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Lead Product(s): CardiAMP cell therapy
Therapeutic Area: Cardiology/Vascular Diseases Product Name: BCDA-01
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 02, 2021
Details:
BCDA-01, our CardiAMP autologous cell therapy under Phase III clinical development for the treatment of ischemic heart failure remains the Company’s top priority. The Company is targeting completion of enrollment without requiring additional financing.
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Lead Product(s): CardiAMP Cell Therapy
Therapeutic Area: Cardiology/Vascular Diseases Product Name: BCDA-01
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2020
Details:
Pivotal Phase 3 CardiAMP Heart Failure Trial aims to determine the safety and efficacy of CardiAMP cell therapy in the treatment of patients with ischemic heart failure.
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Lead Product(s): CardiAMP Cell Therapy
Therapeutic Area: Cardiology/Vascular Diseases Product Name: BCDA-01
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2020
Details:
Helix Biotherapeutic Delivery System demonstrated the best safety profile among clinical transendocardial catheter injection systems used for cardiac cell therapy delivery in an in-press corrected proof published in journal Cardiovascular Revascularization Medicine.
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Lead Product(s): CardiAMP cell therapy
Therapeutic Area: Cardiology/Vascular Diseases Product Name: BCDA-01
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2020
Details:
Published in the International Journal of Cardiology, the study data shows that CardiAMP is a well-tolerated treatment in heart failure patients and demonstrated improved distance in six-minute exercise testing at six months and a trend toward improvement at one year.
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Lead Product(s): CardiAMP cell therapy
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
Details:
The CardiAMP CMI Trial is studying CardiAMP cell therapy, an autologous cell therapy formulation designed to stimulate the body’s natural healing response for the treatment of refractory angina, estimated to impact between 600,000 and 1,800,000 patients in the United States.
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Lead Product(s): CardiAMP cell therapy
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2020
Details:
The CardiAMP Heart Failure Trial is studying CardiAMP cell therapy, an autologous bone marrow-derived mononuclear cell formulation designed to stimulate the body’s natural healing response in treating heart failure which develops after a heart attack.
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Lead Product(s): Neurokinin 1 receptor positive mesenchymal stem cell
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Preclinical Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2020
Details:
Animal research findings show substantial improvements in heart function for heart failure subjects treated with BioCardia's allogeneic neurokinin 1 receptor positive mesenchymal stem cell, CardiALLOTM.
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Lead Product(s): CardiAMP cell therapy
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2020
Details:
The DSMB indicated there were no safety concerns with the CardiAMP study results and recommended that the trial continue, as planned. To date, 74 patients have been enrolled in the trial.
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