• 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
    Sensing Technology Drives the Future of Medical Care

    New and Developing Diabetes Technologies Offer 'Sweet Relief'

    Discussing Matters of Substance in Medtech Materials

    Medical Device Testers Are Caught Up in a Whirlwind

    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    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
    MPO's Most-Read Stories This Week—March 25

    Getinge iCast Receives FDA Premarket Approval

    Tessy Plastics Corp. Celebrates 50th Anniversary

    Carium Expands Customization Options with Care Pathways

    InBody Supplying U.S. Marine Corps With Body Composition Analysis Devices
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Sensing Technology Drives the Future of Medical Care

    New and Developing Diabetes Technologies Offer 'Sweet Relief'

    Discussing Matters of Substance in Medtech Materials

    Medical Device Testers Are Caught Up in a Whirlwind

    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    CR-SOP Neurotechnology Helps to Achieve ‘Sound’ Sleep

    Inside the Hospital Value Analysis Committee

    Face Time: Why Getting Engineers Out of the Lab Is Good for Business

    Common Paratubing Pitfalls and How to Avoid Them

    During Times of Uncertainty, Create Business Value with an Optimized Workforce
    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
    Cirtec Medical

    Arthur G. Russell Co. Inc., The

    NDH Medical Inc.

    Forefront Medical Technology

    Medbio LLC
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing Medical Devices Revolutionized Manufacturing

    5 Current Trends in Medical Device Security

    How Advanced Sensors Improve Design & Functionality of Respiratory Care Equipment

    Sourcing Silicone Parts: Injection Mold or 3D Print?

    Cybersecurity in Healthcare: Getting on the Right Track
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Cirtec Medical

    Arthur G. Russell Co. Inc., The

    NDH Medical Inc.

    Forefront Medical Technology

    Medbio LLC
    • 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

    Berlin Heals' C-MIC Heart Failure Implant Achieves Breakthrough Device Status

    Company initiates an early feasibility study in the United States.

    Michael Barbella, Managing Editor04.07.21
    The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Cardiac Microcurrent Therapy Device (C-MIC) developed by Berlin Heals.

    "Our completely novel therapeutic approach has the potential to almost cure heart failure rather than just delaying the progression of the disease. The FDA Breakthrough Designation is a tremendous turning point in the approval process for the US, enabling us to make our device available to patients with life-threatening heart disease much faster," said Berlin Heals CEO Marko Bagaric. 
     
    The FDA’s Breakthrough Devices program accelerates the development of medical devices with the potential to effectively treat or diagnose life-threatening or irreversibly debilitating diseases. Heart failure, the world's most lethal disease, is a chronic inflammatory disorder affecting millions of patients globally. It is responsible for 16 percent of all deaths and has shown the largest increase amongst all fatal diseases since 2000, rising by more than 2 million to 8.9 million deaths in 2019. The C-MIC device has shown potential to be the first treatment to enable patients of cardiac failure to lead a normal and mobile life and has consequently been assigned as a breakthrough device by the FDA.

    The C-MIC is an implantable device that delivers a constant but minimal electrical DC-current to the heart via two electrodes. Based on results of first-in-human studies in 2019/20, the C-MIC device has shown potential to become the first near-curative heart failure therapy. Berlin Heals, which has already launched a European-wide CE-study, is now about to file an Investigational Device Exemption (IDE) application with the FDA for an Early Feasibility Study (EFS) to begin in the United States later this year.
     
    As of today, no therapy, drug, or method has been developed and made available to reverse cardiac failure. Designation of the C-MIC as a breakthrough device by the FDA allows significant acceleration in the development and review of the technology, providing patients faster access. 

    Since 2014, Berlin Heals has been developing novel and revolutionary technology to treat heart failure. The proprietary C-MIC method was developed following results of pre-clinical trials in an intensive scientific cooperation with the Medical University of Vienna which confirmed that microcurrents have an extremely positive effect on cardiac cells. The C-MIC is a small implantable device that propagates reverse remodeling of the cardiac muscle tissue by delivering a constant but minimal electrical DC current to the heart. Not only did extensive preclinical trials confirm the efficacy and safety of microcurrent application via C-MIC, but also a strong anti-inflammatory effect with significant improvement in cardiac function. After confirming the clearly beneficial effects of microcurrent in preclinical studies, Berlin Heals started first implantations in patients under study conditions.
     
    Berlin Heals successfully completed a pilot study with 10 patients in April 2020. The electrical microcurrent remained completely undetectable to the patients, did not interfere with the heart rhythm, and lead to significant improvements in heart function within a few days. All of the patients' hearts, which are typically enlarged in dilated cardiomyopathies, had shrunk and all patients decreased by 2 NYHA classes. No device-specific side-medication or follow-up procedures were required.
     
