BioCardia Announces New United States Patent for Helix Biotherapeutic Delivery System
BioCardia (NASDAQ: BCDA) has been granted US Patent No. 12,311,127 for its Helix biotherapeutic delivery system, a minimally invasive catheter technology for delivering biological therapies to specific sites in the heart. The patent, titled "Radial and Trans-endocardial Delivery Catheter", protects the company's helical needle-tipped catheter technology platform.
According to scientific literature, this technology represents the safest and most efficient approach for biotherapeutic delivery to the heart. The system is crucial for BioCardia's CardiAMP Cell Therapy development program, targeting patients with ischemic cardiomyopathies of heart failure and refractory angina.
BioCardia (NASDAQ: BCDA) ha ottenuto il Brevetto USA n. 12.311.127 per il suo sistema di somministrazione bioterapeutica Helix, una tecnologia a catetere minimamente invasiva per la somministrazione di terapie biologiche in aree specifiche del cuore. Il brevetto, intitolato "Catetere per somministrazione radiale e trans-endocardica", protegge la piattaforma tecnologica dell'azienda basata su un catetere elicoidale con punta ad ago.
Secondo la letteratura scientifica, questa tecnologia rappresenta l'approccio più sicuro ed efficiente per la somministrazione di bioterapie al cuore. Il sistema è fondamentale per il programma di sviluppo della terapia cellulare CardiAMP di BioCardia, indirizzato a pazienti con cardiomiopatie ischemiche da insufficienza cardiaca e angina refrattaria.
BioCardia (NASDAQ: BCDA) ha recibido la concesión del Patente de EE.UU. No. 12,311,127 para su sistema de administración bioterapéutica Helix, una tecnología de catéter mínimamente invasiva para la entrega de terapias biológicas en sitios específicos del corazón. La patente, titulada "Catéter de entrega radial y transendocárdico", protege la plataforma tecnológica del catéter helicoidal con punta de aguja de la compañía.
Según la literatura científica, esta tecnología representa el método más seguro y eficiente para la administración de bioterapias al corazón. El sistema es clave para el programa de desarrollo de la terapia celular CardiAMP de BioCardia, dirigido a pacientes con miocardiopatías isquémicas de insuficiencia cardíaca y angina refractaria.
BioCardia (NASDAQ: BCDA)는 심장 내 특정 부위에 생물학적 치료제를 전달하는 최소 침습 카테터 기술인 Helix 생물치료 전달 시스템에 대해 미국 특허 번호 12,311,127을 취득했습니다. "방사형 및 심내막 관통 전달 카테터"라는 제목의 이 특허는 회사의 나선형 바늘 팁 카테터 기술 플랫폼을 보호합니다.
과학 문헌에 따르면, 이 기술은 심장에 생물치료제를 전달하는 데 있어 가장 안전하고 효율적인 방법으로 평가됩니다. 이 시스템은 허혈성 심근병증 및 난치성 협심증 환자를 대상으로 하는 BioCardia의 CardiAMP 세포 치료 개발 프로그램에 필수적입니다.
BioCardia (NASDAQ : BCDA) s'est vu accorder le brevet américain n° 12 311 127 pour son système de délivrance biothérapeutique Helix, une technologie de cathéter peu invasive permettant d'administrer des thérapies biologiques à des sites spécifiques du cœur. Le brevet, intitulé « Cathéter de délivrance radiale et trans-endocardique », protège la plateforme technologique du cathéter hélicoïdal à pointe d'aiguille de la société.
Selon la littérature scientifique, cette technologie représente l'approche la plus sûre et la plus efficace pour la délivrance de biothérapies au cœur. Ce système est crucial pour le programme de développement de la thérapie cellulaire CardiAMP de BioCardia, ciblant les patients atteints de cardiomyopathies ischémiques liées à l'insuffisance cardiaque et à l'angine réfractaire.
BioCardia (NASDAQ: BCDA) wurde das US-Patent Nr. 12.311.127 für sein Helix-Biotherapeutika-Abgabesystem erteilt, eine minimalinvasive Kathetertechnologie zur gezielten Verabreichung biologischer Therapien am Herzen. Das Patent mit dem Titel "Radialer und transendokardialer Abgabekatheter" schützt die Helix-Nadelspitzen-Kathetertechnologie des Unternehmens.
Wissenschaftlichen Publikationen zufolge stellt diese Technologie den
- New patent protection secured for key delivery technology platform
- Scientific literature supports system as safest and most efficient for heart biotherapeutic delivery
- Technology enables potential treatment for millions of patients with heart conditions
- System facilitates seamless transition from development to commercialization for partners
- Both CardiAMP Cell Therapy and Helix delivery system still require separate regulatory approvals
- Commercialization timeline remains uncertain pending approvals
SUNNYVALE, Calif., June 25, 2025 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that the United States Patent Office has granted US Patent No. 12,311,127 titled “Radial and Trans-endocardial Delivery Catheter”.
US Patent No. 12,311,127 describes the Company’s minimally invasive interventional catheter systems to deliver biologic therapies to target sites in the heart. This minimally invasive delivery approach enables optimal, site-specific treatment, minimizes off-target toxicities, and avoids the need for surgical access to the heart. The allowed patent protects BioCardia’s helical needle-tipped catheter technology platform, which the scientific literature supports is the safest1, 2 and most efficient3 approach for biotherapeutic delivery to the heart.
“The Helix catheter system underlies the safety and efficacy outcomes in our autologous CardiAMP Cell Therapy development program with potential to improve the lives of millions of patients with ischemic cardiomyopathies of heart failure and refractory angina,” said Dr. Peter Altman, BioCardia CEO. “We are working diligently towards the separate approvals of the CardiAMP Cell Therapy as well as the Helix biotherapeutic delivery system it utilizes, as the latter empowers a seamless transition from bench to commercialization for partners.”
About 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.
Forward Looking Statements
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 and biotherapeutic delivery capabilities. 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.
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 26, 2025, 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.
- Raval AN and Pepine CJ. Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting, Cardiovasc Revasc Med, 2021.
- CardiAMP Cell Therapy Trial
- Mitsutake Y, Pyum WB, Rouy D, et al. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart, Int Heart J. 2017.
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
FAQ
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