Izotropic Completes Pre-Submission Meeting with FDA for Breast Cancer Screening Indication
Izotropic (OTCQB: IZOZF) has completed its pre-submission meeting with the FDA on March 20, 2025, regarding its IzoView Breast CT Imaging System. The meeting focused on advancing the regulatory strategy for breast cancer screening indication.
The discussion involved key stakeholders including Izotropic's executive leadership, technical teams, medical advisors, and FDA representatives. Critical topics addressed included clinical protocol synopsis, radiation dose considerations, and the management of breast cancers detected by IzoView but not visible through digital breast tomosynthesis.
According to FDA Consultant Dr. Kyle Myers, the discussion was positive, with most of Izotropic's clinical data collection and study design approaches aligning with FDA expectations. Research indicates the technology's benefit in detecting additional cancers is approximately 10 times the relative risk from radiation exposure to patients.
Izotropic (OTCQB: IZOZF) ha completato il suo incontro di pre-sottomissione con la FDA il 20 marzo 2025, riguardo al suo IzoView Breast CT Imaging System. L'incontro si è concentrato sull'avanzamento della strategia regolatoria per l'indicazione di screening del cancro al seno.
La discussione ha coinvolto i principali stakeholder, tra cui i leader esecutivi di Izotropic, i team tecnici, i consulenti medici e i rappresentanti della FDA. I temi critici trattati hanno incluso la sinossi del protocollo clinico, le considerazioni sulla dose di radiazioni e la gestione dei tumori al seno rilevati da IzoView ma non visibili attraverso la tomosintesi digitale del seno.
Secondo il consulente della FDA Dr. Kyle Myers, la discussione è stata positiva, con la maggior parte dei dati clinici di Izotropic e degli approcci di design dello studio in linea con le aspettative della FDA. La ricerca indica che il beneficio della tecnologia nel rilevare ulteriori tumori è circa 10 volte il rischio relativo da esposizione alle radiazioni per i pazienti.
Izotropic (OTCQB: IZOZF) ha completado su reunión de pre-sumisión con la FDA el 20 de marzo de 2025, respecto a su IzoView Breast CT Imaging System. La reunión se centró en avanzar en la estrategia regulatoria para la indicación de detección del cáncer de mama.
La discusión involucró a las partes interesadas clave, incluidos los líderes ejecutivos de Izotropic, equipos técnicos, asesores médicos y representantes de la FDA. Los temas críticos tratados incluyeron la sinopsis del protocolo clínico, consideraciones sobre la dosis de radiación y la gestión de los cánceres de mama detectados por IzoView pero no visibles a través de la tomosíntesis digital de mama.
Según el consultor de la FDA, Dr. Kyle Myers, la discusión fue positiva, con la mayoría de la recolección de datos clínicos de Izotropic y los enfoques de diseño del estudio alineados con las expectativas de la FDA. La investigación indica que el beneficio de la tecnología en la detección de cánceres adicionales es aproximadamente 10 veces el riesgo relativo de exposición a radiación para los pacientes.
Izotropic (OTCQB: IZOZF)는 2025년 3월 20일 FDA와의 사전 제출 회의를 완료했습니다. 이번 회의는 IzoView 유방 CT 이미징 시스템에 관한 것입니다. 회의는 유방암 검진 지표에 대한 규제 전략을 발전시키는 데 초점을 맞췄습니다.
이번 논의에는 Izotropic의 경영진, 기술팀, 의료 자문 및 FDA 대표를 포함한 주요 이해관계자가 참여했습니다. 논의된 주요 주제에는 임상 프로토콜 개요, 방사선 용량 고려 사항, IzoView에 의해 감지되지만 디지털 유방 톰신세시스에서 보이지 않는 유방암 관리 등이 포함되었습니다.
FDA 컨설턴트인 Dr. Kyle Myers에 따르면, 논의는 긍정적이었으며, Izotropic의 대부분의 임상 데이터 수집 및 연구 설계 접근 방식이 FDA의 기대와 일치했습니다. 연구에 따르면, 이 기술이 추가 암을 감지하는 데 있어 얻는 이점은 방사선 노출로 인한 환자의 상대적 위험보다 약 10배 더 높습니다.
Izotropic (OTCQB: IZOZF) a terminé sa réunion de pré-soumission avec la FDA le 20 mars 2025, concernant son IzoView Breast CT Imaging System. La réunion s'est concentrée sur l'avancement de la stratégie réglementaire pour l'indication de dépistage du cancer du sein.
La discussion a impliqué des parties prenantes clés, y compris la direction exécutive d'Izotropic, les équipes techniques, les conseillers médicaux et les représentants de la FDA. Les sujets critiques abordés comprenaient le synopsis du protocole clinique, les considérations sur la dose de radiation et la gestion des cancers du sein détectés par IzoView mais non visibles par tomosynthèse numérique du sein.
Selon le consultant de la FDA, Dr. Kyle Myers, la discussion a été positive, la plupart des données cliniques et des approches de conception d'études d'Izotropic étant conformes aux attentes de la FDA. La recherche indique que le bénéfice de la technologie dans la détection de cancers supplémentaires est environ 10 fois le risque relatif d'exposition aux radiations pour les patients.
Izotropic (OTCQB: IZOZF) hat am 20. März 2025 sein Pre-Submission-Meeting mit der FDA abgeschlossen, das sich auf das IzoView Breast CT Imaging System bezog. Das Treffen konzentrierte sich darauf, die regulatorische Strategie für die Indikation des Brustkrebs-Screenings voranzubringen.
