BIOCARDIA INC.NEW DL-,001

BioCardia reported an adjusted EPS loss of $0.13 in the second quarter, better than the expected -$0.18. The PMDA supported a Shonin application for the CardiAMP cell therapy, and FDA staff signaled the ongoing CardiAMP heart‑failure phase II study could support a premarket approval. Cash totaled $5.4 million with funding runway into 2027; management plans to file the Shonin application next quarter. The stock rose in after‑hours trading but remains near its 52‑week low and the company is still unprofitable. » Más en de.investing.com

The FDA confirmed in a meeting record that the ongoing CardiAMP Heart Failure II trial can support a premarket approval (PMA) application for the CardiAMP cell therapy system. The confirmation covers treatment of ischemic heart failure with reduced ejection fraction (HFrEF), an indication with more than one million potential patients in the US. After the announcement, BioCardia shares rose sharply in premarket trading, as the PMA is a stringent approval route that must demonstrate safety and efficacy for high-risk medical devices and the FDA typically requires two substantive studies for widespread indications. » Más en de.investing.com

BioCardia reduced total costs in Q1 2026 by 17% and improved net loss by 14.8%. The CardiAMP heart failure study produced promising data. With cash and equivalents of $951,000, the company plans to complete one or more financing rounds in Q2 2026 to support continued studies and a PMDA regulatory submission in Japan. Japan is highlighted as a market opportunity of about $400 million, while increased operating cash burn and an expected approval timeline of roughly 19 months pose risks. » Más en de.investing.com