Berlin Heals Secures CHF 7 Million to Advance C-MIC, a Novel Cardiac Microcurrent Therapy for Heart Failure

Feb 21, 2025 22:16 CST Updated 22:16

Berlin Heals

Developer of Cardiac Disease Treatment Devices

Berlin HealsAnnounced the completion of a new round of 700CHF million financing, which will be used for its core productsC-MICCE registration and conducting clinical research in the United States, as well as developing next-generation products and FIM clinical research.

CurrentlyBerlin HealsAlready completedC-MICMulticenter randomized controlled clinical trial enrollment for CE registration, innovative heart failure therapy within the next three yearsC-MICWill benefit patients in Europe.

Executive Evaluation

"We are very grateful to our domestic investors who continue to support our mission to treat heart failure.We are also delighted to welcome new investors joining us on this journey.The results of our early clinical work have shown the great potential of this new treatment method.We are pleased to share the results of our new randomized clinical trial later this year."This financing round will give us the opportunity to test this approach through several less invasive new methods to determine which technology should be used for our FDA pivotal trial and global market access."

---John Brumfield CEO of Berlin Heals

"I'm very pleased to have met with several patients alongside co-founder Marko Bagaric in the first two studies and witnessed the real impact of our innovation on their recovery of significant quality of life."They are very grateful to be able to restart their lives and become active again.Through this round of financing, we have further advanced our progress and impacted more future lives.”

--Felix Baader Berlin HealsChairman of the Board

C-MIC

C-MICIt is a new type of implantable electronic device (which looks somewhat like a pacemaker). It delivers a constant direct current equivalent to physiological intensity to the heart through two leads, one located on the epicardium of the left ventricle and the other in the cavity of the right ventricle.C-MICIt is through this microcurrent therapy that reverse remodeling of myocardial tissue is achieved.。

The patient is in a constantWith the help of microcurrent, the inflammatory parameters of the patient's heart tissue continue to improve, and edema (excess water) is drained from the heart.

C-MIC Advantages

Even ifPause, Still Able to Continuously Improve
Implantation is a minimally invasive surgery that takes less than an hour.
Almost no necessity for subsequent intervention
No external power supply required
NYHA class decreased by 2 grades after 6 months of treatment
Reduce the number of hospitalizations per year
Reduce Heart Failure Treatment Costs
Clinical signs of comprehensive improvement can appear within 4 weeks.

C-MIC Demonstration

C-MIC Clinical Study

In 2020, a first-in-human clinical study was completed. This was a single-arm, non-randomized pilot study involving 10 patients (9 males; mean age 62±12 years), with a 6-month follow-up.

AllAll patients had Class III heart failure and non-ischemic dilated cardiomyopathy, with a left ventricular ejection fraction (LVEF) <35%. All were surgically implanted.C-MIC. The following observations were made at six time points: baseline, discharge, and during follow-up: LVEF and left ventricular end-diastolic/systolic dimensions measured by echocardiography.End-stage diameter, 6-minute walk test, and assessment of NYHA classification and quality of life questionnaire.

During the research follow-up, a rapid and significant effect was observed with marked improvements in LVEF, left ventricular end-diastolic diameter, left ventricular end-systolic diameter, and walking distance (P < 0.005). The scores of the 36-Item Short Form Health Survey also showed significant improvement.

The average 6-minute walking distance of patients improved by nearly 100% within 14 days (from an initial count of less than 200 steps to 400 steps).
All patientsThe heart is usually enlarged in dilated cardiomyopathy, but now it has shrunk;
All patients' NYHA classification decreased by two levels;
Six months after implantation and at least six months after the suspension of C-MIC, the patient's indicators continued to improve.

And also achieved unexpected clinical results, even curing the patient's myocarditis.

Berlin Heals

Berlin HealsIs a Swiss innovative medical device company founded in 2015.Berlin HealsIs leading people into a new era of treating heart failure. Heart failure is the leading cause of death worldwide, and it employs microcurrent as a treatment method.Berlin HealsA Preliminary Study on an Innovative and Disruptive Implantable, Minimally Invasive Microcurrent Device Clearly Demonstrates Unprecedented Significant Clinical Outcomes, with Marked Improvement in Ventricular Function and Cardiopulmonary Exercise Capacity, and Excellent Safety.