BioCardia Announces FDA Market Clearance of Morph® DNA™ Steerable Introducer Product Family
BioCardia [Nasdaq: BCDA] has received FDA market clearance for its Morph DNA Steerable Introducer product family. This patented technology provides a pathway for introducing medical instruments into the peripheral vasculature, heart chambers, and coronary vasculature. The clearance covers 16 products in various lengths and diameters, suitable for multiple clinical applications in interventional cardiology, radiology, cardiac electrophysiology, and vascular surgery.
The Morph DNA products are expected to enhance common and advanced procedures, including peripheral vascular intervention, renal denervation, endovascular aortic repair, and atrial fibrillation treatment. BioCardia estimates that over a million procedures per year in the US could benefit from these products, with a starting list price of $1,000. The technology features bidirectional steering, improved torque response, and a unique design resembling DNA's double helix structure for consistent performance.
BioCardia [Nasdaq: BCDA] ha ricevuto l'autorizzazione al mercato FDA per la sua famiglia di prodotti Morph DNA Steerable Introducer. Questa tecnologia brevettata offre un modo per introdurre strumenti medici nel sistema vascolare periferico, nelle camere cardiache e nel sistema vascolare coronarico. L’autorizzazione copre 16 prodotti di diverse lunghezze e diametri, adatti a molteplici applicazioni cliniche in cardiologia interventistica, radiologia, elettrofisiologia cardiaca e chirurgia vascolare.
I prodotti Morph DNA dovrebbero migliorare procedure comuni e avanzate, includendo interventi vascolari periferici, denervazione renale, riparazione endovascolare dell'aorta e trattamento della fibrillazione atriale. BioCardia stima che oltre un milione di procedure all'anno negli Stati Uniti potrebbero beneficiare di questi prodotti, con un prezzo di partenza di $1.000. La tecnologia presenta un sistema di sterzata bidirezionale, una risposta al torque migliorata e un design unico che somiglia alla struttura a doppia elica del DNA per una performance costante.
BioCardia [Nasdaq: BCDA] ha recibido la autorización del mercado de la FDA para su familia de productos Morph DNA Steerable Introducer. Esta tecnología patentada proporciona un camino para la introducción de instrumentos médicos en el sistema vascular periférico, en las cámaras del corazón y en el sistema vascular coronario. La autorización abarca 16 productos de diferentes longitudes y diámetros, adecuados para múltiples aplicaciones clínicas en cardiología intervencionista, radiología, electrofisiología cardíaca y cirugía vascular.
Se espera que los productos Morph DNA mejoren procedimientos comunes y avanzados, incluida la intervención vascular periférica, la denervación renal, la reparación endovascular de la aorta y el tratamiento de la fibrilación auricular. BioCardia estima que más de un millón de procedimientos al año en los EE.UU. podrían beneficiarse de estos productos, con un precio inicial de $1,000. La tecnología cuenta con un sistema de dirección bidireccional, una respuesta al torque mejorada y un diseño único que se asemeja a la estructura de doble hélice del ADN para un rendimiento constante.
BioCardia [Nasdaq: BCDA]는 Morph DNA Steerable Introducer 제품군에 대한 FDA 시장 승인을 받았습니다. 이 특허 기술은 말초 혈관, 심장 챔버 및 관상 혈관에 의료 기기를 도입할 수 있는 경로를 제공합니다. 승인에는 다양한 길이와 직경의 16개 제품이 포함되어 있으며, 이는 인터벤션 심장학, 방사선학, 심장 전기생리학 및 혈관 수술의 다양한 임상 적용에 적합합니다.
Morph DNA 제품은 말초 혈관 인터벤션, 신장 신경 차단, 혈관 내 대동맥 수리 및 심방세동 치료를 포함한 일반 및 고급 절차를 개선할 것으로 예상됩니다. BioCardia는 미국에서 연간 백만 건 이상의 절차가 이러한 제품의 혜택을 볼 수 있다고 추정하며, 시작 가격은 $1,000입니다. 이 기술은 양방향 조향, 향상된 토크 반응 및 일관된 성능을 위한 DNA의 이중 나선 구조와 유사한 독특한 디자인을 특징으로 합니다.
BioCardia [Nasdaq: BCDA] a reçu l'autorisation du marché de la FDA pour sa famille de produits Morph DNA Steerable Introducer. Cette technologie brevetée offre une voie pour introduire des instruments médicaux dans le système vasculaire périphérique, dans les chambres cardiaques et dans le système vasculaire coronaire. L'autorisation couvre 16 produits de différentes longueurs et diamètres, appropriés pour de nombreuses applications cliniques en cardiologie interventionnelle, en radiologie, en électrophysiologie cardiaque et en chirurgie vasculaire.
Les produits Morph DNA devraient améliorer les procédures courantes et avancées, y compris l'intervention vasculaire périphérique, la dénervation rénale, la réparation endovasculaire de l'aorte et le traitement de la fibrillation auriculaire. BioCardia estime que plus d'un million de procédures par an aux États-Unis pourraient bénéficier de ces produits, avec un prix de départ de 1 000 $. La technologie offre une direction bidirectionnelle, une réponse au couple améliorée et un design unique ressemblant à la structure en double hélice de l'ADN pour des performances constantes.
