Izotropic Canada - IZOZF STOCK NEWS

Izotropic (OTCQB: IZOZF) has announced the rescheduling of its investor conference presentation from February 6th to March 13th, 2025, due to a family emergency affecting the CEO's availability. The presentation will now take place at the OTC's Life Science Virtual Investor Forum.

The company, which specializes in medical device development for breast cancer screening and diagnosis, confirmed that its business plans and progress remain unaffected, with the CEO expected to resume normal business operations next week. One-on-one meetings previously scheduled with the CEO will be rearranged directly with affected parties.

Izotropic (OTCQB: IZOZF) has announced its upcoming presentation at the Small Cap Growth Virtual Investor Conference on February 6, 2025. CEO Robert Thast will present from 3:00-3:30 PM EST, discussing the company's recent achievements, regulatory approvals in the U.S. and EU, near-term objectives, and funding options.

This marks the company's first public presentation since revealing its new regulatory strategy for U.S. FDA approval and timeline for launching IzoView, their dedicated breast CT imaging system. The device features contrast-enhancement for breast cancer screening, working alongside 3D mammography for patients with dense breast tissue.

The virtual conference will include a live Q&A session, and attendance is complimentary for individual and institutional investors, advisors, and analysts. Those unable to attend can access an archived webcast of the presentation.

Izotropic has outlined its timeline and milestones for the FDA approval and launch of IzoView Breast CT Imaging System. The company's strategy focuses on dense breast tissue imaging, with a modular clinical study design that reduces PMA submission time by approximately 6 months. The plan includes a 3-site U.S.-based clinical study, which will also facilitate early data collection for European CE Mark Application.

The company has structured its path to market in 7 key phases: Prepare IzoView, Site Setup, Clinical Study, Reader Study, Modular Submissions, PMA Application, and Approval and Sales. Additionally, Izotropic plans to announce the development of two new medical imaging devices within the next 12 months to build momentum and enhance valuation during the clinical data collection phase.

Izotropic has been featured in Research and Markets' analysis of the U.S. breast cancer screening and diagnostic market. The report projects market growth from $1.55 billion in 2024 to $2.34 billion by 2030, with a 7.05% CAGR.

The company's IzoView Breast CT system offers true 3D breast imaging without compression, completing scans in 10 seconds with radiation doses comparable to 2-view mammography. This technology addresses limitations in current screening methods, particularly for dense breast tissue patients who comprise 50% of U.S. women. The system can detect lesions as small as 2mm when used with contrast enhancement, potentially offering 1¼ years earlier detection compared to traditional mammography, which typically finds 11mm tumors.

Digital breast tomosynthesis (DBT) currently leads the market with a 49.93% share as of 2023, though it still faces challenges in detecting cancers in dense breast tissue.

Izotropic has announced key appointments to lead its clinical study design and FDA regulatory submissions for IzoView, its dedicated breast CT imaging system. The team includes Dr. Kyle J. Myers, former FDA Director of Imaging, Diagnostics, and Software Reliability; Dr. Alicia Toledano, former Deputy Director of ACRIN's Biostatistics Center; and John DeLucia, former VP of Regulatory Affairs at iCAD.

The team has developed a regulatory strategy and clinical study design for IzoView, which aims to serve as an adjunctive tool to digital breast tomosynthesis for breast cancer screening in asymptomatic women with dense breast tissue. This initiative targets approximately 50% of the U.S. breast cancer screening population who have dense breasts and are currently underserved by standard imaging modalities.

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.

Izotropic Corporation, a medical device company, announces that it has received a response from the U.S. FDA regarding its pre-submission seeking guidance on a Class II 510(k) pathway for its CT imaging system. The FDA's mammogram and ultrasound team has responded with additional questions, and Izotropic's management, regulatory, and engineering teams will promptly respond and report the outcomes. As of the announcement date, there has been no material change to the Company's regulatory plans and no definitive decision provided by the FDA.