BioCardia, Inc. - BCDA STOCK NEWS

BioCardia (Nasdaq: BCDA) announced a successful consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) regarding its lead therapeutic asset, BCDA-01, for treating ischemic heart failure. The PMDA has invited BioCardia for a follow-up consultation after reviewing final clinical data with two-year follow-up from the CardiAMP Heart Failure Trial.

The agency indicated openness to considering results from the CardiAMP Heart Failure Trial and previous trials as sufficient evidence for registering the CardiAMP Cell Therapy System in Japan. The company expects final data from its fully enrolled 125-patient trial to be available in Q1 2025. The therapy has received FDA Breakthrough Designation and is supported by the Maryland Stem Cell Research Fund and CMS reimbursement.

BioCardia (NASDAQ: BCDA) reported Q3 2024 financial results and business updates. The company completed the last protocol-specified follow-up visit in the CardiAMP Heart Failure Trial, with top-line data expected in Q1 2025. Research and development expenses decreased to $931,000 from $1.9 million in Q3 2023. Net loss improved to $1.7 million from $2.6 million year-over-year. The company closed a $7.2 million public offering in September 2024. Notable developments include FDA approval of their steerable introducer sheath product family and completion of a PMDA submission for potential approval in Japan.

BioCardia (NASDAQ: BCDA), a developer of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, will host its Q3 2024 corporate update and financial results conference call on November 13, 2024, at 4:30 PM ET. The call will include management remarks followed by a Q&A session. Participants can register online or dial in (U.S.: 1-833-316-0559, International: 1-412-317-5730). A live webcast and replay will be available through November 27, 2024.

BioCardia has completed its Phase III CardiAMP HF trial, a randomized, double-blind, placebo-controlled study evaluating the CardiAMP Cell Therapy System for heart failure treatment. The trial enrolled 125 patients across 18 US hospitals, with 115 patients randomized 3:2 between treatment and control groups. The therapy, which received FDA Breakthrough Device Designation, aims to reduce deaths, hospitalizations, and improve quality of life for patients with heart failure of reduced ejection fraction (HFrEF). Top-line results are expected in Q1 2025. The company has submitted plans to the FDA and is pursuing approval discussions with both FDA and Japan's PMDA.

BioCardia, Inc. [Nasdaq: BCDA] has regained full compliance with Nasdaq Capital Market's Listing Requirements, as confirmed by Nasdaq on September 17, 2024. This follows the company's successful efforts to improve its balance sheet, including raising new capital. Recent developments include:

1. FDA approval of CardiAMP® Cell Therapy Heart Failure II protocol amendment
2. Completion of the last roll-in patient in the CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial
3. Positive pre-IND meeting for Helix™ partner CellProthera's cell therapy
4. FDA market clearance for Morph® DNA™ product family
5. Closing of a $7.2M financing

BioCardia's focus remains on developing therapies for cardiovascular and pulmonary diseases, with near-term priorities including finalizing CardiAMP HF I trial data for Japan PMDA and FDA, and randomizing first patients in the CardiAMP HF II trial.

BioCardia, Inc. (Nasdaq: BCDA) has successfully closed an upsized $7.2 million public offering priced at-the-market under Nasdaq rules. The offering included 2,400,000 shares of common stock (or pre-funded warrants) and warrants to purchase up to 2,400,000 shares at a combined price of $3.00 per share and accompanying warrant. The warrants have an exercise price of $3.00 per share, are immediately exercisable, and will expire in five years. The offering saw participation from management, directors, institutional investors, and existing investors. BioCardia plans to use the net proceeds for working capital and general corporate purposes, including advancing their investigational biotherapeutic candidates and biotherapeutic delivery partnering business.

BioCardia (Nasdaq: BCDA), a leader in cardiovascular and pulmonary disease therapeutics, has announced the pricing of an upsized $7.2 million public offering. The offering includes 2,400,000 shares of common stock (or pre-funded warrants) and warrants to purchase up to 2,400,000 shares at $3.00 per share and accompanying warrant. The warrants have a 5-year expiration and are immediately exercisable. The offering, priced at-the-market under Nasdaq rules, is expected to close on September 3, 2024. Proceeds will be used for working capital and advancing BioCardia's biotherapeutic candidates and delivery partnering business. A.G.P./Alliance Global Partners is the sole placement agent for this offering.

BioCardia [Nasdaq: BCDA] has received FDA market clearance for its Morph DNA Steerable Introducer product family. This patented technology provides a pathway for introducing medical instruments into the peripheral vasculature, heart chambers, and coronary vasculature. The clearance covers 16 products in various lengths and diameters, suitable for multiple clinical applications in interventional cardiology, radiology, cardiac electrophysiology, and vascular surgery.

The Morph DNA products are expected to enhance common and advanced procedures, including peripheral vascular intervention, renal denervation, endovascular aortic repair, and atrial fibrillation treatment. BioCardia estimates that over a million procedures per year in the US could benefit from these products, with a starting list price of $1,000. The technology features bidirectional steering, improved torque response, and a unique design resembling DNA's double helix structure for consistent performance.

BioCardia BCDA announced FDA approval for a protocol amendment in its CardiAMP Heart Failure II Trial, a Phase 3 study of autologous cell therapy for ischemic heart failure. The amendment allows for personalized treatment plans based on the proprietary CardiAMP Cell Population Analysis, enabling patients previously excluded to receive additional cell deliveries to achieve the target minimum dosage.

This advancement, built on data from 125 patients in the CardiAMP Heart Failure I Trial, is expected to enhance clinical experience and expand market opportunity. The refined approach adjusts dosing aliquots for patients with lower concentrations of specified cells, potentially increasing patient eligibility for the trial significantly.