Friday, June 30, 2017 10:28:25 AM
I'm not a medical person, so bear with me. It appears CardiAMP competes with $VCEL product ixmyelocel-T.
$VCEL completed the Phase 2 last year and had primary endpoint success with the Heart (left side) therapeutic. But did not meet the secondary endpoint Walk Test (no difference than control). $VCEL investors think they can get FDA approval without Phase 3. But I don't see how with CardiAMP in Phase 3.
I can't find any information on CardiAMP Phase 2.
And I believe the CardiAMP Phase 3, Primary endpoint is the Walk.
Can anyone provide me with more clarity? Thanks.
$VCEL completed the Phase 2 last year and had primary endpoint success with the Heart (left side) therapeutic. But did not meet the secondary endpoint Walk Test (no difference than control). $VCEL investors think they can get FDA approval without Phase 3. But I don't see how with CardiAMP in Phase 3.
I can't find any information on CardiAMP Phase 2.
And I believe the CardiAMP Phase 3, Primary endpoint is the Walk.
Can anyone provide me with more clarity? Thanks.
Recent BCDA News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/28/2026 12:00:11 PM
- BioCardia Announces Japan PMDA Record Of Advice Supports Regulatory Submission For Approval Of CardiAMP Cell Therapy For Ischemic Heart Failure • GlobeNewswire Inc. • 05/28/2026 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/21/2026 10:14:51 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/21/2026 12:00:10 PM
- BioCardia Announces CardiAMP Chronic Myocardial Ischemia Trial Results Presented at EuroPCR Showed Durable Improvements in Exercise Tolerance with Reduced Angina Frequency • GlobeNewswire Inc. • 05/21/2026 12:00:00 PM
- BioCardia to Participate in a Fireside Chat at the Alliance Global Partners (A.G.P) Healthcare Company Showcase • GlobeNewswire Inc. • 05/19/2026 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/19/2026 12:20:23 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/15/2026 09:46:28 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2026 12:05:59 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2026 12:05:55 PM
- BioCardia Reports First Quarter 2026 Business Highlights and Financial Results • GlobeNewswire Inc. • 05/15/2026 12:00:00 PM
- BioCardia to Host Q1 2026 Financial Results and Corporate Update Conference Call on May 15, 2026 • GlobeNewswire Inc. • 05/11/2026 09:10:39 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/08/2026 12:00:09 PM
- BioCardia and FDA Align on Helix Transendocardial Delivery Catheter Clearance Pathways • GlobeNewswire Inc. • 05/08/2026 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/28/2026 12:00:08 PM
- BioCardia Announces Allowance of Japanese Patent on Proprietary Heart3D™ Fusion Imaging Software for Procedure Planning and Realtime Navigation During CardiAMP Cell Therapy Procedures • GlobeNewswire Inc. • 04/28/2026 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/22/2026 09:04:35 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/20/2026 12:00:09 PM
- BioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure • GlobeNewswire Inc. • 04/20/2026 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/15/2026 08:30:15 PM
- BioCardia Files Request for Meeting With FDA to Discuss Accelerated Approval Pathway for CardiAMP® System in Ischemic Heart Failure • GlobeNewswire Inc. • 04/02/2026 02:11:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/02/2026 01:00:11 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/27/2026 12:05:40 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/24/2026 08:31:26 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 03/24/2026 08:30:33 PM
