Tuesday, October 4, 2022


Biotechnology News Magazine

BioCardia Receives No Objection Letter from Health Canada

Enables the Company to Expand CardiAMP Cell Therapy Heart Failure Trial into Canada

Latest Posts

City of Hope to Accelerate Immunotherapy Research & Treatment Innovation with $15 Mil Gift from Ted Schwartz Family

Ted Schwartz, who is now cancer free, achieved complete remission at City of Hope in 2020 with the center's leading CAR T cell therapy after a 16-year battle with lymphoma, provided the gift to City of Hope to advance treatment options that offer better outcomes and quality of life for people living with cancer.

Neurocrine Biosciences Appoints Dr Ingrid Delaet as Chief Regulatory Officer

Prior to joining Neurocrine Biosciences, Dr Ingrid Delaet served as Senior Vice President, Regulatory Affairs at Intercept Pharmaceuticals, which she joined in 2016.

Astrea Bioseparations Introduces Nereus LentiHERO, a Fit-for-purpose Solution for Lentiviral Vector Purification

“We believe that AstreAdept will be a game-changer,” explained Astrea Bioseparations’ CEO Terry Pizzie. “Our approach was to rapidly develop and incorporate this material into the Nereus LentiHERO, a simple, fit-for-purpose device that radically transforms how lentivirus can be purified [in terms of speed, recovery, and efficiency].

At Pack Expo, Schreiner MediPharm to Debut Functional Labels Designed from More Sustainable Materials

Schreiner MediPharm advises he new label concepts are based on existing items in Schreiner MediPharm’s roster of functional labeling solutions.

BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that it has received a No Objection Letter from Health Canada, the country’s health services agency, allowing the CardiAMP® Heart Failure Trial to expand into Canada.

The Phase III pivotal trial is currently enrolling patients in the U.S.

Four world-class Canadian clinical sites are currently working through the activation process in order to be ready to begin enrolling patients in the near future. The Company expects to announce these sites in the coming months.

The CardiAMP Cell Therapy Heart Failure Trial is evaluating the effectiveness of the CardiAMP Cell Therapy System for improving survival, reducing major adverse cardiac events, enhancing functional capacity, and improving quality of life for New York Heart Association (NYHA) Class II and III patients who have heart failure associated with ischemic cardiomyopathy.

“Expansion into respected centers in Canada is expected to strengthen the overall clinical trial and accelerate its completion,” said Peter Altman, Ph.D., President and Chief Executive Officer of BioCardia.   “The Health Canada process has been longer than expected as the trial was required to be approved by both the devices and the biologics groups at Health Canada in a sequential process. We value the rigorous Health Canada reviews as each one has made us stronger. We are delighted to partner with the site leadership teams in Canada and the United States to further the development of this promising treatment option for their patients with ischemic heart failure. ”

Latest Posts

Learn More




Our Sister Publication

Medical Device News Magazine