Izotropic Files Pre-Submission with U.S. FDA for Breast Cancer Screening
Izotropic has filed a pre-submission with the U.S. FDA for its IzoView Breast CT Imaging System, targeting breast cancer screening in women with dense breast tissue as an adjunct to 3D mammography. The company's strategic approach aims to increase potential annual IzoView scans market size by over 800%.
The comprehensive 60-page filing includes clinical study plans projecting a 2.5-year timeline at an approximate cost of USD 3.5 million. IzoView offers high-resolution true 3D imaging with 100 times greater spatial resolution than MRI, potentially detecting lesions and tumors as small as 2mm when used with contrast enhancement. The system operates without painful breast compression and produces approximately 500 high-resolution images in 10 seconds.
The clinical study will involve 3 sites and includes a 1-year negative cancer case validation period. The company awaits FDA's confirmation of the pre-submission meeting date within their 75-day processing window.
Izotropic ha presentato una pre-sottomissione all'U.S. FDA per il suo IzoView Breast CT Imaging System, mirato allo screening del cancro al seno in donne con tessuto mammario denso, come complemento alla mammografia 3D. L'approccio strategico dell'azienda punta ad aumentare le dimensioni del mercato potenziale delle scansioni annuali di IzoView di oltre l'800%.
Il documento completo di 60 pagine include piani per studi clinici che prevedono una tempistica di 2,5 anni a un costo approssimativo di 3,5 milioni di dollari. IzoView offre immagini 3D vere ad alta risoluzione con una risoluzione spaziale 100 volte superiore rispetto alla risonanza magnetica, permettendo potenzialmente di rilevare lesioni e tumori di dimensioni fino a 2 mm quando utilizzato con un miglioramento del contrasto. Il sistema funziona senza compressione dolorosa del seno e produce circa 500 immagini ad alta risoluzione in 10 secondi.
Lo studio clinico coinvolgerà 3 siti e include un periodo di validazione di casi negativi di cancro di 1 anno. L'azienda attende la conferma da parte dell'FDA della data della riunione pre-sottomissone all'interno della loro finestra di elaborazione di 75 giorni.
Izotropic ha presentado una pre-sumisión a la FDA de EE. UU. para su IzoView Breast CT Imaging System, dirigido al cribado del cáncer de mama en mujeres con tejido mamario denso como complemento de la mamografía en 3D. El enfoque estratégico de la empresa tiene como objetivo aumentar el tamaño potencial del mercado de exploraciones anuales de IzoView en más del 800%.
El completo documento de 60 páginas incluye planes de estudios clínicos que proyectan un cronograma de 2.5 años a un costo aproximado de 3.5 millones de dólares. IzoView ofrece imágenes 3D verdaderas de alta resolución con una resolución espacial 100 veces mayor que la de la resonancia magnética, lo que permite detectar potencialmente lesiones y tumores tan pequeños como 2 mm cuando se utiliza con mejora de contraste. El sistema opera sin compresión dolorosa del seno y produce aproximadamente 500 imágenes de alta resolución en 10 segundos.
El estudio clínico involucrará 3 sitios e incluye un período de validación de casos negativos de cáncer de 1 año. La empresa espera la confirmación de la FDA sobre la fecha de la reunión de pre-sumisión dentro de su ventana de procesamiento de 75 días.
Izotropic은 IzoView Breast CT Imaging System에 대해 미국 FDA에 사전 제출을 했으며, 이는 밀도가 높은 유방 조직을 가진 여성의 유방암 선별 검사를 3D 유방촬영술의 보조 수단으로 삼는 것입니다. 회사의 전략적 접근 방식은 IzoView 스캔의 잠재적 연간 시장 규모를 800% 이상 증가시키는 것을 목표로 하고 있습니다.
60페이지에 달하는 포괄적인 제출서에는 약 350만 달러의 비용으로 2.5년의 타임라인을 예상하는 임상 연구 계획이 포함되어 있습니다. IzoView는 MRI보다 100배 더 높은 공간 해상도로 진짜 3D 이미지를 제공하며, 조영제를 사용하면 2mm 크기까지의 병변과 종양을 탐지할 수 있습니다. 이 시스템은 통증 없는 유방 압축으로 작동하며, 10초 안에 약 500장의 고해상도 이미지를 생성합니다.
