Conavi Medical Highly Encouraged by New U.S. Intracoronary Guidelines
Conavi Medical (OTC: CNVIF) received strong validation from new U.S. intracoronary imaging guidelines issued by the American College of Cardiology and American Heart Association. The Class 1A guidelines, representing the highest level of evidence, emphasize the essential roles of both IVUS and OCT imaging in coronary procedures.
The guidelines specifically highlight how these imaging technologies are important for evaluating lesion preparation, stent sizing, reducing geographical errors, confirming stent expansion, identifying complications, and determining stent failure causes. Clinical data shows intracoronary imaging leads to a 46% reduction in cardiac death compared to angiography alone.
Conavi's Novasight system, as the only hybrid IVUS-OCT device in the market, uniquely positions the company by offering both imaging modalities in a single platform. This combination helps streamline procedures, limit contrast usage, and support more informed clinical decisions for complex coronary artery disease patients.
Conavi Medical (OTC: CNVIF) ha ricevuto una forte validazione dalle nuove linee guida per l'imaging intracoronarico degli Stati Uniti emesse dall'American College of Cardiology e dall'American Heart Association. Le linee guida di Classe 1A, che rappresentano il livello più alto di evidenza, sottolineano i ruoli essenziali sia dell'imaging IVUS che dell'OCT nelle procedure coronariche.
Le linee guida evidenziano specificamente come queste tecnologie di imaging siano importanti per valutare la preparazione delle lesioni, dimensionare gli stent, ridurre gli errori geografici, confermare l'espansione degli stent, identificare complicazioni e determinare le cause di fallimento degli stent. I dati clinici mostrano che l'imaging intracoronarico porta a una riduzione del 46% della mortalità cardiaca rispetto all'angiografia da sola.
Il Novasight system di Conavi, essendo l'unico dispositivo ibrido IVUS-OCT sul mercato, posiziona unicamente l'azienda offrendo entrambe le modalità di imaging su un'unica piattaforma. Questa combinazione aiuta a semplificare le procedure, limitare l'uso di contrasto e supportare decisioni cliniche più informate per i pazienti con malattia coronarica complessa.
Conavi Medical (OTC: CNVIF) recibió una fuerte validación de las nuevas directrices de imagen intracoronaria de EE. UU. emitidas por el American College of Cardiology y la American Heart Association. Las directrices de Clase 1A, que representan el nivel más alto de evidencia, enfatizan los roles esenciales tanto de la imagen IVUS como de la OCT en los procedimientos coronarios.
Las directrices destacan específicamente cómo estas tecnologías de imagen son importantes para evaluar la preparación de lesiones, dimensionar stents, reducir errores geográficos, confirmar la expansión de stents, identificar complicaciones y determinar las causas de fallo de stents. Los datos clínicos muestran que la imagen intracoronaria conduce a una reducción del 46% en la mortalidad cardíaca en comparación con la angiografía sola.
El sistema Novasight de Conavi, siendo el único dispositivo híbrido IVUS-OCT en el mercado, posiciona a la empresa de manera única al ofrecer ambas modalidades de imagen en una sola plataforma. Esta combinación ayuda a agilizar los procedimientos, limitar el uso de contraste y apoyar decisiones clínicas más informadas para pacientes con enfermedad arterial coronaria compleja.
Conavi Medical (OTC: CNVIF)는 미국 심장학회와 미국 심장 협회에서 발표한 새로운 관상동맥 내 이미징 가이드라인으로부터 강력한 검증을 받았습니다. 1A 등급 가이드라인은 가장 높은 수준의 증거를 나타내며, 관상동맥 시술에서 IVUS와 OCT 이미징의 필수적인 역할을 강조합니다.
가이드라인은 이러한 이미징 기술이 병변 준비 평가, 스텐트 크기 결정, 지리적 오류 감소, 스텐트 확장 확인, 합병증 식별 및 스텐트 실패 원인 파악에 얼마나 중요한지를 구체적으로 강조합니다. 임상 데이터에 따르면 관상동맥 내 이미징은 단독 혈관 조영술에 비해 심장 사망률을 46% 감소시킵니다.
