BioCardia, Inc. Completes Consultation With Japan's PMDA on BCDA-01 for Ischemic Heart Failure Treatment
BioCardia, Inc. Completes Consultation With Japan's PMDA on BCDA-01 for Ischemic Heart Failure Treatment
BioCardia completed a consultation with Japan's PMDA regarding the registration submission for BCDA-01.BioCardia announces consultation success with PMDA for BCDA-01 registration, targeting ischemic heart failure treatment. Data expected Q1 2025.
biocardia宣布与PMDA就BCDA-01注册的咨询成功，目标是治疗缺血性心力衰竭。数据预计在2025年第一季度发布。
Quiver AI Summary
Quiver AI 概要
BioCardia, Inc., a leader in cell-derived therapeutics for cardiovascular diseases, announced the successful completion of a consultation with Japan's PMDA regarding the registration of its key therapeutic asset, BCDA-01, aimed at treating ischemic heart failure of reduced ejection fraction (HFrEF). During the meeting, PMDA confirmed that it would accept the final clinical data submission with two-year follow-up to assess the safety and efficacy evidence for BCDA-01. The agency is also considering results from the ongoing CardiAMP Heart Failure Trial as sufficient for the registration of the CardiAMP Cell Therapy System in Japan. BioCardia is finalizing data from the trial, which included 125 patients, and expects to release results in early 2025. The therapy has received Breakthrough Designation from the FDA, and its trials are supported by CMS reimbursement.
biocardia公司是心血管疾病细胞来源治疗的领导者，宣布与日本PMDA成功完成了针对其关键治疗资产BCDA-01注册的咨询，旨在治疗射血分数降低的缺血性心力衰竭（HFrEF）。在会议期间，PMDA确认将接受最终临床数据提交，并进行两年跟踪，以评估BCDA-01的安全性和有效性证据。该机构还考虑将正在进行的CardiAMP心力衰竭试验的结果视为在日本注册CardiAMP细胞治疗系统的足够依据。biocardia正在最终整理该试验的数据，该试验包括125名患者，并期望在2025年初发布结果。该疗法已获得FDA的突破性设计认证，试验也得到了CMS的支持。
Potential Positives
潜在的积极因素
- Successful completion of a consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA), indicating progress toward regulatory approval.
- Invitation for a subsequent consultation from PMDA to review the sufficiency of evidence for claims of safety and efficacy, demonstrating regulatory engagement and support.
- Anticipation of final data from the fully enrolled 125 patient CardiAMP Heart Failure Trial in the first quarter of 2025, signaling advancement in clinical development.
- Breakthrough Designation from the FDA for BCDA-01, highlighting the potential significance of the therapy in treating ischemic heart failure.
- 与日本药品和器械管理局（PMDA）成功完成咨询，表明向监管批准的进展。
- PMDA对后续咨询的邀请，以审查安全性和有效性声明的证据是否充分，展现了监管的参与和支持。
- 预计在2025年第一季度发布全部入组的125名患者CardiAMP心力衰竭试验的最终数据，标志着临床开发的进展。
- BCDA-01获得FDA的突破性设计认证，突显了该疗法在治疗缺血性心力衰竭中的潜在重要性。
Potential Negatives
潜在负面影响
- The press release indicates ongoing reliance on future clinical trial results to substantiate claims for BCDA-01, which introduces uncertainty regarding the product's acceptance and potential regulatory hurdles in Japan.
- BioCardia has yet to secure a definitive pathway for the registration of BCDA-01, as future consultations will depend on forthcoming clinical data, indicating a lack of certainty in progress.
- The acknowledgment of risks inherent in the forward-looking statements serves as a reminder of potential setbacks that could affect the company's market performance and investor confidence.
- 新闻稿表明，仍然依赖未来的临床试验结果来证实BCDA-01的声明，这对该产品的接受度和在日本可能面临的监管障碍带来了不确定性。
- biocardia尚未为BCDA-01的注册确定一条明确的路径，因为未来的咨询将取决于即将到来的临床数据，这表明进展缺乏确定性。
- 对前瞻性陈述中固有风险的承认提醒了可能影响公司市场表现和投资者信心的潜在挫折。
FAQ
常见问题
What is the purpose of BioCardia's BCDA-01 therapy?
biocardia的BCDA-01疗法的目的是什么？
BCDA-01 is designed for the treatment of ischemic heart failure with reduced ejection fraction (HFrEF).
BCDA-01旨在用于治疗射血分数降低的缺血性心力衰竭（HFrEF）。
What recent consultation did BioCardia complete?
biocardia最近完成了什么咨询？
BioCardia completed a consultation with Japan's PMDA regarding the registration submission for BCDA-01.
biocardia与日本PMDA进行了关于BCDA-01注册提交的咨询。
What outcomes were expected from the PMDA meeting?
