GlobeNewswire

CellAegis Announces Completion of Patient Enrollment in UK Investigator Sponsored Clinical Trial using autoRIC® Device

Dela

TORONTO, June 14, 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 completion of patient enrollment in a large-scale, investigator-sponsored trial ("ERIC-PPCI") to further assess the efficacy of remote ischemic conditioning ("RIC") in reducing clinical events in patients presenting with ST-segment-elevation myocardial infarction ("STEMI") in patients receiving treatment in hospital catheterization labs or emergency rooms (the "ERIC-PPCI Hospital Trial"). This trial utilized CellAegis' autoRIC® device (http://cellaegis.com/products/) to deliver the RIC therapy.

The ERIC-PPCI Hospital Trial is designed to assess the benefit of RIC versus standard of care treatment in reducing cardiac death and hospitalization for heart failure at twelve months in STEMI patients.  It is a multi-center, randomized, controlled, double-blind clinical trial that has enrolled 2,800 STEMI patients across twenty-six National Health Service hospitals in the United Kingdom.  It is funded by the British Heart Foundation, sponsored by University College London, and is being managed by the clinical trials unit at the London School of Hygiene and Tropical Medicine. CellAegis currently expects patient follow-up in the ERIC-PPCI Hospital Trial to be completed in March 2019.

CellAegis anticipates that data from the ERIC-PPCI Hospital Trial will augment the existing positive dataset of evidence related to the therapeutic benefits of RIC in the treatment of STEMI patients: a recent meta-analysis of multiple randomized trials of RIC in STEMI patients has shown that the treatment significantly reduced infarct (dead tissue) size by 43% (Journal of the American Heart Association: McLeod et al 2017), as well as reduced heart failure.  In a recent prospective trial conducted in 448 STEMI patients at Hospital de Braga in Portugal (Basic Research Cardiology: Gaspar et al 2018), RIC treatment was shown to reduce clinical outcomes heart failure/cardiac death by 62% at two years.

"Our team has had a very positive experience with autoRIC® for the delivery of RIC in the cath lab," said Derek Hausenloy, MD, PhD, FESC, FACC, Professor of Cardiovascular Medicine at the Hatter Cardiovascular Institute, University College London, and the principal investigator for ERIC-PPCI.  "RIC is a quick and simple procedure to perform using CellAegis' fully automated autoRIC® device."

"This ERIC-PPCI Hospital Trial, when combined with the recently announced completed enrollment of an equally large Danish ambulance trial, known as CONDI 2, will result in an unprecedented 5,400 patients having been enrolled to assess the benefit of RIC in the treatment of cardiovascular disease and procedure related kidney damage using our autoRIC® device," said Rocky Ganske, Chief Executive Officer, CellAegis. "We are extremely excited at the completion of this enrollment milestone and look forward to the trial results from both of these studies in 2019."

"There are an estimated one million STEMI incidents annually in North America and Europe that are expected to benefit from our autoRIC® device," added Mr. Ganske. "In addition to the STEMI benefits we also expect to see large opportunities for RIC to improve outcomes for patients undergoing elective PCI (stent) and angiography procedures."

About RIC

RIC is a noninvasive therapy that utilizes four cycles of limb occlusion and reperfusion to protect the heart and other tissue against ischemia-reperfusion injury. RIC is a promising adjunctive treatment to stenting in the prevention of ischemic-reperfusion injury and minimization of post-infarct heart failure in ST-elevation myocardial infarction ("STEMI") patients. Previous proof-of-concept clinical studies with RIC have demonstrated improvements in markers of injury, such as increased myocardial salvage and reduced infarct size as well as reduction of contrast-induced acute kidney injury, in various clinical scenarios such as heart attacks and elective cardiac procedures.

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, and is currently limited to investigational use in the United States. 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:

Melane Sampson
Investor Relations
Melane@kilmerlucas.com
1-888-545-6374

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

GlobeNewswire



Följ GlobeNewswire

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från GlobeNewswire

Karolinska Development's portfolio company Pharmanest changes name and signs licensing agreement15.10.2018 13:25Pressmeddelande

STOCKHOLM, October 15, 2018. Karolinska Development's portfolio company Phamanest changes its name to Palette Life Sciences. The company also announces a global licensing agreement with Nestlé Skin Health. Palette Life Sciences (former Pharmanest) has announced a licensing agreement with Nestlé Skin Health. The agreement gives Palette Life Sciences the worldwide commercialization and development rights for three products: Deflux®, Solesta® and BarrigelTM. The products are all based on the NASHATM (Non Animal Stabilized Hyaluronic Acid) technology. Palette Life Sciences will focus immediately on sales of Deflux and Solesta and will begin preparing for worldwide commercialization of Barrigel. Nestlé Skin Health will continue to manufacture the products on behalf of Palette Life Sciences. Palette Life Science will continue the development of SHACT under the name LidbreeTM. Lidbree will be submitted for European regulatory review later this year. Karolinska Development is a passive investo

Karolinska Development's portfolio company Pharmanest changes name and signs licensing agreement15.10.2018 13:25Pressmeddelande

