BioCardia, Inc. (OTCMKTS:BCDA) Files An 8-K Other EventsItem 8.01Other Events.
On December 11, 2018, BioCardia, Inc. (the “Company”) issued a press release announcing its 510(k) submission for U.S. Drug Administration (FDA) clearance of the AVANCETM steerable introducer, 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.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
Description |
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99.1 |
Press release dated December 11, 2018 |
BioCardia, Inc. ExhibitEX-99.1 2 ex_131477.htm EXHIBIT 99.1 ex_131477.htm FOR IMMEDIATE RELEASE Exhibit 99.1 BIOCARDIA SUBMITS 510(K) APPLICATION TO FDA FOR AVANCE STEERABLE INTRODUCER FOR TRANSSEPTAL ACCESS TO HEART SAN CARLOS,…To view the full exhibit click here
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.