BioCardia Updates Regulatory Timeline for Helix System

BioCardia ( (BCDA) ) has issued an announcement.

On August 4, 2025, BioCardia, Inc. announced updates on the regulatory approval timeline for its CardiAMP® Cell Therapy System and Helix Transendocardial Delivery Catheter. The company plans to submit a DeNovo 510(k) application for the Helix system to the FDA in Q3 2025, leveraging its safety and performance in numerous clinical studies. Additionally, BioCardia aims to discuss the approval pathway for CardiAMP Cell Therapy for ischemic heart failure with the FDA in Q4 2025, highlighting its previous Breakthrough Designation and clinical trial results. A clinical consultation with Japan’s PMDA is also expected in Q4 2025, potentially facilitating market entry in Japan. These developments could significantly impact BioCardia’s market positioning and provide new opportunities for stakeholders.

The most recent analyst rating on (BCDA) stock is a Buy with a $25.00 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.

BioCardia’s overall stock score reflects significant financial challenges, with weak profitability and high reliance on external financing. While technical analysis provides mixed signals, valuation is poor due to negative earnings. However, positive clinical and regulatory developments and strategic corporate events provide some optimism for future prospects.

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 focused on treating cardiovascular and pulmonary diseases. The company’s biotherapeutic platforms include CardiAMP® autologous and CardiALLO™ allogeneic cell therapies, supported by its Helix biotherapeutic delivery and Morph® vascular navigation product platforms.

Average Trading Volume: 116,483

Technical Sentiment Signal: Strong Sell

Current Market Cap: $11.72M

See more insights into BCDA stock on TipRanks’ Stock Analysis page.