photobiomodulation for dry age-related macular degeneration · large and growing macular...
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Photobiomodulation for Dry Age-Related Macular Degeneration
Clark E. Tedford, Ph.D. – CEO
Significant Opportunity for Value Creation
LARGE MARKET OPPORTUNITY
$XB+ Global Market opportunity for first indication in Age Related Dry AMDEU CE Mark – ApprovedExpected US Clearance: 2021
China Approval: 2021
Excellent safety profile
Creating LEVEL 1 CLINICAL EVIDENCE
High efficacy and durability
Three clinical studies show clinically meaningful benefits
ATTRACTIVE PRODUCT PROFILE
• Non- Invasive• Implant & Injection-Free● Preserves future options● Familiar to
Ophthalmologists● High benefit / low risk
TRANSFORMATIVE POTENTIAL
Novel Technology Addresses Clinical Effectiveness and Payer Opportunity
New procedures for providers with lower cost of care
SurgeryPharma
Valeda Light Delivery System
Confidential - Do Not Distribute 2
• Europe CE mark approved for commercialization
• LIGHTSITE III, US trial IDE approved
• LIGHTSITE I, A prospective, sham-controlled dry AMD study with positive clinical and pathology outcomes accepted for publication in Retina, a top-tier ophthalmology journal
• Selling instruments to support initial EU launch
• Closed Series A in 2016 and Series B in 2017
• Awarded five grants of ~$4.0M ($2.5M NIH grant awarded in 1Q 2019 to support LIGHTSITE III)
• Robust Intellectual Property position – 10 patents issued and multiple PCT National phase applications
Progress Update
4Confidential - Do Not Distribute
Large and Growing Macular Degeneration (AMD) Market
• Worldwide prevalence of AMD expected to reach 196Mn by 2020 and increase to 288Mn by 2040
• U.S. AMD prevalence today 10-11Mn with direct health care costs in North America of $98Bn
• Dry type: No proven treatments
• Two types: § Dry type, affecting 90%§ Wet type, affecting 10%
• Wet type: Intra-ocular anti-VEGF injections§ Costly ($1500-2000 per injection/month)§ Invasive
Anti-VEGF injectionConfidential - Do Not Distribute5
Business Model with Multiple Revenue Sources
Confidential - Do Not Distribute 6
Sale/Service + Disposables + Buy to Bill revenue
Distribution Partners
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Ø Optos/Nikon – UK– France– Germany– Spain– Portugal– Switzerland– Sweden– Finland– Norway– Austria– Netherlands
Ø Miloftalmica– Italy
Ø Direct Distribution– Other approved
EU countries– Australia/NZ
Ø Andrec– Columbia– Ecuador– Guatemala– El Salvador– Dominican
Republic– Costa Rica– Panama– Honduras– Nicaragua
CONFIDENTIAL 8
The Effect of PBM on Vision in Early Stage Dry AMD Patients and Correlation to Geographic
Atrophy (GA) with Central Foveola Involvement
• Subset of high PBM responders with 5+ letter improvement
• 11 of 12 (91.6%) did not have foveola GA involvement
• Subset of Low PBM responders with <5 letters improvement
• 10 of 12 (83.3%) had foveola GA involvement
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High Responders
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The Effect of PBM on Central Drusen Volume in a LIGHTSITE I Subject
Baseline
Month 12 after 2 PBM sessions
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Key Timings and Milestones
Valeda CommercializationH2
2017H1
2018H2
2018H1
2019H2
2019H1
2020H2
2020H1
2021H2
2021
Commercial Manufacturing
NIH AMD Study
EU Study
Regulatory
US Study
EU LIGHTSITE II
LIGHTSITE ICommercial Manufacture Regulatory Stage
CE Mark
Confidential - Do Not Distribute
Valeda Commercial Manufacturing
LIGHTSITE I
EU LIGHTSITE II
OUS/FDA
US LIGHTSITE III
CE Approval
US LIGHTSITE III Study
Lumithera Provides Compelling Value Proposition to Stakeholders
Patients• Safely, non-invasively, & effectively addresses a huge unmet medical need – Dry AMD providing a significant improvement in their QOL.
Physicians• Can for the first time provide a therapy to their patients for Dry AMD backed by clinical data and an excellent safety profile• Valeda treatments bring additional procedural volume to their practices without compromising other activitiesCollaborators/Investors• Opportunities for corporate strategic investors and medical schools to work in collaboration with LumiThera to conduct POC test, market validation or strategic business alliance• Large, untapped market opportunity with clinical, technical, & IP leadership positions• Capital efficient business plan with experienced management team and scientific advisors Confidential - Do Not Distribute
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