    Berlin Heals has now launched a European CE-multi-center-study with its C-MIC device in Germany, Serbia, Austria, and Poland which is expected to be complete by the end of 2022. The company will also commence an Early Feasibility Study (EFS) in the United States, which includes 10 patients in mid-2021. It will then confirm the successful results of the first human study in a much larger group of more than 100 patients in a randomized two-arm multicenter trial. Marketing of the C-MIC system could start in Europe in 2022, in the United States in 2025, and globally in 2025.
    Suggested For You
    Nissha Medical Technologies Nissha Medical Technologies
    JK Medirise-Disposable Medical Device Company JK Medirise-Disposable Medical Device Company
    Critical Software Solutions Critical Software Solutions
    sfm medical devices GmbH sfm medical devices GmbH
    Heraeus Medevio Heraeus Medevio
    Simbex Simbex
    Anjon Medical Technologies Anjon Medical Technologies
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    High Tech Turning Co. Inc. High Tech Turning Co. Inc.
    Breakthrough Device Designation Granted for New Neuromodulation Platform Breakthrough Device Designation Granted for New Neuromodulation Platform
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    Accu-Tube Appoints Matthew Haddle as CEO Accu-Tube Appoints Matthew Haddle as CEO
    First CellFX Procedure Performed in Canada First CellFX Procedure Performed in Canada
    Turner Imaging Systems Announces International Expansion Turner Imaging Systems Announces International Expansion
    Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

    Related Buyers Guide Companies

    • Nissha Medical Technologies

      ...
      Amy Jeary, Market Development Manager 11.18.22

    • JK Medirise-Disposable Medical Device Company

      ...
      Ketan Munjani, Marketing Manager 11.17.22

    • Critical Software Solutions

      ...
      Allen Curtis, CTO 11.16.22


    • sfm medical devices GmbH

      ...
      Albert Busch, Head of Marketing 11.11.22

    • Heraeus Medevio

      Heraeus Medevio

      Heraeus is a globally active precious metals and technology Group with firm roots in Germany, headquartered in Hanau near Frankfurt.
      Megan Erd, Global Marketing Coordinator 11.02.22

    Loading, Please Wait..

    Trending
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    • InBody Supplying U.S. Marine Corps With Body Composition Analysis Devices
    • A New Approach To Post-Market Surveillance
    • Tessy Plastics Corp. Celebrates 50th Anniversary
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    Breaking News
    • MPO's Most-Read Stories This Week—March 25
    • Getinge iCast Receives FDA Premarket Approval
    • Tessy Plastics Corp. Celebrates 50th Anniversary
    • Carium Expands Customization Options with Care Pathways
    • InBody Supplying U.S. Marine Corps With Body Composition Analysis Devices
    View Breaking News >
    CURRENT ISSUE

    March 2023

    • Sensing Technology Drives the Future of Medical Care
    • New and Developing Diabetes Technologies Offer 'Sweet Relief'
    • Discussing Matters of Substance in Medtech Materials
    • Medical Device Testers Are Caught Up in a Whirlwind
    • 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

    NPA: ‘Major Victory’ in Colorado After Amendment to Eating Disorder Bill
    GOOD Meat Receives FDA Go-Ahead for Cultured Meat
    IFF Achieves Industrial-Scale Production of Anaerobic Probiotic Strain
    Coatings World

    Latest Breaking News From Coatings World

    HOFFMANN MINERAL to Focus on Comprehensive Sustainability Strategy
    HMG and Prodrive Renew Technical Partnership
    Eastern Coatings Show Sets Schedule for Technical Papers
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—March 25
    Getinge iCast Receives FDA Premarket Approval
    Tessy Plastics Corp. Celebrates 50th Anniversary
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Willow, Suanfarma Complete Manufacturing Process for Cannabigerol
    Berkshire Sterile to Install nearly 1,500 solar panels at Massachusetts site
    Harm Reduction Therapeutics, Catalent Ink Naloxone Commercial Supply Pact
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Interpack 2023 Introduces New Special Areas and Activities
    eSalon Expands into Over 1,900 CVS Stores Nationwide
    The RealReal Discontinues Beauty Business
    Happi

    Latest Breaking News From Happi

    Henkel Patents Washing Agent with Improved Optical, Rheological Properties
    Food or Drink with Blended Cannabis and Vitamins
    Mermaid Brand Holdings Patents Depilatory Wax Additive
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: Packaging Inks, Toyo Ink Top This Week’s Stories
    Eastern Coatings Show Announces Schedule for Technical Papers
    Pulse Roll Label Products Adds Sean Labas to Technical Sales Team
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    TLMI announces 2022 Eugene Singer Award winners
    Pulse Roll Label Products expands technical sales team
    Mark Andy introduces ProWORX Label Suite
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Heartland Polymers Begins Production, Zeta Polimeri Becomes Radici EcoMaterials & More
    Heartland Polymers Begins Production in Alberta
    Zeta Polimeri Becomes Radici EcoMaterials
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—March 25
    AI is Effective at Documenting Orthopedic Encounters in Hand Surgery
    3D LifePrints Rebrands to Insight Surgery & Launches New Business in Houston
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: Dave Rahami, Zebra, Dracula Technologies Top This Week’s Stories
    Midsummer, UCLA Collaborate on Perovskite-CIGS Tandem Solar Cells
    HID Reports on Reshaping the Security Industry

    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