BioCardia Announces Commercial Availability of Morph DNA Steerable Introducer Product Family
BioCardia Announces Commercial Availability of Morph DNA Steerable Introducer Product Family
SUNNYVALE, Calif., Dec. 17, 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 commercial availability of its Morph DNA steerable introducer product family, currently utilized in the Company's ongoing cell-therapy clinical trials.
加利福尼亚州阳光谷,2024年12月17日(全球新闻)—— BioCardia公司(纳斯达克:BCDA),一家全球领先的针对心血管和肺部疾病的细胞和细胞衍生疗法的公司,今天宣布其Morph DNA可导向引导器系列产品的商业可用性,该产品目前用于公司的持续细胞疗法临床试验。
"Our team is exploring an initial sales pipeline organically, without expending the operating costs associated with engaging a direct sales force or third-party medical device commercial partners." said BioCardia CEO, Peter Altman, PhD. "We look forward to demonstrating the value of the Morph DNA product family to physicians for procedures throughout the vascular system."
BioCardia首席执行官Peter Altman博士表示:"我们的团队正在有机探索初步销售管道,而不涉及直接销售团队或第三方器械商业合作伙伴的运营成本。" "我们期待向医生展示Morph DNA产品系列在整个血管系统程序中的价值。"
Dr. Altman added, "BioCardia remains focused on our CardiAMP Heart Failure I and II clinical trials, studying our investigational FDA designated breakthrough cell therapy product candidate to treat ischemic heart failure. We anticipate final results in the CardiAMP Heart Failure I Trial and five actively enrolling world class centers in the CardiAMP Heart Failure II Trial by the end of the first quarter of 2025."
Altman博士补充说:"BioCardia仍然专注于我们的CardiAMP心力衰竭I和II临床试验,研究我们的FDA指定的突破性细胞疗法候选药物用于治疗缺血性心力衰竭。我们预计到2025年第一季度末,CardiAMP心力衰竭I试验的最终结果将会出来,并且CardiAMP心力衰竭II试验正在招募中的五个世界级中心也将完成招募。"
About Morph DNA Steerable Introducers
关于Morph DNA可导向引导器
Developed initially to provide enhanced control for biotherapeutic delivery procedures within the heart, the Morph DNA steerable introducer family has bidirectional steering, a proprietary layup for torque response, ergonomic actuation, an adjustable brake for fine control, and a swiveling side port in its hemostasis valve to solve tangling issues and enhance procedures.
Morph DNA可操控引入器系列最初是为了在心脏内提供增强的生物治疗输送程序的控制,具备双向操控、专有的扭矩响应层叠、符合人体工程学的操作、可调节的刹车以进行精细控制,以及血液止流阀中的旋转侧口,以解决缠绕问题并增强操作。
Morph DNA designs contain tensioning elements in the catheter that rotate around the catheter shaft, allowing consistent catheter performance in any direction. The DNA name reflects this design, as these tensioning elements resemble the double helix in a strand of DNA. This design is intended to enable smooth navigation and prevent "whip," when the build-up of mechanical forces in the device causes a catheter to suddenly jump from one orientation to another.
Morph DNA的设计在导管中含有张力元件,这些元件围绕导管轴旋转,从而允许导管在任何方向上保持一致的性能。DNA名称反映了这种设计,因为这些张力元件类似于DNA链中的双螺旋。这种设计旨在实现顺畅导航,并防止"挥动",即设备中机械力的积累导致导管突然从一个方向跳转到另一个方向。
A product brochure detailing available model numbers and sizes is available on the Company's website at brochure link.
有关可用型号和尺寸的产品手册可以在公司网站的手册链接上找到。
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.
BioCardia有限公司,总部位于加利福尼亚州的阳光谷,是全球领先的细胞和电芯衍生疗法,用于治疗心血管和肺部疾病。CardiAMP自体和CardiALLO异体电芯疗法是公司生物治疗的平台,目前有三个临床阶段的产品候选正在开发中。这些疗法是通过其Helix生物治疗递送和Morph血管导航产品平台实现的。
Forward Looking Statements:
前瞻性声明:
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 advantages of the Morph DNA design and expectations for data availability and enrollment in the Company's clinical trials. 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,受多种风险和不确定性的影响。前瞻性声明包括但不限于对公司研究产品候选、Morph DNA设计的优势以及公司临床试验的数据可用性和入组预期的参考。这些前瞻性声明是在本新闻稿发布日期作出的,BioCardia不承担更新这些前瞻性声明的义务。
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 one or more risk factors. 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 its 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.
我们可能会使用诸如"相信"、"估计"、"预期"、"期待"、"计划"、"打算"、"可能"、"可以"、"可能会"、"将"、"应该"、"大约"或其他传达未来事件或结果不确定性的词来识别这些前瞻性声明。尽管我们认为我们对每一个前瞻性声明都有合理的依据,但我们提醒您,前瞻性声明并不保证未来的表现,而我们的实际结果可能会由于一种或多种风险因素而与本新闻稿中包含的前瞻性声明有重大差异。因此,基于这些因素,我们不能保证本新闻稿中的前瞻性声明将被证明是准确的。可能对实际结果产生重大影响的其他因素可以在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,在名为"风险因素"的标题下,以及在其随后提交的季度报告的10-Q表格中。BioCardia明确声明不打算或不承担更新这些前瞻性声明的义务,除非法律要求。
CONTACT: Media Contact:
Miranda Peto, Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
联系人:媒体联系人:
米兰达·佩托,投资者关系
邮箱:mpeto@BioCardia.com
电话:650-226-0120
投资者联系人:
大卫·麦克拉恩,首席财务官
邮箱:investors@BioCardia.com
电话:650-226-0120