Heart Failure Breakthrough: Berlin Heals Secures $5M for Less Invasive Cardiac Treatment
September 5, 2025, 3:37 pm
Berlin Heals Holding AG successfully secured over $5 million in Series A2 funding. This critical capital accelerates the development of C-MIC, an innovative implantable device for heart failure. C-MIC applies constant direct microcurrent to reverse heart damage, reduce inflammation, and restore cardiac function. A groundbreaking, less invasive outpatient procedure is now in advanced testing, promising faster patient recovery and vastly expanded access to this therapy. The company, recognized with FDA Breakthrough Device Designation, is pushing forward with clinical trials and preparing for key regulatory submissions. This marks a transformative step in treating chronic heart failure, offering new hope to millions worldwide.
Heart failure devastates lives. Millions suffer globally. Traditional treatments often manage symptoms. They rarely reverse the disease itself. A Swiss MedTech firm, Berlin Heals Holding AG, challenges this paradigm. They secured over $5 million in Series A2 funding. This capital fuels a revolutionary approach. It promises to redefine heart failure treatment.
The company focuses on its C-MIC device. C-MIC stands for Cardiac Microcurrent. This implantable system offers a novel therapy. It delivers a constant direct microcurrent to the diseased heart. This microcurrent is subtle. Yet, its effects are profound. It reduces inflammation. It actively remodels the heart. The goal is clear: reverse damage, restore function.
Heart failure results from progressive heart weakening. The heart struggles to pump blood efficiently. This leads to fatigue, shortness of breath, and fluid retention. Current therapies include medications, lifestyle changes, and sometimes surgical interventions. These methods improve quality of life for many. They do not typically cure the underlying condition. Berlin Heals seeks to change this narrative.
The C-MIC device represents a paradigm shift. Its design includes two electrodes. These connect to an implantable generator. The generator provides a continuous, low-level direct current. This current mimics physiological electrical signals. It prompts cellular repair. It targets inflammation. Early studies show impressive results. Cardiac function improves. Patient symptoms diminish significantly. The heart's structure itself begins to recover.
Berlin Heals began its journey in 2014. The company has methodically advanced its technology. A First-In-Human study in 2019 proved successful. Patients experienced long-term benefits. These positive outcomes built momentum. A Randomized Controlled Trial concluded in 2024. This trial further validated the C-MIC system's efficacy. It demonstrated tangible improvements for patients.
The new funding round signals a major strategic pivot. Berlin Heals is developing a less invasive implantation method. Historically, C-MIC placement required open surgery. The new approach uses an outpatient cardiac cath lab procedure. This is a game-changer. It means less trauma for patients. Recovery times will shorten dramatically. Many more hospitals can offer the therapy. Access expands exponentially.
The Series A1 funding, secured earlier this year, kickstarted this initiative. It allowed initial testing and development. The new Series A2 capital continues this acceleration. It directly supports the ongoing CMIC-III trial. This open-label study involves 10 patients. Researchers will implant leads less invasively. The focus is on safety, feasibility, and patient recovery. Results will inform future development.
The company's vision extends beyond current trials. The fresh capital will fund preparations for double-blind studies. These are crucial for rigorous regulatory approval. It also supports extensive testing and documentation. The ultimate goal is submission for an FDA Investigational Device Exemption (IDE) study. This is a critical step towards bringing C-MIC to the U.S. market.
Regulatory bodies recognize C-MIC's potential. The system recently received Breakthrough Device Designation from the FDA. This designation fast-tracks its review. It acknowledges the device offers significant advantages over existing treatments. It addresses a life-threatening or irreversibly debilitating condition. The FDA also selected C-MIC for its Total Product Life Cycle Advisory Program (TAP). This provides enhanced support and communication with the agency. It streamlines the regulatory path.
Berlin Heals aims to reshape the heart failure market. Their mission, established over a decade ago, gains tangible momentum. Early clinical results validate their ambitious goals. The focus remains on reversing disease. It is not merely symptom management. The less invasive procedure multiplies its impact. It positions C-MIC for broad adoption. Millions of heart failure patients await better options.
The company expresses gratitude for sustained investor support. Both existing and new investors recognize the vast potential. This investment underscores confidence in the technology. It validates the clinical progress. It empowers Berlin Heals to push boundaries. The future of heart failure treatment looks brighter. A less invasive, disease-reversing therapy moves closer to reality.
