TORONTO, Canada, April 24, 2018 (GLOBE NEWSWIRE) – CellAegis Devices Inc. (“CellAegis”) a commercial-stage medical device company advancing innovative, non-invasive, safe and cost-effective solutions for acute and chronic cardiovascular conditions, today announced that it has entered into a definitive agreement with Cardiologic Ltd., for the marketing and distribution of its autoRIC® device in the United Kingdom (“UK”) and Ireland.
The autoRIC® device automatically delivers remote ischemic conditioning (“RIC”) to provide a non-invasive, cardio-protective therapy shown to reduce heart damage during heart attacks and certain cardiovascular procedures. The technology is CE Marked, and Health Canada approved, and is currently limited to investigational use in the United States.
“This marks the first distribution agreement for the autoRIC® device outside of Canada and is a significant step forward for our international commercialization strategy,” said Rocky Ganske, Chief Executive Officer of CellAegis. “Cardiologic’s strong track record of success launching innovative medical devices and novel technologies in the UK and Ireland, combined with its focus on improving both the treatment and the standard of care for cardiology and cardiac surgery patients, makes them an ideal partner for CellAegis as we work to introduce autoRIC® to clinicians in Europe.”
“We are delighted to have CellAegis’ autoRIC® device as a key product in our portfolio,” said Martyn Dixon, Managing Director of Cardiologic. “This distribution agreement for the UK and Ireland will give us the opportunity to enhance our offering in interventional cardiology addressing the very significant costs caused by ischemic and reperfusion injuries. These are exciting times.”
Two major clinical trials (ERIC-PPCI and CONDI-II) designed to further evaluate the safety and efficacy of the autoRIC® device are nearing completion in the UK, Denmark, Spain and Serbia with top-line results anticipated in the second half of 2019. These trials are randomized studies enrolling 5,400 ST-elevation myocardial infarction (“STEMI”) patients. The primary efficacy endpoints of the trials are mortality and hospitalization for heart failure at one-year post primary percutaneous coronary intervention (“pPCI”). These trials are expected to support expanded adoption of CellAegis’ proprietary technology in Europe.
RIC is a noninvasive therapeutic that uses four cycles of limb occlusion and reperfusion to protect the myocardium against ischemia-reperfusion injury. RIC is a promising adjunctive treatment to PCI in the prevention of ischemic-reperfusion injury and minimization of postinfarction heart failure in STEMI patients. Previous proof-of-concept clinical studies using RIC before or during a major ischemic event have demonstrated improvements in surrogate markers of ischemia, such as increased myocardial salvage and reduced infarct size, in a variety of clinical scenarios including acute STEMI, elective PCI, and coronary artery bypass grafting surgery. Furthermore, in patients with STEMI, RIC before PCI has been shown to reduce the incidence of contrast-induced acute kidney injury and has prevented acute kidney injury in patients undergoing cardiopulmonary bypass-assisted cardiac surgery.
The autoRIC® device is designed to provide remote ischemic conditioning to adult patients over 18 years of age undergoing cardiothoracic surgery, interventional cardiothoracic procedures or patients with evolving myocardial infarction. The technology is intended for use in hospital and ambulance settings as directed by healthcare professionals.
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 remote RIC 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. 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.
Cardiologic Ltd., headquartered in North Yorkshire, UK, specializes in the development, marketing and distribution of innovative medical devices and novel technologies to improve both the treatment and the standard of care for cardiology and cardiac surgery patients. The company works closely with cardiologists, cardiac surgeons, technicians and nursing staff to provide a highly competent technical support and professional assistance in both the catheter laboratory and the cardiac operating theatre. Cardiologic’s extensive network allows it to quickly introduce innovative therapies into the UK market, and work closely with suppliers to develop strategies for rapid and sustained success.
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.