BioCardia Announces Commercial Availability of Morph® DNA™ Steerable Introducer Product Family
BioCardia (NASDAQ: BCDA) has announced the commercial launch of its Morph DNA steerable introducer product family, which is currently being used in the company's ongoing cell-therapy clinical trials. The company is pursuing an organic sales approach without engaging a direct sales force or third-party partners to minimize operating costs.
The company maintains its focus on the CardiAMP Heart Failure I and II clinical trials, which are studying their FDA-designated breakthrough cell therapy product for ischemic heart failure treatment. Final results for CardiAMP Heart Failure I Trial and updates on five actively enrolling centers in the CardiAMP Heart Failure II Trial are expected by the end of Q1 2025.
BioCardia (NASDAQ: BCDA) ha annunciato il lancio commerciale della sua famiglia di prodotti Morph DNA steerable introducer, attualmente utilizzata negli studi clinici in corso sulla terapia cellulare dell'azienda. L'azienda sta perseguendo un approccio alle vendite organico, senza coinvolgere una forza vendita diretta o partner terzi, per minimizzare i costi operativi.
L'azienda mantiene la sua attenzione sugli studi clinici CardiAMP Heart Failure I e II, che stanno studiando il loro prodotto per la terapia cellulare designato come breakthrough dalla FDA per il trattamento dell'insufficienza cardiaca ischemica. I risultati finali dello studio CardiAMP Heart Failure I e aggiornamenti su cinque centri in fase di arruolamento attivo nello studio CardiAMP Heart Failure II sono previsti entro la fine del primo trimestre del 2025.
BioCardia (NASDAQ: BCDA) ha anunciado el lanzamiento comercial de su familia de productos Morph DNA steerable introducer, que actualmente se utiliza en los ensayos clínicos en curso de terapia celular de la compañía. La empresa está siguiendo un enfoque de ventas orgánico sin involucrar una fuerza de ventas directa o socios externos para minimizar los costos operativos.
La compañía se mantiene enfocada en los ensayos clínicos CardiAMP Heart Failure I y II, que están estudiando su producto de terapia celular designado como innovador por la FDA para el tratamiento de la insuficiencia cardíaca isquémica. Se esperan los resultados finales del ensayo CardiAMP Heart Failure I y actualizaciones sobre cinco centros que están enrolando activamente en el ensayo CardiAMP Heart Failure II para finales del primer trimestre de 2025.
BioCardia (NASDAQ: BCDA)는 현재 회사의 세포 치료 임상 시험에서 사용되고 있는 Morph DNA steerable introducer 제품군의 상업 출시를 발표했습니다. 이 회사는 운영 비용을 최소화하기 위해 직접 판매 인력이나 제3자 파트너를 참여시키지 않는 유기적인 판매 접근 방식을 취하고 있습니다.
회사는 CardiAMP 심부전 I 및 II 임상 시험에 집중하고 있으며, 이는 허혈성 심부전 치료를 위한 FDA 지정 혁신 세포 치료 제품을 연구하고 있습니다. CardiAMP 심부전 I 시험의 최종 결과와 CardiAMP 심부전 II 시험에서 다섯 개의 적극적인 등록 센터에 대한 업데이트는 2025년 1분기 말까지 나올 예정입니다.
BioCardia (NASDAQ: BCDA) a annoncé le lancement commercial de sa gamme de produits Morph DNA steerable introducer, actuellement utilisée dans les essais cliniques de thérapie cellulaire en cours de l'entreprise. La société adopte une approche de vente organique sans faire appel à une force de vente directe ou à des partenaires tiers afin de minimiser les coûts opérationnels.
La société reste concentrée sur les essais cliniques CardiAMP Heart Failure I et II, qui étudient leur produit de thérapie cellulaire désigné par la FDA comme innovation pour le traitement de l'insuffisance cardiaque ischémique. Les résultats finaux de l'essai CardiAMP Heart Failure I et des mises à jour sur cinq centres en cours d'inscription dans l'essai CardiAMP Heart Failure II sont attendus d'ici la fin du premier trimestre 2025.
BioCardia (NASDAQ: BCDA) hat die kommerzielle Einführung seiner Morph DNA steerable introducer Produktlinie bekannt gegeben, die derzeit in den laufenden klinischen Studien zur Zelltherapie des Unternehmens eingesetzt wird. Das Unternehmen verfolgt einen organischen Verkaufsansatz, ohne eine direkte Vertriebsmannschaft oder Drittpartner einzubeziehen, um die Betriebskosten zu minimieren.
Das Unternehmen konzentriert sich weiterhin auf die CardiAMP Herzinsuffizienz I und II klinischen Studien, die ihr von der FDA als Durchbruch anerkanntes Zelltherapieprodukt zur Behandlung von ischämischer Herzinsuffizienz untersuchen. Die endgültigen Ergebnisse der CardiAMP Herzinsuffizienz I Studie und Aktualisierungen zu fünf aktiv rekrutierenden Zentren in der CardiAMP Herzinsuffizienz II Studie werden bis Ende des ersten Quartals 2025 erwartet.
- Commercial launch of Morph DNA steerable introducer product family
- Cost-effective organic sales strategy without additional sales force expenses
- FDA breakthrough designation for CardiAMP cell therapy product
- initial sales approach without dedicated sales force may restrict market penetration
Insights
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.
“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.”
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.”
About Morph DNA Steerable Introducers
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 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.
A product brochure detailing available model numbers and sizes is available on the Company’s website at brochure link.
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, 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.
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.
FAQ
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