Post by icemandios on Aug 10, 2018 0:21:11 GMT
BioCardia, Inc. Reports Second Quarter 2018 Financial Results and Business Highlights
SAN CARLOS, Calif., Aug. 9, 2018 /PRNewswire/ -- BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and business highlights for the second quarter 2018 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2018 with the Securities and Exchange Commission.
Revenues increased to $239,000 for the second quarter of 2018 compared to $112,000 for the second quarter of 2017.
Net loss was $3.2 million for the second quarter of 2018, compared to $2.9 million for the second quarter of 2017.
Selling, general and administrative expenses decreased to $1.3 million in the second quarter of 2018, compared to $1.6 million in the second quarter of 2017, primarily due to lower stock compensation expense.
2018 Corporate Highlights:
Enrollment in the pivotal CardiAMP Heart Failure Trial has expanded to 17 world class centers in the United States as detailed on ClinicalTrials.Gov.
"The CardiAMP Heart Failure Study: First Results from Unblinded Roll-In Phase", to be presented at 9:06 am PDT.
The U.S. Food and Drug Administration approved a second pivotal Investigational Device Exemption trial for the CardiAMP Cell Therapy System for the treatment of chronic myocardial ischemia with refractory angina, the "CardiAMP Chronic Myocardial Ischemia Trial". The Centers for Medicare and Medicaid Services (CMS) has approved this trial for national reimbursement coverage.
Anticipated Upcoming Milestones:
12-month data from the CardiAMP Heart Failure Trial 10-patient roll-in cohort in the fourth quarter 2018.
Filing of the Investigational New Drug (IND) for the CardiALLO Cell Therapy System, an investigational allogenic culture expanded "off the shelf" mesenchymal cell therapy for the treatment of ischemic heart failure, in the fourth quarter 2018.
Filing for FDA approval of an advanced bidirectional steerable guide system in the fourth quarter 2018.
Dosing of the first patient in the pivotal CardiAMP Chronic Myocardial Ischemia Trial in the first quarter 2019.
About BioCardia®
BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP™ and CardiALLO™ cell therapies are the Company's biotherapeutic product candidates in clinical development. The Company's current products include the Helix™ transendocardial delivery system and the Morph® steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.