Izotropic Announces Timelines and Milestones to IzoView Product Launch
- Unique dense breast tissue focus to drive expedited recruitment rates; modular clinical study design reduces time to PMA submission by ~6 months -- 3 Site U.S.-based clinical study enables early data collection to kickstart European CE Mark Application -- Company to announce development of 2 new medical imaging devices in the next 12 months to trigger momentum and increase valuation during clinical data collection phase -Vancouver, British Columbia and Sacramento, California--(Newsfile Corp. - January 29, 2025) - Izotropic Corporation...
2025-01-29 8:00 AM EST
Izotropic Featured in Announcement of Research and Markets' U.S. Breast Cancer Analysis and Forecast
- Company listed in Research and Markets' announcement and description of new research report on the U.S. Breast Cancer Screening and Diagnostic Market- - "U.S. breast cancer screening and diagnostic [device] market was valued at $1.55 billion in 2024 and is anticipated to reach $2.34 billion by the end of 2030, at a CAGR of 7.05% during the forecast period 2024-20301"--Report supports Company's regulatory strategy for IzoView Breast CT, reinforces high demand for new breast imaging modalities, strengthens the potential...
2025-01-17 8:00 AM EST
Izotropic Announces Team Leading Clinical Study Design and FDA Regulatory Submissions
-New FDA Consultant is the former Director of the Division of Imaging, Diagnostics, and Software Reliability at the U.S Food and Drug Administration--New Biostatistical Consultant is the former Deputy Director of the Biostatistics and Data Management Center of the American College of Radiology Imaging Network, an NIH-funded cooperative that conducts clinical trials to evaluate the use of diagnostic imaging and image-guided treatments for cancer, has decades of successful experience in design and analysis of clinical studies of medical imaging devices...
2025-01-15 8:00 AM EST
Izotropic Files Pre-Submission with U.S. FDA for Breast Cancer Screening
-A screening indication for women with dense breast tissue adjunctive to 3D mammography increases the market size for annual IzoView scans by over 800%1 for initial approval and product launch- -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...
2025-01-09 8:00 AM EST
Izotropic Provides Update on Annual General Meeting Materials and Voting Procedures
Vancouver, British Columbia--(Newsfile Corp. - December 4, 2024) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing IzoView, a CT (computed tomography) imaging system, announces that due to the suspension of mail service in Canada due to the nationwide strike of the Canadian Union of Postal Workers, that the notice of meeting, information circular, requests for financial statements and proxy form (the "Meeting Materials") for the Company's upcoming Annual General...
2024-12-04 2:43 PM EST
Izotropic Announces Regulatory Approval Plans to Launch Izoview for Breast Cancer Diagnostics in Patients with Dense Breasts in the U.S. and EU
Vancouver, British Columbia--(Newsfile Corp. - August 23, 2024) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing IzoView, a breast CT (computed tomography) imaging system, is pleased to announce that it is pursuing a regulatory strategy in the U.S. and EU to launch IzoView as a diagnostic device indicated for use in patients with dense breast tissue, a normal variation associated with an increased risk for developing breast cancers.The Company's reformed regulatory strategy positions IzoView...
2024-08-23 9:00 AM EDT
Izotropic Corporation Announces Closing of First Tranche of Non-Brokered Private Placement
Vancouver, British Columbia--(Newsfile Corp. - June 14, 2024) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company") - Further to the Company's news release of June 6, 2024, the Company is pleased to announce that it has completed the first tranche of its non-brokered private placement financing (the "Offering"), whereby the Company issued 1,800,000 units (each, a "Unit") at a price of $0.10 per Unit for gross proceeds of $180,000.00. Each Unit consists of one...
2024-06-14 9:00 AM EDT
Izotropic Corporation Announces Non-Brokered Private Placement
Vancouver, British Columbia--(Newsfile Corp. - June 6, 2024) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing IzoView, a CT (computed tomography) imaging system, announced today that it intends to complete a small non-brokered private placement financing (the "Offering") of up to 3,000,000 units of the Company, (each a "Unit") at a price of $0.10 per each Unit for a gross proceeds of up to $300,000.00. Each Unit will consist of one...
2024-06-06 9:00 AM EDT
Izotropic erhält Antwort von der US-Behörde FDA
Vancouver, British Columbia--(Newsfile Corp. - Mittwoch, 31. Januar 2024) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" oder das "Unternehmen"), ein Medizintechnikunternehmen, das IzoView vermarktet (ein anatomisches CT-Bildgebungssystem für nicht-invasive Gewebecharakterisierung mit einer Anwendung in der Brustbildgebung), kündigt an, dass in Bezug auf seine Einreichung vom 8. Januar eine Antwort von der U.S.-amerikanischen Behörde FDA ergangen ist.Mitarbeiter der Abteilung für Mammographie- und Ultraschall der FDA stellten Izotropic zusätzliche Fragen zu seinem Vorantrag auf definitive Leitlinien für das Vorgehen zur 510(k)-Zulassung der Klasse...
2024-01-31 12:58 PM EST
Izotropic Receives Response From U.S. FDA
Vancouver, British Columbia--(Newsfile Corp. - January 30, 2024) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing IzoView, a CT (computed tomography) imaging system, that produces images of anatomy for non-invasive characterization of tissue with an application in breast imaging, announces that further to its January 8th disclosure, it has received a response from the U.S. FDA. The FDA's mammogram and ultrasound team has responded to Izotropic with additional questions regarding...
