BioCardia Submits for FDA Approval of Morph® DNA™ Steerable Introducer Product Family
BioCardia, Inc. [Nasdaq: BCDA] has submitted a 510(k) for FDA approval of its Morph® DNA™ Steerable Introducer Sheath product family. This technology is designed to provide a pathway for medical instruments in cardiovascular procedures. The Morph DNA design allows for smooth navigation and prevents catheter 'whip' during use. The potential market for this product spans millions of procedures annually, including cardiac interventions, peripheral vascular interventions, and structural heart procedures. This submission follows the FDA approval of BioCardia's Helix biotherapeutic delivery Morph DNA guide system and Avance transseptal steerable introducer. The company aims to use this technology platform in its biotherapeutic interventions for heart failure, refractory angina, and acute myocardial infarction treatments.
BioCardia, Inc. [Nasdaq: BCDA] ha presentato una richiesta 510(k) per l'approvazione della FDA della sua famiglia di prodotti Morph® DNA™ Steerable Introducer Sheath. Questa tecnologia è progettata per fornire un percorso per strumenti medici nelle procedure cardiovascolari. Il design Morph DNA consente una navigazione fluida e previene il 'whip' del catetere durante l'uso. Il mercato potenziale per questo prodotto comprende milioni di procedure annuali, tra cui interventi cardiaci, interventi vascolari periferici e procedure cardiache strutturali. Questa presentazione segue l'approvazione da parte della FDA del sistema di guida bioterapeutica Morph DNA di BioCardia e dell'introduttore transettale steerable Avance. L'azienda intende utilizzare questa piattaforma tecnologica nei suoi interventi bioterapeutici per l'insufficienza cardiaca, l'angina refrattaria e i trattamenti per l'infarto miocardico acuto.
BioCardia, Inc. [Nasdaq: BCDA] ha presentado una solicitud 510(k) para la aprobación de la FDA de su familia de productos Morph® DNA™ Steerable Introducer Sheath. Esta tecnología está diseñada para proporcionar un camino para instrumentos médicos en procedimientos cardiovasculares. El diseño Morph DNA permite una navegación suave y previene el 'whip' del catéter durante su uso. El mercado potencial para este producto abarca millones de procedimientos anuales, incluidos intervenciones cardíacas, intervenciones vasculares periféricas y procedimientos cardíacos estructurales. Esta presentación sigue a la aprobación por parte de la FDA del sistema de guía de entrega bioterapéutica Morph DNA de BioCardia y del introducer transseptal steerable Avance. La empresa tiene como objetivo utilizar esta plataforma tecnológica en sus intervenciones bioterapéuticas para la insuficiencia cardíaca, angina refractaria y tratamientos para infartos de miocardio agudos.
BioCardia, Inc. [Nasdaq: BCDA]는 Morph® DNA™ Steerable Introducer Sheath 제품군에 대한 FDA 승인을 위한 510(k)를 제출했습니다. 이 기술은 심혈관 절차에서 의료 기기를 위한 경로를 제공하도록 설계되었습니다. Morph DNA 디자인은 부드러운 내비게이션을 가능하게 하고 사용 중 카테터 '휘어짐'을 방지합니다. 이 제품의 잠재적 시장은 연간 수백만 건의 절차에 걸쳐 있으며, 심장 개입, 말초 혈관 개입 및 구조적 심장 절차를 포함합니다. 이 제출은 BioCardia의 Helix 바이오 치료 배달 Morph DNA 가이드 시스템과 Avance 트랜섹탈 스티어러블 인트로듀서의 FDA 승인을 따릅니다. 이 회사는 심부전, 난치성 협심증 및 급성 심근 경색 치료를 위한 바이오 치료 개입에 이 기술 플랫폼을 활용하는 것을 목표로 하고 있습니다.
BioCardia, Inc. [Nasdaq: BCDA] a soumis une demande 510(k) pour l'approbation de la FDA de sa famille de produits Morph® DNA™ Steerable Introducer Sheath. Cette technologie est conçue pour fournir un chemin pour les instruments médicaux lors des procédures cardiovasculaires. Le design Morph DNA permet une navigation fluide et prévient l'effet de 'whip' du cathéter durant son utilisation. Le marché potentiel pour ce produit couvre des millions de procédures annuelles, y compris des interventions cardiaques, des interventions vasculaires périphériques et des procédures cardiaques structurelles. Cette soumission fait suite à l'approbation par la FDA du système de guidage biothérapeutique Morph DNA de BioCardia et de l'introducteur transseptal steerable Avance. L'entreprise vise à utiliser cette plateforme technologique dans ses interventions biothérapeutiques pour l'insuffisance cardiaque, l'angine réfractaire et les traitements pour l'infarctus du myocarde aigu.
