istar medical 2017 · • current and past board memberships include adocia, confo therapeutics,...

13
Corporate Presentation JULY 2017 1

Upload: duongthuan

Post on 11-Sep-2018

214 views

Category:

Documents


0 download

TRANSCRIPT

Corporate PresentationJULY 2017

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

through bio-integration

• MINIject™ designed to be best in class MIGS

device

• Strong, experienced management team, board

of Directors and Scientific Advisors

2

STAR® material

MINIject™

History of iSTAR Medical

3

2011STARflo Glaucoma

Drainage Device;

First In Human

2013Series A financing

€4 Mln

2014First multicentre

clinical trial for

STARflo

2016Series B financing

€10 Mln

2010iStar Medical

founded

2016MINIject (MIGS)

Design finalised

2017MINIject

First In Human

2011Grants from

Belgium Region

Board of Directors and Management Team

Michel Lussier, Chairman of the Board

• 30 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 Biosciences

• Formerly a senior executive with Medtronic and Volcano

Philippe Degive

• Representative of Société Régionale d'Investissement de Wallonie (“SRIW”)

• Formerly with BNP Paribas Fortis

• Current and past board memberships include Bone Therapeutics, Promethera Biosciences,

Euroscreen, Cardio Life Research

David Guyer, MD

• CEO of multiple public and private biotechnology companies

• Co-Founder, Chairman and CEO of Ophthotech Corp.

• Previously: SV Life Sciences. Co-founded at 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

• 30 years of industry experience and a successful track record in building and leading

companies in ophthalmology

• Currently board membership include Bone Therapeutics, Cardiatis, Mymicroinvest, Endo

Tools Therapeutics, Biotech Coaching and Aliaxis

• CEO of PhysIOL,, an innovative med-tech company active in the conception, manufacturing

and sales of cutting-edge intraocular lenses (IOLs)

Katya Smirnyagina

• Partner, Capricorn Health-Tech Venture Fund

• Formerly with Alta Partners

• Current and past board memberships include Adocia, Confo Therapeutics, Nexstim Oy,

Ablynx, Cerenis Therapeutics, Innate Pharma and Kiadis Pharma

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.

• Formerly with Pfizer, Alcon, Ipsen

• Experience in Global Regulatory, both strategic and operational, Clinical Affairs,

including in Vision care

Dan Scherrer, Operations

• 20+ years experience in Operations and Supply Chain Management for Medical

Device, Food and Electronics.

• Formerly with DePuy Spine (JNJ), Synthes, Biwi

• Experience in overall operations from Product Development to Supply Chain

Pierre Geens, R&D

• 15 years of experience in manufacturing, engineering, and international quality

assurance roles

• Formerly with GSK Pharmaceuticals, Baxter Healthcare, GSK Vaccines

• Experience in manufacturing, validation, R&D quality system, quality assurance and

market access

Cecile Roy, Manufacturing

• 5 years of research experience with bio-polymeric products for drug delivery

applications

• Co-inventor of the MINIject device

• Master’s Degree in Civil Engineering and a Ph.D. in Engineering Sciences from the

Université Catholique de Louvain

4

Bo

ard

of

Dir

ect

ors

Man

ag

em

en

t T

eam

Marty Wax, MD

• Chief 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 Laboratories

• Clinical Professor of Ophthalmology and Visual Sciences at Rutgers Medical

School in Newark, N.J.

Bo

ard

Glaucoma: Progressive, sight-threatening disease

5

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

Second cause of blindness after macular degeneration worldwide 22

Therapeutic options aim at lowering intraocular pressure (IOP)

iSTAR Product Pipeline

6

Feasibility study

complete

Multi-center Study in

progress

Product Development

complete

First in Human H1-2017

STARflo MINIject

STAR BiomaterialProof of Concept

(Ab Externo Version)

MIGS

(Ab Interno Version)

The STAR® anti-fibrotic material

7

Medical grade silicone with precision-pore geometry

Soft, flexible, tissue-friendly

STAR® material developed at the University of Washington, Seattle, USA

Pore Throat

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.

The STARflo Drainage Implant

9

STARflo

Inserted through an

incisional surgical

procedure by

Glaucoma surgeons

Intended Benefits

STARflo: A Unique Drainage Implant for Glaucoma

10

Medical-grade silicone with micro-porous geometry

Soft, flexible, biocompatible

STAR Material

Bleb-free surgery

Acts on the natural uveoscleral

drainage pathway

Anti-fibrotic biomaterial

Adjunct 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

STARflo

The MINIject Glaucoma Drainage System

11

• Designed to be 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 –

understanding real patient needs

• Ergonomic shape for optimal

grip and precision

Handle

Shaft

• Pre-loaded with implant

• Smooth pull-back release

mechanism

MINIject

MINIject Delivery

12

Targeting suprachoroidal space

Avoiding bleb formation

Minimising post-operative patient management

• Delivery through a small corneal incision of 2.2 mm

• Can be performed by cataract and glaucoma surgeons

Milestones

13

2016

H1 2017

H2 2017

Series B

financing

1st patient

in MINIject

trial

Results from

STARflo

multi-centre

trial

2019

IDE

MINIject

filing

2019

CE-Marking

MINIject