The global burden of chronic heart failure is huge. Despite the success of optimal medical treatment, available drugs cannot heal heart failure. Surgical treatment if indicated – which includes cardiac transplantation – is increasingly prolific, but extremely limited by the number of available donor organs. Available devices for patients with heart failure focus on symptoms and are successful when the options of pharmaceuticals are exhausted. Stem cell therapy has deceived hopes. Gene therapy is not really ready for use right now.
The significance of biophysics and the options which the application of biophysical methods provide in the treatment of diseases are underestimated in the medical world. The relevance of DC electrical gradient of voltage within tissue is more or less ignored. The education of MDs includes lessons in biochemistry and pharmacology but hardly lessons in biophysics, possibly, because of the complexity and the sophisticated comprehension of biophysics. However, recent methods of measurements allow increasingly understanding of the impact of electrical gradients in living tissue and how alterations in tissue components can be influenced just by the adjustment of the electrical gradient.
By intensive basic research over a period of years, in cooperation with university institutions, Berlin Heals has recognized the impact of the electrical gradient for the treatment of diseases. Following this recognition, Berlin Heals is developing an electroceutical device which is able to readjust the disturbed myocardial electrical gradient. Preclinical trials have confirmed that failing hearts with an extremely remodeled myocardium show a reverse remodeling with normalized heart function after a short treatment period. The founders of Berlin Heals feel that it is their responsibility not to withhold this knowledge from patients who suffer from heart failure.
We have initiated a multicenter pilot study at 2 sites in Austria and Serbia and have implanted the first patients.