Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3), a medical technology company that is bringing the IzoView CT (Computed Tomography) imaging system to market, which generates images of anatomy for non-invasive tissue characterization with its initial application in breast imaging, has announced today that it has submitted a „Pre-Market Approval“ application to the US Food and Drug Administration (FDA) to outline its plans to pursue initial market clearance for IzoView as a Class II device through a 510(k) premarket notification, with the following indication for use:
„The lzoView CT imaging system is intended to generate cross-sectional images of anatomy that may be displayed by computer reconstruction of X-ray data for non-invasive visualization of tissue within the 30 cm aperture. The lzoView CT Imaging System is intended for non-invasive visualization of breast tissue as an adjunct to mammography and may be used by qualified healthcare providers as an aid in the computer-reconstructed X-ray image.“
After the anticipated acceptance of the Pre-Market Approval by the FDA, the Company intends to complete the 510(k) submission using previously acquired phantom image data obtained with the IzoView system at its technical facility in Sacramento, California, later this year and obtain market clearance in the second half of 2024. This regulatory clearance would enable Izotropic to market and sell its IzoView CT imaging system in the US.
The Company also intends to collaborate with prestigious hospitals that could utilize IzoView as an investigative tool. Such partnerships are expected to provide the Company with clinical data that would support new IzoView products and indications for future clearance submissions.
Figure 1: Market clearance plan. Explanation of changes: From Class III Pre-Market Approval to Class II 510(k)
In June 2023, Izotropic announced that it changed its FDA clearance plan and strategy and put on hold its intention to classify its device under Class III, which would have required Pre-Market Approval (PMA). The decision to pursue regulatory clearance as a Class II medical device was made as an operational plan revealed that the costs of deployment (including clinical study on human patients) with no operating cost (USD 10 million or more regulatory pre-deployment investment) would be three times higher than originally thought, and the timeframe for market clearance within the PMA process for Class III would be twice as long as originally estimated with a cautiously estimated four years.
In the context of the Class III clearance process, Izotropic sought FDA clearance for the IzoView breast CT as a standalone diagnostic imaging device through a clinical study comparing the product’s capabilities to the current standard of care in breast diagnostics such as diagnostic mammography, tomosynthesis, and breast ultrasound. Under the Class II process, Izotropic is now seeking FDA clearance for the IzoView CT imaging system for characterization of breast tissue as an adjunct to mammography, as an aid to healthcare providers, and for the generation of cross-sectional images of anatomy. The IzoView CT imaging system is fully mature and easily upgradeable for imaging other body parts such as hands and feet. The Class II clearance pathway affects both how Izotropic intends to position IzoView and the parameters by which healthcare providers are initially expected to utilize IzoView as a more comprehensive imaging investigational tool.
Support of Class II 510(k) Clearance Pathway
According to the FDA, „The 510(k) requires proof that a product is substantially equivalent to another product that is legally marketed in the United States. Substantially equivalent means that the new product is as safe and effective