Slide 1: Optiscan Imaging Ltd FY21 Annual Results Presentation
Optiscan Imaging Ltd FY21 Annual Results Presentation
Slide 2: Notice
Notice This presentation has been prepared by Optiscan Imaging Limited (OIL or the Company) as at 30 August 2021. The information in this presentation is of a general nature and does not purport to be complete. The presentation does not contain all of the information which a prospective investor may
Slide 3: Notice
Notice Not an offer or financial product advice This presentation is not a prospectus, product disclosure statement or other offering document under Australian law (and will not be lodged with ASIC) or any other law. This presentation does not satisfy the disclosure requirements for a disclosure doc
Slide 4: Optiscan Imaging Transformation in FY21
4 Optiscan Imaging Transformation in FY21 Major advances towards becoming a global medical imaging and diagnostics company
Slide 5: Optiscan at a glance
5 Optiscan at a glance Optiscan Imaging Ltd (ASX:OIL) is a global leader in the development of endomicroscopic technology which enables real-time, ‘in vivo’ imaging of human tissue for cancer screening, diagnoses and in surgery Develops and manufactures Key clinical device (InVivage®) well Significa
Slide 6: Optiscan Key Achievements in FY21
6 Optiscan Key Achievements in FY21 ✓ Pathway to US FDA approval for use of InVivage® device in Oral Cancer on track • Oral Cancer Clinical Trial to Support FDA approval process underway • Internal and third party device testing progressing • US market entry planning ✓ Receipt of Federal Government
Slide 7: Milestones and Recent Share Price Movement
7 Milestones and Recent Share Price Movement 7 $0.50 $0.40 Adelaide Dental School receives ethics approval for ex vivo oral cancer study Expansion of breast cancer trial to 40 patients Appointment of Ms Karen Borg $0.30 as non-executive director Success in 2 tenders in China for the A$9.8m capital r
Slide 8: FY21 Financial Highlights
8 FY21 Financial Highlights FY21 Total Income (operating revenue and other income) of $2.54m, up ~28% on FY20 • Benefits of new distribution arrangements for FIVE2 - 2 sales in FY21 and order received in July ‘21; • Continued orders from CZM with sales of $500k as part of CONVIVO® co-operation agree
Slide 9: FY21 Profit and Loss, Balance Sheet and Cash Flow
9 FY21 Profit and Loss, Balance Sheet and Cash Flow Profit and Loss* Cash Flow* FY20 FY21 FY20 FY21 Revenue $940k $500k Carl Zeiss Co-operation Cashflow from operations ($1,400k) ($2,130k) Cashflow from investing ($20k) ($30k) $170k $370k FIVE2 Sales Cashflow from financing $190k $10,070k Capital Ra
Slide 10: Optiscan devices and current positioning
10 Optiscan devices and current positioning
Slide 11: Overview of Optiscan devices
11 Overview of Optiscan devices There are currently three devices at different stages of development and marketing, which all use Optiscan’s unique hand- held, confocal endomicroscopic technology to deliver real time imaging at sub-cellular level InVivage® FIVE2 (ViewnVivo) CONVIVO® (co-operation ag
Slide 12: Optiscan InVivage Clinical Device
12 Optiscan InVivage® Clinical Device • Cancer screening and surgical applications • Miniaturised hand-held probe (4mm diameter tip) • Instantaneous, sub-cellular resolution imaging • Enabling more targeted biopsies and reduced surgical margins • Digital transmission of images • Initially targeting
Slide 13: Advantages of InVivage over Current Standard of Care
13 Advantages of InVivage® over Current Standard of Care Screening applications (Oral and Cervical) • Instantaneous, high-resolution images to enable fewer and more targeted biopsies • Non-invasive image capture encourages screening and early detection • Changes in cellular architecture not visible
Slide 14: InVivage FDA approval process update
14 InVivage® FDA approval process update Optiscan is preparing a submission for 510(k) clearance for FDA approval for InVivage® device’s use in oral cancer screening and surgery in the United States. Optiscan has successfully passed multiple external and internal tests on its pathway to lodging its
Slide 15: Optiscan's FIVE2 (ViewnVivo) pre-clinical device
15 Optiscan’s FIVE2 (ViewnVivo) pre-clinical device • Designed for translational and pre-clinical research • Research findings from FIVE2 (ViewnVivo) in the laboratory are transferrable to InVivage®’s use in human patients • New distribution arrangements commenced in North America, Taiwan and South
Slide 16: ZEISS CONVIVO – Carl Zeiss Meditec AG (CZM) Co-operation
16 ZEISS CONVIVO® – Carl Zeiss Meditec AG (CZM) Co-operation • The ZEISS CONVIVO® demonstrates how Optiscan’s confocal imaging technology can be customised for specific medical applications • Through close collaboration with CZM, Optiscan’s technology is now being used in neurosurgery • In recent ye
Slide 17: Optiscan – Clinical Studies
17 Optiscan – Clinical Studies • 150 patient Oral Cancer Study at Melbourne Dental School (ranked #14 in world) funded by Australian Government BioMedtech Horizons Program. 91 sets of imaging completed • Oral Cancer Study at Memorial Sloan Kettering Cancer Centre in New York (#2 cancer centre in US)
Slide 18: Optiscan's relationships and partnerships
18 Optiscan’s relationships and partnerships Optiscan’s established relationships with leading global medical technology companies, universities and hospitals are a strong endorsement of its unique technology. Examples include: Working with two highest ranked Memorial Sloan Kettering, Carl Zeiss den
Slide 19: Improving survival rates for oral cancer through early diagnosis
19 Improving survival rates for oral cancer through early diagnosis World Lip & Oral Cavity Cancer Incidence And Mortality 2% • Early diagnosis is critical due to the rapidly declining survival rates as cancer progresses • Historically patients have delayed screening of oral lesions due to invasive
Slide 20: Improving patient and hospital outcomes in breast cancer
20 Improving patient and hospital outcomes in breast cancer Breast cancer is most common cancer in women 2.3 15% 11.1% Million 2.3 million new worldwide cases 15% of all new cancer cases in the 11.1% of all new cancer cases of breast cancer in 20201 US are breast cancer2 in China are breast cancer1
Slide 21: FY22 priorities and conclusions
21 FY22 priorities and conclusions
Slide 22: FY22 Key Priorities
22 FY22 Key Priorities ▪ Lodgment of FDA 510(k) oral cancer screening and surgical submission ▪ Finalise distribution strategy for InVivage® into United States market ▪ Plan regulatory submissions for InVivage® into European and other markets ▪ Undertake additional clinical studies in oral and other
Slide 23: Conclusions
23 Conclusions ▪ Optiscan’s technology changing standard of care for human cancer screening and surgery ▪ Portfolio of world leading patent protected imaging technology ▪ Well-progressed on FDA approval process for the use of the InVivage® device in oral cancer in US ▪ Significant interest and endor