BioCardia and CART-Tech Announce Exclusive Partnership to Develop and Commercialize Heart3D™ Fusion Imaging for Interventional Cardiology
BioCardia (NASDAQ:BCDA) and CART-Tech have formed an exclusive partnership to develop and commercialize Heart3D™ Fusion Imaging technology for cardiac interventions. The system enhances 2D x-ray images by fusing them with annotated 3D heart models from MRI and CT scans.
Under the agreement, BioCardia secures exclusive worldwide distribution rights for biotherapeutic delivery and U.S. rights for cardiac biopsy. Management estimates that a single approved biologic therapy could generate $100 million in annual revenue if Heart3D becomes the standard of care. The system will initially launch as a research tool before seeking approval for clinical practice.
BioCardia (NASDAQ:BCDA) e CART-Tech hanno stretto una partnership esclusiva per sviluppare e commercializzare la tecnologia Heart3D™ Fusion Imaging per interventi cardiaci. Il sistema arricchisce le immagini radiografiche 2D fondendole con modelli 3D annotati del cuore derivati da risonanza magnetica e TAC.
Con l'accordo, BioCardia ottiene i diritti esclusivi di distribuzione worldwide per la somministrazione di bioterapici e i diritti negli USA per la biopsia cardiaca. La direzione stima che un singolo trattamento biologico approvato potrebbe generare 100 milioni di dollari di ricavi annui se Heart3D diventasse lo standard di cura. Il sistema verrà lanciato inizialmente come strumento di ricerca prima di richiedere l'autorizzazione per l'impiego clinico.
BioCardia (NASDAQ:BCDA) y CART-Tech han establecido una asociación exclusiva para desarrollar y comercializar la tecnología Heart3D™ Fusion Imaging para intervenciones cardíacas. El sistema mejora las imágenes de rayos X 2D fusionándolas con modelos 3D anotados del corazón procedentes de resonancias magnéticas y tomografías.
Según el acuerdo, BioCardia obtiene los derechos exclusivos de distribución mundial para la administración de bioterapéuticos y los derechos en EE. UU. para biopsia cardíaca. La dirección estima que un único tratamiento biológico aprobado podría generar 100 millones de dólares anuales si Heart3D se convierte en el estándar de atención. El sistema se lanzará inicialmente como herramienta de investigación antes de solicitar la aprobación para su uso clínico.
BioCardia (NASDAQ:BCDA)와 CART-Tech가 심장 시술용 Heart3D™ Fusion Imaging 기술을 개발·상용화하기 위한 독점 파트너십을 체결했습니다. 이 시스템은 2D 엑스선 영상을 MRI 및 CT 스캔에서 얻은 주석이 달린 3D 심장 모델과 융합해 성능을 향상시킵니다.
계약에 따라 BioCardia는 생물치료제 전달에 대한 전 세계 독점 유통권과 심장 생검에 대한 미국 내 권리를 확보했습니다. 경영진은 Heart3D가 치료 표준이 될 경우 단일 승인된 생물학적 치료제가 미화 1억 달러의 연간 매출을 창출할 수 있다고 추정합니다. 이 시스템은 임상 사용 승인 전에 먼저 연구용 도구로 출시될 예정입니다.
BioCardia (NASDAQ:BCDA) et CART-Tech ont conclu un partenariat exclusif pour développer et commercialiser la technologie Heart3D™ Fusion Imaging destinée aux interventions cardiaques. Le système améliore les images radiographiques 2D en les fusionnant avec des modèles 3D annotés du cœur issus d'IRM et de scanners.
Dans le cadre de l'accord, BioCardia obtient les droits exclusifs de distribution mondiaux pour l'administration des biothérapies et les droits aux États-Unis pour la biopsie cardiaque. La direction estime qu'un seul traitement biologique approuvé pourrait générer 100 millions de dollars de revenus annuels si Heart3D devenait la norme de soins. Le système sera d'abord lancé comme outil de recherche avant de demander une autorisation pour un usage clinique.
BioCardia (NASDAQ:BCDA) und CART-Tech haben eine exklusive Partnerschaft zur Entwicklung und Kommerzialisierung der Heart3D™ Fusion Imaging-Technologie für Herzinterventionen geschlossen. Das System verbessert 2D-Röntgenaufnahmen, indem es diese mit annotierten 3D-Herzmodellen aus MRT- und CT-Scans verschmilzt.
Gemäß der Vereinbarung sichert sich BioCardia die weltweiten exklusiven Vertriebsrechte für die Verabreichung biotherapeutischer Mittel sowie die US-Rechte für Herzbiopsien. Das Management schätzt, dass eine einzelne zugelassene biologische Therapie 100 Millionen US-Dollar Jahresumsatz erzielen könnte, falls Heart3D zum Versorgungsstandard wird. Das System wird zunächst als Forschungswerkzeug eingeführt, bevor eine Zulassung für den klinischen Einsatz angestrebt wird.
