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Corporate PresentationDEC 2016
1
Executive Summary
• Clinical stage medical technology company
• Targeting Glaucoma, a major market with high potential for growth
• Innovative biocompatible STAR® material offers unique potential for treating glaucoma thru bio-integration
• MINIject™ designed to be best in class MIGSdevice
• Strong, experienced management team, board of Directors and Scientific Advisors
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STAR® material
MINIject™
History
Patent filed: ‘Novel Porous Biomaterials’
iStar Medical Founded
STARflo™ Glaucoma Drainage Device; First in Human
Series A Financing
Initiated First Multicentre Clinical Trial for STARflo™
Strengthened Management Team & Board
Series B Financing
2003
2010
2011
2013
2014
2016
2015
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Board of Directors and Management Team
Michel Lussier, Chairman of the Board30 years of experience in Medical Technology Chairman of Celyad, founder of Medpole, a European distribution incubator for medical device start-up companies and co-founder of Cardio3 BiosciencesFormerly a senior executive with Medtronic and Volcano
Philippe DegiveRepresentative of Société Régionale d'Investissement de Wallonie (“SRIW”)Formerly with BNP Paribas FortisCurrent and past board memberships include Bone Therapeutics, PrometheraBiosciences, Euroscreen, Cardio Life Research
Max MaginnessPresident and co-founder, Healionics CorporationFormerly with Siemens Medical, ATL (now Philips Ultrasound) and subsidiaries of CIBA-Geigy managing multiple new product development and technology transfer projects
Marc Nolet de Brauwere30 years of industry experience and a successful track record in building and leading companies in ophthalmologyCurrently board membership include Bone Therapeutics, Cardiatis, Mymicroinvest, Endo Tools Therapeutics, Biotech Coaching and AliaxisCEO of PhysIOL,, an innovative med-tech company active in the conception, manufacturing and sales of cutting-edge intraocular lenses (IOLs)
Katya SmirnyaginaPartner, Capricorn Health-Tech Venture FundFormerly with Alta PartnersCurrent and past board memberships include Adocia, Confo Therapeutics, NexstimOy, Ablynx, Cerenis Therapeutics, Innate Pharma and Kiadis Pharma
Marty Wax, MDChief Medical Officer and Executive VP of R&D at PanOptica, Inc., Formerly Vice-President and Head of Discovery Research and Pre-Clinical Sciences at Alcon LaboratoriesClinical Professor of Ophthalmology and Visual Sciences at Rutgers Medical School in Newark, N.J.
Michel Vanbrabant, CEO20 years of experience in Medical TechnologyHeld several international positions at leading MedTech companies including Guidant Inc. (now Boston Scientific) and St.Jude MedicalExperience in several start-up organisations with a focus on go-to market strategy and implementation
Zubair Hussain, Regulatory & Clinical Affairs20+ years experience in Regulatory, Quality, Compliance and Clinical Affairs for Pharmaceutical and Medical Device companies.Formerly with Pfizer, Alcon, IpsenExperience in Global Regulatory, both strategic and operational, Clinical Affairs, including in Vision care
Dan Scherrer, Operations20+ years experience in Operations and Supply Chain Management for Medical Device, Food and Electronics.Formerly with DePuy Spine (JNJ), Synthes, BiwiExperience in overall operations from Product Development to Supply Chain
Pierre Geens, R&D10 years of experience in manufacturing, engineering, and international quality assurance rolesFormerly with GSK Pharmaceuticals, Baxter Healthcare, GSK VaccinesExperience in manufacturing, validation, R&D quality system, quality assurance and market access
Cecile Roy, Manufacturing5 years of research experience with bio-polymeric products for drug delivery applications Co-inventor of the STARflo MINIject deviceMaster’s Degree in Civil Engineering and a Ph.D. in Engineering Sciences from the UniversitéCatholique de Louvain
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Boa
rd o
f Dire
ctor
s
Man
agem
ent
Team
Glaucoma: Progressive, sight-threatening disease
80 million suffering
today90 million in
20201
Chronic progressive
diseaseDevastating
impact on patient’s
vision
Current therapeutic options aim at lowering intraocular
pressure (IOP)
2nd cause of blindness
after macular degeneration
worldwide2
1 Glaucoma Research Foundation
2. WHO/NMH/PBD/12.01 – Global data on visual impairments 2010 & Glaucoma Devices: Progress On Multiple Fronts, Elsevier Business Intelligence, April 2013
Fastest growing segment
(MIGS)
>€4.0 B care costsMeds
Laser & surgery
Drainage Devices
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Intended Benefits
iSTAR Technology:A Unique Drainage Implant for Glaucoma
Medical-grade silicone with micro-porous geometry
Soft, flexible, biocompatible
STAR Biomaterial
Bleb-free surgery
Acts on the natural uveoscleral drainage pathway
Anti-fibrotic biomaterialAdjunct of antimetabolites (mitomycin) not required
Living tissue integration without blockage
Sustained efficacy
Fewer complications
Less post-op patient management
Better drainage
Low scarring and infection
Supra-choroidal Placement
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iSTAR Product Pipeline
Feasibility study complete
Multi-center Study in progress
Product Development complete
First in Human H2-2016
STARflo MINIject
STAR Biomaterial Proof of Concept(Ab Externo Version)
MIGS(Ab Interno Version)
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The STARflo Technology:Anti-fibrotic STAR® Biomaterial
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STAR® Biomaterial developed at the University of Washington, Seattle, USA
PoreThroat
Medical grade silicone with precision-pore geometry
Soft, flexible, tissue-friendly
Rabbit Study: Suprachoroidal Placement – 6m Follow Up
IrisCornea
Sclera
Choroid
STARflo
Retina
No Encapsulation
observed as shown by the absence of surrounding fibrous capsule or continuous macrophage or fibroblast layer
Exceptional Biointegration
of the device with surrounding tissue colonizing the porous structure while preserving in vivo drainage efficacy
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iSTAR Product PipelineProof of Concept (Ab Externo version)
STARflo
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Inserted through an incisional surgical
procedure by Glaucoma surgeons
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Targeting suprachoroidal space, avoiding bleb formation,
minimising post-operative patient management
• Design objective: a high-performing, safe MIGS device resulting in significant
and sustained intraocular pressure (IOP) reduction
• Developed in close collaboration with world leading scientific and clinical advisors
• Delivery through a small corneal incision of 2.2 mm ; can be performed by cataract and glaucoma surgeons
iSTAR Product PipelineMIGS (Micro-Invasive): MINIject
Milestones
Series B Financing
1st Patient in MINIject trial
Results from STARflo Multi-centre Study
CE-Marking MINIject
IDE MINIjectFiling
April 2016
H2 2016
Q2 2017
2018
2018
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✔