Further Studies to Confirm the Healing Effects of the C-MIC Technology
Berlin Heals is committed to building a body of evidence to show the impact of Microcurrent on the failing heart.
FDA Pathway
Breakthrough Device Designation granted by US Food and Drug Administration (FDA)
As early as March 11, 2021, Berlin Heals was able to announce that the US Food and Drug Administration (FDA) granted a Breakthrough Device Designation for its proprietary Cardiac Microcurrent Therapy Device («C-MIC»).
Faster Access
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. As a consequence, the company decided to increase its activities in the US – in parallel to its European-wide Early Feasibility Studies – with the aim to formally file an Investigational Device Exemption (IDE) application with the FDA for an Pivotal Trial. After initial preparations, Berlin Heals US, Inc., Delaware was incorporated in January 2022 as part of the group and to serve as a hub and domestic counterparty for all submissions to be made to the FDA.
FDA’s Total Product Lifecycle Advisory Program (TAP
Within the highly selective FDA Breakthrough Device Program, key innovations are invited to join an even more selective program called the TAP Program. Berlin Heals received this award on November of 2023. This program gives hand-picked technologies a concierge level of access to the FDA to remove all potential barriers and give priority access to reviewers and experts to answer questions on a monthly basis and provides pre-submission reviews to speed the review process.
Less Invasive
Less Invasive Procedure
After verifying the effect of microcurrent through two surgical studies, Berlin Heals looked to see if the same therapeutic effect could be achieved through a less invasive out-patient procedure in the cath lab. Enrollment has been completed in the 10-patient Open Label study with results expected in Spring of 2026.
This study has now been extended to patients with a higher mildly reduced Ejection Fraction (EF 40-50%). Enrollment will begin in early 2026.
Randomized Controlled Trial
International Multi-Centered Randomized Controlled Trial
An International Multi-Centered Randomized Controlled Trial was conducted 2021-2024. The results verified what was shown in the first-in-human study. A highly significant treatment effect vs Guideline Directed Medical Therapy.
These patients are now being followed for two additional years after therapy with 1-year results expected mid 2026 and 2-year results expected mid 2027.
First-in-human
Promising Results in
First-in-human Studies
After years of cellular and animal work to identify the right dosage of Amperage, Duration and Location of electrodes, a First-In-Man (FIM) study was completed in 2019 on 10 NYHA III Non-ischemic HF patients with an EF 25-35%. After 6 months of therapy, the Ejection Fraction improved by 30%. 8 out of 10 patients improved to zero symptoms at NYHA I, their hearts got smaller and 6 Minute Walk Tests and Quality of Life Scores both doubled.
These patients were then followed for two additional years after therapy and the benefits sustained. There is no other known therapy in Heart Failure or Cardiology where a therapy can be given and has a lasting effect like what was shown in this study.