- Potential $100 million annual revenue opportunity from a single approved biologic therapy
- Exclusive worldwide distribution rights for biotherapeutic delivery
- Exclusive U.S. distribution rights for cardiac biopsy
- Technology enhances procedural precision and planning capabilities
- Initial research tool deployment provides early market entry opportunity
- System requires regulatory approval for clinical practice
- Revenue potential dependent on adoption as standard of care
- Success relies on approval of third-party biologic therapies
Insights
BioCardia-CART-Tech partnership creates strategic value through exclusive Heart3D Fusion Imaging rights with significant revenue potential in interventional cardiology.
This exclusive partnership between BioCardia and CART-Tech represents a strategic expansion of BioCardia's capabilities in the interventional cardiology space. The Heart3D Fusion Imaging system addresses a critical visualization challenge by enhancing 2D x-ray images with annotated 3D heart models derived from MRI and CT scans.
The technology has dual applications - improving biotherapeutic delivery precision and enhancing cardiac biopsy procedures. This addresses a significant limitation in current cardiac interventions where physicians must mentally reconstruct 3D cardiac anatomy while working with 2D fluoroscopic images.
The partnership includes strategic IP cross-licensing, with BioCardia securing global rights for biotherapeutic interventions while CART-Tech gains rights for cardiac resynchronization therapy. This arrangement maximizes the commercial potential for both companies while creating technological synergies.
Management's projection of
The initial commercialization strategy is pragmatic - starting as a research tool with support services before pursuing clinical approval. This approach allows for revenue generation during the regulatory pathway while building clinical evidence and partner relationships.
SUNNYVALE, Calif. and UTRECHT, Netherlands, Aug. 13, 2025 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, and CART-Tech, B.V., a provider of vendor independent platform technology for augmented fluoroscopy during cardiac interventions, today announce that they have entered into an exclusive development and commercialization agreement for Heart3D™ Fusion Imaging. The Heart3D system is expected to enhance two-dimensional x-ray images used for cardiac biotherapeutic delivery and biopsy procedures by fusing these images with annotated pre-procedure three-dimensional anatomical heart models created from gold standard MRI and CT images.
Under the development and commercialization partnership, the parties are advancing Heart3D Fusion Imaging for biotherapeutic interventions and cardiac biopsy. The system is expected to be sold initially as a research tool with support services for partners in preclinical studies and subsequently approved for standard clinical practice. This partnership leverages the parties’ clinical experience in positioning electrodes and drug delivery systems in the heart and their complimentary intellectual property portfolios for cardiac fusion imaging. BioCardia will have exclusive distribution rights for biotherapeutic delivery world-wide and for cardiac biopsy in the United States. All other distribution rights remain with CART-Tech.
“Heart3D Fusion Imaging has potential to enhance the procedural experience for interventional cardiologists, improve therapeutic strategies for sponsors and most importantly, benefit patients,” said Peter Altman, BioCardia CEO. “This is a significant opportunity for both firms, as management estimates that a single approved biologic therapy for a large market cardiology indication could potentially generate
“Together, we present the ultimate biotherapeutic delivery solution for partners developing cell, gene, and protein-based therapies to the heart,” said Johan Maas, CART-Tech CEO. “The Heart3D Fusion Imaging product offering has potential to significantly enhance procedural planning and real time image precision for the delivery of biologic agents. Our mission is to help advance these therapies for the patients suffering from cardiovascular disease.”
As part of the partnership, BioCardia has licensed global exclusive rights to CART-Tech intellectual property for the fields of biotherapeutic intervention. CART-Tech has licensed global exclusive rights to BioCardia intellectual property for cardiac resynchronization therapy.
About Heart3D™ Fusion Imaging
Heart3D Fusion Imaging is intended to enhance real time 2D X-ray imaging by fusing pre-procedure three-dimensional anatomical heart models created from gold standard MRI and CT images for the interventional cardiologist with a focus on cardiac biotherapeutic interventions and biopsies. This system is currently for investigational use only and is not CE-marked or FDA approved. For more information, go to: https://www.biocardia.com/pipeline/heart3d-fusion-imaging/id/5011
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.
About CART-Tech, B.V.
CART-Tech, B.V., headquartered in Utrecht, Netherlands, has been developing a vendor independent platform technology for augmented fluoroscopy during cardiac interventions for over ten years. Approved products for Cardiac Resynchronization Therapy and developing products for Ventricular Tachycardia-ablation, biotherapeutic delivery and biopsy are steps towards our goal of improving the quality of life and life expectancy of patients with image guidance technology.
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, fusion imaging capabilities, future development, potential markets and future revenues. 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.
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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