BIOCARDIA, INC. (OTCMKTS:BCDA) Files An 8-K Other Events
Item 8.01 Other Events.
On September 16, 2019, BioCardia, Inc. (the “Company”) issued a press release announcing that the independent Data Safety Monitoring Board has completed its prespecified data review for the Phase III pivotal CardiAMP Heart Failure Trial, which included safety follow-up results on 35 patients and all additional data available on the 50 patients randomized in the trial as of August 31, 2019. The DSMB indicated there were no safety concerns with the CardiAMP study results and recommended that the trial continue as planned. A copy of the press release is attached hereto as Exhibits 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
BioCardia, Inc. Exhibit
EX-99.1 2 ex_158035.htm EXHIBIT 99.1 ex_158035.htm Exhibit 99.1 FOR IMMEDIATE RELEASE BIOCARDIA ANNOUNCES POSITIVE DSMB RECOMMENDATION TO CONTINUE PHASE 3 PIVOTAL CARDIAMP HEART FAILURE STUDY AS PLANNED SAN CARLOS,…
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About BIOCARDIA, INC. (OTCMKTS:BCDA)
BioCardia, Inc., formerly Tiger X Medical, Inc., is a clinical-stage regenerative medicine company. The Company is engaged in developing therapeutics for cardiovascular diseases. The Company’s lead therapeutic candidate is the CardiAMP Cell Therapy System (CardiAMP). It focuses on the Phase III trial for CardiAMP in ischemic systolic heart failure. The Company also offers CardiALLO Cell Therapy System (CardiALLO), an allogeneic off the shelf mesenchymal stem cell product candidate from other donors. It focuses on the Phase II trial for CardiALLO for the treatment of ischemic systolic heart failure. The Company focuses on various fields of autologous and allogeneic cell-based therapies to manage the lives of patients with cardiovascular conditions. CardiAMP is a therapeutic treatment that includes a companion diagnostic. It consists of a cell potency screening test, a point of care cell processing platform and a biotherapeutic delivery system.