Accessibility Statement Skip Navigation
  • Resources
  • Investor Relations
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Explore Our Platform
  • Plan Campaigns
  • Create with AI
  • Distribute Press Releases
  • Amplify Content
  • All Products
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Explore Our Platform
  • Plan Campaigns
  • Create with AI
  • Distribute Press Releases
  • Amplify Content
  • All Products
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Worldwide Offices
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

Berlin Heals Holding AG Successfully Completes Enrollment in Phase I of the CMIC-III Less Invasive Study

This image opens in the lightbox

News provided by

Berlin Heals Holding AG

10 Oct, 2025, 07:00 GMT

Share this article

Share toX

Share this article

Share toX

  • Completed Enrollment in First-In-Human Phase I study of Less Invasive Approach
  • Expected to Present 6-Month data in 2026 at a major Cardiology Congress
  • Via Less Invasive Approach, more Cardiologists could implant out-patient
  • Additional studies expanding indications and level of evidence are planned next

ZUG, Switzerland, Oct. 10, 2025 /PRNewswire/ -- Berlin Heals Holding AG, a leading clinical-stage medical device company focused on revolutionizing the care of Heart Failure with a first of its kind durable treatment, today announced it has completed enrollment in the First-In-Human (FIH) CMIC-III study to evaluate the safety of a new Less Invasive approach to implanting the CMIC device. Topline data are expected in 2026 and will be submitted for presentation at a major Cardiology Congress. Berlin Heals is on track to expand this new Less Invasive approach to a wider population of patients and build on the body of evidence already seen in the first-generation surgical approach. As part of the FDA Breakthrough and TAP programs, we intend to pursue a pivotal FDA IDE trial that will lead to regulatory and reimbursement approvals for market launch.

"Completing enrollment in under 6 months since implanting our first patient marks a pivotal moment for the company and reflects the degree of unmet need we are hearing from people living with Heart Failure," said Berlin Heals Holding Chief Executive Officer John Brumfield. "We are very grateful to the patients, their families and the trial investigators for their enthusiasm and look forward to sharing topline results from the Phase I study next year."

"Based on results from the CMIC-I FIH and CMIC-II Randomized Controlled Trial (RCT), Microcurrent therapy showed great promise to positively transform the treatment for Heart Failure," said Stefan Anker, M.D., Professor of Medicine at Charite, Berlin and Senior Author of the CMIC-II Manuscript. "If similar results can be shown in a less invasive implant approach, many more patients could benefit from this new therapy."

About CMIC Therapy

Cardiac Microcurrent (CMIC) Therapy is delivered via a fully implantable medical device that consists of two electrodes connected to an implantable generator that provides constant direct microcurrent across the diseased heart. This constant DC current reduces inflammation and reverse remodels the heart that has been shown in previous studies to improve cardiac function and reduce symptoms. The first generation required a minimally invasive surgical procedure where a cardiothoracic surgeon placed an electrode on the outside of the heart. The new Less Invasive approach can be implanted in a cardiac catheterization lab through a conscious sedation out-patient procedure by a Cardiologist.

About Heart Failure

Heart Failure is a condition where the heart is weakened and cannot meet the body's demand for blood flow. Symptoms include shortness of breath, fatigue and palpitations limiting ability to perform daily activities. The progressive disease leads to high frequency of hospital admissions, poor clinical outcomes and high cost of care. Heart Failure is a Global Pandemic that affects over 64 Million people around the world. In the western world, 1 in 4 people will develop the disease in their lifetime. The Global cost of Heart Failure care is $287Billion annually. The disease is a leading cause of death with worse mortality than cancer. There is currently no commercially available cure.

About Berlin Heals Holding AG

Berlin Heals Holding is developing a novel treatment to reverse remodel and recover from Heart Failure. After a successful First-In-Human study in 2019 followed by sustaining long-term results and a successful Randomized Controlled Trial completed in 2024, the company has been developing a new approach to implant the device less invasively in an outpatient cardiac cath lab procedure. The company is based in Zug, Switzerland with subsidiaries in Germany and the United States.

Logo: https://mma.prnewswire.com/media/2622179/5553910/Berlin_Heals_Logo.jpg

Modal title

Also from this source

Berlin Heals Holding AG Successfully Raises Over 5Million USD Round for Advancing New Less Invasive Approaches

Berlin Heals Holding AG Successfully Raises Over 5Million USD Round for Advancing New Less Invasive Approaches

Berlin Heals Holding AG, a MedTech company, is developing a novel treatment to reverse remodel and recover from Heart Failure. After a successful...

Landmark Trial Demonstrates Efficacy of Microcurrent Therapy in Heart Failure: C-MIC II Results Published in the European Journal of Heart Failure

Landmark Trial Demonstrates Efficacy of Microcurrent Therapy in Heart Failure: C-MIC II Results Published in the European Journal of Heart Failure

Berlin Heals and the C-MIC II Investigators today announced the publication of the C-MIC II trial results in the European Journal of Heart Failure....

More Releases From This Source

Explore

Health Care & Hospitals

Health Care & Hospitals

Medical Pharmaceuticals

Medical Pharmaceuticals

Medical Equipment

Medical Equipment

Clinical Trials & Medical Discoveries

Clinical Trials & Medical Discoveries

News Releases in Similar Topics

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • Accessibility Statement
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • PR Newswire Amplify™
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.