Berlin Heals Secures CHF 10 Million to Advance C-MIC for Heart Failure Treatment

Jun 17, 2024 22:15 CST Updated 22:15

Berlin Heals

Developer of Cardiac Disease Treatment Devices

Berlin HealsAnnounced the completion of a new round of 1000CHF million financing, which will be used for its core productsC-MICCE registration and conducting clinical research in the United States.

Berlin HealsImplanted in about 50 patients in EuropeC-MIC, and some patients completed a 3-year follow-up.ThroughC-MICAll patients treated were in NYHA Class I, achieving approximately 400 meters in the 6-minute walk test (6MWT), and most importantly, the patients reported a very high level of well-being. Excellent clinical data was also observed.Berlin HealsObtainKey Reasons for Capital Favor.

So far,Berlin HealsThe investment cost has reached 40 million Swiss francs forC-MICDevelopment and Clinical. WithC-MICComplete the relevant development work,Berlin HealsWill also soon reach the harvest period. It is expected thatC-MICExpected to receive CE approval by the end of next year or early 2026.At the same timeC-MICAttracted FDA's attention, encouragedBerlin HealsInClinical research conducted in the United States.

Executive Evaluation

"We are convinced that we have developed a product for the treatment of severe heart failure that will restore the quality of life for many patients around the world and significantly extend their life expectancy. I believe that C-MIC will set a new standard for the treatment of these patients in the future. After a short surgical procedure, an imperceptible, continuous microcurrent flow ensures that patients feel well again within a few weeks."

--Marko Bagaric CEO of Berlin Heals

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 cardiac 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-MICThe 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 evaluation of NYHA classification and quality of life questionnaire.

During the study 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 initially less than 200 steps to 400 steps).
All patientsIn dilated cardiomyopathy, the heart is typically enlarged, but now it has shrunk;
All patients had a two-grade reduction in NYHA class;
Six months after implantation and at least six months after the suspension of C-MIC, the patient's indicators continued to improve.

And 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.