Tag: biocardia

BioCardia gets FDA clearance for catheter to guide Helix delivery system

BioCardia has received US Food and Drug Administration (FDA) 510(k) clearance for its Morph DNA deflectable guide catheter, used to guide the Helix biotherapeutic...

Early treatment with Helix system improves ejection fraction and symptoms

The Helix biotherapeutic delivery system (Biocardia), which delivers cell therapy to patients within four weeks of a heart attack, led to improved ejection fraction...

BioCardia submits 510(k) application to US FDA for its Avance steerable...

BioCardia has announced its 510(k) submission for US FDA clearance of the Avance steerable introducer, which is designed for introducing various cardiovascular catheters into...

Mark Schwartz become vice president of Clinical Affairs at BioCardia

BioCardia has announced that Mark Schwartz—a 25-year veteran of cardiovascular device development—has joined the company as Vice President of Clinical Affairs. A press release...

BioCardia and CellProThera to partner for clinical trial and marketing in...

CellProThera and BioCardia announced an agreement to expand their current collaboration to the SIngXpand clinical trial in Singapore. The study will evaluate the safety...
BioCardia CardiAMP

BioCardia phase III CardiAMP trial passes interim safety analysis

The independent Data Safety Monitoring Board (DSMB) has found no significant safety concerns with BioCardia’s CardiAMP trial results. It recommends that the study continue...

CardiAMP Heart Failure trial to further evaluate use of regenerative therapy...

BioCardia has revealed the trial design for its pivotal Phase III CardiAMP Heart Failure Trial at the Texas Heart Institute International Symposium on Cardiovascular...

Transendocardial delivery results in greater myocardial stem cell therapy retention

According to a study published in the International Heart Journal, delivery of stem cell therapy to the heart using BioCardia’s Helix transendocardial delivery system...

First patient treated with CardiAmp cell therapy for ischaemic heart failure...

Johns Hopkins Medicine, Baltimore, USA, the Maryland Stem Cell Research Fund (MSCRF) and BioCardia have announced that the first patient has been treated in...