BCDA

BioCardia Reports Fourth Quarter and Full Year 2023 Business Highlights and Financial Results

Retrieved on: 
Wednesday, March 27, 2024
Research, Finkelstein, Arrhythmia, Stroke, Annual report, Certification, Myocardial infarction, BCDA, Partnership, Patient, The Study, Morph, Mortality, Form 10-K, Security (finance), Death, Heart transplantation, Quality of life, Doctor of Philosophy, Heart failure, Therapy, Heart, Safety, Data, Medicare, FDA, Helix, Arrest, Hospital, Pharmaceutical industry

The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights with call details below.

Key Points: 
  • The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights with call details below.
  • The Company anticipates completing follow-up in the trial and preparing this dataset on 115 randomized patients enrolled with a minimum of one-year follow-up for final lock in the fourth quarter of 2024.
  • BioCardia has had discussions on partnering its CardiAMP therapy for other clinical indications and continues to explore partnerships worldwide.
  • All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the BioCardia call.

BioCardia to Host 2023 Financial Results and Corporate Update Conference Call on March 27, 2024

Retrieved on: 
Wednesday, March 20, 2024
Therapy, BCDA

Participants can register for the conference by navigating to https://dpregister.com/sreg/10187416/fbec8cfa30 .

Key Points: 

BioCardia Announces CMS Approval of Coverage for CardiAMP Cell Therapy Confirmatory Phase III Heart Failure Study

Retrieved on: 
Tuesday, March 12, 2024
BCDA, Patient, Mortality, Quality of life, Therapy, LVAD, Medicare, FDA, CMS, Arrest, Heart failure, Pharmaceutical industry

CMS has reviewed the CardiAMP Heart Failure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage.

Key Points: 
  • CMS has reviewed the CardiAMP Heart Failure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage.
  • The CardiAMP Heart Failure II Trial is FDA approved to enroll up to 250 patients at up to 40 clinical centers.
  • “We are pleased that CMS has provided coverage support for the confirmatory CardiAMP Heart Failure II study.” said Peter Altman, PhD., BioCardia’s President and Chief Executive Officer.
  • “To my knowledge, no therapy has been proven to reduce mortality in these patients, and CardiAMP Heart Failure II has great potential to achieve this outcome by confirming our CardiAMP Heart Failure Trial results.”

BioCardia Doses First Patient in CardiALLO Phase I/II Clinical Trial of BCDA-03 Allogeneic Mesenchymal Stem Cells for the Treatment of Ischemic Heart Failure of Reduced Ejection Fraction

Retrieved on: 
Tuesday, December 19, 2023
Immunosuppression, Culture, Partnership, Division, Risk, Data monitoring committee, Vascular disease, TRIDENT, University of Florida, MD, Microsoft Exchange Server, Heart, University, BCDA, Patient, Interventional cardiology, NCT, Clinical, Therapy, MSC, Heart failure, Principal investigator, Pharmaceutical industry

These proprietary CardiALLO human cells and their dedicated proprietary catheter delivery system are manufactured at BioCardia’s facility in Sunnyvale, California.

Key Points: 
  • These proprietary CardiALLO human cells and their dedicated proprietary catheter delivery system are manufactured at BioCardia’s facility in Sunnyvale, California.
  • We look forward to continuing this close partnership as we actively enroll additional patients in the CardiALLO MSC Study.
  • The CardiALLO MSC trial builds on the compelling early signals for benefit demonstrated in these previous trials.
  • The Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial (TAC-HFT, NCT00768066),
    The Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis Pilot Study (POSEIDON, NCT01087996),
    The Transendocardial Stem Cell Injection Delivery Effects on Neomyogenesis Study (TRIDENT, NCT 02013674)

BioCardia Announces Expected CardiAMP Heart Failure Japan Approval Timeline Based on Pharmaceutical and Medical Device Agency Consultation Minutes

Retrieved on: 
Monday, December 18, 2023
Immunosuppression, Cardiology, FDA, Mortality, Heart, BCDA, Patient, HF, Therapy, Heart failure, PMDA, Pharmaceutical industry

PMDA and its medical advisors have seen these and additional results that will be presented and published in the appropriate peer reviewed scientific forums.

