Nova Eye Medical Ltd · ASX:EYE
Nova Eye Medical — Investor Presentation (May 2022)
11 slides from Nova Eye Medical's investor presentation, May 3, 2022
Slide 1: 2RT Pivotal Study and Regulatory Pathway
AMD is the leading cause of blindness in the developed world for people over 50 2RT Pivotal Study and Regulatory Pathway May 2022 AlphaRET Pty Ltd is a wholly owned subsidiary of Nova Eye Medical Limited (ASX:EYE) and was established to progress the development of 2RT®
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by Nova Eye Medical Limited (ASX: EYE). While the information in this presentation has been prepared in good faith and with reasonable care, no representation or warranty, express or implied, is made as to the accuracy, adequacy or reliability of any st
Slide 3: Age-Related Macular Degeneration
Age-Related Macular Degeneration alpha-ret.com | 3
Slide 4: 2RT - Subthreshold Nanosecond Laser
2RT® - Subthreshold Nanosecond Laser 2RT® is a rejuvenative retinal laser therapy that utilizes a nanosecond laser pulse and unique pixelated laser beam profile “Based on the LEAD study outcomes, 2RT® is currently a leading candidate treatment in the world for slowing the progression of patients wit
Slide 5: 2RT for intervention in AMD progression
2RT® for intervention in AMD progression Intervention concept schematic based on a post hoc analysis reported within “Subthreshold Nanosecond Laser Intervention in Age-Related Macular Degeneration - The LEAD Randomized Controlled Clinical Trial” Robyn H. Guymer, MBBS, PhD, et al and published in pee
Slide 6: Pivotal Clinical Study to address USA and Europe
Pivotal Clinical Study to address USA and Europe AlphaRET’s recent communications with the FDA has provided guidance on the clinical study plan and a subsequent regulatory pathway for a clearance to market 2RT® in the USA for the treatment of patients with iAMD, and who do not have RPD, to delay pro
Slide 7: 2RT Roadmap Pivotal Study
2RT ® Roadmap Pivotal Study PRE-CLINCAL WORK PILOT CLINICAL TRIAL CE MARK (iAMD) APPROVED FOR SALE IN AUST, NZ & EUROPE EFFICACY & SAFETY DEMONSTRATION CLINICAL STUDY (“LEAD”) PROTOCOL PREPARATION FOR PIVOTAL STUDY TO CONFIRM LEAD USA FDA FEEDBACK RECEIVED ENGAGE WITH POTENTIAL PARTNERS AND FUNDING
Slide 8: Global Retinal Experts Support
Global Retinal Experts Support Principal Investigator Professor Robyn Guymer, AM MBBS, Phd “I am pleased the be a part of this follow up study. 2RT® addresses the disease in its earlier stages. No other device or pharmaceutical in the world does this. Like all chronic disease, early detection and tr
Slide 9: US$600 million Estimated Revenue Opportunity for 2RT
Estimated Revenue Opportunity for 2RT® Subject to the Business model Number of Procedure completion of a people comprising of fee-based pivotal study or worldwide revenue capital equipment similar to confirm with iAMD1 model 3 sale and procedure Global annual results of the LEAD revenue4 fee has cor
Slide 10: Program milestones
Program milestones Program milestones are set out below: Current Year 1 Year 2 Year 3 Year 4 Year Engage contract research organisation and investigator site selection Australia, Canada and Europe Partnering arrangements finalised Enrolment in Australia, Europe and Canada Additional clinical data pr
Slide 11: Tom Spurling, Managing Director; Mark Flynn, Investor Relations
Tom Spurling Mark Flynn Managing Director Investor Relations W: +61 8 8362 0193 M: +61 416 068 733 E: tspurling@nova-eye.com E: mflynn@nova-eye.com