Nasdaq GlobeNewswire

CellAegis Announces First Patients Enrolled in U.S. SHIELD Pivotal Clinical Trial

Del

TORONTO, April 10, 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 enrollment of the first patients in a U.S. clinical trial ("SHIELD") of its autoRIC® device.

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.  

SHIELD is a 500 patient, multi-center, randomized, controlled single-blind clinical trial designed to evaluate the safety and effectiveness of the autoRIC® device to attenuate myocardial injury, as measured by the validated biomarker cardiac Troponin I ("cTnl") levels in patients undergoing elective percutaneous coronary intervention ("PCI").  Patients that are scheduled for either an elective PCI procedure, or a diagnostic catheterization procedure that may be followed with stenting, will be enrolled in the study across up to 15 research sites in the U.S. and Canada. The primary efficacy outcome of this trial is to show a statistically significant reduction in the prevalence of ischemia-reperfusion injury to the myocardium in patients using the autoRIC® device compared to patients using a placebo device. Patients will be exited from the study after completion of their 30-day post-procedure follow-up.

"We are pleased to start enrolling patients in this clinical trial," commented Roxana Mehran, MD, principal investigator for SHIELD, Professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Weiner Cardiovascular Institute at Mount Sinai School of Medicine. "While there have been tremendous advancements in cardiac care over the past several years, there is no question that significant unmet medical need remains. We believe this trial has been designed to clearly demonstrate whether the autoRIC® can reduce heart damage during PCI. This study will answer the question of whether the autoRIC®device; which is easy to use and implement, will have clinical utility in this patient population."

The autoRIC® device is approved by Health Canada and in Europe, where it is being used in multiple large investigator-sponsored trials to further assess effectiveness in reducing adverse events after a heart attack. A positive SHIELD study will be used to support CellAegis's premarket submission to the U.S. Food and Drug Administration (FDA) for US commercialization of the autoRIC® device.

"There are approximately 1 million elective PCI procedures performed annually in the US, in patients with ischemic heart disease and elevations of troponin resulting from the procedure, that have been shown to result in poorer clinical outcomes," said Rocky Ganske, Chief Executive Officer, CellAegis.  "Enrollment of the first patients in this U.S. pivotal clinical trial represents an important step forward in the autoRIC® clinical development program. Our current expectations are to complete the study in the third quarter of 2018."

About RIC

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 ST-elevation myocardial infarction ("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 RIC 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. The autoRIC® device is CE Marked, and Health Canada approved, and is currently limited to investigational use in the United States.

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. 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.

Forward-Looking Statements

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.

Contact:
Rocky Ganske
Chief Executive Officer
rganske@cellaegisdevices.com
www.cellaegis.com




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: CellAegis Devices Inc. via Globenewswire

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

Bombardier Delivers First 90-seat Q400 Aircraft to SpiceJet21.9.2018 16:00Pressemelding

SpiceJet becomes the first airline to take advantage of the Q400 aircraft’s increased profit potential TORONTO, Sept. 21, 2018 (GLOBE NEWSWIRE) -- Bombardier Commercial Aircraft today announced the delivery of its first 90-seat Q400 aircraft. The aircraft was handed over to India’s SpiceJet Limited (“SpiceJet”) the launch operator for the extra-capacity, 90-seat aircraft. “We are excited to induct the 90-seat Q400 aircraft into our fleet,” said Ajay Singh, Chairman and Managing Director, SpiceJet. “The additional seats and performance improvements will result in substantial reduction in unit costs and also we will enable us to address our market needs in the regional space.” “The delivery of the first 90-seat Q400 aircraft showcases the commitment of Bombardier’s Q Series turboprop program to respond to customer requirements as they address traffic growth in regional markets,” said Todd Young, Head of the Q Series Aircraft Program, Bombardier Commercial Aircraft. “I thank and congratul

Service Providers Speed Deployment, Reduce Costs with Patton Cloud Edge Orchestration Service20.9.2018 22:16Pressemelding

