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BioCardia Announces Commercial Availability of Morph DNA Steerable Introducer Product Family

BioCardia Announces Commercial Availability of Morph DNA Steerable Introducer Product Family

BioCardia宣佈Morph DNA可控引導器產品系列的商業可用性
GlobeNewswire ·  12/17 20:00

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.

加利福尼亞州陽光谷,2024年12月17日(全球新聞)—— BioCardia公司(納斯達克:BCDA),一家全球領先的針對心血管和肺部疾病的細胞和細胞衍生療法的公司,今天宣佈其Morph DNA可導向引導器系列產品的商業可用性,該產品目前用於公司的持續細胞療法臨床試驗。

"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首席執行官Peter Altman博士表示:"我們的團隊正在有機探索初步銷售管道,而不涉及直接銷售團隊或第三方器械商業合作伙伴的運營成本。" "我們期待向醫生展示Morph DNA產品系列在整個血管系統程序中的價值。"

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博士補充說:"BioCardia仍然專注於我們的CardiAMP心力衰竭I和II臨床試驗,研究我們的FDA指定的突破性細胞療法候選藥物用於治療缺血性心力衰竭。我們預計到2025年第一季度末,CardiAMP心力衰竭I試驗的最終結果將會出來,並且CardiAMP心力衰竭II試驗正在招募中的五個世界級中心也將完成招募。"

About Morph DNA Steerable Introducers

關於Morph DNA可導向引導器

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爲了在心臟內提供增強的生物治療輸送程序的控制,具備雙向操控、專有的扭矩響應層疊、符合人體工程學的操作、可調節的剎車以進行精細控制,以及血液止流閥中的旋轉側口,以解決纏繞問題並增強操作。

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的設計在導管中含有張力元件,這些元件圍繞導管軸旋轉,從而允許導管在任何方向上保持一致的性能。DNA名稱反映了這種設計,因爲這些張力元件類似於DNA鏈中的雙螺旋。這種設計旨在實現順暢導航,並防止"揮動",即設備中機械力的積累導致導管突然從一個方向跳轉到另一個方向。

A product brochure detailing available model numbers and sizes is available on the Company's website at brochure link.

有關可用型號和尺寸的產品手冊可以在公司網站的手冊鏈接上找到。

About BioCardia

關於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,總部位於加利福尼亞州的陽光谷,是全球領先的細胞和電芯衍生療法,用於治療心血管和肺部疾病。CardiAMP自體和CardiALLO異體電芯療法是公司生物治療的平台,目前有三個臨床階段的產品候選正在開發中。這些療法是通過其Helix生物治療遞送和Morph血管導航產品平台實現的。

Forward Looking Statements:

前瞻性聲明:

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.

本新聞稿包含前瞻性聲明,受多種風險和不確定性的影響。前瞻性聲明包括但不限於對公司研究產品候選、Morph DNA設計的優勢以及公司臨床試驗的數據可用性和入組預期的參考。這些前瞻性聲明是在本新聞稿發佈日期作出的,BioCardia不承擔更新這些前瞻性聲明的義務。

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.

我們可能會使用諸如"相信"、"估計"、"預期"、"期待"、"計劃"、"打算"、"可能"、"可以"、"可能會"、"將"、"應該"、"大約"或其他傳達未來事件或結果不確定性的詞來識別這些前瞻性聲明。儘管我們認爲我們對每一個前瞻性聲明都有合理的依據,但我們提醒您,前瞻性聲明並不保證未來的表現,而我們的實際結果可能會由於一種或多種風險因素而與本新聞稿中包含的前瞻性聲明有重大差異。因此,基於這些因素,我們不能保證本新聞稿中的前瞻性聲明將被證明是準確的。可能對實際結果產生重大影響的其他因素可以在BioCardia於2024年3月27日提交給證券交易委員會的10-K表格中找到,在名爲"風險因素"的標題下,以及在其隨後提交的季度報告的10-Q表格中。BioCardia明確聲明不打算或不承擔更新這些前瞻性聲明的義務,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
聯繫人:媒體聯繫人:
米蘭達·佩託,投資者關係
郵箱:mpeto@BioCardia.com
電話:650-226-0120

投資者聯繫人:
大衛·麥克拉恩,首席財務官
郵箱:investors@BioCardia.com
電話: 650-226-0120

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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