Navigation Links
Delcath Announces Fiscal 2011 Third Quarter Results and Recent Developments
Date:11/7/2011

NEW YORK, Nov. 7, 2011 /PRNewswire/ -- Delcath Systems (NASDAQ: DCTH) today reported financial results for the fiscal 2011 third quarter ended September 30, 2011.  Highlights for the quarter and recent developments include:

  • Research & Development:  Accelerated development of Generation Two of the Delcath Hepatic CHEMOSAT® Delivery system, which has demonstrated significantly higher filtration efficiency of melphalan in pre-clinical testing compared to Generation One of the system.
  • European Commercialization: Submission of CE Mark application for high-efficiency filter of Generation Two CHEMOSAT system, and earlier than anticipated availability of Generation Two for initial launch in European markets in early Q1 2012, subject to CE Mark approval.
  • Establishment of European Business Entity & Headquarters: Formation of Delcath Systems Ltd. (Delcath Limited), an Irish company headquartered in Galway, Ireland, under which Delcath will conduct its European operations. Delcath Limited received a development grant from IDA Ireland to support the hiring of staff over the next three years.
  • U.S. Regulatory:  Pre-New Drug Application (NDA) meeting scheduled with U.S. Food and Drug Administration (FDA) for mid-January 2012.
  • International Regulatory:  Completion of product notification process for CHEMOSAT with the Medicines and Medical Device Safety Authority in New Zealand, and submission of applications to obtain regulatory approval for CHEMOSAT for several other markets including Australia, Singapore and Hong Kong. The Company also submitted an application to obtain European CE Mark approval for the Generation Two high efficiency filter.
  • Clinical Trial Data Update: Updated efficacy results from the Company's Phase 3 trial showed the potential for CHEMOSAT as a promising
    '/>"/>

  • SOURCE Delcath Systems, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5 6 7 8

    Related medicine technology :

