24/7 Market News Snapshot 04 August, 2025 – BioCardia, Inc. Common Stock (NASDAQ:BCDA)

August 4, 2025

DENVER, Colo., 04 August, 2025 (www.247marketnews.com) – (NASDAQ:BCDA) are discussed in this article.
BioCardia, Inc. (NASDAQ:BCDA), recognized for its innovative cellular therapies targeting cardiovascular and pulmonary conditions, is experiencing significant market momentum with its stock surging to $2.608, reflecting a remarkable 22.44% increase from the previous close. The company recorded a robust trading volume of 1.69 million shares, indicating strong investor interest and enthusiasm.

As part of its strategic advancements, BioCardia is gearing up for a pivotal regulatory journey. It plans to submit a DeNovo 510(k) application for its Helix Transendocardial Delivery Catheter to the FDA in the third quarter of 2025. The Helix device’s development is backed by comprehensive clinical data from twelve studies, demonstrating its safety and effectiveness through over 4,000 intramyocardial deliveries. This innovative technology is expected to enhance therapeutic agent retention in the heart compared to traditional delivery methods.

In addition, BioCardia is set to engage with the FDA in the fourth quarter of 2025 to discuss the approval process for its CardiAMP® Cell Therapy System. This groundbreaking therapy utilizes patients’ own bone marrow cells to address ischemic heart failure, which has garnered Breakthrough Designation from the FDA due to the significant unmet medical need in this area.

The company is also taking steps to expand its reach internationally, coordinating an in-person clinical consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), anticipated for mid-Q4 2025. This engagement may facilitate the introduction of CardiAMP to the Japanese market amid growing interest in regenerative medicine.

BioCardia’s commitment to advancing treatment options for cardiovascular diseases is supported by robust clinical evidence, including promising results from its Phase I and II clinical trials, highlighting improvements in heart function and patient quality of life. The ongoing enrollment in the confirmatory CardiAMP HF II Trial further underscores the company’s dedication to driving innovation in cardiac therapies.

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