임상 연구에는 3개 사이트가 참여하며 1년의 음성 암 사례 검증 기간이 포함됩니다. 회사는 75일 처리 기간 내에 FDA가 사전 제출 회의 날짜를 확인하기를 기다리고 있습니다.
Izotropic a soumis une pré-demande à la FDA des États-Unis pour son IzoView Breast CT Imaging System, visant le dépistage du cancer du sein chez les femmes ayant un tissu mammaire dense en complément à la mammographie 3D. L'approche stratégique de l'entreprise vise à augmenter la taille potentielle du marché des scans IzoView annuels de plus de 800%.
Le dossier complet de 60 pages comprend des plans d'études cliniques prévoyant un délai de 2,5 ans pour un coût approximatif de 3,5 millions de dollars. IzoView offre des images 3D réelles de haute résolution avec une résolution spatiale 100 fois supérieure à celle de l'IRM, permettant de détecter potentiellement des lésions et des tumeurs aussi petites que 2 mm lorsqu'il est utilisé avec un agent de contraste. Le système fonctionne sans compression douloureuse du sein et produit environ 500 images haute résolution en 10 secondes.
L'étude clinique impliquera 3 sites et comprend une période de validation de 1 an pour les cas de cancer négatifs. L'entreprise attend la confirmation par la FDA de la date de la réunion de pré-demande dans sa fenêtre de traitement de 75 jours.
Izotropic hat eine Pre-Einreichung bei der U.S. FDA für ihr IzoView Breast CT Imaging System vorgenommen, das auf das Screening von Brustkrebs bei Frauen mit dichtem Brustgewebe abzielt und als Ergänzung zur 3D-Mammographie dient. Der strategische Ansatz des Unternehmens zielt darauf ab, die potenzielle jährliche Marktgröße für IzoView-Scans um über 800% zu erhöhen.
Die umfassende 60-seitige Einreichung beinhaltet klinische Studienpläne, die einen Zeitrahmen von 2,5 Jahren bei ungefähren Kosten von 3,5 Millionen USD vorsehen. IzoView bietet hochauflösende echte 3D-Bilder mit einer 100-mal höheren räumlichen Auflösung als MRT, was potenziell die Erkennung von Läsionen und Tumoren von bis zu 2 mm ermöglicht, wenn es mit Kontrastmittel verwendet wird. Das System arbeitet ohne schmerzhafte Brustkompression und produziert in 10 Sekunden etwa 500 hochauflösende Bilder.
Die klinische Studie wird 3 Standorte umfassen und beinhaltet einen Validierungszeitraum von 1 Jahr für negative Krebsfälle. Das Unternehmen erwartet die Bestätigung des Termins für das Pre-Einreichungstreffen durch die FDA innerhalb ihres 75-tägigen Bearbeitungsfensters.
- Market size increase of over 800% through screening indication strategy
- Superior imaging capability with 100x greater spatial resolution than MRI
- Early detection potential with 2mm lesion identification capability
- Relatively modest clinical study cost of USD 3.5 million
- Comparable radiation dose to 2-view mammography
- 2.5-year timeline for clinical study completion
- Requires contrast injection for optimal performance
- Additional FDA approval needed for expanded indications
-A screening indication for women with dense breast tissue adjunctive to 3D mammography increases the market size for annual IzoView scans by over
-Regulatory strategy responds to the "urgent call2" from the U.S. Preventative Services Task Force for solutions to finding breast cancers earlier in women with dense breast tissue-
-Comprehensive filing includes patient acquisition and clinical study plans that validate a projected clinical study timeline of 2.5 years with an approximate cost of USD 3.5 million-
Vancouver, British Columbia and Sacramento, California--(Newsfile Corp. - January 9, 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 it has filed a pre-submission with the U.S. FDA to obtain actionable feedback on a clinical study design for the approval of its first medical imaging device, the IzoView Breast CT Imaging System ("IzoView"), with contrast-enhancement for breast cancer screening adjunctive to digital breast tomosynthesis ("DBT") commonly referred to as 3D mammography.