BioCardia, Inc. [Nasdaq: BCDA] hat einen 510(k) zur Genehmigung durch die FDA für seine Produktfamilie Morph® DNA™ Steerable Introducer Sheath eingereicht. Diese Technologie soll einen Zugang für medizinische Instrumente bei kardiovaskulären Verfahren bieten. Das Morph DNA Design ermöglicht eine sanfte Navigation und verhindert das 'Whip' des Katheters während der Anwendung. Der potenzielle Markt für dieses Produkt umfasst Millionen von Eingriffen jährlich, einschließlich kardiologischer Interventionen, peripherer vaskulärer Interventionen und struktureller Herzverfahren. Diese Einreichung folgt der Genehmigung durch die FDA des biotherapeutischen Liefersystems Morph DNA von BioCardia sowie des Avance transseptalen steuerbaren Introducers. Das Unternehmen plant, diese Technologieplattform in seinen biotherapeutischen Eingriffen zur Behandlung von Herzinsuffizienz, refraktärer Angina und akutem Myokardinfarkt zu nutzen.
- Submission of 510(k) for FDA approval of Morph® DNA™ Steerable Introducer Sheath
- Potential market of millions of procedures annually
- Previously received FDA approval for related Morph DNA technology products
- Technology designed to improve catheter performance and prevent 'whip'
- None.
BioCardia's submission of a 510(k) for the Morph® DNA™ Steerable Introducer Sheath family is a significant development in the medical device sector. This innovative product line aims to address a substantial market, potentially impacting
The Morph DNA technology's unique design, which allows for consistent catheter performance in any direction, could be a game-changer in complex vascular interventions. By potentially reducing the risk of catheter "whip," it may enhance procedural safety and efficiency.
However, it's important to note that FDA approval is not guaranteed. The review process typically takes 3-6 months and the FDA may request additional data or modifications. If approved, BioCardia will face the challenge of market adoption, competing against established products from larger medical device companies.
The broad applicability of this technology across various cardiovascular and pulmonary interventions could position BioCardia favorably in the market. However, the company will need to demonstrate clear clinical benefits and cost-effectiveness to drive adoption among healthcare providers.
From a financial perspective, this FDA submission represents a potential catalyst for BioCardia's stock. If approved, the Morph DNA Steerable Introducer Sheath could significantly expand the company's addressable market and revenue streams.
However, investors should exercise caution. As a small-cap biotech company (market cap of approximately
It's worth noting that BioCardia's stock has historically reacted positively to FDA-related news. For instance, when the FDA approved the Helix biotherapeutic delivery system in May 2022, the stock saw a significant uptick. However, past performance doesn't guarantee future results.
Investors should also consider the broader competitive landscape. While this product could give BioCardia an edge, larger medical device companies with more resources could potentially develop similar technologies or acquire BioCardia if the product proves successful.
SUNNYVALE, Calif., July 30, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported it has submitted a 510(k) for approval of its patented Morph® DNA™ Steerable Introducer Sheath. This product family is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.
The filing for approval of this product family follows the FDA approval of BioCardia’s Helix biotherapeutic delivery Morph DNA guide system and its Avance transseptal steerable introducer, both of which incorporate Morph DNA technology. Morph DNA designs enable the tensioning elements in the catheter to rotate around the catheter shaft, allowing consistent catheter performance in any direction. The DNA name reflects this design, as these tensioning elements appear as a double helix like that 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.
This potential vascular market for this product family is measured in millions of procedures per year, including cardiac interventions such as structural heart procedures and electrophysiology procedures, peripheral vascular interventions including renal interventions, endovascular aortic repair, and carotid artery interventions. The product family approval is intended to span the range of sizes and lengths to accommodate many of these procedures.
“All of the biotherapeutic interventions we support for treatment of heart failure, refractory angina, and acute myocardial infarction are expected to utilize this same introducer technology platform,” said Peter Altman, PhD, BioCardia’s President and Chief Executive Officer. “This submission for approval of the Morph DNA Steerable Introducer Sheath product family for broader clinical usage in other complex clinical procedures is in line with our mission to enable and advance therapeutic solutions for cardiovascular and pulmonary diseases.”
About BioCardia®
BioCardia, Inc., headquartered in Sunnyvale, California, is developing 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. For more information visit: www.biocardia.com/.
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 the potential vascular market for the Morph DNA steerable introducer product Family. 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 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.
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
FAQ
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