BioCardia recently announced that it had submitted its leading product, CardiAMP, to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). CardiAMP is under development for ischemic systolic heart failure (HF). It has regenerative effects as the therapy involves the stem cells that were differentiated into new functional tissue to augment cardiac function.

A key opinion leader (KOL) interviewed by GlobalData stated stem cell therapy studies so far have failed to improve outcomes for HF patients. In addition, the KOL believes trying to put cells into dead tissue will likely not work, and hence doesn’t believe stem cells to be a viable therapy for HF. CardiAMP’s application was supported by efficacy and safety clinical data from the ongoing Phase III CardiAMP HF trial. Results showed that left ventricular ejection fraction is improved or stable with continued improvements in wall motion score index due to the recruitment of akinetic myocardial segments in subjects with HF. If approved by the PMDA, CardiAMP would be a minimally invasive stem cell therapy option for patients with ischemic systolic HF.

There is strong opportunity in the HF space for new agents that could further reduce the incidence of HF-associated hospitalisations and mortality. The stem cell pipeline for cardiovascular (CV) conditions sees lower investment from the larger pharmaceutical industry and is mainly developed by smaller biotech companies, compared to areas such as diabetes where big pharma investment is common. Positively for HF, stem cell developers are concentrating efforts on chronic CV conditions including HF. Furthermore, the cost of stem cell therapies plays a major role in their uptake and also the willingness for development. Compared to the HF standard of care, a space that is mostly filled with generics, stem cell therapy prices could reach more than $150,000 per full course of treatment, a significant barrier to entry.

HF is a critical clinical condition where certain structural and functional abnormalities in the heart impair its ability to meet systemic circulation. The various causes that contribute to these abnormalities are hypertension, arrhythmia, valvular heart disease, and risk factors including high cholesterol, infection, and genetic factors. BioCardia expects a consultation with Japan’s PMDA to review CardiAMP’s submission within three months.

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By GlobalData