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BioCardia Submits CardiAMP Therapy for PMDA Review

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BioCardia Submits CardiAMP Therapy for PMDA Review

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The latest announcement is out from BioCardia ( (BCDA) ).

On July 24, 2025, BioCardia announced the submission of its CardiAMP autologous cell therapy for heart failure to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for clinical consultation. This submission is a crucial step towards potential regulatory approval in Japan, a significant market for advanced heart failure treatments. The consultation will involve a comprehensive review of clinical data from the CardiAMP HF trial, assessing the therapy’s efficacy, safety, and fit within the Japanese healthcare system. Successful alignment with PMDA could lead to market entry in Japan and a subsequent post-marketing study, enhancing BioCardia’s industry positioning and offering new opportunities for collaboration.

The most recent analyst rating on (BCDA) stock is a Buy with a $4.00 price target. To see the full list of analyst forecasts on BioCardia stock, see the BCDA Stock Forecast page.

Spark’s Take on BCDA Stock

According to Spark, TipRanks’ AI Analyst, BCDA is a Neutral.

The overall stock score reflects significant financial challenges despite positive technical trends and promising corporate developments. The negative valuation and financial instability weigh heavily, while recent clinical progress and strategic advancements provide a positive counterbalance.

To see Spark’s full report on BCDA stock, click here.

More about BioCardia

BioCardia, Inc., based in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics targeting cardiovascular and pulmonary diseases. The company develops biotherapeutic platforms, including CardiAMP® autologous and CardiALLO™ allogeneic cell therapies, supported by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms.

Average Trading Volume: 137,515

Technical Sentiment Signal: Sell

Current Market Cap: $13.21M

Find detailed analytics on BCDA stock on TipRanks’ Stock Analysis page.

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