to standard treatment at the first point of medical contact (in an ambulance or at the hospital). Results of the study are expected to be published early in 2019.
“We are extremely excited to complete enrollment in this, the first ever North American study designed to explore the use of RIC treatment prior to coronary intervention to reduce the heart muscle damage from a STEMI heart attack,” said Dr. Sheldon Cheskes, Medical Director of the Sunnybrook Centre for Prehospital Medicine, and principal investigator of FIRST. “This study has the potential to truly impact outcomes through the use of a simple, inexpensive technique that can be applied either in the emergency department or prehospital [ambulance] care field.”
“The FIRST study exemplifies how innovative healthcare can be evaluated in real-world settings using existing infrastructure across a healthcare region,” said Dr. Ronald Heslegrave, Chief of Research and study sponsor at William Osler Health System. “Osler’s catchment area has very high cardiovascular risks compared to other parts of Ontario, and we are excited that the FIRST study gives us a chance to quantify the benefits of this cardioprotective therapy in our population. If we obtain the expected result, such as decreased readmissions to hospitals, the autoRIC® device could be put into ambulances and emergency rooms across Ontario, which could have a huge impact on the community we serve as well as communities throughout the province.”
“There are approximately 160,000 Canadians who annually receive a diagnosis of ischemic heart disease and about 63,000 who have a first heart attack. There are an estimated one million STEMI heart attacks annually in North America and Europe that may benefit from RIC therapy using our autoRIC® device,” commented Rocky Ganske, Chief Executive Officer, CellAegis.
FIRST is supported by the Ontario Centres of Excellence in partnership with Shared Services West. Partner ambulance services include Peel Paramedic and Halton Paramedic Services, with partner cardiac hospitals Trillium Health Partners, and Brampton Civic Hospital. Research support is provided by the Institute of Clinical and Evaluative Sciences at Sunnybrook Hospital.
“CellAegis wants to recognize and thank the many healthcare professionals who made FIRST possible,” continued Mr. Ganske. “This real-world clinical implementation could not have been done without the devotion and dedication of paramedic services, and the many emergency and cath lab doctors and nurses of Peel and Halton Region who applied our autoRIC® device to administer the RIC therapy. CellAegis looks forward to repeating a full clinical implementation in all health systems across Ontario and Canada upon the companies anticipation of strong supporting economics data from this study.”
RIC is a noninvasive therapy that utilizes four cycles of limb occlusion and reperfusion to protect the heart and other tissue against ischemia-reperfusion injury. RIC is a promising adjunctive treatment to stenting in the prevention of ischemic-reperfusion injury and minimization of post-infarct heart failure in ST-elevation myocardial infarction (“STEMI”) patients. Previous proof-of-concept clinical studies with RIC have demonstrated improvements in markers of injury, such as increased myocardial salvage and reduced infarct size as well as reduction of contrast-induced acute kidney injury, in various clinical scenarios such as heart attacks and elective cardiac procedures.
CellAegis Devices, headquartered in Toronto, Canada, is the world leader in automated remote ischemic conditioning. The company has patented and developed the non-invasive autoRIC® device, which delivers RIC therapy to patients with acute and chronic cardiovascular conditions. The autoRIC® device has CE Mark and Health Canada approvals for treatment during heart attacks, cardiothoracic or surgical procedures, and is currently limited to investigational use in the United States. Investigator sponsored clinical research studies for chronic conditions such as heart failure and stroke are also underway. The autoRIC® device was developed from the clinical work of clinicians and researchers at Toronto’s world-renowned Hospital for Sick Children.
This press release may contain forward-looking statements identified by words such as “expects”, “anticipates”, “will” and similar expressions, which reflect CellAegis’ current expectations regarding future events. The forward-looking statements involve risks and uncertainties that could cause the Company’s actual events to differ materially from those projected herein. The forward-looking statements are made as of the date of this press release and CellAegis does not undertake and is not obligated to publicly update such forward looking statements to reflect new information, subsequent events or otherwise, except as required by law.