Welcome to our dedicated page for Izotropic Canada news (Ticker: IZOZF), a resource for investors and traders seeking the latest updates and insights on Izotropic Canada stock.
Izotropic Canada (IZOZF) specializes in advanced breast imaging technology designed to improve cancer detection in dense breast tissue. This news hub provides investors and healthcare professionals with official updates on regulatory progress, clinical developments, and corporate milestones.
Access timely press releases covering FDA communications, European regulatory strategies, and peer-reviewed study results. Our curated collection includes updates on the IzoView Breast CT system's commercialization efforts, partnership announcements, and financial disclosures.
Key content categories include regulatory filings, clinical trial updates, technology enhancements, and strategic collaborations. All materials are sourced directly from the company to ensure accuracy and compliance with financial disclosure standards.
Bookmark this page for streamlined access to critical updates about Izotropic's innovative diagnostic solutions. Check regularly for new developments in contrast-enhanced imaging technology and market expansion initiatives.
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 (OTCQB: IZOZF), a medical device company developing the IzoView CT imaging system, has announced changes to its Annual General Meeting materials distribution due to a Canadian postal workers' strike. The company will not mail physical meeting materials but has made them available on SEDAR+ and the company website.
Shareholders can obtain voting control numbers by December 9, 2024, by contacting ir@izocorp.com and can vote online at vote.odysseytrust.com. Those who previously consented to electronic communications will receive materials and voting instructions via email from their respective holding organizations.
Izotropic (CSE: IZO) (OTCQB: IZOZF) announces plans to launch IzoView, a breast CT imaging system, as a diagnostic device for patients with dense breast tissue in the U.S. and EU. The company is pursuing a Pre-Market Authorization (PMA) clinical study in the U.S., estimated to cost $3.5M USD and involve 400 patients. The study aims to prove the superiority of Digital Breast Tomosynthesis (DBT) combined with Contrast-Enhanced Breast CT over DBT alone for breast cancer detection in women with dense breasts.
Izotropic is also seeking CE Mark approval in the EU, which may result in earlier commercialization. The company's strategy focuses on patients with BI-RADS C and D breast density classifications, addressing a significant market as nearly half of U.S. women aged 40+ have dense breasts, which increases breast cancer risk.
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