    1. Delcath Systems to Report Third Quarter Progress and Conduct Conference Call
    2. FDA Schedules Delcath Pre-New Drug Application Meeting Date
    3. Delcath Announces Completion of Regulatory Notification Process in New Zealand
    4. Delcath Announces Updated Efficacy Results From Phase 3 Trial of Chemosaturation for Melanoma Metastases in the Liver Presented at European Multidisciplinary Cancer Congress
    5. Delcath to Present at the JMP Securities Healthcare Conference on September 28, 2011
    6. Delcath Systems, Inc. Hosts Symposium on Chemosaturation at CIRSE Annual Meeting
    7. Delcath Announces Top-Line Results From Metastatic Colorectal Cohort in Phase II Trial of Chemosaturation System
    8. Delcath Announces Encouraging Top-Line Results From Hepatobiliary Cohort in Phase II Trial of Chemosaturation System
    9. Delcath to Present at the Wedbush 2011 Life Sciences Conference on August 16, 2011
    10. Delcath Systems to Report Second Quarter Progress Update and Conduct Conference Call
    11. Delcath Systems, Inc. Announces the Completion of Common Stock Offering
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:10/25/2014)... ARBOR, Mich. , Oct. 24, 2014 Advanced ... second quarter (ending September 26, 2014) financial results on Monday, ... will be released after the close of the market and ... discuss the results at 4:30 p.m. EDT on the same ... Richard Kurtz (CEO and Director), Rob Risser ...
    (Date:10/25/2014)... Oct. 24, 2014  In 2008, two of Dr. ... of multiple controlled substances, on a regular basis, that ... that Dr. Gurney was practicing "all the time" while ... of his employees said that Dr. Gurney was prone ... patients." Dr. Gurney,s behavior became increasingly erratic ...
    (Date:10/25/2014)... HILL, N.C. , Oct. 24, 2014 /PRNewswire/ ... to provide Medical Affairs leaders with a forum ... face. The consortium has developed a mechanism for ... discussions where leaders discuss key findings from the ... Practices has completed the analysis for the first ...
    Breaking Medicine Technology:Advanced Photonix to Webcast Fiscal 2015 Second Quarter Earnings 2Doctors That Harm: The Real Stories Insurance Companies Against Prop 46 Don't Want You To Know, Part 8 of Consumer Watchdog Campaign Series 2Doctors That Harm: The Real Stories Insurance Companies Against Prop 46 Don't Want You To Know, Part 8 of Consumer Watchdog Campaign Series 3Strong Participation in Best Practices' Medical Affairs Consortium Survey 2
    ... company at the forefront of immunology treatment and research, is ... Washington, D.C. by reinforcing its commitment to improving the lives ... a large body of UCB data will highlight the potential ... Crohn,s disease. "ACG is an opportunity for UCB ...
    ... Zimmer Holdings, Inc. (NYSE and SIX: ZMH), a ... be participating in the 2011 Credit Suisse Annual Health ... in Phoenix, Arizona on November 9, 2011, at 8:00 ... of the presentation can be accessed via Zimmer,s Investor ...
    Cached Medicine Technology:UCB Proudly Reinforces Long-Standing Commitment to Patients and Physicians at American College of Gastroenterology 2011 Annual Scientific Meeting 2UCB Proudly Reinforces Long-Standing Commitment to Patients and Physicians at American College of Gastroenterology 2011 Annual Scientific Meeting 3Zimmer Holdings to Present at 2011 Credit Suisse Annual Health Care Conference 2
    (Date:10/22/2014)... 2014 For Dr. Iris Hunter, a job ... an extension of her life’s mission. Her extensive experience in ... owner of FirstLight HomeCare, make it clear that Hunter’s mission ... that my work makes a difference in the lives of ... so after much research, I felt ready to start on ...
    (Date:10/22/2014)... Shriners Hospitals for Children® and UK HealthCare ... location of Shriners Hospitals for Children - Lexington from ... University of Kentucky Albert B. Chandler Hospital. The new ... and operated by Shriners Hospitals for Children, and designed ... their families well into the future. , “The quality ...
    (Date:10/22/2014)... 22, 2014 With the Affordable Care Act ... by the American Institutes for Research (AIR) finds that three ... use health insurance, but 42 percent say they are not ... before signing up for coverage. , The AIR survey found ... percent able to calculate correctly how much they owe for ...
    (Date:10/22/2014)... Plano, Texas (PRWEB) October 22, 2014 ... convenience of completing their continuing education at home ... now have access to 20 brand new, premium ... HomeCEUConnection.com’s robust catalog of over 2,000 hours ... to fully customize their educational experience. With such ...
    (Date:10/22/2014)... CA (PRWEB) October 22, 2014 Lintelus, ... Cormier, Sr. Vice President of Sales, will be speaking ... upcoming Meetings Technology Expo on October 28, at the ... be hosting a booth as well as a Tech ... Lintelus Meeting can create a more engaging event experience. ...
    Breaking Medicine News(10 mins):Health News:Dr. Iris Hunter to Host Grand Opening of FirstLight HomeCare Tomorrow 2Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 2Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 3Health News:Many Americans Fail to Ask Basic Questions Before Signing Up for Health Insurance, National Survey Finds 2Health News:Many Americans Fail to Ask Basic Questions Before Signing Up for Health Insurance, National Survey Finds 3Health News:Many Americans Fail to Ask Basic Questions Before Signing Up for Health Insurance, National Survey Finds 4Health News:Top Provider of Continuing Education at Home Releases 20 New Online Courses 2Health News:Jay Cormier, Sr. Vice President of Sales for Lintelus, Speaks about Event Technology Integration at Meetings Technology Expo in NYC 2
    ... at greater risk of heart-rhythm abnormality: study , TUESDAY, ... severe sleep-related breathing problems are at increased risk for ... study included 2,911 men who underwent sleep testing between ... paused or shallow breathing during sleep were more likely ...
    ... Inc. (NYSE: HGR ) announced today that it plans ... for the second quarter ending June 30, 2009, on Tuesday, July ... , The conference call is scheduled to begin at 9:00 a.m., ... call 1-800-931-9710. In addition, a replay will be available until August ...
    ... Japan, June 23 A U.S. patent infringement lawsuit ... K.K., Hamamatsu Corporation, and Olympus America, Inc. The ... District Court for the District of Delaware, accuses products ... U.S. Patent Nos. 6,917,696; 7,457,446; and 7,518,652. , ...
    ... FamilyCord , one of the nation,s leading ... of the WBLI 106.1 Baby Shower event where 250 pregnant New ... of fun, prizes, and education on June 28. FamilyCord will ... to protect newborns against 70 life-threatening diseases. Leading up to the ...
    ... WASHINGTON, June 23 The National Medical Association (NMA) congratulates ... on their work with PhRMA to bring down health care ... "While the adoption of Medicare Part D has been a ... in the system," said Dr. Mohammad N. Akhter, Executive Director ...
    , Journalists and other readers should disregard the news release, PHT Names VP to Lead Sales of A-Claim Payment Solution for Doctors, Hospitals, issued 23-Jun-2009. The release was transmitted prema...
    Cached Medicine News:Health News:Sleep Disorders Linked to Arrhythmias 2Health News:U.S. Patent Infringement Lawsuit Filed by Aperio Technologies, Inc. 2
    Includes conservation device, matched regulator, standard supply tubing, cannula, carrying case, batteries, and instruction booklet....
    ... Control Catheter with Accutrol is similar in ... except that it incorporates a temperature probe ... The temperature probe can accurately determine the ... catheter provides temperature accuracy comparable to a ...
    ... Insertion Through A 1.0mm Incision., ,Special Direct ... ... Comfortable Approach., ,Recessed Jaws For Improved Sub-Incisional ... Of Jaws During Sterilization., ,Reusable, Autoclaveable, Guaranteed ...
    ... Spatula Tips That Mimic Corneal Curvature. Designed To ... Created With The IntraLase TMFS Laser System., ... Of The Forceps Are Designed To Facilitate Access ... Achieved, The Cross-Action Forceps Design Allows The Surgeon ...
    Medicine Products: