TORONTO, Canada, May 17, 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 trial (“CONDI 2”) to further assess the efficacy of remote ischemic conditioning (“RIC”) in reducing clinical events in patients presenting with ST-segment-elevation myocardial infarction (“STEMI”) and receiving point of care treatment by paramedics in an ambulance. This trial utilized CellAegis’ autoRIC® (http://cellaegis.com/products/) device to deliver the RIC therapy.
CONDI 2 is a multinational, randomized, controlled, single-blind, parallel assignment clinical trial which enrolled 2,600 STEMI patients in ambulances in Denmark, Serbia, and Spain. The study was sponsored by the Aarhus University Hospital in Denmark and is designed to show the benefit of RIC versus standard of care treatment in reducing cardiac death and hospitalization for heart failure at twelve months in STEMI patients.
Data from the CONDI 2 trial is expected to augment existing positive evidence related to the therapeutic benefits of RIC in the treatment of cardiovascular disease and procedure related kidney damage. CellAegis currently expects to report the topline results of CONDI 2 trial in mid- 2019.
Meta-analysis of multiple previous studies has shown that RIC significantly reduced infarct (dead tissue) size by 43% (Journal American Heart Association: McLeod et al 2017). In a recent prospective trial conducted in 448 patients at Hospital de Braga in Portugal (Basic Research Cardiology: Gaspar et al 2018), RIC treatment was also shown to reduce heart failure/cardiac death events by 62% at two years.
“The portability and ease of use of the autoRIC® device fit seamlessly into the ambulance setting,” said Hans Erik Bøtker, MD, PhD, FESC, FACC, Professor of Cardiovascular Medicine and Interventional Cardiology and co-director of Department of Cardiology, Aarhus University Hospital Skejby, the principal investigator for CONDI 2. “The autoRIC’s fully automated features allows emergency response professionals to deliver a novel, non-invasive therapy while focusing on other patient care needs.”
“More than 2.9 million patients worldwide are hospitalized each year with an acute coronary syndrome,” said Rocky Ganske, Chief Executive Officer, CellAegis. “One-third of those patients have STEMI, which may lead to heart failure. While there has been advancement in the treatment of these patients utilizing PCI and other therapies, there is no question that significant unmet medical need remains. This trial, with over 2,600 patients, is unprecedented in size for medical devices, and if the outcome is positive, as the company anticipates, we believe autoRIC® has the potential to change the standard of care for STEMI patients.”
“This trial, in combination with a large UK hospital STEMI trial (“ERIC-PPCI”) and our US FDA registration trial (“SHIELD”), is expected to definitively demonstrate whether RIC can improve outcomes for patients with STEMI or undergoing elective PCI procedures while at the same time lowering patient treatment costs. Data from these trials is expected to drive expanded adoption of the autoRIC® device in Europe followed by the U.S.,” continued Mr. Ganske.
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.