NASDAQ OMX

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

Dela

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 OMX
NASDAQ OMX



Följ NASDAQ OMX

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

Forterra Announces First Quarter 2018 Earnings Schedule24.4.2018 12:00Pressmeddelande

IRVING, Texas, April 24, 2018 (GLOBE NEWSWIRE) -- Forterra, Inc. ("Forterra") (Nasdaq:FRTA) plans to release first quarter 2018 financial results before the market open on Tuesday, May 8, 2018. A conference call to review financial results will also be held on Tuesday, May 8, 2018 at 8:30 a.m. Eastern time (7:30 a.m. Central). Hosting the call will be Jeff Bradley, Chief Executive Officer, and Charlie Brown, Executive Vice President and Chief Financial Officer. CONFERENCE CALL AND WEBCAST DETAILS Webcast Information Event: Q1 2018 Forterra, Inc. Earnings Call Date: Tuesday, May 8, 2018 Time: 8:30 a.m. Eastern Time (7:30 a.m. Central) https://edge.media-server.com/m6/p/a3wzhe79 Conference Call Information U.S.: 1-574-990-1396 Toll-Free: 1-844-498-0572 Participant Passcode: 6398379 Replay Information A replay of the conference call and archive of the webcast will be available within 24 hours after the call on the "Events & Presentations" page under the Investor section of the Company's w

Meltwater acquires leading social analytics company Sysomos24.4.2018 10:00Pressmeddelande

Acquisition expands Meltwater's ability to incorporate online news and data with social media analytics in one robust platform SAN FRANCISCO, April 24, 2018 (GLOBE NEWSWIRE) -- Meltwater, a pioneer of media intelligence and now Outside Insight, today announced its acquisition of Sysomos, a leader in social analytics and engagement. The addition of Sysomos to Meltwater enables organizations to analyze social media, news and other human-generated content in one platform, furthering Meltwater's mission to give businesses the insights from outside data, helping them stay ahead. "All the social analytics companies look at social data in isolation, limiting the insights for brands and businesses," says Jorn Lyseggen, founder and CEO of Meltwater. "With our acquisition of Sysomos, we can bring together news and social media under one company, giving social data context while adding social engagement to our news and media monitoring offering." For the PR and communications teams who engage wit

New leaders emerge in 2018 All-Europe trading team ranking24.4.2018 10:00Pressmeddelande

NEW YORK, April 24, 2018 (GLOBE NEWSWIRE) -- Competition in electronic trading is becoming fierce as global trade execution teams re-position themselves for delivering their solutions at scale in a post MiFID II regulatory environment. J.P. Morgan continues to dominate claiming first place in electronic trading, for a second consecutive year, according to Institutional Investor's All-Europe Trading Team survey. Meanwhile Bank of America Merrill Lynch took home second place, up two spots from fourth place last year; a significant move for Bank of America Merrill Lynch, which bumped its peers Credit Suisse in third place and UBS in fourth place to win the No. 2 position. The two-rung move is a marked shift away from its previous high-touch leadership and is an endorsement that the bank's investments in technology are resonating with clients. In high-touch trading, UBS leapt to No. 1 swapping its fifth place position last year with Bank of America Merrill Lynch, who took fifth in the high

BT Dials in Corvil Analytics to Help Achieve World-Class Service Delivery for World's Largest Virtual Contact Centre24.4.2018 10:00Pressmeddelande

Corvil empowers BT with the visibility and insight to achieve outstanding caller experience for a public sector customer serving 20M+ citizens DUBLIN, Ireland, April 24, 2018 (GLOBE NEWSWIRE) -- Corvil today announced that BT Global Services has deployed Corvil Analytics to manage and optimise VoIP call quality of one of the largest contact centres in the world channelling its services through 30,000 agents across 180 sites. As a leading provider of contact centre solutions globally, BT has a strong track-record in designing and implementing large-scale transformational engagements. Looking to simplify service assurance and maintain call quality excellence in an environment where call volumes continually reach 12500 concurrent calls (12 new calls per second), BT sought to enlist an analytics partner. In a climate of intense scrutiny on public sector performance and with stringent customer Service Level Agreements (SLAs) in place, BT selected Corvil to help improve caller experience by

MedicCoin Unveils International Adoption Strategy Based on Integrating Blockchain Technology into Everyday Life24.4.2018 09:00Pressmeddelande

Strategy focuses on improving health of mankind through blockchain-powered rewards, advancing scientific research and charitable donations NEW YORK, April 24, 2018 (GLOBE NEWSWIRE) -- via NetworkWire -- MedicCoin, a community-driven crypto focused on improving the lives of millions worldwide, today provides the multifaceted roadmap established for global adoption while recapping practical innovations that set MedicCoin apart for everyday use. Introducing Multiple Ways to Earn Crypto as a Reward for Positive Choices The MedicCoin founders envisioned using blockchain technology to make life better for all mankind. A key part of staying true to this vision is ensuring people around the world can join the MedicCoin community without highly technical skills or expensive mining equipment. Living an Active Lifestyle By simply installing the MedicWalk app and staying active, anyone will be able to acquire MedicCoin. MedicWalk will be launched within the next few weeks. Donating Unused Computer

In-Memory Computing Summit Europe Announces Full Breakout Session Schedule24.4.2018 09:00Pressmeddelande

Register by April 29th to Receive a 30 Percent Discount FOSTER CITY, Calif., April 24, 2018 (GLOBE NEWSWIRE) -- GridGain Systems, provider of enterprise-grade in-memory computing platform solutions based on Apache® Ignite(TM), today released the full breakout session schedule for the second annual In-Memory Computing Summit® Europe, the premier conference for individuals from Europe and Asia that are currently using or exploring using in-memory computing. Conference breakout sessions are in five tracks: Tales from the Trenches, New Capabilities, Architecture, Streaming Data, and Hardware. Speakers include representatives from companies such as Oracle, Intel, NEC Corporation of America, GridGain Systems, Hazelcast, iguazio, Neeve Research, ScaleOut Software, Software AG, Bouquet.ai, and VoltDB. The IMC Summit Europe will take place at the Park Plaza Victoria London, June 25-26, 2018. Attendees can receive a 30 percent Super Saver discount off the full price registration fee by purchasin

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum