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BioCardia Announces FDA Market Clearance of Morph® DNA™ Steerable Introducer Product Family
GlobeNewswire News Room· 2024-08-29 12:30
Core Insights - BioCardia, Inc. has received FDA clearance to market the Morph DNA Steerable Introducer product family, which is designed for use in cardiovascular and pulmonary disease treatments [1][2] - The Morph DNA product family includes sixteen products with various lengths and diameters, aimed at enhancing interventional cardiology and related procedures [1][2] Product Overview - The Morph DNA Steerable Introducer allows for the introduction of medical instruments into the peripheral and coronary vasculature, covering a range of clinical applications [1][2] - The product family is expected to improve procedures such as renal denervation, endovascular aortic repair, and atrial fibrillation mapping and ablation, potentially benefiting over a million procedures annually in the U.S. [2][3] Design Features - The Morph DNA design includes bidirectional steering, ergonomic actuation, and a proprietary layup for torque response, aimed at enhancing control and navigation during procedures [4] - The design incorporates tensioning elements that allow for consistent catheter performance and smooth navigation, reducing the risk of sudden movements during use [4] Company Background - BioCardia is a leader in cellular and cell-derived therapeutics, with a focus on cardiovascular and pulmonary diseases, and has three clinical stage product candidates in development [5]
FDA Approves CardiAMP® Heart Failure II Protocol Amendment to Use Proprietary Cell Population Analysis Screening to Define Treatment
GlobeNewswire News Room· 2024-08-21 11:00
Patented personalized medicine approach for patient dosing for autologous cell therapyExpected to meaningfully enhance clinical experience and market opportunity SUNNYVALE, Calif., Aug. 21, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the FDA has approved a protocol amendment for the CardiAMP Heart Failure II Trial, BioCardia’s confirmatory Phase 3 trial of i ...
BioCardia(BCDA) - 2024 Q2 - Earnings Call Transcript
2024-08-13 23:53
BioCardia, Inc. (NASDAQ:BCDA) Q2 2024 Earnings Conference Call August 13, 2024 4:30 PM ET Company Participants Miranda Peto - Investor Relations Peter Altman - President and CEO David McClung - Chief Financial Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Laura Suriel - Alliance Global Partners Kevin Marshall - Innovative Financial Group Operator Ladies and gentlemen, thank you for standing by. Good afternoon. And welcome to the BioCardia Second Quarter 2024 Financial Results and Busi ...
BioCardia Reports Second Quarter 2024 Business Highlights and Financial Results
GlobeNewswire News Room· 2024-08-13 20:30
SUNNYVALE, Calif., Aug. 13, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the second quarter of 2024 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2024 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. ...
BioCardia(BCDA) - 2024 Q2 - Quarterly Results
2024-08-13 20:06
Exhibit 99.1 BioCardia Reports Second Quarter 2024 Business Highlights and Financial Results Sunnyvale, Calif. – August 13, 2024 - BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the second quarter of 2024 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2024 with the Securities and Exchange Commission. The Company will also hold a conf ...
BioCardia(BCDA) - 2024 Q2 - Quarterly Report
2024-08-13 17:57
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-38999 BioCardia, Inc. (Exact name of registrant as specified in its charter) Delaware 23-2753988 (State or another jurisdiction of incorporation or organization) ...
BioCardia Submits for FDA Approval of Morph® DNA™ Steerable Introducer Product Family
Newsfilter· 2024-07-30 11:00
SUNNYVALE, Calif., July 30, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported it has submitted a 510(k) for approval of its patented Morph® DNA™ Steerable Introducer Sheath. This product family is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripher ...
BioCardia Announces United States Patent Issuance on Morph DNA Multi-Directional Steerable Catheter Transseptal Application
GlobeNewswire News Room· 2024-07-17 11:00
SUNNYVALE, Calif., July 17, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases today announces that the Unites States Patent Office has granted Patent No: 12,036,371 titled “Method of Accessing the Left Atrium with a Multi-Directional Steerable Catheter,” with a patent term that will expire in 2035. The present invention relates to medical methods for transseptal access to the heart u ...
BioCardia Announces United States Patent Issuance on Morph DNA Multi-Directional Steerable Catheter Transseptal Application
Newsfilter· 2024-07-17 11:00
SUNNYVALE, Calif., July 17, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases today announces that the Unites States Patent Office has granted Patent No: 12,036,371 titled "Method of Accessing the Left Atrium with a Multi-Directional Steerable Catheter," with a patent term that will expire in 2035. The present invention relates to medical methods for transseptal access to the heart u ...
CellProthera and BioCardia Collaborate on Successful Phase II Trial of ProtheraCytes™ for the Treatment of Acute Myocardial Infarction
Newsfilter· 2024-07-08 11:00
MULHOUSE, France, and SUNNYVALE, Calif., July 08, 2024 (GLOBE NEWSWIRE) -- CellProthera, a private company specializing in cell-based therapies for repairing ischemic tissues, and BioCardia, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announce success from a collaborative Phase II trial of ProtheraCytes for the treatment of acute myocardial infarction (AMI) led by CellProthera, as well as plans to continue the re ...