bionic vision technologies - webflow
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Bionic Vision TechnologiesRestoring Functional Vision for the Blind
© 2020 Bionic Vision Technologies - CONFIDENTIAL www.bionicvis.com
PAsh Attia PhDChief Executive Officer
DISCLAIMER§ This presentation is intended to provide a general outline only and is not intended to be a definitive statement on the
subject matter.
§ The Company is subject to a number of risks and this presentation is not financial advice and has been prepared without taking into account the objectives, financial situation or needs of a particular person or company.
§ Any description of device usage is for the sharing of scientific knowledge and is not a recommendation or promotion of unapproved product, off-label use or indication of product.
§ Neither the Company nor its officers or advisors or any other person warrants the accuracy of the analysis herein or guarantees the investment performance of the Company.
§ Investors must make their own independent assessment of the Company and undertake such additional enquiries as they deem necessary or appropriate for their own investment purposes.
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VisionA world leader restoring functional vision to the blind
We will achieve this by:• Developing unique, safe and reliable vision restoring systems• Providing easy patient access and user experience• Investing in technologies that provide meaningful improvement to patients’ vision.
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Inherited Retinal DiseaseInitial Commercial Focus: Retinitis Pigmentosa
Gradual loss of peripheral vision leading to “tunnel vision” until all meaningful sight is lost.
Leading cause of inherited blindness.
1.9 million people affected world wide.
80% will become legally blind.
No known effective treatment.
Bare Light Perception (Blind)
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Implant and transmitter inserted in patient
Exterior camera connects to small computer
On board computer processes image
Signal passed through implant to eye
How the BVT Bionic Eye Works
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Our Proposition is Unique
• Results in faster, safer, and less invasive surgery with no retinal damage • Improves patients’ mobility and independence using our unique algorithms • Allows for implant upgrades as procedure is reversible• Enables patients’ participation in future stem cell or gene therapy trials.
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Current Clinical StudyInterim Results: Obstacle Detection
Study Participant
Obstacle DetectionHigher is Better1
Significant Improvement in Avoiding Obstacles with Device On
0.0
20.0
40.0
60.0
80.0
100.0
Pre-Surgery Week 17 Week 20 Week 32 Week 44 Week 56 Week 68
% S
ucce
ss
Test Internal
Device Off Device On
1 Fully Implantable Study Outcome Measures Week 92 (P1/P2) / Week 68 (P3 & P4)-Apr 2020Note: Weeks 17, 20 & 44 (n=4) with Weeks 32, 56 & 68 (n=3)
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Current Clinical StudyInterim Results: Window Detection
Test Subject1 Fully Implantable Study Outcome Measures Week 92 (P1/P2) / Week 68 (P3 & P4)-Apr 2020Note: Weeks 17, 20, & 32 (n=4) and Weeks 44, 56 & 68 (n=3)
Significant Improvement in Detecting Objects with Device On
Study Participant
0.0
20.0
40.0
60.0
80.0
100.0
Pre-Surgery Week 17 Week 20 Week 32 Week 44 Week 56 Week 68
% S
ucce
ss
Test Interval
Device Off Device On
Window DetectionHigher is Better1
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“…I have found that with the device, I am much more aware of what is going on around me…”
“…I’ve got more confidence and the device is really helping me…”
“…It gave a sense of ‘belonging’ in the gathering and not just solely relying on hearing to be more aware of my environment…”
Bionic Vision TechnologiesImproving Peoples Lives
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What patient sees – BVT depth algorithm
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What patient sees – BVT face detection algorithm
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Bionic Vision Technologies Welcomes Federal Government Medical Research Future Fund Grant of A$1million
MELBOURNE Australia, 2 Oct 2020: Bionic Vision Technologies (BVT) welcomed a grant of $1 million from the Australian Government’s Medical Research Future Fund BioMedTech Horizons program, operated by MTPConnect, to support development of an advanced vision processing software system.
