Biocardia Inc Stock Price, News & Analysis

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.

BioCardia, Inc. [Nasdaq: BCDA] has been granted U.S. Patent No. 12,036,371 for its Morph DNA multi-directional steerable catheter transseptal application. The patent, expiring in 2035, covers medical methods for transseptal access to the heart using steerable introducers based on BioCardia's Morph DNA technology. This innovation enhances shareholder value by protecting current and future products in the transseptal access systems market, which was valued at $941.3 million in 2022 and is projected to reach $2.1 billion by 2033.

The Morph DNA design allows for consistent catheter performance in any direction, preventing sudden jumps or 'whip' during procedures. BioCardia aims to provide or partner this solution for approximately 500,000 transseptal procedures performed annually in the United States, as well as other vascular access markets.

CellProthera and BioCardia announced the successful completion of a collaborative Phase II trial of ProtheraCytes for treating acute myocardial infarction (AMI). The EXCELLENT Trial results showed that the transendocardial injection of ProtheraCytes, which are autologous, expanded CD34+ stem cells, in combination with standard care, helped prevent heart failure progression in high-risk heart attack patients.

The treatment demonstrated improvements in multiple efficacy endpoints, including better segment viability, consistent positive trends in LV volumes, and faster decreases in NTproBNP, a key heart failure biomarker. The therapy was well tolerated with no unexpected serious adverse events. Both companies plan to continue their collaboration into Phase III trials.

BioCardia announces the issuance of a new U.S. patent for its radial and transendocardial delivery catheter, Patent No. 11,986,611, which will expire in 2036.

This patent pertains to methods and systems for delivering substances to the heart via the radial artery, enabling minimally invasive procedures.

The radial artery approach allows patients to leave the hospital soon after the procedure and significantly reduces overall healthcare costs.

BioCardia's Helix system, used in ongoing clinical trials, is the only known system capable of radial transendocardial biotherapeutic delivery and the new patent enhances its protection and value.

Therapeutic cell aggregates have potential advantages over single cell suspensions but also carry risks like strokes if they leak into the ventricular chamber.

BioCardia's delivery systems are designed to mitigate these risks by preventing leakage during the delivery process.

According to CEO Dr. Peter Altman, the patent issuance strengthens the company's technology and product offerings, benefiting both shareholders and patients.

BioCardia announced a 1-for-15 reverse stock split of its common stock, effective May 30, 2024, to meet Nasdaq's minimum bid price requirement. Shares will trade on a split-adjusted basis under the ticker BCDA. The reverse stock split will uniformly affect all shareholders, converting every 15 shares into 1 share without altering percentage ownership. Fractional shares will not be issued; instead, cash payments will be made. The authorized shares of common stock will be reduced from 100 million to 50 million. Further details are available in the company's proxy statement on the SEC's website.