Conavi의 Novasight 시스템은 시장에서 유일한 하이브리드 IVUS-OCT 장치로, 두 가지 이미징 모드를 단일 플랫폼에서 제공하여 회사를 독특하게 위치시킵니다. 이 조합은 절차를 간소화하고, 조영제 사용을 제한하며, 복잡한 관상동맥 질환 환자에 대한 보다 정보에 기반한 임상 결정을 지원하는 데 도움이 됩니다.
Conavi Medical (OTC: CNVIF) a reçu une forte validation des nouvelles directives d'imagerie intracoronaire des États-Unis émises par l'American College of Cardiology et l'American Heart Association. Les directives de classe 1A, représentant le plus haut niveau de preuve, soulignent les rôles essentiels de l'imagerie IVUS et OCT dans les procédures coronaires.
Les directives mettent spécifiquement en avant l'importance de ces technologies d'imagerie pour évaluer la préparation des lésions, dimensionner les stents, réduire les erreurs géographiques, confirmer l'expansion des stents, identifier les complications et déterminer les causes d'échec des stents. Les données cliniques montrent que l'imagerie intracoronaire entraîne une réduction de 46 % de la mortalité cardiaque par rapport à l'angiographie seule.
Le système Novasight de Conavi, étant le seul dispositif hybride IVUS-OCT sur le marché, positionne l'entreprise de manière unique en offrant les deux modalités d'imagerie sur une seule plateforme. Cette combinaison aide à rationaliser les procédures, à limiter l'utilisation de contraste et à soutenir des décisions cliniques plus éclairées pour les patients atteints de maladies coronariennes complexes.
Conavi Medical (OTC: CNVIF) erhielt eine starke Bestätigung durch die neuen US-amerikanischen intrakoronaren Bildgebungsrichtlinien, die vom American College of Cardiology und der American Heart Association herausgegeben wurden. Die Richtlinien der Klasse 1A, die das höchste Evidenzniveau darstellen, betonen die wesentlichen Rollen sowohl der IVUS- als auch der OCT-Bildgebung bei koronaren Eingriffen.
Die Richtlinien heben insbesondere hervor, wie wichtig diese Bildgebungstechnologien für die Bewertung der Läsionsvorbereitung, die Größenbestimmung von Stents, die Reduzierung geografischer Fehler, die Bestätigung der Stent-Expansion, die Identifizierung von Komplikationen und die Bestimmung der Ursachen für Stentversagen sind. Klinische Daten zeigen, dass die intrakoronare Bildgebung zu einer 46%igen Reduktion der Herzsterblichkeit im Vergleich zur alleinigen Angiographie führt.
Das Novasight-System von Conavi, als das einzige hybride IVUS-OCT-Gerät auf dem Markt, positioniert das Unternehmen einzigartig, indem es beide Bildgebungsmodalitäten auf einer einzigen Plattform anbietet. Diese Kombination hilft, Verfahren zu optimieren, den Einsatz von Kontrastmitteln zu begrenzen und informiertere klinische Entscheidungen für Patienten mit komplexer koronarer Herzkrankheit zu unterstützen.
- Only provider of hybrid IVUS-OCT imaging technology
- New Class 1A guidelines validate company's technology
- Clinical data shows 46% reduction in cardiac death risk
- Strong market positioning for complex coronary procedures
- None.
– IVUS and OCT cited as playing essential and complementary roles, validating Novasight’s unique hybrid imaging capability
– Guidelines constitute strong recommendations based on the highest level of evidence
– Clinical data show intracoronary imaging leads to lower risk of target vessel failure (including cardiac death) in coronary procedures
– Company anticipates similar changes to other guidelines covering coronary procedures
TORONTO, March 04, 2025 (GLOBE NEWSWIRE) -- Conavi Medical Corp. (TSXV: CNVI; OTC: CNVIF) (“Conavi Medical” or the “Company”), a commercial stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures, responded today to new intracoronary imaging guidelines by the American College of Cardiology, American Heart Association and other medical organizations. The guidelines apply to patients presenting with acute coronary syndrome (ACS) and undergoing a coronary intervention in the left main artery or complex lesions. Notably, the guidelines are rated Class 1A, indicating the highest level of evidence and strongest level of recommendation.
