Optiscan Imaging Limited announced that it has received feedback from the US Food and Drug Administration (FDA) in relation to its Pre-Market Notification (510(k)) application for the InVivage® product intended for oral tissue imaging. Regulatory clearance of the Company's combination product mandates that both the fluorescent contrast agent drug and the device used to visualise microscopic structures are cleared for use in the intended clinical setting. The additional data requested by the FDA for inclusion in the Company's De Novo submission relates mostly to the novelty of the contrast agent and its intended application to oral tissues.

Optiscan intends to carry out additional studies to satisfy the recommendations made by the FDA in the shortest time possible, while remaining in close contact with the review team to accelerate progress. In addition to the De Novo submission for the InVivage® product, the Company is expanding its product portfolio with planning underway for new devices and novel applications that will benefit from the FDA feedback.