Biocardia Inc Stock Price, News & Analysis

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.

BioCardia (NASDAQ: BCDA) reported Q2 2024 financial results and business highlights. Key points include:

1. Final patient follow-up data for CardiAMP Heart Failure I trial expected in late Q3 2024.
2. Enrollment commenced in confirmatory pivotal CardiAMP Heart Failure II trial.
3. Promising early results from CardiAMP therapy for refractory angina.
4. Operational cash burn reduced to $1.3M for the quarter.
5. Revenues were $3,000 in Q2 2024, down from $43,000 in Q2 2023.
6. Net loss decreased to $1.6M in Q2 2024 from $3.4M in Q2 2023.
7. R&D expenses decreased to $800,000 from $2.3M year-over-year.
8. SG&A expenses reduced to $852,000 from $1.2M year-over-year.

BioCardia aims to regain NASDAQ compliance and deliver final data for CardiAMP Heart Failure I trial in Q4 2024.

BioCardia (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, has announced its Q2 2024 corporate update and financial results conference call. The call is scheduled for August 13, 2024, at 4:30 PM ET. Participants can register online or dial in to join the call. For U.S. callers, the number is 1-833-316-0559, while international callers should use 1-412-317-5730. A live webcast will also be available. Replay options include a webcast replay and a telephonic replay accessible with specific access codes. This event provides an opportunity for investors and analysts to gain insights into BioCardia's recent performance and future outlook.

BioCardia, Inc. [Nasdaq: BCDA] has submitted a 510(k) for FDA approval of its Morph® DNA™ Steerable Introducer Sheath product family. This technology is designed to provide a pathway for medical instruments in cardiovascular procedures. The Morph DNA design allows for smooth navigation and prevents catheter 'whip' during use. The potential market for this product spans millions of procedures annually, including cardiac interventions, peripheral vascular interventions, and structural heart procedures. This submission follows the FDA approval of BioCardia's Helix biotherapeutic delivery Morph DNA guide system and Avance transseptal steerable introducer. The company aims to use this technology platform in its biotherapeutic interventions for heart failure, refractory angina, and acute myocardial infarction treatments.

BioCardia [Nasdaq: BCDA] has initiated patient enrollment for its pivotal Phase 3 trial of CardiAMP Cell Therapy, targeting ischemic heart failure with reduced ejection fraction (HFrEF). The 250-patient randomized, controlled trial aligns with FDA guidelines and features a 12-month primary composite endpoint. CardiAMP has received Breakthrough Device Designation from the FDA, potentially expediting development and review processes.

Dr. Leslie Miller, a trial investigator, emphasized the therapy's potential to be groundbreaking for heart failure patients. BioCardia CEO Peter Altman expressed optimism about swift enrollment and the therapy's potential to enhance survival, reduce adverse events, and improve quality of life, addressing a significant need in ischemic heart failure treatment.