Friday, June 30, 2017 10:54:01 AM
https://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=11966159
Our FDA accepted Phase III pivotal trial is designed to provide the primary support for the safety and efficacy of CardiAMP. The primary endpoint is functional capacity, as measured by the six minute walk test. Based on the results achieved in the Phase II trial, our Phase III pivotal trial is designed to have more than 90% probability of achieving a positive result with statistical significance. Statistical significance denotes the mathematical likelihood that the results observed are real and not due to chance.
Recent BCDA News
- BioCardia’s CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial Results Show Patient Benefits in Important Outcomes • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- BioCardia Completes Enrollment of CardiAMP Cell Therapy for the Treatment of Chronic Myocardial Ischemia Trial Open Label Roll-In Cohort • GlobeNewswire Inc. • 04/25/2024 01:00:00 PM
- BioCardia Reports Fourth Quarter and Full Year 2023 Business Highlights and Financial Results • GlobeNewswire Inc. • 03/27/2024 08:00:00 PM
- BioCardia to Host 2023 Financial Results and Corporate Update Conference Call on March 27, 2024 • GlobeNewswire Inc. • 03/20/2024 11:00:00 AM
- BioCardia and StemCardia Announce Biotherapeutic Delivery Partnership • GlobeNewswire Inc. • 03/13/2024 11:00:00 AM
- BioCardia Announces CMS Approval of Coverage for CardiAMP Cell Therapy Confirmatory Phase III Heart Failure Study • GlobeNewswire Inc. • 03/12/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/04/2024 01:00:21 PM
- BioCardia Reports Positive Interim Results from Phase III CardiAMP Cell Therapy Heart Failure Trial, with Compelling Data in Subgroup with Elevated NTproBNP Biomarker for Heart Failure • GlobeNewswire Inc. • 03/04/2024 01:00:00 PM
- Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend] • Edgar (US Regulatory) • 02/27/2024 09:53:40 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 12:00:19 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 10:06:32 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 02/14/2024 09:17:23 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/09/2024 02:58:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/08/2024 12:03:57 PM
- BioCardia Announces Activation of CardiAMP Heart Failure II Phase 3 Pivotal Study Recently Approved by FDA • GlobeNewswire Inc. • 02/08/2024 12:00:00 PM
- Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend] • Edgar (US Regulatory) • 02/06/2024 09:28:23 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/02/2024 07:06:12 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/31/2024 12:00:22 PM
- BioCardia Announces Two Scientific Abstracts Have Been Accepted at the 2024 Technology and Heart Failure Therapeutics Conference • GlobeNewswire Inc. • 01/31/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/03/2024 12:00:18 PM
- BioCardia Biotherapeutic Delivery and Morph Access Innovations Business Development Update for Shareholders • GlobeNewswire Inc. • 01/03/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/19/2023 12:00:27 PM
- 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 • GlobeNewswire Inc. • 12/19/2023 12:00:00 PM
- BioCardia Announces Expected CardiAMP Heart Failure Japan Approval Timeline Based on Pharmaceutical and Medical Device Agency Consultation Minutes • GlobeNewswire Inc. • 12/18/2023 12:16:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/18/2023 12:00:30 PM
FEATURED Cannabix Technologies Launches New Compact Breath Logix Workplace Series and Prepares for Delivery to South Africa • May 7, 2024 8:51 AM
Moon Equity Holdings, Corp. Announces Acquisition of Wikolo, Inc. • MONI • May 7, 2024 9:48 AM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM