Upload
others
View
2
Download
0
Embed Size (px)
Citation preview
Corporate PresentationJAN 2018
1
• Private VC-backed company based in
Belgium
• Targeting Glaucoma, a major market with
high potential for growth
• Lead product MINIject™ completed
enrolment of First-In-Human clinical trial
• Exclusive rights to
innovative anti-fibrotic
STAR® material
Developing a
new generation
of MIGS made of
anti-fibrotic
material
2
iSTAR Key Messages
MINIject™ STAR® material
History of iSTAR Medical
3
2011STARflo
(Ab externo GDD)
First In Human
2013Series A financing
€4 Mln
2014STARflo
First multicentre
clinical trial
2016Series B financing
€10 Mln
2010iStar Medical founded
2016MINIject (MIGS)
Design finalised
2017MINIject
First In Human
2011Grants from
Belgium
Region
Scientific & Clinical Advisors
4
Andrew Marshall, Ph.D.
Chief Technology Officer
Healionics, Seattle, USA
Christophe Baudouin, MD, Ph.D.
Chairman, Department of
Ophthalmology, Hopital des Quinze-
Vingt, Paris, France
Steven Vold, MD
Assistant Professor, Department
of Ophthalmology & Surgery
Fayetteville, Arkansas, USA
Murray Johnstone, MD
Professor of Ophthalmology,
University of Washington,
Seattle, USA
Ike Ahmed, MD
Assistant Professor at the
University of Toronto, Canada
Norbert Pfeiffer, MD, Ph.D.
Director of Dpt of Ophthalmology,
University Medical Center of Mainz,
Germany
Philippe Denis, MD, Ph.D.
Head Ophthalmology Department,
Croix-Rousse University Hospital,
Lyon, France
Julian Garcia Feijoo, MD, Ph.D.
Professor and Chairman of
Opthalmology at Universidad
Complutense, Madrid, Spain
Board of Directors and Management Team
Philippe Degive
• Representative of Société Régionale d'Investissement de Wallonie (“SRIW”)
• Current and past board memberships: one Therapeutics, Promethera
Biosciences, Ogeda, Cardio Life Research
David Guyer, MD
• Co-Founder & Chairman of Ophthotech Corp.
• Previously: SV Life Sciences. Co-founder of Eyetech Pharmaceuticals, Inc.,
• B.S. from Yale College & M.D. from Johns Hopkins
Max Maginness
• President and co-founder, Healionics Corporation
• Formerly with Siemens Medical, ATL (now Philips Ultrasound) and
subsidiaries of CIBA-Geigy managing multiple new product development
and technology transfer projects
Marc Nolet de Brauwere
• CEO of PhysIOL (cutting-edge IOLs)
• Current board membership: Bone Therapeutics, Cardiatis, Mymicroinvest,
Endo Tools Therapeutics, Biotech Coaching and Aliaxis
Katya Smirnyagina
• Partner, Capricorn Health-Tech Venture Fund
• Formerly with Alta Partners
• Current and past board memberships: Adocia, Confo Therapeutics,
Nexstim, Ablynx, Cerenis Therapeutics, Innate Pharma and Kiadis Pharma
Marty Wax, MD
• CMO and Executive VP of R&D at PanOptica, Inc.
• Formerly VP and Head of Discovery Research and Pre-Clinical Sciences at
Alcon
• Clinical Professor of Ophthalmology and Visual Sciences at Rutgers
Medical School in Newark, N.J.
Michel Vanbrabant, CEO
• 20+ years of experience in Medical Technology
• Held several international positions at leading MedTech companies
including Guidant Inc. (now Boston Scientific) and St.Jude Medical
• Experience in several start-up organisations with a focus on go-to
market strategy and implementation
Zubair Hussain, Regulatory & Clinical Affairs
• 20+ years experience in Regulatory, Quality, Compliance and Clinical
Affairs for Pharmaceutical and Medical Device companies including in
Vision care
• Formerly with Pfizer, Alcon, Ipsen
Dan Scherrer, Operations
• 20+ years experience in Operations, Product Development and Supply
Chain Management for Medical Device, Food and Electronics.
