Pioneering Heart Failure Treatment via Electrical Microcurrent

Founded in 2014, the company built on decades of research in wound and bone healing through the use of Direct microCurrent (DC). After years of cellular and animal work to identify the right dosage of Amperage, Duration and Location of electrodes, a First-In-Human (FIH) study was completed in 2019 on 10 NYHA III Non-ischemic HF patients with an EF 25-35%. After 6 months of therapy, Ejection Fraction improved by 30%. 8 out of 10 patients improved to zero symptoms at NYHA I, 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. Then an International Multi-Centered Randomized Controlled Trial was conducted 2021-2024. The results verified what was shown in the first study. A highly significant treatment effect vs Guideline Directed Medical Therapy.

Then the company looked to see if the same therapeutic effect could be achieved through a less invasive out-patient procedure in the cath lab. This fully enrolled study is completing follow-up with results expected in 2026. Now the company looks to expand indications into wider patient populations and begin larger double blinded trials to prepare for the FDA IDE submission.