Ann: Change of Director's Interest Notice - R Cooke, page-7

There are several studies complete or on going. Whether there is enough data almost ready to complete a new submission without having to do another oral study I don't know. If there is, it might just be a blessing that they started several studies simultaneously.

Optiscan Imaging LimitedDirectors' report31 December 2022

“INVIVAGE®” ORAL CANCER SCREENING DEVICEOptiscan has developed the “InVivage®” clinical device as its own hand-held confocal endomicroscope. The initial intended use for the InVivage device is Oral Cancer Screening and/or Surgical Margin determination. The same device is also intended to be used as a platform for other clinical applications.

Oral Cancer StudiesThe Melbourne Dental School clinical imaging study to improve screening, diagnosis, and treatment of oral cancer concluded in the period; with all planned imaging for the study completed. Data analysis continued, with a significant amount of data included in the Company’s FDA 510(k) submission for its InVivage® device.

Oral Cancer Studies (continued)Data curation, annotation and correlation was ongoing with collected images as part of the Oral Lesion clinical studyundertaken by Professor Farah and his team at the Australian Centre for Oral Oncology Research & Education. The team also assessed alternative contrast agents and protective sheaths with potential incorporation into future iterations of the Company’s devices.

In the period, the Company acquired Intellectual Property in relation to 228 patient datasets from Professor Farah which was approved by a majority of shareholders at the Company’s Annual General Meeting. Finally, imaging as part of the Adelaide Dental School study was completed with positive results for determination of oralcancer on resected tumors compared to traditional histopathology. The team are preparing manuscripts and future submissions for funding to continue their work. The data shared with Optiscan further validates the utility of the technology for ex vivo imaging applications in surgery.

BioMed Tech Horizons Program grant for Oral Cancer Study at Melbourne Dental School Optiscan continued with its BioMedTech Horizons Program grant with the University of Melbourne’s Dental School to undertake a trial with approximately 150 patients, to improve screening, diagnosis, and treatment of oral cancer. The BioMedTech Horizons Program is an initiative of the Medical Research Future Fund, operated by MTPConnect, designed to foster innovative collaborative health technology development. This study was completed in the reporting period with good correlation between imaging features using fluorescein and acriflavine, and oral lesion type. Data from this study was used in the Company’s FDA 510(k) submission for its InVivage® device.

BREAST CANCER SURGICAL MARGIN ASSESSMENT STUDY
The Breast Cancer Intraoperative Assessment Study at Royal Melbourne, Frances Perry and Epworth Hospitals concluded recruitment for the first stage of image analysis and correlation with histopathology. Ethical approvals for the extension to theBreast Cancer Surgical study were received, and the Company continued with imaging additional patient samples and pathology specimens adding new insights to the utility of the technology in breast resection surgery. The collaborative work between Optiscan, breast surgeon Professor Bruce Mann, pathologist Dr Anand Murugasu and the Breast Cancer Network Australia is supported by the Medical Device Partnering Program (MDPP). Image analysis and correlation with histopathology is ongoing.