This significant funding round propels C-MIC forward. It brings a novel therapy nearer to those who need it most. The less invasive approach ensures wider accessibility. It promises faster patient recovery. Berlin Heals stands poised to revolutionize cardiac care. Their innovative device offers a path to genuine heart recovery, not just symptom relief. The medical community watches keenly. Patients hold new hope.
Heart failure devastates lives. Millions suffer globally. Traditional treatments often manage symptoms. They rarely reverse the disease itself. A Swiss MedTech firm, Berlin Heals Holding AG, challenges this paradigm. They secured over $5 million in Series A2 funding. This capital fuels a revolutionary approach. It promises to redefine heart failure treatment.
The company focuses on its C-MIC device. C-MIC stands for Cardiac Microcurrent. This implantable system offers a novel therapy. It delivers a constant direct microcurrent to the diseased heart. This microcurrent is subtle. Yet, its effects are profound. It reduces inflammation. It actively remodels the heart. The goal is clear: reverse damage, restore function.
Heart failure results from progressive heart weakening. The heart struggles to pump blood efficiently. This leads to fatigue, shortness of breath, and fluid retention. Current therapies include medications, lifestyle changes, and sometimes surgical interventions. These methods improve quality of life for many. They do not typically cure the underlying condition. Berlin Heals seeks to change this narrative.
The C-MIC device represents a paradigm shift. Its design includes two electrodes. These connect to an implantable generator. The generator provides a continuous, low-level direct current. This current mimics physiological electrical signals. It prompts cellular repair. It targets inflammation. Early studies show impressive results. Cardiac function improves. Patient symptoms diminish significantly. The heart's structure itself begins to recover.
Berlin Heals began its journey in 2014. The company has methodically advanced its technology. A First-In-Human study in 2019 proved successful. Patients experienced long-term benefits. These positive outcomes built momentum. A Randomized Controlled Trial concluded in 2024. This trial further validated the C-MIC system's efficacy. It demonstrated tangible improvements for patients.
The new funding round signals a major strategic pivot. Berlin Heals is developing a less invasive implantation method. Historically, C-MIC placement required open surgery. The new approach uses an outpatient cardiac cath lab procedure. This is a game-changer. It means less trauma for patients. Recovery times will shorten dramatically. Many more hospitals can offer the therapy. Access expands exponentially.
The Series A1 funding, secured earlier this year, kickstarted this initiative. It allowed initial testing and development. The new Series A2 capital continues this acceleration. It directly supports the ongoing CMIC-III trial. This open-label study involves 10 patients. Researchers will implant leads less invasively. The focus is on safety, feasibility, and patient recovery. Results will inform future development.
The company's vision extends beyond current trials. The fresh capital will fund preparations for double-blind studies. These are crucial for rigorous regulatory approval. It also supports extensive testing and documentation. The ultimate goal is submission for an FDA Investigational Device Exemption (IDE) study. This is a critical step towards bringing C-MIC to the U.S. market.
Regulatory bodies recognize C-MIC's potential. The system recently received Breakthrough Device Designation from the FDA. This designation fast-tracks its review. It acknowledges the device offers significant advantages over existing treatments. It addresses a life-threatening or irreversibly debilitating condition. The FDA also selected C-MIC for its Total Product Life Cycle Advisory Program (TAP). This provides enhanced support and communication with the agency. It streamlines the regulatory path.
Berlin Heals aims to reshape the heart failure market. Their mission, established over a decade ago, gains tangible momentum. Early clinical results validate their ambitious goals. The focus remains on reversing disease. It is not merely symptom management. The less invasive procedure multiplies its impact. It positions C-MIC for broad adoption. Millions of heart failure patients await better options.
The company expresses gratitude for sustained investor support. Both existing and new investors recognize the vast potential. This investment underscores confidence in the technology. It validates the clinical progress. It empowers Berlin Heals to push boundaries. The future of heart failure treatment looks brighter. A less invasive, disease-reversing therapy moves closer to reality.
This significant funding round propels C-MIC forward. It brings a novel therapy nearer to those who need it most. The less invasive approach ensures wider accessibility. It promises faster patient recovery. Berlin Heals stands poised to revolutionize cardiac care. Their innovative device offers a path to genuine heart recovery, not just symptom relief. The medical community watches keenly. Patients hold new hope.