Breast cancer remains an unfortunately common disease accounting for
There is a clear unmet need for high-resolution, true 3D imaging modalities, especially for women with dense breast tissue which is both a risk factor for developing breast cancer and a patient characteristic that makes current standard-of-care breast cancer screening modalities less effective at detecting cancers. Approximately
Izotropic intends to launch its first medical imaging device, IzoView, a dedicated Breast CT imaging system, as an adjunct to DBT. DBT, like traditional mammography, is a breast compression-based imaging device that uses software and 15-50 degree image acquisition to generate slightly 3D images from a series of x-ray images acquired in 2D. Compression-based breast imaging devices are less effective in patients with dense breast tissue, as both dense breast tissue and suspicious lesions and tumors appear white on compression-based breast images, and the density of the tissue itself can overlap under compression creating imaging artifacts that can mimic the appearance of cancer and mask cancers within the dense tissue itself. While studies have confirmed that DBT has been shown to have "higher sensitivity than digital mammography and at least as high specificity7" and it has been argued that clinics with DBT are "ethically required to use DBT in screening when practically possible8", studies have also shown that DBT still produces false negative results and that women with extremely dense breast tissue are predisposed to missed cancers on DBT screening9. In March of 2023, the FDA updated its mammography regulations under the Mammography Quality Standards Act ("MQSA") to require reporting of breast density information to patients, giving them access to this information and helping them to understand how this might influence the accuracy of their mammography examinations10. In September of 2024, the regulation was enforced across all 8,931 MQSA-certified facilities in the U.S.11 The obstacles with screening for breast cancers in patients with dense breasts using the current standard-of-care modalities are so prevalent that even the U.S. Preventative Services Task Force is "urgently calling for more research on whether and how additional screening might help women with dense breasts find cancers earlier12."
Contrast-enhanced breast CT has proven more than promising in research studies at UC Davis Medical Center where the technology was founded and from which Izotropic has the exclusive global licensing rights. Four successive breast CT systems have been built and tested in clinical trials for research purposes at UC Davis, funded primarily by U.S government grants, resulting in a fully de-risked technology with a large volume of published, peer-reviewed scientific research supporting its capabilities and potential. The research trials have shown that "malignant masses are more conspicuous on dedicated contrast-enhanced breast CT than both mammography and tomosynthesis [DBT]13". Breast CT's impressive capabilities are a result of its extremely high spatial resolution that is 100 times greater than MRI14 the current highest standard in 3D breast imaging. Studies have shown that compared to MRI, breast CT "should allow [for] more accurate margin analysis, lesion characterization, and microcalcification visualization15", while being less expensive with a faster imaging exam time.
IzoView will be a whole new experience for patients, radiologists, and providers: to complete the exam, the patient receives a standard pre-approved contrast injection, positions themselves face down on the tabletop and places their own breast in the IzoView imaging cup. The patient tabletop can accommodate patients up to 440 lbs and is the approximate height of a standard bed allowing for ease of access for patients of most sizes. Optical cameras below the tabletop allow the imaging operator to verbally guide the patient's positioning if required, avoiding direct physical contact with the patient's breast, promoting a more considerate and patient-focused experience. Patient dignity is further preserved as no painful breast compression is required owing to the comfortable face-down view in which natural breast orientation is maintained, producing more suitable image outputs. The imaging hardware beneath the table then circles around the patient's breast, producing approximately 500 high-resolution images (depending on breast length) in approximately 10 seconds with a radiation dose that is comparable to 2-view mammography16. A true 3D reconstructed image is produced within 30 seconds, which a radiologist can then view from any angle like a 3D model or slide through the 500 cross-sectional images individually to determine any abnormalities in size, shape, location, and relation to other internal breast structures.
