• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    Vascular Surgeon Imprisoned and Fined for Decade-Long Healthcare Fraud

    Remote Monitoring, Digital Health Help Advance Wound Care Treatment

    MLM Biologics Developing Wound Infection Prevention Device for Military

    NovaScan, PHC Corporation Working on Skin Cancer Detection Device

    Ur24Technology Granted Medicare Reimbursement for External Catheter System
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Checking Up on Surgical Robotics

    Building a Network: How Synchron Is Developing a New Device—and a New Market

    Six Lessons Learned on Developing a Strong Company Culture

    As Hiring Slows, Companies Look Inward to Fulfill Talent Needs

    Artificial Intelligence: Medtech Opportunity or Health Danger?
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Providence Enterprise USA Inc.

    Medbio LLC

    Cirtec Medical

    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3 Key Elements to Consider When Managing a Medtech Sales Force

    Tech-Enabled Virtual Speech Therapy Improves Speech & Communication Skills

    Practical Strategies for Digitization and Integration in Medtech Manufacturing

    Sensors: The Heart of Minimally Invasive Equipment Technology

    Optimizing UX for the Internet of Medical Things
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Cirtec Medical

    Halkey-Roberts Corporation

    Medbio LLC

    NDH Medical Inc.

    Arthur G. Russell Co. Inc., The
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Approves Increase in Number of Clinical Sites for E-QURE’s Pivotal Trial of BST Device

    The approval could potentially shorten study period by more than six months.

    FDA Approves Increase in Number of Clinical Sites for E-QURE’s Pivotal Trial of BST Device
    E-QURE Corp.'s Bio-electrical Signal Therapy (BST) device.
    E-QURE Corp. 03.06.17
    E-QURE Corp., a developer of advanced wound care treatment devices, has received U.S. Food and Drug Administration (FDA) approval to conduct its pivotal trial for the company's patented Bio-electrical Signal Therapy (BST) device in the treatment of chronic wound care as a staged study, potentially shortening the duration of the trial.
     
    The conditional approval that was granted to E-QURE under an Investigational Device Exemption (IDE) in October 2016 said the company may conduct the safety stage of the trial in one U.S. institution. The company has since requested an increase in the number of institutions in the safety stage and the FDA responded with an approval, increasing the number of U.S. institutions where the first 10 patients will be treated from one to five.
     
    “We are delighted the FDA has granted us the opportunity to shorten the trial period by increasing the number of sites we can use. This may shorten our whole study period by more than six months. We intend to fulfill all FDA requirements and start the trial as soon as we can,” said Ron Weissberg, chairman of E-QURE Corp.

    The approval to increase the number of institutions where the first 10 patients can be treated is expected to allow the company to dramatically shorten the safety portion of the trial, resulting in an accelerated timeline to treat all 90 patients planned for inclusion in the study. E-QURE may request approval to expand enrollment in the study to 90 patients following its submission of an IDE supplement which includes a safety profile of the 10 patients who completed 56 days’ treatment with the E-QURE BST device.
     
    E-QURE Corp.'s patented Bioelectrical Signal Therapy device is the only method in the world to non-invasively close and heal chronic wounds and ulcers. Current methods of chronic wound treatment at best treat or reduce the wound, but none consistently heal or cure it. The BST Device not only cures wounds, it does so faster, at lower cost, and with more convenience to the patient and the healthcare system. The BST Device has received regulatory approval in Europe and Israel, and is expected to launch between the first and third quarters in Israel and Argentina, where approval is pending. E-QURE plans to begin its FDA trial in the first quarter of 2017. The New York, N.Y.-based company’s pipeline includes additional proprietary wound care products in development.
    Related Searches
    • regulatory
    • it
    • ulcers
    • wound care
    Related Knowledge Center
    • Electronics
    Suggested For You
    Boyd Biomedical Boyd Biomedical
    Wear-time comparison of three pressure-sensitive acrylic skin adhesives Wear-time comparison of three pressure-sensitive acrylic skin adhesives
    FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers
    FDA Approves First First Flexible Shaver for Interventional Gastroenterology FDA Approves First First Flexible Shaver for Interventional Gastroenterology
    Four Takeaways from Recent Regulatory Audit Changes Four Takeaways from Recent Regulatory Audit Changes
    FDA Designates N8 Medical FDA Designates N8 Medical's CeraShield Endotracheal Tube as a Breakthrough Device
    Theranos to Exit Lab Business for Two Years in Deal with CMS Theranos to Exit Lab Business for Two Years in Deal with CMS
    FDA Clears First Whole Slide Imaging System for Digital Pathology FDA Clears First Whole Slide Imaging System for Digital Pathology
     Acelity Introduces V.A.C. VERAFLO CLEANSE CHOICE Dressing Acelity Introduces V.A.C. VERAFLO CLEANSE CHOICE Dressing
    Collaborating on Custom Materials Development Collaborating on Custom Materials Development
    Extractable/Leachable Chemistry Testing Strategies for Medical Devices Extractable/Leachable Chemistry Testing Strategies for Medical Devices
    GI Dynamics Announces New Scientific Advisory Board and First Two Members GI Dynamics Announces New Scientific Advisory Board and First Two Members
    Balloon Technology Study Launched for Treatment of Below-The-Knee PAD Balloon Technology Study Launched for Treatment of Below-The-Knee PAD
    Four Common Misperceptions of Accelerated FDA Approval Four Common Misperceptions of Accelerated FDA Approval
    First in Man First in Man