2024-01-30 8:00 AM EST
Izotropic gibt Updates zu regulatorischen und betrieblichen Themen
Vancouver, British Columbia--(Newsfile Corp. - Mittwoch, 10. Januar 2024) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" oder das "Unternehmen"), ein Medizintechnikunternehmen, das IzoView vermarktet (ein anatomisches CT-Bildgebungssystem für nicht-invasive Gewebecharakterisierung mit einer Anwendung in der Brustbildgebung), gibt ein Update zum regulatorischen Stand bei der der US-amerikanischen Food and Drug Administration (FDA) sowie zu betrieblichen Aktivitäten.Update zum FDA-StatusAm 25. Oktober 2023 schloss Izotropic ein Treffen mit FDA-Vertreter:innen zur Vorbereitung der Einreichung ab. Zweck und Ziel dieses Treffens war die Einleitung eines produktiven...
2024-01-10 9:13 AM EST
Izotropic Provides Regulatory and Operational Updates
Vancouver, British Columbia--(Newsfile Corp. - January 8, 2024) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing IzoView, a CT (computed tomography) imaging system, that produces images of anatomy for non-invasive characterization of tissue with an application in breast imaging, provides an update on its regulatory status with the U.S. Food and Drug Administration ("FDA") and operational activities. FDA Regulatory UpdateIzotropic completed a pre-submission meeting with the FDA on October 25,...
2024-01-08 8:00 AM EST
Izotropic Completes Pre-Submission Meeting with U.S. FDA
Vancouver, British Columbia--(Newsfile Corp. - November 1, 2023) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing IzoView, a CT (computed tomography) imaging system, that produces images of anatomy for non-invasive tissue characterization with an application in breast imaging, announced today that it completed its previously announced pre-submission meeting with the U.S. FDA.The purpose of the meeting was to discuss the Company's pre-submission application, obtain feedback and confirm next steps. The meeting was...
2023-11-01 8:00 AM EDT
Izotropic bestätigt Besprechungstermin mit der FDA vor der Antragseinreichung
Vancouver, British Columbia--(Newsfile Corp. - Freitag, 29. September 2023) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" oder das "Unternehmen"), ein Medizintechnikunternehmen, das IzoView vermarktet (ein anatomisches CT-Bildgebungssystem für nicht-invasive Gewebecharakterisierung mit seiner ersten Anwendung in der Brustbildgebung), bestätigt heute den 25. Oktober 2023 als Termin für ein Treffen mit der US-amerikanischen Food and Drug Administration (FDA) vor Antragseinreichung.Wie in seiner Pressemitteilung vom 6. September 2023 angekündigt, hat Izotropic zur Untermauerung seiner Pläne für die Marktzulassung von
2023-09-29 9:59 AM EDT
Izotropic Confirms FDA Pre-Submission Meeting Date
Vancouver, British Columbia--(Newsfile Corp. - September 27, 2023) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing IzoView, a CT (computed tomography) imaging system, that produces images of anatomy for non-invasive tissue characterization with the first application in breast imaging, announced today it has confirmed a pre-submission meeting date with the U.S. Food and Drug Administration (FDA) scheduled for October 25, 2023.Further to its news release on September 6, 2023, Izotropic completed a pre-submission application...
2023-09-27 9:00 AM EDT
Izotropic Closes Non-Brokered Private Placement
Vancouver, British Columbia--(Newsfile Corp. - September 20, 2023) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing IzoView, a CT (computed tomography) imaging system, that produces images of anatomy for non-invasive tissue characterization with the first application in breast imaging, announced today that, further to its news release on September 13, 2023, that it has completed a non-brokered private placement financing (the "Offering") of 2,841,325 units of the Company (each, a "Unit")...
2023-09-20 4:48 PM EDT
Izotropic reicht Klasse II-Antrag auf Vorabgenehmigung bei der FDA ein und gibt Einzelheiten zu Prädikatsprodukten bekannt
Vancouver, British Columbia--(Newsfile Corp. - Montag, 11. September 2023) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" oder das "Unternehmen"), ein Medizintechnikunternehmen, das IzoView auf den Markt bringt, ein CT (Computertomographie)-Bildgebungssystem, das Bilder der Anatomie zur nicht-invasiven Gewebecharakterisierung mit der ersten Anwendung in der Brustbildgebung erzeugt, gab heute bekannt, dass es einen "Antrag auf Vorabgenehmigung" bei der US-Gesundheitsbehörde FDA (Food and Drug Administration) eingereicht hat, um seine Pläne zu konkretisieren, zunächst die Marktfreigabe für IzoView als Gerät der Klasse II
2023-09-11 9:29 PM EDT
Izotropic Files Class II Pre-Submission with FDA & Releases Details on Predicate Devices
Vancouver, British Columbia--(Newsfile Corp. - September 6, 2023) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing IzoView, a CT (computed tomography) imaging system, that produces images of anatomy for non-invasive tissue characterization with the first application in breast imaging, announced today that it has completed a pre-submission application to the U.S. Food and Drug Administration (FDA) to solidify its plans to initially pursue market clearance for IzoView as a Class...
2023-09-06 8:00 AM EDT
Izotropic Modifies Market Approval Pathway & Strategy
Vancouver, British Columbia--(Newsfile Corp. - June 20, 2023) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing IzoView, a 360-degree computed tomography (CT) imaging system designed for breast imaging and cancer diagnosis, announced that it is modifying its U.S. FDA market approval pathway and strategy by deferring its plan to undertake a Class III device classification requiring Pre-Market Approval (PMA) and will initially pursue regulatory clearance as a Class II device,...
2023-06-20 8:00 AM EDT
Izotropic CEO Resigns
Vancouver, British Columbia--(Newsfile Corp. - June 8, 2023) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical imaging device company, announces that effective May 31, 2023, Dr. John McGraw has resigned as Chief Executive Officer (CEO) for personal reasons and has stepped down from the Company's Board of Directors. Dr. McGraw will remain an Advisor to the Company and consult on future projects. The Company thanks Dr. McGraw for his service and management...
2023-06-08 8:00 AM EDT