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Continual Enhancements
Key Enhancements for Generation 3
• Thinner implant for faster and safer surgery• Miniaturized external components• Depth algorithm for improved object detection• Eye tracking to stabilize image• Targeted stimulation to improve resolution• Easier fitting and patient training
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SURGICAL
• 3 granted patents on the implant shape and surgical insertion
• 1 PCT filed
VISION PROCESSING
• 4 granted patents on optimising the vision processing and functionaloutcomes
• 2 PCTs & 3 provisional patents filed
STIMULATION
• 3 granted patents on electrical stimulation methods
Intellectual Property: • 10 Granted Patents (US, Australia, France, Germany, UK, Switzerland)• 3 International applications (PCTs filed)• 3 Provisional patents filed
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2020
Scale UpWorldwide Clinical Studies
Regulatory Approvals
US$20M
2022
Establish Global OperationsLaunch Commercial Bionic Eye
US$7M
Investment Opportunity
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Clinical and Commercial Development Schedule2020 2021 2022 2023
MANUFACTURE CLINICAL SYSTEM
CLINICAL STUDY / REGULATORY APPROVALS
Clinical Study Strategy§ Pivotal Study: n=30
Ø Australia: 5 patients/ 1 siteØ USA: 25 patients/ 5 sites
§ Additional Study:Ø China: 15 patients/ 3 site
Cap Raise
COMMERCIAL LAUNCH
2024
Cap Raise
Launch Targets§ Australia§ USA§ Europe§ China§ India
Regulatory Strategy§ Class III Medical Device§ Global Technical File
Ø USA: PMA Breakthrough Device PathwayØ Europe/Australia/India: Tech File ReviewØ China: Rare Disease Pathway
2025
2020 2021 2022 2023 2024Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Design for large scale manufacturing
V&V testingImplant
EthicsAustralia
Recruit TGA12Mon endpoint
EUEthics Recruit 12Mon endpoint
USIDE/IRB
Recruit 12Mon endpoint
CE submission
FDA submission
ChinaRecruit 12Mon endpoint CMDE
subEthics
CMDE Type Testing
First implantation
Europe Approval
FDA Approval
China Approval
Australia Approval
Cap Raise
$-
$5
$10
$15
$20
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
CY 2021 CY 2022 CY 2023
Millions
Cash Balance (USD)
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Capital Investment: Allocation of Funds
SUMMARY
• Two Cap Raises required thru to launch in 2024o 1st focussed on design to scale up
manufacturing/clinical Trial/regulatory approvals.o 2nd focussed on operations/launch set up
• Liquidity maintained thru to launch (+ve cash balance)• Initial launch in USA/China with revenues funding future
launches
Cap Raise
Phase Milestones Amount (USD)
2021 2022 2023
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
$20m
1 Clinical Build Designed $5m
2 Clinical Build Manufactured $5m
3 Clinical Build Verified $5m
4Clinical Trial (12mo Data)
$5mReg File Submission/Reviews
$7m5
Cont’d Operations including reg approvals, post trial support, and commercial plans set up
$5m
6 Launch set up and execution $2mCosts (US$ millions) $27m 7 3.5 2.4 2.3 2.3 1.7 1.2 1.1 1.1 1.3 2 1.5
Cumulative Costs (US$ millions) $27m 7 10.5 12.9 15.2 17.5 19.2 20.4 21.5 22.6 23.9 25.9 27.4
$-
$200
$400
$600
$800
$-
$100
$200
$300
CY 2024 CY 2025 CY 2026 CY 2027
Milli
ons
Milli
ons
Revenue Forecasts (USD)
Australia USA Europe China India Cumulative Total
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Current addressable market
Prevalence§ 1 in 4,000 Western world§ 1 in 1,000 China & India
Addressable RP MarketNo or bare light perception3% or 90,000 implants
Growth Year on Year
Reimbursement/Private/Tender§ Western world: USD$100,000§ China/India: USD$25,000
Market & Revenue Opportunity
5,8004,8001700 6,800
IMPLANTS
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The Executive Team
ASH ATTIAChief Executive OfficerBSc (E.Eng/Med Eng with Honors), MSc (Med. Eng), PhD (Med. Sc)GDip (Mktg), FAICDJuly 2019 – present
§ 30+ years of senior executive management experience in implantable devices and biotechnology.
§ Vice President and Managing Director roles with global medical devices organizations including TransMedics, St. Jude Medical, Thoratec, Syncardia,Ventarcor, Biotronik, SulzerMedica, and Telectronics/Nucleus Group.
§ Extensive experience in Class III medical devices commercialization including market entry strategies, R&D, Clinical, Regulatory, Reimbursement, General Management and Global Expansion.
BRIAN GORDONChief Technology Officer B Eng (Electrical with Honors) B Commerce (Marketing/ Economics)MBA, PMPJan 2019 – present
§ 20 years experience of new product development in implantable medical devices and the electronics industry.
§ Senior leadership roles at market leading companies including Cochlear & RØDE Microphones.
§ Recently the Senior Portfolio Manager at Cochlear responsible for delivery of new implantable systems to global market.
§ Extensive experience in bringing Class III medical devices to market in highly regulated environments.
ADRIAN OATESChief Operating Officer BSc (Biochemistry/ Microbiology)MSc (Biochemistry)PhD (Medicine)Mar 2019 – present
§ 25+ years experience of leadership roles in the medical device, in-vitro diagnostic, biological and pharmaceutical health care industries.
§ Vice President and Director level roles at global companies including Cochlear, CSL Behring and Universal Biosensors.
§ Extensive experience across quality, regulatory, clinical & operations in highly regulated environments including Class III implantable medical devices.
Medical Advisory Board
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PENNY ALLEN, M.D. CENTRE FOR EYE RESEARCH AUSTRALIA
DAVID BOYER, M.D. RETINA-VITREOUS ASSOCIATES
NINEL GRIGORI, M.D. BASCOM PALMER EYE INSTITUTE
PETER K KAISER, M.D. COLE EYE INSTITUTE, CLEVELAND CLINIC
STANISLAO RIZZO, M.D. UNIVERSITY OF FLORENCE
CHARLES WYKOFF M.D., PHD RETINA CONSULTANTS OF HOUSTON
DAVID T. TSE, M.D.BASCOM PALMER EYE INSTITUTE
JEFFREY HEIER, M.D.OPHTHALMIC CONSULTANTS OF BOSTON
Commercialisation Partners
22Health Policy Strategies Inc
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Contact Details:Ash Attia, CEOBionic Vision Technologies
ACN 124 162 634The Executive Center Tower 5, Level 23/ 727 Collins StreetDocklands, 3008Victoria, Australia
T: +61 (0) 419 691 229E: [email protected]
BIONIC VISION TECHNOLOGIES