FDA Sets Meeting Date with Izotropic
Izotropic (OTCQB: IZOZF) announces that the FDA has scheduled a pre-submission meeting for March 20, 2025, regarding the clinical study design for its IzoView Breast CT Imaging System. The company plans to launch IzoView with contrast-enhancement as an adjunctive screening tool to 3D mammography, specifically targeting patients with dense breast tissue.
Dense breast tissue, affecting approximately 50% of U.S. women, is both a risk factor for breast cancer and makes standard screening methods less effective. The technology, developed at UC Davis Medical Center, has demonstrated promising results through four successive breast CT systems tested in clinical trials. Izotropic holds exclusive global licensing rights to this technology, which has been supported by peer-reviewed scientific research.
Izotropic (OTCQB: IZOZF) annuncia che la FDA ha programmato un incontro pre-sottomissione per il 20 marzo 2025, riguardo al design dello studio clinico per il suo IzoView Breast CT Imaging System. L'azienda prevede di lanciare IzoView con miglioramento del contrasto come strumento di screening aggiuntivo alla mammografia 3D, mirato specificamente a pazienti con tessuto mammario denso.
Il tessuto mammario denso, che colpisce circa il 50% delle donne negli Stati Uniti, è sia un fattore di rischio per il cancro al seno sia riduce l'efficacia dei metodi di screening standard. La tecnologia, sviluppata presso il UC Davis Medical Center, ha dimostrato risultati promettenti attraverso quattro sistemi di TC mammaria successivi testati in studi clinici. Izotropic detiene i diritti di licenza esclusiva a livello globale per questa tecnologia, che è stata supportata da ricerche scientifiche sottoposte a revisione paritaria.
Izotropic (OTCQB: IZOZF) anuncia que la FDA ha programado una reunión previa a la presentación para el 20 de marzo de 2025, sobre el diseño del estudio clínico para su IzoView Breast CT Imaging System. La compañía planea lanzar IzoView con un contraste mejorado como herramienta de detección complementaria a la mamografía 3D, dirigiéndose específicamente a pacientes con tejido mamario denso.
El tejido mamario denso, que afecta aproximadamente al 50% de las mujeres en EE. UU., es un factor de riesgo para el cáncer de mama y hace que los métodos de detección estándar sean menos efectivos. La tecnología, desarrollada en el Centro Médico UC Davis, ha demostrado resultados prometedores a través de cuatro sistemas sucesivos de TC mamaria probados en ensayos clínicos. Izotropic posee los derechos de licencia global exclusiva para esta tecnología, que ha sido respaldada por investigaciones científicas revisadas por pares.
이조트로픽 (OTCQB: IZOZF)는 FDA가 2025년 3월 20일 IzoView 유방 CT 이미징 시스템의 임상 연구 설계에 관한 사전 제출 회의를 예정했다고 발표했습니다. 이 회사는 3D 유방촬영술에 대한 보조 스크리닝 도구로서 대비 증강을 포함한 IzoView를 출시할 계획이며, 특히 밀도가 높은 유방 조직을 가진 환자를 대상으로 하고 있습니다.
밀도가 높은 유방 조직은 미국 여성의 약 50%에 영향을 미치며, 이는 유방암의 위험 요소이자 표준 스크리닝 방법의 효과를 감소시킵니다. UC 데이비스 의료 센터에서 개발된 이 기술은 임상 시험에서 테스트된 네 개의 연속 유방 CT 시스템을 통해 유망한 결과를 보여주었습니다. 이조트로픽은 이 기술에 대한 독점적인 글로벌 라이선스 권리를 보유하고 있으며, 동료 검토된 과학 연구에 의해 뒷받침되고 있습니다.
Izotropic (OTCQB: IZOZF) annonce que la FDA a programmé une réunion pré-soumission pour le 20 mars 2025, concernant la conception de l'étude clinique pour son IzoView Breast CT Imaging System. L'entreprise prévoit de lancer IzoView avec un renforcement du contraste comme outil de dépistage complémentaire à la mammographie 3D, ciblant spécifiquement les patientes ayant un tissu mammaire dense.
Le tissu mammaire dense, qui affecte environ 50 % des femmes aux États-Unis, est à la fois un facteur de risque pour le cancer du sein et rend les méthodes de dépistage standard moins efficaces. La technologie, développée au UC Davis Medical Center, a montré des résultats prometteurs à travers quatre systèmes de CT mammaire successifs testés dans des essais cliniques. Izotropic détient les droits de licence exclusifs à l'échelle mondiale pour cette technologie, qui a été soutenue par des recherches scientifiques évaluées par des pairs.
Izotropic (OTCQB: IZOZF) gibt bekannt, dass die FDA für den 20. März 2025 ein Pre-Submission-Meeting bezüglich des klinischen Studiendesigns für ihr IzoView Breast CT Imaging System angesetzt hat. Das Unternehmen plant, IzoView mit Kontrastverstärkung als ergänzendes Screening-Tool zur 3D-Mammographie auf den Markt zu bringen, wobei es speziell auf Patienten mit dichtem Brustgewebe abzielt.
Dichtes Brustgewebe, das etwa 50% der Frauen in den USA betrifft, ist sowohl ein Risikofaktor für Brustkrebs als auch macht die standardmäßigen Screening-Methoden weniger effektiv. Die Technologie, die am UC Davis Medical Center entwickelt wurde, hat durch vier aufeinanderfolgende in klinischen Studien getestete Brust-CT-Systeme vielversprechende Ergebnisse gezeigt. Izotropic hält die exklusiven globalen Lizenzrechte an dieser Technologie, die durch peer-reviewed wissenschaftliche Forschung unterstützt wird.
- FDA pre-submission meeting date confirmed for March 20, 2025
- Technology targets large market with ~50% of U.S. women having dense breast tissue
- Exclusive global licensing rights secured from UC Davis
- Technology de-risked through four successive clinical trials
- Substantial peer-reviewed research supporting technology capabilities
- Product still pending FDA approval
- Timeline to market launch remains uncertain
Vancouver, British Columbia and Sacramento, California--(Newsfile Corp. - February 19, 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, announces that the U.S. Food and Drug Administration ("FDA") has set the Company's pre-submission meeting date, further to its January pre-submission filing.
The Company filed a pre-submission with the FDA on the subject of its clinical study design for the approval of its first medical imaging device, the IzoView Breast CT Imaging System ("IzoView"). The FDA has scheduled the pre-submission meeting for March 20, 2025.
Izotropic intends to launch IzoView with contrast-enhancement for breast cancer screening adjunctive to digital breast tomosynthesis, commonly referred to as 3D mammography, for patients with dense breast tissue. Dense breast tissue is both a risk factor for developing breast cancer and a patient characteristic that affects ~
Izotropic is committed to its mission to bring new devices and technologies to the market and will continue to seek out opportunities to increase efficiency and expedite patient access to its products to achieve better outcomes for patients and save lives from breast cancer.
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:
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/241425
FAQ
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