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
The Graduate Management Admission Council Selects Three New Business Schools for Membership10.12.2018 16:26 | Pressemelding
Schools Bring Expertise and Insight in Support of GMAC Mission RESTON, Va., Dec. 10, 2018 (GLOBE NEWSWIRE) -- The Graduate Management Admission Council (GMAC), a global association of leading graduate business schools, welcomes three new members. The addition of ESCP Europe, WHU – Otto Beisheim School of Management, and Xavier University Bhubaneswar brings GMAC’s total membership to 225. Select business schools are invited to apply for GMAC membership by its Board of Directors. Each school goes through a comprehensive application process that addresses the sustained commitments to supporting GMAC’s mission: providing the tools and information necessary for schools and talent to discover and evaluate each other. “GMAC continues to strengthen our membership of graduate business schools that are not only working to address the changing needs of students, but also understanding the landscape and what can be done to better prepare students for their careers,” said Sangeet Chowfla, president
Doc re. GE Files Form 8-K10.12.2018 16:08 | Pressemelding
FAIRFIELD, Conn., Dec. 10, 2018 (GLOBE NEWSWIRE) -- Company General Electric Company ISIN US3696041033 Symbol London: GEC | Paris: GNE Headline Doc re: GE files Form 8-K December 10, 2018 On December 10, 2018, General Electric Company (the "Company") filed a Form 8-K with the U.S. Securities and Exchange Commission ("SEC"), which has been submitted to RNS. It is also available on the SEC's website at http://www.sec.gov and on the Company's website at https://www.ge.com/investor-relations/events-reports. http://www.rns-pdf.londonstockexchange.com/rns/0008K_1-2018-12-10.pdf CONTACT: GE Jennifer Erickson +001 646 682 5620 firstname.lastname@example.org This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact email@example.com or visi
Robex Resources Inc.: Drilling Results Confirming and Extending Gold Mineralization at Nampala10.12.2018 15:28 | Pressemelding
QUÉBEC CITY, Dec. 10, 2018 (GLOBE NEWSWIRE) -- Robex Resources Inc. (« Robex » and/or « the Company ») (TSXV : RBX / FWB : RB4) is pleased to provide drilling results from the ongoing drill definition and exploration program at its 100% owned Nampala gold project located in the Sikasso administrative region of the Republic of Mali. The 20,000 meters drill program commenced in September 2018. The program is currently focused on infill drilling within the Nampala open pit and resource area and on exploration drilling on the adjacent Mininko exploration permit. The Company is reporting assay results from 57 drill holes (totaling 5,392 metres): 13 diamond drill holes (totaling 1,272 meters) and 44 RC holes (totaling 4,120 meters). The program is still ongoing and other results will be reported once the results are received, validated and compiled. In this release, significant assay results from 43 intercepts in 23 drill holes are reported herein are provided in Table 1 below and include th
WillScot Announces Completion of Warrant Exchange Offer10.12.2018 15:09 | Pressemelding
BALTIMORE, Dec. 10, 2018 (GLOBE NEWSWIRE) -- WillScot Corporation (“WillScot”) (NASDAQ: WSC), the specialty rental services market leader providing innovative modular space and portable storage solutions across North America, today announced the completion of its previously announced exchange offer (the “Exchange Offer”) relating to certain outstanding warrants (the “Warrants”). The Exchange Offer expired at 11:59 p.m., Eastern Time, on December 7, 2018. Under the terms of the Exchange Offer, each Warrant holder had the opportunity to receive 0.18182 shares of WillScot Class A Common Stock, par value $0.0001 per share (“Common Stock”), for each Warrant tendered by the holder and exchanged pursuant to the Exchange Offer. As of the expiration of the Exchange Offer on December 7, 2018 at 11:59 p.m. Eastern Time, 45,131,827 outstanding Warrants were properly tendered and not withdrawn in the Exchange Offer. 45,031,827 of the Warrants tendered were public warrants, representing approximatel
CERESPIR INCORPORATED and the NATIONAL NEUROSCIENCE INSTITUTE SINGAPORE Announce Positive Data Showing Beneficial Effects of CERESPIR’s Clinical Stage Compound Itanapraced in a LRRK2 Model of Parkinson’s Disease 10.12.2018 15:00 | Pressemelding
Itanapraced blocks LRRK2 expression and LRRK2-mediated neurotoxicity Itanapraced ready to advance to Phase 2 in Parkinson’s disease patients with and without genetic mutation NEW YORK and SINGAPORE, Dec. 10, 2018 (GLOBE NEWSWIRE) -- CERESPIR INCORPORATED a pharmaceutical company engaged in the discovery and development of disease-modifying therapeutics for the treatment of neurodegenerative diseases, and THE NATIONAL NEUROSCIENCE INSTITUTE SINGAPORE, a national and international center of excellence in neuroscience with its mission to improve lives through integrated clinical service, research and education, announced today that they have obtained animal proof of concept for CERESPIR’s clinical stage compound itanapraced in Parkinson’s disease models. Specifically, itanapraced, which was previously tested with positive results in patients with mild cognitive impairment (MCI), was shown to block the expression of LRRK2 and, additionally, prevent neurotoxicity resulting in the preservati
DSM Sinochem Pharmaceuticals announces its new name - Centrient Pharmaceuticals10.12.2018 13:29 | Pressemelding
The name, resulting from a change in ownership, reflects its role at the centre of modern healthcare ROTTERDAM, Netherlands, Dec. 10, 2018 (GLOBE NEWSWIRE) -- Effective December 10, 2018 Centrient Pharmaceuticals is the new name for DSM Sinochem Pharmaceuticals, the leading manufacturer of beta-lactam antibiotics and a provider of next-generation statins and anti-fungals . The new name has been chosen to reflect the company’s key contribution to modern healthcare, and marks the next phase in its strategic evolution following a change of ownership to Bain Capital Private Equity. CEO Karl Rotthier states: “Our bold and creative new name and logo showcase our company as one which prides itself on being at the centre of modern healthcare, through our life-saving active pharmaceutical ingredients and finished dosage forms. We’re building on a rich history that began 150 years ago as the ‘Nederlandsche Gist- en Spiritusfabriek’, then Gist Brocades and more recently DSM Sinochem Pharmaceutica
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom