Filing Pre-Submission with U.S. FDA Sends Shares Of This Biotech Higher

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Thursday, January 9, 2025

On a slower trading day due to the U.S. markets being shuttered in memory of former President Jimmy Carter, there was some big news in the biotech space.

Canadian-listed shares of Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) are marching higher as the medical device company commercializing imaging-based products for the more accurate screening, diagnoses, and treatment of breast cancers, announced 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, with contrast-enhancement for breast cancer screening adjunctive to digital breast tomosynthesis ("DBT") commonly referred to as 3D mammography.

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.

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.

As mentioned, U.S. listed shares (IZOZF) are not trading today and will likely play catch-up tomorrow to this news announcement, while Canadian listed shares (IZO) are currently up 9.09% at $0.18 in early-afternoon trading.

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