Dr. John McGraw reports

IZOTROPIC COMPLETES QSUB MEETING WITH FDA REGARDING CLINICAL STUDY ACCELERATION

Izotropic Corp. has conducted a presubmission meeting with the FDA on April 28, 2023 to present a detailed and updated protocol and accompanying statistical analysis plan (SAP). The SAP is a technical document that outlines the analytical approach of the data that is gathered during the clinical study. The new protocol proposes a reduced patient number and broader device comparator to its original submission which could also reduce overall recruitment time. The completion of the SAP is a critical step and must be completed prior to study initiation as it determines the patient numbers and how all data will be analyzed for statistical significance of the primary endpoint, as well as analysis of additional exploratory and other endpoints.

At the suggestion of the agency from its initial meeting, key details on the clinical workflow that incorporated operational considerations from the company's clinical study hospital partners was also discussed. The focus was to indicate and incorporate potential clinical benefits for patients participating in the study.

Chief executive officer Dr. John McGraw commented: "Over all, this was a very productive meeting as part of our ongoing discussions with the FDA under the premarket approval submission process. The ongoing dialogue with the agency provides support for a clinical study design that is aligned with all corporate, commercial and clinical objectives. The agency suggested further meetings be held to review the various technical aspects of the device while the study is under way, which will include testing protocols and hardware and software device characteristics. These future meetings aim to streamline our path to market and ideally reduce the normal review time by the agency on the final regulatory submission for approval. An initial response from this submission is expected in approximately four weeks and any resulting material development will be announced when received".

The company notes that it is also investigating different 510(k) pathways for market clearance and will continue discussion with the agency focused on bringing IzoView to market as efficiently as possible.

About Izotropic Corp.

Izotropic is the only publicly traded company commercializing a dedicated breast CT imaging platform, IzoView, for the more accurate detection and diagnosis of breast cancers. To expedite patient and provider access to IzoView, Izotropic's initial clinical study intends to demonstrate superior performance of diagnostic breast CT imaging over diagnostic mammography procedures. In follow-on clinical studies, Izotropic intends to validate platform applications, including breast screening in radiology, treatment planning and monitoring in surgical oncology, and breast reconstruction and implant monitoring in plastic and reconstructive surgery.

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