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BioCardia Advances CardiAMP Therapy in Japan

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BioCardia Advances CardiAMP Therapy in Japan

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BioCardia ( (BCDA) ) has issued an update.

On December 16, 2025, BioCardia announced the completion of a third preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) for its CardiAMP Cell Therapy aimed at treating Heart Failure with Reduced Ejection Fraction (HFrEF). The PMDA has agreed to allow BioCardia to advance to a formal clinical consultation, which could lead to regulatory approval in Japan if the data is deemed sufficient. The CardiAMP Cell Therapy, which uses a patient’s own bone marrow cells, has shown positive outcomes in clinical trials, including improved survival rates and reduced major adverse cardiovascular events. This development could significantly impact BioCardia’s operations and its positioning in the cardiovascular therapeutics market.

The most recent analyst rating on (BCDA) stock is a Hold with a $1.50 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.

BioCardia’s overall stock score reflects significant financial challenges, with ongoing losses and reliance on external financing. While there are positive developments in clinical trials and corporate events, the financial instability and negative valuation metrics weigh heavily on the score.

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

More about BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. The company focuses on its CardiAMP autologous and CardiALLO allogeneic cell therapies, which are part of its biotherapeutic platforms. These therapies are supported by its Helix biotherapeutic delivery and Morph vascular navigation product platforms, with plans to introduce the Heart3D fusion imaging platform.

Average Trading Volume: 588,246

Technical Sentiment Signal: Sell

Current Market Cap: $15.39M

For a thorough assessment of BCDA stock, go to TipRanks’ Stock Analysis page.

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