When used with contrast enhancement in research trials, breast CT may find lesions and tumors in the 2mm size range17. Compared to the average-sized 11mm tumor found on screening mammography18 and considering that the average growth rate of breast cancers results in their doubling in size every 6 months19, breast CT may offer approximately 1 ¼ (one and one quarter) years earlier detection of breast cancers. With the risk of death increasing by an average of
Izotropic, with the support of recognized industry experts, has thoroughly investigated the challenges and opportunities associated with launching IzoView as a screening or diagnostic imaging device either stand-alone or adjunctive to another imaging modality. To enable the Company to be revenue generating as soon as possible to fund clinical trials to approve IzoView with more indications for use (e.g. diagnostic, robotic-guided biopsy, and more), the expansion and creation of additional divisions, and the development of different imaging-based devices, the most efficient track to achieving regulatory approval that leads to a larger number of eligible end users while minimizing risk has been identified and is being pursued. By indicating IzoView for use adjunctive to DBT for breast cancer screening in asymptomatic women with dense breast tissue versus a straight diagnostic focus where breast CT enters a patients workup journey after breast cancer screening has taken place, the market size of patients that are eligible to have an annual IzoView exam increases favorably by over
The extensive 60-page pre-submission filing describes a full technical indication for use, and identifies intended patient populations and intended users; a thorough device description with system and sub-system schematics and component descriptions covering the imaging, mechanical, electrical, power, communications and controls, safety, software and accessories; system operation, patient positioning and breast radiation dosimetry details; a comprehensive synopsis of prospective case collection for the clinical study; a comprehensive synopsis of the proposed clinical study protocol complete with statistical considerations; and specific confirmatory questions for the FDA to ensure the Company's outcome of the forthcoming pre-submission meeting will enable actionable steps on the path to regulatory approval and commercialization of IzoView.
The filing identifies a requirement for 3 clinical study sites, identifies the number of patients and exams required to provide the required volume of data for demonstrating safety and effectiveness of IzoView, identifies the number of radiologists required to read and score imaging scans, and confirms the clinical data collection phase of the clinical study will take 2.5 years (including a 1-year negative cancer case validation period to confirm that the patients diagnosed cancer-free during the clinical study remain cancer free) followed by the final submission to the FDA for device approval, and confirms previously disclosed estimates of an overall cost of USD 3.5 million for the clinical study.
The Company has provided the FDA with options for meeting dates congruent with the FDA's processing time of 75 days for pre-submissions. The pre-submission meeting date will be announced when confirmed by the FDA.
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
Chief Executive Officer
Telephone: 1-604-220-5031 or 1-833-IZOCORP ext. 1
Email: bthast@izocorp.com
General Inquiries
Telephone: 1-604-825-4778 or 1-833-IZOCORP ext. 3
Email: info@izocorp.com
Sources:
1 ~42 million compression-based breast cancer screening images are taken annually, with
(2024, November 4). MQSA National Statistics. U.S Food & Drug Administration. Retrieved December 2, 2024, from https://www.fda.gov/radiation-emitting-products/mammography-information-patients/mqsa-national-statistics
(2024, October 2). Dense Breasts: Answers to Commonly Asked Questions. National Cancer Institute. Retrieved December 2, 2024, from https://www.cancer.gov/types/breast/breast-changes/dense-breasts
(2024, October 4). Some Women Avoid Breast Cancer Screening After False-Positive Mammogram Results. National Cancer Institute. Retrieved December 2, 2024, from https://www.cancer.gov/news-events/cancer-currents-blog/2024/mammogram-false-positives-affect-future-screening
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16 Journal of Breast Imaging, 2024, Vol. 6, No. 5, 465-475 doi:10.1093/jbi/wbae043 Scientific Review Received: December 15, 2023; Editorial Decision: May 25, 2024 Published Online: August 31, 2024
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20 (2020, April 11). Every month delayed in cancer treatment can raise risk of death by around
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FAQ
What is the expected timeline for IzoView's clinical trials for IZOZF stock?
How much better is IzoView's resolution compared to existing breast imaging technologies?
What is the market size increase potential for IZOZF's IzoView system?
How long does an IzoView breast scan take to complete?
What are the radiation exposure levels of IzoView compared to mammography?