Now, Telecom and UCaaS service providers can easily provision, manage, monitor, secure, alert, troubleshoot, analyze, and optimize services on the customer premise GAITHERSBURG, Md., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Patton Electronics—US-manufacturer of UC, cloud, and IoT-enabling solutions for carrier, enterprise, and industrial networks—has launched the new Patton Cloud service for carriers and service providers that deliver All-IP and hybrid voice-and-data services to business subscribers. Patton Cloud delivers a low-cost, easy-to-use, web-based edge-orchestration service that delivers a superior user experience. It offers remote touchless provisioning, monitoring, and troubleshooting—as well as security and alerting tools that reduce service turn-up costs, trouble tickets, and subscriber attrition. The Patton Cloud service offers quality-control mechanisms including pro-active monitoring and troubleshooting—combined with feature-license distribution pools for managing value-added

Inspirata Promotes Top Executives to Expanded Roles in Digital Pathology20.9.2018 21:12Pressemelding

Inspirata Founder and Executive Vice President, Mark Lloyd, is taking on an expanded role overseeing product management, and Inspirata Senior Vice President, Andrew Chomos, has been appointed to General Manager, Digital Pathology, overseeing the Center of Excellence in Pittsburgh along with all North America sales and customer support efforts. Tampa, FL, Sept. 20, 2018 (GLOBE NEWSWIRE) -- Cancer informatics and digital pathology workflow solution provider Inspirata®, Inc. announced today that two of its executives have taken on expanded roles in the company. The two are Inspirata Executive Vice President and Founder, Mark Lloyd, and Senior Vice President and General Manager, Digital Pathology, Andrew Chomos. Dr. Lloyd has accepted the expansion of his role to include product management for Digital Pathology. He is former cancer researcher at both Lombardi Cancer and Moffitt Cancer Center and is Inspirata’s foremost subject matter expert and thought leader on digital pathology and image

Tetraphase Pharmaceuticals Announces Adoption of Commission Decision Granting Marketing Authorisation Approval in the European Union for XERAVA™ (eravacycline) for the Treatment of Complicated Intra-Abdominal Infections20.9.2018 19:08Pressemelding

– Broad Product Label for Treatment of Complicated Intra-Abdominal Infections – – Phased Commercial Launch Expected in the First Half of 2019 – WATERTOWN, Mass., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that the European Commission (EC) has adopted the Decision granting marketing authorisation for XERAVA (eravacycline) for injection for the treatment of complicated intra-abdominal infections (cIAI) in adults in the European Union. In clinical trials, XERAVA was well-tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical non-inferiority to two widely used comparators – ertapenem and meropenem. “The European approval of XERAVA, right after our recently announced FDA approval, marks our second significant regulatory approval within one month

UPDATE— Taconic Biosciences Becomes the First Animal Model Provider on General Services Administration Contract Schedule20.9.2018 18:07Pressemelding

RENSSELAER, N.Y., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Taconic Biosciences, a global leader in providing genetically engineered rodent model solutions, announces a new relationship with Government Scientific Source (GSS). GSS is a leading dedicated distributor of laboratory equipment to federal, state, and local governments on contract with the GSA (General Services Administration). By having Taconic’s products available via GSS, they can now be accessed by all federal agencies, including but not limited to the National Institutes of Health and the Department of Defense. Taconic is the only animal model provider affiliated with GSS and the only animal model provider available on GSA Contract. “An important component of providing customers with the best animal model solutions is access to key resources. Through this exciting new relationship with GSS, Taconic can now easily connect with scientists doing some of the most valuable research in the world and provide them with high quality sol

Digital Transformation is Not a One-Off — It’s About the Digital Journey20.9.2018 17:44Pressemelding

SoftServe study confirms four digital journey states with 71 percent of enterprises reporting early stages of adoption AUSTIN, Texas, Sept. 20, 2018 (GLOBE NEWSWIRE) -- SoftServe, a leading digital authority and consulting company, today released the results of its market research study that examines how enterprises are responding to the digital economy. The research found that 71 percent of the respondents in the United States and the European Union are in the early stages—Reveal and Transform—of four unique states across the Enterprise Digital Journey. For an in-depth analysis and the full results, read The Enterprise Digital Journey white paper. With fierce competition in today’s global landscape, leveraging cutting-edge technology and deploying new business models is not a one-off pursuit, but rather a continuous process of iteration and refinement. Companies should stop referring to Digital Transformation and instead plan for a continuous Digital Journey. “The term Digital Transfo

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom