CellAegis Announces Completion of Patient Enrollment in UK Investigator Sponsored Clinical Trial using autoRIC® Device
TORONTO, June 14, 2018 (GLOBE NEWSWIRE) -- 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 (“ERIC-PPCI”) to further assess the efficacy of remote ischemic conditioning (“RIC”) in reducing clinical events in patients presenting with ST-segment-elevation myocardial infarction (“STEMI”) in patients receiving treatment in hospital catheterization labs or emergency rooms (the “ERIC-PPCI Hospital Trial”). This trial utilized CellAegis’ autoRIC® device ( http://cellaegis.com/products/ ) to deliver the RIC therapy.
The ERIC-PPCI Hospital Trial is designed to assess the benefit of RIC versus standard of care treatment in reducing cardiac death and hospitalization for heart failure at twelve months in STEMI patients. It is a multi-center, randomized, controlled, double-blind clinical trial that has enrolled 2,800 STEMI patients across twenty-six National Health Service hospitals in the United Kingdom. It is funded by the British Heart Foundation, sponsored by University College London, and is being managed by the clinical trials unit at the London School of Hygiene and Tropical Medicine. CellAegis currently expects patient follow-up in the ERIC-PPCI Hospital Trial to be completed in March 2019.
CellAegis anticipates that data from the ERIC-PPCI Hospital Trial will augment the existing positive dataset of evidence related to the therapeutic benefits of RIC in the treatment of STEMI patients: a recent meta-analysis of multiple randomized trials of RIC in STEMI patients has shown that the treatment significantly reduced infarct (dead tissue) size by 43% (Journal of the American Heart Association: McLeod et al 2017), as well as reduced heart failure. In a recent prospective trial conducted in 448 STEMI patients at Hospital de Braga in Portugal (Basic Research Cardiology: Gaspar et al 2018), RIC treatment was shown to reduce clinical outcomes heart failure/cardiac death by 62% at two years.
“Our team has had a very positive experience with autoRIC® for the delivery of RIC in the cath lab,” said Derek Hausenloy, MD, PhD, FESC, FACC, Professor of Cardiovascular Medicine at the Hatter Cardiovascular Institute, University College London, and the principal investigator for ERIC-PPCI. “RIC is a quick and simple procedure to perform using CellAegis’ fully automated autoRIC® device.”
“This ERIC-PPCI Hospital Trial, when combined with the recently announced completed enrollment of an equally large Danish ambulance trial, known as CONDI 2, will result in an unprecedented 5,400 patients having been enrolled to assess the benefit of RIC in the treatment of cardiovascular disease and procedure related kidney damage using our autoRIC® device,” said Rocky Ganske, Chief Executive Officer, CellAegis. “We are extremely excited at the completion of this enrollment milestone and look forward to the trial results from both of these studies in 2019.”
“There are an estimated one million STEMI incidents annually in North America and Europe that are expected to benefit from our autoRIC® device,” added Mr. Ganske. “In addition to the STEMI benefits we also expect to see large opportunities for RIC to improve outcomes for patients undergoing elective PCI (stent) and angiography procedures.”
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.
About CellAegis Devices 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.
Melane SampsonInvestor Relations Melane@kilmerlucas.com 1-888-545-6374