PMDA会议预期的结果是什么？
PMDA invited a follow-up consultation to review clinical data supporting safety and efficacy claims for BCDA-01.
PMDA邀请进行后续咨询，审查支持BCDA-01安全性和有效性声明的临床数据。
When will final data from the CardiAMP Heart Failure Trial be available?
CardiAMP心力衰竭试验的最终数据将于何时可用？
Final data from the trial is anticipated to be available in the first quarter of 2025.
试验的最终数据预计将在2025年第一季度可用。
What recognition has the CardiAMP Cell Therapy received from the FDA?
CardiAMP电芯治疗获得了FDA的什么认可？
CardiAMP Cell Therapy received Breakthrough Designation from the FDA's Center for Biological Evaluation and Research.
CardiAMP电芯治疗获得了FDA生物评价和研究中心的突破性设计认定。
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
免责声明：这是由GlobeNewswire分发的新闻稿的人工智能生成摘要。用于总结这份稿件的模型可能会出错。请在这里查看完整发布。
$BCDA Insider Trading Activity
$BCDA内部交易活动
$BCDA insiders have traded $BCDA stock on the open market 1 times in the past 6 months. Of those trades, 1 have been purchases and 0 have been sales.
$BCDA内部人士在过去6个月内在公开市场上交易了$BCDA股票1次。其中1次是购买，0次是出售。
Here's a breakdown of recent trading of $BCDA stock by insiders over the last 6 months:
以下是内部人士在过去6个月内对$BCDA股票的近期交易情况：
- PETER ALTMAN (President and CEO) purchased 1,350 shares.
- 彼得·阿尔特曼（总裁兼首席执行官）购买了1,350股。
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
要跟踪内部交易，请查看Quiver Quantitative的内部交易特斯拉-仪表。
$BCDA Hedge Fund Activity
$BCDA对冲基金活动
We have seen 0 institutional investors add shares of $BCDA stock to their portfolio, and 22 decrease their positions in their most recent quarter.
我们看到0家机构投资者在最近一个季度中增持了$BCDA股票，22家则减少了他们的持仓。
Here are some of the largest recent moves:
以下是一些最近最大的交易动态：
- CM MANAGEMENT, LLC removed 700,000 shares (-100.0%) from their portfolio in Q2 2024
- VANGUARD GROUP INC removed 650,763 shares (-100.0%) from their portfolio in Q2 2024
- GEODE CAPITAL MANAGEMENT, LLC removed 155,859 shares (-100.0%) from their portfolio in Q2 2024
- TWO SIGMA SECURITIES, LLC removed 111,079 shares (-100.0%) from their portfolio in Q2 2024
- FAMILY MANAGEMENT CORP removed 77,500 shares (-100.0%) from their portfolio in Q2 2024
- BLACKROCK, INC. removed 45,891 shares (-100.0%) from their portfolio in Q2 2024
- BROWN ADVISORY INC removed 33,085 shares (-100.0%) from their portfolio in Q2 2024
- Cm gestion, LLC 在2024年第二季度从他们的投资组合中移除了700,000股（-100.0%）
- 先锋集团公司在2024年第二季度从他们的投资组合中移除了650,763股（-100.0%）
- Geode资本管理公司在2024年第二季度从他们的投资组合中移除了155,859股（-100.0%）
- 两只信号证券公司在2024年第二季度从他们的投资组合中移除了111,079股（-100.0%）
- 家庭管理corp在2024年第二季度从他们的投资组合中移除了77,500股（-100.0%）
- 黑岩公司在2024年第二季度从他们的投资组合中移除了45,891股（-100.0%）
- 布朗顾问公司在2024年第二季度从他们的投资组合中移除了33,085股（-100.0%）
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
要追踪对冲基金的股票组合，请查看Quiver Quantitative的机构持股仪表板。
Full Release
全面发布
SUNNYVALE, Calif., Dec. 04, 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 the successful completion of a consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) on the next steps for the submission for registration of its lead therapeutic asset, BCDA-01, for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF).
加州阳光谷，2024年12月04日（全球新闻网）--
BioCardia, Inc.