The new guidelines offer strong validation for Conavi as the only provider of hybrid IVUS (ultrasound) and OCT (optical) imaging technology. As the authors explain, “both IVUS and OCT play essential roles in evaluating the necessity for lesion preparation, choosing the appropriate stent size, reducing the likelihood of geographical errors, confirming proper stent expansion, identifying complications, and determining the underlying reasons for stent failure.”
"The updated guidelines reaffirm the critical role of intracoronary imaging in optimizing stent procedures and improving patient outcomes," said Dr. Megha Prasad, an interventional cardiologist. "By leveraging the advantages of both IVUS and OCT, we can enhance precision in stent placement, minimize complications, and ultimately optimize care for patients with complex coronary artery disease. Conavi’s Novasight system, as the only hybrid IVUS-OCT device, uniquely equips physicians with both imaging modalities in a single platform, streamlining procedures, limiting contrast usage, and supporting more informed clinical decisions."
“We’re highly encouraged that both IVUS and OCT imaging are recognized as important and complementary,” commented Thomas Looby, Conavi’s CEO. “The changes reflect the mounting evidence of improved patient outcomes, including a
The new guidelines are available at doi.org/10.1016/j.jacc.2024.11.009. Please see section 7.3 for “Use of Intracoronary Imaging”.
About Conavi Medical
Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ System is the first system to combine both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to enable simultaneous and co-registered imaging of coronary arteries. The Novasight Hybrid System has 510(k) clearance from the U.S. Food and Drug Administration; and regulatory approval for clinical use from Health Canada, China’s National Medical Products Administration, and Japan’s Ministry of Health, Labor and Welfare. For more information, visit conavi.com.
Cautionary Statement Regarding Forward-Looking Information
This news release contains “forward-looking statements” within the meaning of applicable Canadian and U.S. securities laws, which reflect the current expectations of management of Conavi’s future growth, results of operations, performance and business prospects and opportunities. Forward-looking statements are frequently, but not always, identified by words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions, although these words may not be present in all forward-looking statements. Forward-looking statements that appear in this release may include, without limitation, references to Conavi’s plans for the commercialization of its Novasight Hybrid™ system and potential future changes to clinical guidelines.
These forward-looking statements reflect management’s current beliefs with respect to future events, and are based on information currently available to management that, while considered reasonable by management as of the date on which the statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in actions, events, conditions, results, performance or achievements to be materially different from those projected in the forward-looking statements. Forward-looking statements involve significant risks, uncertainties and assumptions and many factors could cause Conavi’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. Such factors and assumptions include, but are not limited to, Conavi’s ability to retain key personnel; its ability to execute on its business plans and strategies; and other factors listed in the “Risk Factors” sections of the joint information circular of Conavi dated August 30, 2024 and of the Preliminary Prospectus of the Company dated January 29, 2025 (each of which may be viewed at sedarplus.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance, or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements.
Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions and Conavi has attempted to identify important factors that could cause actual actions, events, conditions, results, performance or achievements to differ materially from those described in forward-looking statements, Conavi cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by law, Conavi expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Accordingly, investors should not place undue reliance on forward-looking statements. All the forward-looking statements are expressly qualified by the foregoing cautionary statements.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Contacts
Stefano Picone
Chief Financial Officer
ir@conavi.com
(416) 483-0100
1 Stone GW, Intravascular imaging-guided coronary drug-eluting stent implantation: an updated network meta-analysis, The Lancet 2024; 403: 824–3.
FAQ
What impact do the new intracoronary guidelines have on Conavi Medical (CNVIF)?
How much do intracoronary imaging procedures reduce cardiac death risk according to CNVIF's data?
What specific benefits does Conavi's Novasight system offer for coronary procedures?
What is the significance of the Class 1A rating in the new guidelines for CNVIF?