• Formerly with DePuy Spine (JNJ), Synthes, Biwi
Cecile Roy, Manufacturing
• 7 years of research experience with bio-polymeric products for drug
delivery applications
• Co-inventor of the MINIject device
5
Bo
ard
of
Dir
ect
ors
Man
ag
em
en
t Team
Michel Lussier, Chairman of the Board• CEO of Metronom Health, Chairman of Celyad
• Formerly a senior executive with Medtronic and Volcano
Ch
air
man
CEO
Associated with elevated Intraocular Pressure
(IOP) in most cases
Proven therapeutic options aim at lowering
IOP
Progressive, sight-
threatening disease,
largely asymptomatic
Second cause of
blindness after macular
degeneration
worldwide22
6
Glaucoma
Sources:
1. Market Scope estimates for Glaucoma prevalence (September 2016)
2. WHO/NMH/PBD/12.01 – Global data on visual impairments 2010 & Glaucoma Devices: Progress On
Multiple Fronts, Elsevier Business Intelligence, April 2013
>80 million
people
>90 million
people 1
2016 2021
Blocked drainage
canal builds up
fluid
Excess fluid increases
pressure which
damages optic nerve
The STAR® anti-fibrotic material
7
• Medical grade silicone with precision-pore geometry
• Soft, flexible, tissue-friendly
Developed at the University of Washington, Seattle, USA
iSTAR has exclusive IP rights in Ophthalmology to the STAR® anti-fibrotic material
Pore Throat
The STAR® anti-fibrotic material
Rabbit Study, Suprachoroidal Placement – 6m Follow Up
8
IrisCornea
Sclera
Choroid
STARflo
Retina
No Encapsulation
observed as shown by the
absence of a continuous
surrounding fibrous
capsule, nor continuous
macrophage, nor a
continuous fibroblast layer
Exceptional
Biointegration
of the device with
surrounding tissue
colonizing the porous
structure while preserving
in vivo drainage efficacy
Source:
Prof. Nathalie Collignon (CHU of Liège, Liège, Belgium); In-
vivo: CER Groupe (Marloie, Belgium); Histology: GIGA-ULg
Immunohistology Platform (University of Liège, Liège,
Belgium). March 2013.
iSTAR Product Pipeline
9
Feasibility study complete
Multi-center Study in
progress
>100 patients implanted
First-in-Human Study in
progress
CE-marking Study
planned H2-2018
STARflo
MINIject
STAR ®
anti-fibrotic material Ab Externo
Implant
MIGS
Served as a proof of concept for the STAR material
COMMERCIAL PRODUCT
• Micro-invasive technology which is safe and
easy to implant in a single-step procedure
• Entirely made of proprietary anti-fibrotic
STAR material
• Designed for significant and sustained IOP
reduction
• Targeting the supra-choroidal space - no
bleb formation
• Strong IP around material, device design
and implantation method
• Developed in close collaboration with world
leading KOLs – understanding real patient
needs
The next
generation MIGS
made of
anti-fibrotic
STAR material
10
MINIject
MINIject™
The MINIject™ Glaucoma Drainage System
11
• Ergonomic shape
for optimal grip
and precision
Handle Shaft
• Pre-loaded with implant
• Smooth pull-back release
mechanism
• Delivery through a small
corneal incision of
2.0mm.
• Can be performed by
cataract and glaucoma
surgeons.
Targeting the suprachoroidal space - Avoiding bleb formation
Company Milestones
12
H1-2018STARflo
Results from
Multi-centre
clinical trial
2016Series B financing
€10 Mln
H2-2018MINIject
IDE Filing
H1-2017MINIject
First Patient
in FIH Study
✓
✓
H1-2018Next financing round
H2-2019MINIject
CE mark