STOCKHOLM, October 15, 2018. Karolinska Development's portfolio company Phamanest changes its name to Palette Life Sciences. The company also announces a global licensing agreement with Nestlé Skin Health. Palette Life Sciences (former Pharmanest) has announced a licensing agreement with Nestlé Skin Health. The agreement gives Palette Life Sciences the worldwide commercialization and development rights for three products: Deflux®, Solesta® and BarrigelTM. The products are all based on the NASHATM (Non Animal Stabilized Hyaluronic Acid) technology. Palette Life Sciences will focus immediately on sales of Deflux and Solesta and will begin preparing for worldwide commercialization of Barrigel. Nestlé Skin Health will continue to manufacture the products on behalf of Palette Life Sciences. Palette Life Science will continue the development of SHACT under the name LidbreeTM. Lidbree will be submitted for European regulatory review later this year. Karolinska Development is a passive investo

ICONOVO TECKNAR AVTAL MED MCMASTER UNIVERSITY AVSEENDE UTVECKLING AV VACCIN MOT TUBERKULOS15.10.2018 09:00Pressmeddelande

Det innovativa, Lundabaserade medicinteknikföretaget Iconovo AB (publ) meddelar i dag att bolaget har skrivit samarbetsavtal med McMaster University i Kanada. Avtalet avser utveckling av en torrpulverberedning av inhalerbart vaccin mot tuberkulos som ska användas i Iconovos unika engångsinhalator ICOone. Iconovo kommer att ingå i ett tvärvetenskapligt forsknings- och utvecklingsprojekt som syftar till att ta fram nästa generations virusbaserade vaccin i pulverform som är stabilt i rumstemperatur. Att kunna transportera vaccin utan krav på kylförvaring är en förutsättning för att snabbt och effektivt nå ut till de behövande. I det projekt som nu påbörjas kommer Iconovos unika engångsinhalator ICOone att användas som testplattform för att underlätta en framtida kommersialisering och storskalig tillverkning. Projektet beräknas pågå i tre år och finansieras bland annat av den kanadensiska staten (CIHR/NSERC). Tuberkulos förekommer i hela världen och är en av de tio vanligaste dödsorsakerna

Stillfront Group AB: Babil Games lanserar Arab Gamers' League4.10.2018 10:02Pressmeddelande

PRESSMEDDELANDE 4 oktober 2018 Babil Games, en del av Stillfront Group, ökar affärstillväxten och lanserar Arab Gamers' League, AGL Babil Games, ett dotterbolag till Stillfront Group, inleder partnerskap med kreativa byrån Grape Creations i Dubai och lanserar Arab Gamers' League (AGL), en ny studio som fokuserar på att lansera så kallade 'social casual games' till MENA-regionen. Babil Games kontrollerar 51% av AGL och Grape Creations övriga 49%. Babil Games är ansvarig för verksamheten och sourcing av spel medan Grape Creations ansvarar för marknadsföring och distribution. "Vi är mycket glada över vårt inledda partnerskap med Grape Creations gällande lanseringen av Arab Gamers' League. AGLs fokus är att lansera nästa generations 'social casual games' till MENA-regionen", säger MJ Fahmi, VD för Babil Games. Babil Games kommer att fortsätta att fokusera på MMO-strategispel. Antalet anställda i Babil Games har fördubblats under det senaste året och studion kommer att flytta till ett nytt

Stillfront Group AB: Babil Games launches Arab Gamers' League4.10.2018 10:02Pressmeddelande

PRESS RELEASE 4 October 2018 Babil Games, part of the Stillfront Group, accelerates business growth and launches Arab Gamers' League, AGL Babil Games, a subsidiary of Stillfront Group, is partnering with Dubai based creative agency Grape Creations to launch Arab Gamers' League (AGL), a new studio focused on bringing social casual games to the MENA-region. Babil Games controls 51% of AGL and Grape Creations the other 49%. Babil Games is head of the operations and the sourcing of the games while Grape Creations is responsible for marketing and distribution. "We are pleased to have Grape Creations as our partner for the launch of Arab Gamers League. In AGL we will focus on bringing the next generation of social casual games to the MENA region", says MJ Fahmi, CEO of Babil Games. Babil Games will continue to focus on strategy MMO games. The number of employees in Babil Games has doubled during the year and the studio will relocate to a new larger office in Amman, Jordan. "The expansion is

Hoylu AB: UNITED STATES AIR FORCE SELECTS HOYLU FOR COLLABORATION AND INNOVATION SOLUTIONS28.9.2018 08:30Pressmeddelande

Malmo, Sweden, September 28, 2018 - Hoylu, a leading enterprise collaboration company announced today that the United States Air Force has selected Hoylu Software and multiple large format HoyluWall systems as a digital workspace tool for workspace innovation and collaboration. Hoylu software will be used at multiple sites to create joined environments within the division. The order will be delivered in Q4 2018 and represents a deal value of SEK 3,670,000 in product and software revenue. The Air Force will use the system for training and education purposes, with the ability to connect users together and collaborate in real-time. The order represents a growing market for Hoylu software and services within the government sector. It is expected that Hoylu's solutions will continue to expand within this industry as innovative collaboration solutions are in demand. Hoylu's solutions and software offer new and exciting ways to learn and collaborate smarter, faster and more efficiently. Creat

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

Besök vårt pressrum