    Related Buyers Guide Companies

    • Boyd Biomedical

      Boyd Biomedical

      ...
      Linnea Koons, Director of Marketing 11.17.22

    • Wear-time comparison of three pressure-sensitive acrylic skin adhesives

      Wear-time comparison of three pressure-sensitive acrylic skin adhesives

      The results emphasize the importance of selecting the right adhesive for the right application.

    • Cardiovascular
      FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers

      FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers

      Portfolio of heart failure devices offers effective pacing and access to the most advanced diagnostic imaging procedures.
      Medtronic plc 05.11.17


    • Surgical
      FDA Approves First First Flexible Shaver for Interventional Gastroenterology

      FDA Approves First First Flexible Shaver for Interventional Gastroenterology

      Interscope's EndoRotor performs tissue dissection, resection, and retrieval in a single step.
      Business Wire 05.05.17

    • Four Takeaways from Recent Regulatory Audit Changes

      Four Takeaways from Recent Regulatory Audit Changes

      ...
      Alexa Sussman, Content Marketing Writer, EtQ 05.01.17

    Loading, Please Wait..

    Trending
    • Philips Names New Supervisory Board Chairman
    • A New Approach To Post-Market Surveillance
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    • Vascular Surgeon Imprisoned And Fined For Decade-Long Healthcare Fraud
    Breaking News
    • Vascular Surgeon Imprisoned and Fined for Decade-Long Healthcare Fraud
    • Remote Monitoring, Digital Health Help Advance Wound Care Treatment
    • MLM Biologics Developing Wound Infection Prevention Device for Military
    • NovaScan, PHC Corporation Working on Skin Cancer Detection Device
    • Ur24Technology Granted Medicare Reimbursement for External Catheter System
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • Computer Concepts for Medical Device Design
    • IVD Manufacturers Are Being Put to the Test
    • The New State of Medtech Outsourcing
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Premium Label & Packaging Solutions Receives Safe Quality Food (SQF) Certification
    Inulinase Enzymes May Benefit Gut Symptoms of FODMAP Digestion
    Verdure Sciences’ Boswellia Ingredient Receives USP Verification
    Coatings World

    Latest Breaking News From Coatings World

    BASF Celebrates 10 Years of its Northeast Research Alliance in the U.S.
    BCF Elects Sharon Harte Its First Female President
    OQ Chemicals Launches Cost-Cutting Program and Organizational Realignment in Germany
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Vascular Surgeon Imprisoned and Fined for Decade-Long Healthcare Fraud
    Remote Monitoring, Digital Health Help Advance Wound Care Treatment
    MLM Biologics Developing Wound Infection Prevention Device for Military
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Catalent Adds New Cryogenic Capabilities at Japanese Facility
    Lifecore Biomedical Enters into $150M New Financing Deal
    WuXi Biologics Receives 2023 ISPE Facility of the Year Award
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    How Robots & Artificial Intelligence are Transforming Unilever's Material Innovation Factory
    Top 10 Most Popular Hair Care Brands in the U.S.—Ranked by Searches
    Aloette Cosmetics Launches Daily Mineral Shield Sunscreen
    Happi

    Latest Breaking News From Happi

    Kérastase Donates $25,000 to The Trevor Project
    Aveda Launches Hypernature Artist Collection
    Amika Leads as the Most Popular Hair Care Brand in the US: Curl Centric
    Ink World

    Latest Breaking News From Ink World

    BCF Elects Sharon Harte First Female President in Its History
    Weekly Recap: INX Digital, Mexar and hubergroup Top This Week’s Stories
    Richnerstutz AG Acquires an EFI VUTEk Q5r Superwide Roll-to-Roll Printer
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Mactac acquires Label Supply, Beontag grows and more
    Sun Chemical releases Spring 2023 Regulatory Newsletter
    Tageos unveils new RAIN RFID inlays
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Corman, Tosama Develop Biodegradable Plastic Tampon Applicator, Trevira Changes Name
    Suominen Appoints SVP, Transformation Management Office
    Minnesota Signs PFAS Ban in Consumer Products
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    AlloSource Launches AlloMend Duo Acellular Dermal Matrix
    TendoNova Inks Partnership With AcCELLerated Biologics
    Stryker Achieves First Surgeries Using Q Guidance System with Cranial Guidance Software
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Partner Workshops Start Solliance 2.0
    Weekly Recap: Smart Skis, Universal Display Top This Week’s Stories
    Wiliot Appoints Antony Yousefian as VP of Climate & Circularity

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login