SUNNYVALE, Calif., May 01, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the primary endpoint results of the open label roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial. Study clinical cardiology leadership and members of the Executive Steering Committee, Dr. Carl Pepine, Professor of Medicine at the University Florida at Gainesville, an ...

BioCardia公司最新动态 - BioCardia公司宣布完成了CardiAMP®细胞疗法慢性心肌缺血试验的开放标签滚入队列的招募和主要终点结果[1] - 公司将于2024年4月30日星期二下午3:00举行电话会议，报告此次试验结果，并与研究临床心脏病学领导层进行讨论[2] - CardiAMP细胞疗法计划被FDA指定为缺血性心力衰竭的突破性疗法，使用患者自身的骨髓细胞通过微创、导管介入程序输送到心脏，可能刺激身体的自然愈合反应[6]

BioCardia, Inc. (NASDAQ:BCDA) Q4 2023 Results Conference Call March 27, 2024 4:30 PM ET Company Participants Miranda Peto - Investor Relations Peter Altman - President and Chief Executive Officer David McClung - Chief Financial Officer Operator Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia 2023 Year-End Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions]. Participants on this ...

Exhibit 99.1 BioCardia Reports Fourth Quarter and Full Year 2023 Business Highlights and Financial Results SUNNYVALE, Calif. – March 27, 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 year ended December 31, 2023 and filed its annual report on Form 10-K with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today ...

公司财务状况 - 公司历史上一直处于亏损状态，未来盈利能力存在不确定性[186] - 公司截至2023年12月31日的净亏损为1160万美元，累计亏损达到1.522亿美元[187] - 公司预计未来支出将增加，特别是在研发和其他运营支出方面[190] - 公司需要大量额外融资才能实现目标，未能及时获得必要资本可能会迫使延迟、限制、减少或终止产品开发或商业化努力[193] - 公司的现金和现金等价物可能会受到不利影响，如果持有现金的金融机构出现问题[199] 产品开发与监管 - 公司的长期生存主要取决于成功开发和商业化CardiAMP细胞疗法系统[205] - FDA接受第三阶段关键试验并不保证产品候选人或产品候选人的任何可允许声明的批准[208] - 公司已获得FDA接受CardiAMP细胞疗法系统用于治疗HFrEF和慢性心肌缺血的第三阶段关键试验[210] - FDA等监管机构对于新型产品候选药物的审批要求可能更昂贵且时间更长[214] - 临床试验的延迟可能会对公司完成疗法候选药物的临床试验产生负面影响[218] 市场竞争与商业化 - 公司的未来商业成功取决于其治疗候选药物在医生、患者和医疗支付方中的市场接受程度[242] - 公司面临激烈竞争，可能导致其他公司在我们之前或更成功地发现、开发或商业化产品[247] - 如果公司无法建立销售和营销能力或与第三方达成协议以销售其治疗候选药物，公司可能无法产生任何收入[249] 风险与挑战 - 公司依赖第三方供应商制造部分组件和子组件，可能会导致供应短缺和价格波动[239] - 未来商业潜力难以估计，可能受安全性、有效性、第三方支付者标准等因素影响[275] - 严重不良事件或其他安全风险可能导致放弃开发，延迟或限制治疗候选人或产品的批准[287] 法律合规与知识产权 - 公司在全球范围内进行专利申请、维护和辩护可能成本过高[354] - 公司可能被迫进行知识产权诉讼，耗费大量资源[358] - 如果第三方声称公司的治疗候选品或其他产品侵犯其知识产权，可能会对公司的商业化和运营利润产生不利影响[367]

SUNNYVALE, Calif., March 20, 2024 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ:BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced it will report its financial results for the year ended December 31, 2023 and provide a corporate update by conference call on Wednesday, March 27, 2024 at 4:30 PM ET. Following management’s formal remarks, there will be a question-and-answer session. Participants can register for the conference ...

公司介绍 - BioCardia®公司是一家位于加州Sunnyvale的生物技术公司，专注于开发用于治疗心血管和肺部疾病的细胞和细胞衍生治疗方法[4] 财务业绩 - 公司将于2023年12月31日结束的财政年度公布财务业绩[1] 企业更新 - 公司将于2024年3月27日下午4:30 ET通过电话会议提供企业更新[1] 参与方式 - 参与者可以通过注册链接参加电话会议，未注册的人士可通过电话拨打指定号码收听会议，也可通过网页直播观看[2] 回放方式 - 电话会议结束后约一小时，可通过网页链接回放，电话回放则可在截止日期前拨打指定号码进行回放[3]

Partnership targets heart failure, the leading cause of death and a condition with limited treatment options BioCardia's biotherapeutic delivery system with established safety profile enables minimally invasive transplantation of StemCardia's off-the-shelf cardiac muscle cells SUNNYVALE, Calif., March 13, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ:BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, and StemCardia, Inc., a biotechnolog ...

SUNNYVALE, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced Centers for Medicare & Medicaid Services (CMS) approval for reimbursement coverage of the confirmatory Phase III clinical trial of CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure. CMS has reviewed the CardiAMP Heart Failure II Trial and approved the inve ...

CardiAMP cell therapy-treated patients had 37% relative risk reduction in heart death equivalent (death, heart transplant, left ventricular assist device implantation) and 9% relative risk reduction in non-fatal major adverse cardiac and cerebrovascular events (MACCE) at mean 20-month follow-up compared to control patients on guideline-directed heart medications alone Large sub-set of treated patients with elevated NTproBNP – a marker of heart distress – showed greater reductions, with 86% relative risk red ...