[纳斯达克: BCDA]，全球领先的电芯及电芯衍生疗法在心血管和肺部疾病治疗领域，今天宣布成功完成与日本药品和器械监管局（PMDA）关于其主要治疗资产BCDA-01在缺血性心衰（HFrEF）治疗中注册提交的下一步咨询。
"This most recent meeting with PMDA had several important outcomes," said Peter Altman, Ph.D., BioCardia's President and Chief Executive Officer." First, PMDA has invited our next consultation after the submission of our final clinical data with two-year follow-up to review the sufficiency of evidence to support claims of safety and efficacy for the BCDA-01 program. Second, PMDA remains open to the results from the CardiAMP Heart Failure Trial and our previous trials being sufficient evidence for registering CardiAMP Cell Therapy System for patients with heart failure in Japan."
"最近与PMDA的会议达成了几项重要结果，" bioCordia总裁兼首席执行官Peter Altman博士说。"首先，PMDA邀请我们在提交最终临床数据并进行两年随访后进行下一次咨询，以审查支持BCDA-01项目安全性和有效性声明的证据是否充分。其次，PMDA仍然认为CardiAMP心衰试验及我们之前的试验结果，足以为在日本注册CardiAMP细胞治疗系统提供支持。"
Dr. Altman continued, "We are working on data lock from our fully enrolled 125 patient CardiAMP Heart Failure Trial and anticipate final data will be available in the first quarter of 2025."
Altman博士继续说道，"我们正在锁定我们完全招募的125名患者的CardiAMP心衰试验的数据，并预计最终数据将在2025年第一季度可用。"
CardiAMP Cell Therapy for the treatment of HFrEF (BCDA-01) has received Breakthrough Designation from Food and Drug Administration Center for Biological Evaluation and Research (FDA CBER), with development supported by the Maryland Stem Cell Research Fund. All CardiAMP Cell Therapy clinical trials in the United States (BCDA-01 and BCDA-02) are also supported by reimbursement from the Center for Medicaid and Medicare Services (CMS).
CardiAMP细胞治疗（BCDA-01）用于治疗HFrEF已获得食品药品监督管理局生物评价和研究中心（FDA CBER）的突破性认证，发展得到了马里兰干细胞研究基金的支持。所有在美国进行的CardiAMP细胞治疗的临床试验（BCDA-01和BCDA-02）也得到了康哲药业的报销支持。
About BioCardia:
关于biocardia:
BioCardia, Inc.
, headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP
autologous and CardiALLO allogeneic cell therapies are the Company's biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix biotherapeutic delivery and Morph
vascular navigation product platforms. For more information visit:
.
BioCardia, Inc.
位于加利福尼亚州圣尼维尔，总部设在此，是治疗心血管和肺部疾病的电芯及电芯衍生疗法的全球领导者。CardiAMP
自体和CardiALLO异体电芯疗法是公司的生物治疗平台，目前有三款处于临床阶段的产品候选者正在开发中。这些疗法得益于其Helix生物治疗输送和Morph
血管导航产品平台。更多信息请访问：
.
Forward Looking Statements:
前瞻性陈述：
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company's investigational product candidates, the timing of data lock on the CardiAMP Heart Failure Trial, the timing of availability of data from this trial, and future consultations with Japan PMDA. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.
本新闻稿包含前瞻性声明，这些声明受到许多风险和不确定性的影响。前瞻性声明包括但不限于提及公司的研究产品候选者、CardiAMP心力衰竭试验数据锁定的时间、该试验数据的可用时间，以及与日本PMDA的未来咨询。这些前瞻性声明在本新闻稿发布之日作出，BioCardia不承担更新前瞻性声明的任何义务。
We may use terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia's Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled "Risk Factors" and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
我们可能会使用如“相信”、“估计”、“预期”、“期待”、“计划”、“打算”、“可能”、“能够”、“会”、“应该”、“大约”或其他传达未来事件或结果不确定性的词语来识别这些前瞻性声明。虽然我们相信对此处包含的每一项前瞻性声明都有合理的依据，但我们提醒您，前瞻性声明并不是未来表现的保证，我们的实际结果可能与本新闻稿中包含的前瞻性声明有实质性差异。由于这些因素，我们无法确保本新闻稿中的前瞻性声明将被证明是准确的。其他可能实质性影响实际结果的因素可以在BioCardia于2024年3月27日提交给证券交易委员会的10-k表格中找到，标题为“风险因素”，以及在随后的10-Q季度报告中。BioCardia明确声明不具备更新这些前瞻性声明的意图或义务，除非法律要求。
Media Contact:
Miranda Peto, Investor Relations
Email:
mpeto@BioCardia.com
Phone: 650-226-0120
媒体联系：
Miranda Peto，投资者关系
电子邮件：
mpeto@biocardia.com
电话：650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email:
investors@BioCardia.com
Phone: 650-226-0120
投资者联系人：
David McClung, 首席财务官
电子邮件：
investors@biocardia.com
电话：650-226-0120