BioCardia [Nasdaq: BCDA] hat die Marktzulassung der FDA für seine Produktfamilie Morph DNA Steerable Introducer erhalten. Diese patentierte Technologie bietet einen Weg zur Einführung medizinischer Instrumente in das periphere Gefäßsystem, die Herzkammern und das koronare Gefäßsystem. Die Zulassung umfasst 16 Produkte in verschiedenen Längen und Durchmessern, die für zahlreiche klinische Anwendungen in der interventionellen Kardiologie, Radiologie, elektrophysiologischen Kardiologie und Gefäßchirurgie geeignet sind.
Die Morph DNA Produkte werden voraussichtlich gängige und fortgeschrittene Verfahren verbessern, darunter periphere Gefäßeingriffe, renale Denervation, endovaskuläre Aortenreparatur und Behandlung von Vorhofflimmern. BioCardia schätzt, dass jährlich über eine Million Eingriffe in den USA von diesen Produkten profitieren könnten, bei einem Einstiegspreis von 1.000 $. Die Technologie bietet eine bidirektionale Steuerung, verbesserte Drehmomentreaktion und ein einzigartiges Design, das der Doppelhelixstruktur der DNA ähnelt, um eine konsistente Leistung zu gewährleisten.
- FDA market clearance for Morph DNA Steerable Introducer product family
- 16 products cleared, covering various clinical applications
- Potential to enhance common and advanced medical procedures
- Estimated market of over 1 million procedures per year in the US
- Starting list price of $1,000 per product
- None.
Insights
The FDA clearance of BioCardia's Morph® DNA™ Steerable Introducer product family is a significant milestone for the company. This approval expands their product line from a single diameter to 16 different configurations, potentially addressing a wider range of clinical applications. The device's innovative design, featuring bidirectional steering and a proprietary layup for torque response, could offer improved control and efficiency in various cardiovascular procedures.
The potential market for this product family is substantial, with BioCardia estimating over
While the clearance is promising, investors should note that successful commercialization and market acceptance are important next steps. The company's ability to effectively market and distribute these products will be key to realizing their potential value.
This FDA clearance represents a positive development for BioCardia's financial outlook. The expansion of their product line could potentially diversify and increase their revenue streams. With an estimated
However, investors should consider several factors:
- Market penetration rate and adoption by healthcare providers
- Production costs and profit margins
- Potential competition in the market
- The company's current financial position and ability to scale production and sales
While the news is encouraging, it's important to note that FDA clearance doesn't guarantee commercial success. The company's execution in manufacturing, marketing and sales will be important in translating this opportunity into tangible financial results.
The Morph® DNA™ Steerable Introducer's FDA clearance is a noteworthy development for cardiovascular procedures. Its bidirectional steering and proprietary design could potentially enhance control and precision in complex interventions. The product's versatility across various applications, including peripheral vascular intervention, renal denervation and atrial fibrillation treatments, is particularly impressive.
The device's ability to potentially reduce procedure times and access difficult anatomies could lead to improved patient outcomes and increased procedural efficiency. However, as with any new medical device, real-world performance and long-term safety data will be crucial. Adoption rates among surgeons will likely depend on:
- Ease of use and learning curve
- Comparative effectiveness against existing solutions
- Cost-effectiveness in improving patient outcomes
While promising, the true clinical impact of this device family will only be determined through extensive use in various surgical settings.
SUNNYVALE, Calif., Aug. 29, 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 that the Food and Drug Administration (FDA) has cleared BioCardia to market the Morph DNA Steerable Introducer product family, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act.
The patented Morph® DNA™ Steerable Introducer product family now has FDA market clearance 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 clearance covers sixteen products in lengths of 30, 45, 71, and 90 centimeters in 5, 6, 7, and 8 French introducer sheath equivalent diameters.
These products are expected to cover most clinical applications in interventional cardiology, interventional radiology, cardiac electrophysiology, and vascular surgery. The product solution is also expected to enhance some of the most common and advanced procedures performed in the United States, including peripheral vascular intervention for contralateral access, renal denervation for the treatment of high blood pressure, endovascular aortic repair, carotid artery stenting, treating perivalvular leaks in structural heart procedures, and enabling left heart access for the mapping and ablation of atrial fibrillation.
“BioCardia’s previous Morph product in a single diameter has already been used in each of these various clinical indications, totaling approximately 12,000 commercial procedures,” said Peter Altman PhD, President and CEO. He continued, “We are looking forward to introducing the more advanced Morph DNA products to our valued physician customers and earning their business. Over time, I expect this product family to provide value to physicians and their patients. We estimate that more than a million procedures performed per year in the United States may benefit from these products, which are expected to have a list price starting at
“We developed this product initially to address our own needs for enhanced control navigating inside the left ventricle of the heart to perform our CardiAMP® and CardiALLO™ cell therapy procedures, and this Morph DNA product family is the outcome of our belief that there are additional advanced interventional procedures where the Morph DNA platform could provide physicians with improved access and control, resulting in reduced procedure times, access to new or difficult to reach anatomies, and predictable and reliable performance for their patients,” said Edward Gillis, BioCardia’s Senior Vice President of Devices.
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.
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 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 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.
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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