BioCardia eyes heart failure space in Japan with CardiAMP Cell Therapy System

By Isabel Cameron

- Last updated on GMT

© Getty Images
© Getty Images

Related tags Heart cardiovascular disease Research

BioCardia has recently completed the submission of CardiAMP Cell Therapy System to Japan’s Pharmaceutical and Medical Device Agency (PMDA) towards approval for the indication of ischemic heart failure (HF) with reduced ejection fraction.

If approved, CardiAMP would be a minimally invasive stem cell therapy option for patients with ischemic systolic HF, says data and analytics company GlobalData.

Kajal Jaddoo, senior pharma analyst at GlobalData, said: “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.”

A key opinion leader 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 does not believe stem cells to be a viable therapy for HF.

CardiAMP has regenerative effects as the therapy involves the stem cells that were differentiated into new functional tissue to augment cardiac function. CardiAMP’s application was supported by efficacy and safety clinical data from the ongoing phase 3 CardiAMP HF trial.

Results showed that left ventricular ejection fraction is improved or stable with continued improvements in wall motion score index due to recruitment of akinetic myocardial segments in subjects with HF.

Jaddoo concludes: “The cost of stem cell therapies plays a major role in their uptake and 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 a treatment, a significant barrier to entry.”

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