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2018-06-14 13:00 CEST
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CellAegis Announces Completion of Patient Enrollment in UK Investigator Sponsored Clinical Trial using autoRIC® Device

<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" ""><html xmlns=""> <head> <style>body { font-family: Arial, Verdana, Helvetica; font-size: 13px;} table.hugin { border-color:black;} td.hugin { padding: 3px; border-color:black;}</style> <title></title></head> <body class="hugin" lang="EN-US" link="blue" vlink="purple"> <p class="hugin">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<sup class="hugin" style="vertical-align: text-top; font-size: 0.8em;">�</sup>�device (<a class="hugin" href="" target="_blank"></a>) to deliver the RIC therapy.</p> <p class="hugin">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.</p> <p class="hugin">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% (<i class="hugin">Journal of the American Heart Association</i>: 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 (<i class="hugin">Basic Research Cardiology</i>: Gaspar et al 2018), RIC treatment was shown to reduce clinical outcomes heart failure/cardiac death by 62% at two years.</p> <p class="hugin">"Our team has had a very positive experience with autoRIC<sup class="hugin" style="vertical-align: text-top; font-size: 0.8em;">�</sup>�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<sup class="hugin" style="vertical-align: text-top; font-size: 0.8em;">�</sup>�device."</p> <p class="hugin">"This ERIC-PPCI Hospital Trial, when combined with the recently announced completed enrollment of an equally large Danish ambulance trial, known as�<a class="hugin" href="" target="_blank">CONDI 2</a>, 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<sup class="hugin" style="vertical-align: text-top; font-size: 0.8em;">