In der Diskussion waren wichtige Interessengruppen beteiligt, darunter die Geschäftsführung von Izotropic, technische Teams, medizinische Berater und Vertreter der FDA. Kritische Themen, die angesprochen wurden, umfassten die Zusammenfassung des klinischen Protokolls, Überlegungen zur Strahlendosis und das Management von Brustkrebsfällen, die von IzoView erkannt, aber nicht durch digitale Brusttomosynthese sichtbar sind.
Laut dem FDA-Berater Dr. Kyle Myers war die Diskussion positiv, da die meisten klinischen Datensammlungen und Studienansätze von Izotropic mit den Erwartungen der FDA übereinstimmten. Die Forschung zeigt, dass der Nutzen der Technologie bei der Erkennung zusätzlicher Krebserkrankungen etwa 10-mal höher ist als das relative Risiko einer Strahlenexposition für die Patienten.
- Technology shows 10x benefit-to-risk ratio in cancer detection
- Strong alignment between company's clinical approach and FDA expectations
- System capable of detecting tumors not visible through current technology
- Additional radiation exposure and contrast agent risks require careful consideration
- Complex workflow considerations for contrast-enhanced imaging of both breasts
- FDA meeting facilitated positive collaborative exchange -
- Key topics included the clinical study protocol synopsis, the benefits versus risks of contrast-enhancement, and the management of breast cancers found on IzoView Breast CT that are not visible on digital breast tomosynthesis -
- Izotropic to submit meeting minutes to the FDA prior to more detailed disclosure -
Vancouver, British Columbia and Sacramento, California--(Newsfile Corp. - March 25, 2025) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing imaging-based products utilizing innovative and emerging technologies for the more accurate screening, diagnoses, and treatment of breast cancers, is pleased to announce that it completed its pre-submission meeting with the U.S. Food and Drug Administration ("FDA") as scheduled on March 20, 2025.
The purpose of the meeting was to discuss Izotropic's recent pre-submission filing and advance the regulatory strategy for its IzoView Breast CT Imaging System. Participants included Izotropic's executive leadership, technical and engineering teams, medical advisors, FDA and statistical consultants, and legal counsel, alongside FDA representatives. The meeting discussion facilitated a collaborative exchange with the FDA, allowing the Company to address the agency's questions and considerations while aligning on expectations for the indication for use and overall clinical study.
Key topics included the overall protocol synopsis, cumulative radiation dose, study patient populations, the number and types of participating clinical study sites, and detailed discussions surrounding contrast agent usage. Specific focus was given to the benefits of contrast-enhanced breast CT in improving breast cancer detection rates in patients with dense breast tissue balanced against the associated risks of additional radiation and iodinated contrast agents. The Company and the FDA further reviewed the expected scan times and workflow for contrast-enhanced imaging when both breasts are scanned in a screening environment. Discussions also covered the proposed protocol and management of lesions and tumors visible only on IzoView Breast CT and not on digital breast tomosynthesis, and how the reference standard or "truth" for these cases would be determined to support evaluation of radiologist performance.
Izotropic's FDA Consultant, Dr. Kyle Myers reflects on the discussion:
"I thought the Izotropic-FDA pre-submission discussion was very positive. Given the large number of points for which Izotropic's approach to the clinical data collection and study design are in alignment with the FDA's expectations, we were able to focus on a small number of remaining questions from the Agency. Having Dr. Martin Yaffe and Dr. John Boone lay out their consistent finding that the estimated benefit of this technology, in terms of the additional cancers found, is around 10 times the relative risk due to the radiation to the patients was a great place to close out the meeting."
For congruence and per the FDA's procedures, the Company will submit meeting minutes to the FDA for their review prior to additional disclosure.
About Izotropic:
More information about Izotropic Corporation can be found on its website at izocorp.com and by reviewing its profile on SEDAR+ at sedarplus.ca.
Forward-Looking Statements:
This document may contain statements that are "Forward-Looking Statements," which are based upon the current estimates, assumptions, projections, and expectations of the Company's management, business, and its knowledge of the relevant market and economic environment in which it operates. The Company has tried, where possible, to identify such information and statements by using words such as "anticipate," "believe," "envision," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "contemplate" and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words.
These statements are not guarantees of performance and involve risks, including those related to capital requirements and uncertainties that are difficult to control or predict, and as such, they may cause future results of the Company's activity to differ significantly from the content and implications of such statements. Forward-Looking Statements are pertinent only as of the date on which they are made, and the Company undertakes no obligation to update or revise any Forward-Looking Statements to reflect new information or the occurrence of future events or circumstances unless otherwise required to do so by law. Neither the Company nor its shareholders, officers, and consultants shall be liable for any action and the results of any action taken by any person based on the information contained herein, including, without limitation, the purchase or sale of Company securities. Nothing in this document should be deemed to be medical or other advice of any kind. All images are for illustrative purposes only. IzoView has not yet been approved or cleared for sale.
Contacts:
Izotropic Corporation
Robert Thast
Interim Chief Executive Officer
Telephone: 1-604-220-5031 or 1-800-IZOCORP ext. 3
Email: bthast@izocorp.com
General Inquiries
Telephone: 1-604-825-4778 or 1-800-IZOCORP ext. 1
Email: info@izocorp.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/245948
FAQ
What was the outcome of IZOZF's FDA pre-submission meeting on March 20, 2025?
What are the key benefits vs risks of IzoView Breast CT discussed with FDA?
How does IZOZF's IzoView technology handle breast cancer detection in dense tissue?
What unique detection capabilities does IZOZF's IzoView Breast CT offer?
