Welcome to our dedicated page for Biocardia news (Ticker: BCDA), a resource for investors and traders seeking the latest updates and insights on Biocardia stock.
BioCardia, Inc. (NASDAQ: BCDA) generates news centered on its development of cellular and cell-derived therapeutics for cardiovascular and pulmonary disease. As a clinical-stage company headquartered in Sunnyvale, California, its updates often relate to progress in late-stage trials, regulatory interactions, and advances in its enabling delivery and imaging technologies.
Investors and clinicians following BCDA news can expect regular coverage of the CardiAMP autologous cell therapy platform in ischemic heart failure with reduced ejection fraction (HFrEF) and chronic myocardial ischemia with refractory angina, as well as the CardiALLO allogeneic mesenchymal stem cell platform in ischemic heart failure. Recent announcements have highlighted Phase 3 CardiAMP HF II trial enrollment at leading centers, subgroup efficacy signals from prior trials, and discussions with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the potential approvability of CardiAMP Cell Therapy for HFrEF.
News items also address BioCardia’s Helix transendocardial biotherapeutic delivery system, Morph vascular navigation platform, and Heart3D fusion imaging platform, including updates on planned regulatory submissions and performance in preclinical and clinical settings. Corporate developments such as leadership appointments, board changes, financing activities, and Nasdaq listing compliance updates are disclosed through press releases and corresponding SEC filings.
This BCDA news page brings together these announcements so readers can follow clinical milestones, regulatory consultations, device platform progress, and governance developments in one place. For those tracking investigational therapies in heart failure, refractory angina, and related conditions, the BioCardia news feed provides an ongoing view into how the company’s programs and platforms are evolving over time.
BioCardia, Inc. (NASDAQ: BCDA) announced it will report its financial results for the year ended December 31, 2022, during a conference call on March 29, 2023, at 4:30 PM ET. The call will include a corporate update followed by a Q&A session. Interested participants can register for the call through a provided link and will receive their dial-in number upon registration. The conference call will also be accessible via a live webcast. A replay of the call will be available shortly after, lasting until June 29, 2023. BioCardia focuses on developing biotherapeutics for cardiovascular and pulmonary diseases, leveraging two main platforms for its product candidates.
BioCardia (Nasdaq: BCDA) has presented new echocardiography data from the roll-in cohort of the Phase III CardiAMP® Cell Therapy Heart Failure Trial, revealing significant improvements in heart function over two years. The data, shared by Dr. Peter Johnston at the American College of Cardiology meeting, shows a more than doubling of heart segments functioning normally post-treatment. Left ventricular ejection fraction (LVEF) improved from 27% at baseline to 37% at two years. Notably, there were no serious adverse events, and two-year survival was 100%. The ongoing trial, which has FDA Breakthrough Device designation, aims to further evaluate the therapy's efficacy.
BioCardia, Inc. (Nasdaq: BCDA) and CellProthera have strengthened their partnership through an amendment to their Clinical Research Supply Agreement. This agreement allows CellProthera to utilize BioCardia's Helix™ delivery system for its Phase I/IIb EXCELLENT study of ProtheraCytes™, an autologous cell therapy addressing severe post-Acute Myocardial Infarction (AMI) cases. The collaboration aims to enhance patient outcomes and expedite commercialization efforts, with potential early access in 2024. BioCardia will receive a low single-digit royalty on future sales of ProtheraCytes if not partnered directly.
BioCardia (Nasdaq: BCDA) has made significant advancements in its clinical-stage therapies, particularly with its lead product, CardiAMP, which targets ischemic heart failure. The ongoing Phase III trial is showing promising results, with a mortality rate below 3% across multiple phases. The FDA has granted Breakthrough Device Designation for CardiAMP. In addition, BioCardia has secured IND approvals for two allogeneic therapies. The company has successfully navigated regulatory milestones, including a $3.6 million financing that enhances its future prospects.
BioCardia, Inc. (Nasdaq: BCDA) has announced a private placement agreement to sell 2,122,017 shares of its common stock to institutional investors at $1.68 per share, yielding expected gross proceeds of approximately $3.6 million. The closing is anticipated on December 16, 2022, subject to customary conditions. Proceeds will support general corporate purposes, including research and development of cell therapies. The shares are unregistered under the Securities Act and will require a registration statement for resale.
BioCardia has received FDA approval for a Phase I/II clinical trial of its NK1R+ allogeneic MSC therapy aimed at treating ischemic heart failure. This marks the second clinical trial approval for the company's NK1R+ MSC platform this year. The therapy complements the ongoing Phase III CardiAMP trial, which studies autologous cell therapy. The NK1R+ therapy is designed for patients ineligible for the CardiAMP trial and may offer a synergistic approach to treatment, addressing the needs of a broader patient population.
BioCardia, Inc. (BCDA) reported its Q3 financial results for 2022, revealing revenue growth to approximately $1.2 million year-to-date. The company's lead therapy, CardiAMP, is progressing in pivotal trials for ischemic heart failure and chronic myocardial ischemia, with positive DSMB support for study continuation. New IND applications for allogeneic cell therapies are anticipated to receive FDA approval soon, further supporting growth. Despite a net loss of approximately $8.9 million, the modest burn rate and funding initiatives aim to strengthen the balance sheet.
BioCardia, Inc. (NASDAQ:BCDA) will report its financial results for the three and nine months ended September 30, 2022, on November 9, 2022. The announcement includes a corporate update during a conference call scheduled for 4:30 PM ET. Interested parties can register for the call or join via phone, with a replay available afterward. BioCardia focuses on developing cellular therapies for cardiovascular and pulmonary conditions, utilizing two biotherapeutic platforms that aim to benefit millions of patients.
BioCardia, Inc. (Nasdaq: BCDA) announces encouraging results from its CardiAMP Cell Therapy pivotal trial for heart failure, presented at the Heart Failure Society of America meeting. In a roll-in cohort, patients demonstrated a remarkable 100% two-year survival rate, surpassing existing therapies which reported 79.9% survival. Additionally, significant improvements were noted in functional capacity, with a median walking distance increase from baseline. No serious adverse events occurred, indicating a favorable safety profile. A conference call is scheduled for October 5, 2022, to discuss the results and next steps.
BioCardia Inc. (Nasdaq: BCDA) announced the presentation of new data from its CardiAMP® Cell Therapy for Heart Failure pivotal trial at the Heart Failure Society of America Annual Meeting on October 1, 2022. The data will reveal efficacy outcomes at two years for the roll-in cohort of Phase III trial NCT02438306. A follow-up conference call on October 3, 2022, will discuss the trial status and the implementation of an adaptive statistical analysis plan suggested by the Data Safety Monitoring Board.