Key Points: 
  • PMDA and its medical advisors have seen these and additional results that will be presented and published in the appropriate peer reviewed scientific forums.
  • The FDA reviewed this data and recently approved the CardiAMP Heart Failure II Study protocol.
  • With PMDA confirmation, BioCardia expects to submit for approval in Japan based on the data available in late Q4 2024.
  • “We aim to partner with Japanese heart failure cardiologists and their interventional cardiology colleagues to be able to offer this therapeutic option for heart failure patients.”

BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Ischemic Heart Failure; Foreign Data Expected to be Sufficient for Product Approval

Retrieved on: 
Wednesday, November 29, 2023
Cell therapy, Physician, Heart, Element, BCDA, Patient, Therapy, Heart failure, BNP, Medical device

Japan’s PMDA asked for further details on a number of elements included in BioCardia’s CardiAMP preclinical and clinical packages in order to gain approval.

Key Points: 
  • Japan’s PMDA asked for further details on a number of elements included in BioCardia’s CardiAMP preclinical and clinical packages in order to gain approval.
  • For the points raised with respect to the pre-clinical package, BioCardia management believes that these can be readily addressed.
  • Formal minutes from the PMDA meeting are expected in four weeks and a follow-up consultation is being planned.
  • PMDA approval would enable physicians and patients to consider the CardiAMP cell therapy option alongside other cell therapy approaches for the treatment of heart failure already in clinical use in Japan requiring open heart surgical administration of the cells.”

BioCardia Announces $1.3 Million Registered Direct Offering of Common Stock Priced At-the-Market under Nasdaq Rules

Retrieved on: 
Thursday, November 16, 2023
Sale, Security (finance), Form, Therapy, Prospectus, BCDA, 3rd Floor

The closing of the offering is expected to occur on or about November 20, 2023, subject to the satisfaction of customary closing conditions.

Key Points: 
  • The closing of the offering is expected to occur on or about November 20, 2023, subject to the satisfaction of customary closing conditions.
  • H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
  • The gross proceeds to the Company from the offering are expected to be $1.3 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.
  • The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

BioCardia Announces FDA Approval of CardiAMP Heart Failure II Protocol for Autologous Cell Therapy for Ischemic Heart Failure

Retrieved on: 
Tuesday, November 14, 2023
Cerebrovascular disease, Food, Patient, Major adverse cardiovascular events, Heart failure, FDA, Therapy, BCDA, Guideline, Pharmaceutical industry, Medical device

BioCardia announces that the Food and Drug Administration (FDA) has approved its proposed CardiAMP Heart Failure II study protocol.

Key Points: 
  • BioCardia announces that the Food and Drug Administration (FDA) has approved its proposed CardiAMP Heart Failure II study protocol.
  • The currently ongoing CardiAMP Heart Failure trial has completed enrollment and it is anticipated that the final data analyses will be reported in Q4 2024.
  • Statistical significance (p
  • The FDA has approved the proposed CardiAMP Heart Failure II study which includes an eligibility requirement that patients demonstrate a pre-specified NT-proBNP level at baseline.

BioCardia Reports Third Quarter 2023 Business Highlights and Financial Results

Retrieved on: 
Wednesday, November 8, 2023
FDA, Research, Security (finance), N-terminal prohormone of brain natriuretic peptide, Heart failure, Arrest, Heart, Therapy, Facial muscles, Medicare, Microsoft Exchange Server, Mortality, Data, BCDA, Pharmaceuticals and Medical Devices Agency, Maintenance, Ischemia, Phase, Quality of life, Data monitoring committee, PMDA, LVAD, Clinical trial, Risk, Marketing, III, Safety, Trial of the century, Patient, DSMB, Pharmaceutical industry, Medical device, Cryptocurrency, Helix

The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.

Key Points: 
  • The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.
  • During the third quarter of 2023, BioCardia worked with the DSMB to unblind a small committee within the Company to review the closed session DSMB report of interim study results to better understand the rationale behind their recommendation.
  • The Company expects to complete the roll-in cohort of patients in the fourth quarter of 2023 and begin the randomized phase of the trial.
  • Third Quarter 2023 Financial Results:
    Revenues were approximately $357,000 for the three months ended September 2023, compared to approximately $212,000 for the three months ended September 2022.

BioCardia to Host Q3 2023 Corporate Update and Financial Results Conference Call on November 8, 2023

Retrieved on: 
Wednesday, November 1, 2023
BCDA, Therapy

Participants can register for the conference by navigating to https://dpregister.com/sreg/10184161/faf88f5b32 .

Key Points: