CellAegis Announces First Patients Enrolled in U.S. SHIELD Pivotal Clinical Trial
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."
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.
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.
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
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
Gratomic Announces Non-Brokered Private Placement21.7.2018 19:41 | Pressemelding
TORONTO, July 21, 2018 (GLOBE NEWSWIRE) -- Gratomic Inc. ("GRAT" or the "Company") (TSX-V:GRAT) (FRANKFURT:CB81) (WKN:A143MR) is pleased to announce the offering of a non-brokered private placement of up to 20,000,000 working capital units (the "WC Unit") for up to $2,000,000 (the "Offering"). Each WC Unit is priced at $0.10 and consists of one (1) common share and one (1) common share purchase warrant ("WC Warrant"). Each WC Warrant entitles the holder to purchase one (1) common share (a "WC Warrant Share") at a price of $0.20 per WC Warrant Share until the earlier of: (i) three (3) years following the Closing of the Offering; and (ii) in the event that the closing price of the Common Shares on the TSX Venture Exchange is at least $0.30 for ten (10) consecutive trading days, and the 10th trading day (the "Final Trading Day") is at least four (4) months from the Closing Date, the date which is thirty (30) days from the Final Trading Day. Eligible Finders may receive 5% of the value of
eGain Enables Conversational Customer Service Through Apple Business Chat20.7.2018 12:30 | Pressemelding
SUNNYVALE, Calif. and NEWBURY, United Kingdom, July 20, 2018 (GLOBE NEWSWIRE) -- eGain (NASDAQ:EGAN), the leading provider of cloud-based customer engagement solutions, today announced its integration with Apple Business Chat. According to Gartner, requests for customer support through consumer mobile messaging apps will exceed requests for customer support through traditional social media by 2019*. Moreover, 56% of consumers surveyed in a Nielsen study would rather message a business than call customer service, and 67% expect to message businesses even more over the next two years. Key capabilities Among key capabilities of the integrated solution are: Enabling hundreds of millions of consumers on iPhone and iPad to interact with businesses through the Messages app Leverage eGain AI to infer customer intent, power bot conversations through messaging, route escalations to contact center agents, and guide agents through messaging conversations Provide immersive customer experiences with
Marcus Hiles - Texas Takes #1 Four Years in a Row in America's Top States for Business19.7.2018 23:39 | Pressemelding
DALLAS, July 19, 2018 (GLOBE NEWSWIRE) -- The future business scene in Texas is looking brighter than ever as the state continues to hold its place as a national leader. Growth is spreading across areas such as North Texas, Houston and San Antonio with businesses quickly expanding their operations in the state that offers some of the best in business-friendly climates and overall growth potential. Tapping into the market recently are global leaders such as Toyota, Liberty Mutual and JP Morgan who have taken advantage of the state's increasing network of commercial properties, workforce and business resources. Named by CNBC for the fourth consecutive year as America's Top State for Business, Texas scored above all 50 states on overall business competitiveness. With the business hub building on its role as a national leader for the past decade, this top rank title reflects the progress Texas has made in cementing its place in the global economy. "This national recognition comes without s
Second Quarter 2018 Results Conference Call19.7.2018 21:34 | Pressemelding
AURORA, Ontario, July 19, 2018 (GLOBE NEWSWIRE) -- Magna International Inc. (TSX:MG) (NYSE:MGA) SECOND QUARTER 2018 RESULTS CONFERENCE CALL WEDNESDAY - AUGUST 8th, 2018 7:30 AM ET DIAL IN NUMBERS North America Toll Free: International Toll: Webcast: 1-888-223-4641 1-416-981-9080 www.magna.com Slide presentation will be available on our website prior to the call. REBROADCAST INFORMATION Replay available 2 hours after the call until August 15, 2018 North America Toll Free: International Toll: Reservation No.: 1-800-558-5253 1-416-626-4100 21892829 INVESTOR CONTACT Louis Tonelli, Vice-President, Investor Relations firstname.lastname@example.org, 905-726-7035 TELECONFERENCE CONTACT Nancy Hansford, Executive Assistant, Investor Relations email@example.com, 905-726-7108 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 originali
Uganda National Airlines Company Limited Signs Firm Order for Four Bombardier CRJ900 Aircraft19.7.2018 18:36 | Pressemelding
First operator of the new CRJ Series ATMOSPHÈRE cabin in Africa MONTREAL, July 18, 2018 (GLOBE NEWSWIRE) -- Bombardier Commercial Aircraft announced today that it has signed a firm order for four new CRJ900 regional jets with Uganda National Airlines Company. Based on the list price for the CRJ900 aircraft, the firm order is valued at approximately US$190 million. "We congratulate the Government of Uganda for the revival of its national flag carrier, and are thrilled that the new airline has selected Bombardier and the CRJ900 regional jets for its upcoming debut," said Jean-Paul Boutibou, Vice President, Sales, Middle-East and Africa, Bombardier Commercial Aircraft. "Recognized for its superior economics and efficiency, the CRJ Series aircraft have enabled airlines worldwide to serve communities with better connectivity, and we look forward to supporting the development of Uganda's regional air travel with these CRJ900 regional jets." Uganda Airlines will operate the CRJ900 in dual-cla
CrownBio Supports Excellence in Translational Research with Grant Award that Funds Innovative PDX Model Development in Immuno-Oncology19.7.2018 15:03 | Pressemelding
"Cancer Research Center of Lyon iPS novel PDX models formulate new immune cell focused strategies" SAN DIEGO, July 19, 2018 (GLOBE NEWSWIRE) -- Crown Bioscience, a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, is proud to announce the award of its Patient-Derived Xenograft (PDX) grant program to doctors Fabrice Lavial, Christophe Caux and Bertrand Dubois from the Cancer Research Center of Lyon (CRCL). The grant program was established to support oncology researchers pursuing scientific advancements in cancer using PDX technology. Following an extensive review, CrownBio's Scientific Steering Committee selected Dr. Lavial and his colleagues at the CRCL due to their project's potential to create breakthroughs in preclinical oncology strategies. Their research combines PDX and iPS cell technologies to create patient-specific, humanized models. These unique models wil
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom