BioCardia Announces Japanese Patent for Helix™ Biotherapeutic Delivery System
BioCardia (BCDA) has been granted Japanese Patent No. 7641330 for its Helix™ Biotherapeutic Delivery System, extending protection until at least September 30, 2034. The patent covers minimally invasive catheter-based delivery systems for cell and gene-based therapies to the heart.
The Helix System, featuring helical needle-tipped catheter technology, is currently the only catheter-based intramyocardial delivery system in active clinical use. The technology enables targeted treatment while minimizing off-target toxicities and avoiding surgical heart access.
Japan represents a strategic market for these therapies due to its national commitment to supporting novel cell therapy solutions for its aging population while developing its stem cell industry.
BioCardia (BCDA) ha ricevuto il Brevetto Giapponese n. 7641330 per il suo sistema di somministrazione bioterapeutica Helix™, estendendo la protezione fino almeno al 30 settembre 2034. Il brevetto copre i sistemi di somministrazione basati su cateteri minimamente invasivi per terapie cellulari e geniche destinate al cuore.
Il sistema Helix, che presenta una tecnologia di catetere con punta a forma elicoidale, è attualmente l'unico sistema di somministrazione intramiocardica basato su catetere in uso clinico attivo. La tecnologia consente un trattamento mirato riducendo al minimo le tossicità non specifiche e evitando l'accesso chirurgico al cuore.
Il Giappone rappresenta un mercato strategico per queste terapie a causa del suo impegno nazionale nel sostenere soluzioni innovative per la terapia cellulare per la sua popolazione anziana, mentre sviluppa la sua industria delle cellule staminali.
BioCardia (BCDA) ha recibido la Patente Japonesa No. 7641330 para su Sistema de Administración Bioterapéutica Helix™, extendiendo la protección hasta al menos el 30 de septiembre de 2034. La patente cubre sistemas de administración basados en catéteres mínimamente invasivos para terapias celulares y génicas dirigidas al corazón.
El Sistema Helix, que cuenta con tecnología de catéter con punta helicoidal, es actualmente el único sistema de administración intramiocárdica basado en catéter en uso clínico activo. La tecnología permite un tratamiento dirigido mientras minimiza las toxicidades fuera de objetivo y evita el acceso quirúrgico al corazón.
Japón representa un mercado estratégico para estas terapias debido a su compromiso nacional de apoyar soluciones innovadoras de terapia celular para su población envejecida, mientras desarrolla su industria de células madre.
BioCardia (BCDA)는 헬릭스™ 생물치료 전달 시스템에 대해 일본 특허 제7641330호를 부여받아 2034년 9월 30일까지 보호를 연장했습니다. 이 특허는 심장에 대한 세포 및 유전자 기반 치료를 위한 최소 침습 카테터 기반 전달 시스템을 포함합니다.
헬릭스 시스템은 나선형 바늘 끝 카테터 기술을 특징으로 하며, 현재 임상에서 사용 중인 유일한 카테터 기반 심근 내 전달 시스템입니다. 이 기술은 표적 치료를 가능하게 하면서 비표적 독성을 최소화하고 외과적 심장 접근을 피할 수 있게 합니다.
일본은 노인 인구를 위한 혁신적인 세포 치료 솔루션을 지원하는 국가적 노력을 통해 이러한 치료법에 대한 전략적 시장을 나타내며, 줄기 세포 산업을 발전시키고 있습니다.
BioCardia (BCDA) a obtenu le brevet japonais n° 7641330 pour son système de délivrance biothérapeutique Helix™, prolongeant ainsi la protection jusqu'au moins le 30 septembre 2034. Le brevet couvre les systèmes de délivrance par cathéter minimement invasifs pour les thérapies cellulaires et géniques destinées au cœur.
Le système Helix, qui utilise une technologie de cathéter à pointe hélicoïdale, est actuellement le seul système de délivrance intramyocardique par cathéter en utilisation clinique active. Cette technologie permet un traitement ciblé tout en minimisant les toxicités hors cible et en évitant l'accès chirurgical au cœur.
Le Japon représente un marché stratégique pour ces thérapies en raison de son engagement national à soutenir des solutions innovantes de thérapie cellulaire pour sa population vieillissante tout en développant son industrie des cellules souches.
BioCardia (BCDA) hat das japanische Patent Nr. 7641330 für sein Helix™ Biotherapeutic Delivery System erhalten, das den Schutz bis mindestens zum 30. September 2034 verlängert. Das Patent umfasst minimal-invasive katheterbasierte Abgabesysteme für Zell- und gentherapeutische Behandlungen des Herzens.
Das Helix-System, das über eine kathetertechnologie mit spiralförmiger Nadelspitze verfügt, ist derzeit das einzige katheterbasierte intramiokardiale Abgabesystem, das aktiv in der klinischen Anwendung ist. Die Technologie ermöglicht eine gezielte Behandlung und minimiert gleichzeitig unerwünschte Nebenwirkungen sowie den chirurgischen Zugang zum Herzen.
Japan stellt einen strategischen Markt für diese Therapien dar, da es sich national verpflichtet hat, innovative Zelltherapielösungen für die alternde Bevölkerung zu unterstützen und gleichzeitig seine Stammzellindustrie zu entwickeln.
- Secured patent protection in Japan until 2034
- Only active catheter-based intramyocardial delivery system in clinical use
- Strategic market access in Japan's growing cell therapy market
- None.
Insights
BioCardia's newly secured Japanese patent represents a meaningful enhancement to their intellectual property portfolio, extending protection for their Helix™ Biotherapeutic Delivery System in Japan until at least 2034. This strategic asset strengthens the company's competitive position in the specialized cardiovascular biotherapeutic delivery space.
For a micro-cap company with a market cap of just
Japan represents a particularly valuable market for BioCardia's technology due to its aging population and national commitment to cell therapy development. This patent could potentially facilitate partnerships or licensing agreements with Japanese pharmaceutical companies or research institutions.
While patent approvals don't typically generate immediate revenue, they create barriers to competition and enhance licensing potential. BioCardia's claim that their Helix System is "the only catheter-based intramyocardial delivery system in active clinical use" suggests a potential first-mover advantage in this niche technological space.
This patent adds incremental value to BioCardia's asset base but shouldn't be viewed as a near-term catalyst for significant financial performance improvement. Rather, it's another building block in their long-term intellectual property strategy that could eventually translate to commercial opportunities.
SUNNYVALE, Calif., March 10, 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 Japan Patent Office has granted Japanese Patent No. 7641330 titled “Radial and Transendocardial Delivery Catheter” with a patent term that will expire on or after September 30, 2034.
“This new patent in Japan adds to our growing patent position with respect to minimally invasive catheter-based delivery systems for cell and gene-based therapies to the heart,” said Dr. Peter Altman, BioCardia CEO. “Our clinical cell therapy candidates for the treatment of ischemic cardiomyopathies benefit greatly from the performance of these systems, as will current and future biotherapeutic partners supported by our extensive preclinical and clinical experience. Japan is an important initial market for these therapies because of their national commitment to support novel and cost-effective cell therapy solutions for their aging population while also developing the Japanese stem cell industry (1).”
BioCardia’s newly issued Japanese Patent No. 7641330 describes minimally invasive interventional biotherapeutic delivery catheters to deliver biologic therapies to target sites in the heart. This minimally invasive delivery approach enables optimal treatment at the sites where needed, minimizes off-target toxicities, and avoids the need for surgical access to the heart. The allowed claims cover BioCardia’s helical needle-tipped catheter technology platform, which available data supports is the safest and most efficient approach for biotherapeutic delivery to the heart (2, 3). BioCardia believes its Helix System to be the only catheter-based intramyocardial delivery system in active clinical use.
BioCardia has secured an extensive portfolio of issued patents and pending patent applications around cell, exosome, and microRNA biotherapeutic candidates, minimally invasive biotherapeutic delivery platforms, and advanced cardiac imaging technologies. These inventions have resulted from the pursuit of its ongoing mission to develop new therapies for the patients suffering from cardiovascular disease.
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 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.
- Konomi K, Tobita M, Kimura K, Sato D. New Japanese initiatives on stem cell therapies. Cell Stem Cell. 2015 Apr 2;16(4):350-2.
- Mitsutake Y, Pyum WB, Rouy D, Wong Po Foo C, Stertzer SH, Altman P, Ikeno F. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart, Int Heart J. 2017.
- Raval AN and Pepine CJ. Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting, Cardiovasc Revasc Med, 2021.
Media Contact: Miranda Peto, Marketing / 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
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