Mr. Robert Thast reports

IZOTROPIC FILES CLASS II PRE-SUBMISSION WITH FDA & RELEASES DETAILS ON PREDICATE DEVICES

Izotropic Corp. has completed a presubmission application to the U.S. Food and Drug Administration (FDA) to solidify its plans to initially pursue market clearance for IzoView as a Class II device through a 510(k) premarket notification submission with the following indication for use.

The IzoView CT (computerized tomography) imaging system is intended to produce cross-sectional images of anatomy that can be imaged in the 30-centimetre aperture by computer reconstruction of X-ray transmission data for non-invasive visualization of tissue.

The IzoView CT imaging system is indicated for use in the non-invasive visualization of breast tissue, as an adjunct tool to mammography, by providing X-ray computer reconstructed images as an aid for qualified health care providers.

Upon an anticipated acceptance of the presubmission application from the FDA, the company intends to complete the 510(k) submission using pre-existing data from phantom images obtained from the IzoView system located in its engineering facility in Sacramento, Calif., later this year, with the objective of obtaining market clearance in the second half of 2024. Receiving this regulatory clearance would enable Izotropic to begin marketing and selling IzoView CT imaging systems in the United States.

The company also intends to secure collaborations with notable hospitals to utilize IzoView as an investigational device. Such partnerships are expected to generate clinical data that would support new IzoView products and indications for use for new regulatory submissions in the future.

In June, 2023, Izotropic announced that it was modifying its FDA market approval pathway and strategy by deferring its plan to undertake a Class III device classification requiring premarket approval (PMA). The decision to seek regulatory clearance as a Class II device resulted after the completion of an operational plan estimated that costs to market (including a clinical study on human patients) would be three times higher than initially predicted before factoring in operating costs (at least $10-million plus in precommercial regulatory investment), and the timeline is twice as long as initially anticipated at a conservative four years to obtain market approval under the Class III PMA pathway.

Under the Class III pathway, Izotropic was seeking FDA approval for IzoView Breast CT to be used as a stand-alone diagnostic imaging device through a clinical study comparing its capabilities against current standard-of-care breast diagnostic modalities, including diagnostic mammography, tomosynthesis and breast ultrasound. Under the Class II pathway, Izotropic is seeking FDA clearance for the IzoView CT imaging system to be indicated for breast tissue characterization, adjunct to mammography, an aid for health care providers, with an intended use to produce CT images of anatomy. The IzoView CT imaging system is fully engineered and is easily retrofitted to accommodate imaging of other body appendages such as hands and feet. The Class II pathway affects both the way Izotropic presents IzoView and the parameters in which IzoView will initially be used by providers in a health care setting as a broader investigational imaging device.

Supporting Class II 510(k) pathway

According to the FDA, a 510(k) requires demonstration of substantial equivalence to another legally U.S.-marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate. A device is substantially equivalent if, in comparison with a predicate it: has the same intended use as the predicate; and has the same technological characteristics as the predicate; or has the same intended use as the predicate; and has different technological characteristics and does not raise different questions of safety and effectiveness; and the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device. A claim of substantial equivalence does not mean the new and predicate devices need to be identical.

Given these parameters, Izotropic has selected two predicate devices to support its Class II 510(k) pathway in discussions with the FDA: CurveBeam HiRise and NeuroLogica OmniTom.

The attached predicate table showcases select information, including intended use and indication for use statements for all three devices. IzoView is comparable, with each system having specific anatomical indications.

Given the similarities to the CurveBeam HiRise and NeuroLogica OmniTom devices that are already cleared for sale in the United States, Izotropic is proceeding confidently with its plans under the Class II 510(k) regulatory pathway.

We seek Safe Harbor.