BioCardia, Inc. (OTCMKTS:BCDA) Files An 8-K Other Events
Item 8.01 Other Events.
On May 8, 2018, BioCardia, Inc. (the “Company”) issued a press release announcing U.S. Food and Drug Administration (FDA) 510(k) clearance of its AVANCE™ 510(k) submission for clearance of the AVANCETM steerable introducer product family, designed for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum. 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
BioCardia, Inc. Exhibit
EX-99.1 2 ex_143810.htm EXHIBIT 99.1 ex_143810.htm Exhibit 99.1 FOR IMMEDIATE RELEASE BIOCARDIA RECEIVES FDA CLEARANCE FOR AVANCE STEERABLE INTRODUCER FOR TRANSSEPTAL ACCESS TO HEART 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.
