ict meets biowin - glaucoma & remote par istar medical
TRANSCRIPT
![Page 1: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/1.jpg)
BioWin Namur, 16 Dec 2014
![Page 2: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/2.jpg)
© 2014 iSTAR Medical S.A. -‐ CONFIDENTIAL
Mission Statement
2
Help the millions suffering from eye diseases and disorders with implants made from STAR® Biomaterial
Primary focus: GLAUCOMA
![Page 3: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/3.jpg)
Market Size
GDD market: est.150-‐200M 2
1. Glaucoma Devices: Progress On MulQple Fronts, Elsevier Business Intelligence, April 2013; esQm. Impact of Xalatan
(Latanoprost) patent expiraQon 2. ConfidenQal data, Prof M.Belkin, Aug 2014; Report on the Global Glaucoma Device Market, Market Scope, 2008; Market
Scope Aug 2014; other publicaQons.
> 60 Mio people suffering 80 Mio in 2020
1
>$4.0 B care costs
Drug Therapy (drops)
Laser & Surgical
Glaucoma Drainage Devices
![Page 4: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/4.jpg)
Glaucoma – the issue to solve
1. WHO/NMH/PBD/12.01 – Global data on visual impairments 2010 2. Glaucoma Devices: Progress On MulQple Fronts, Elsevier Business Intelligence, April 2013
Prevalence • 2nd cause of blindness globally aaer
cataract1 • 2nd cause of blindness aaer
macular degeneraQon in the USA2
• Largely undetected in its early stages (>1/2)
Therapy • Current therapeuQc opQons aim at
lowering IOP
Progressive, sight-‐threatening disease in which damage to the opTc nerve leads to gradual and irreversible vision loss
![Page 5: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/5.jpg)
© 2014 iSTAR Medical S.A. -‐ CONFIDENTIAL
Glaucoma treatment algorithm
![Page 6: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/6.jpg)
Glaucoma – Unmet Clinical Needs
Meds (drops) • PaQent Compliance (<50%)
due to asymptomaQc disease & difficulty to self administer
• Inconsistent medicaQon levels • Side effects, Ocular Surface
Disease (OSD)
Trabeculectomy • Blebs (eye blisters) are
problemaQc • High Failure Rate (50%+ within
5yrs) • Fibrosis (FBR) major cause of
failure
![Page 7: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/7.jpg)
© 2014 iSTAR Medical S.A. -‐ CONFIDENTIAL
iSTAR Product Pipeline
1st in Human
2014 2015 2016 2017
STARflo Glaucoma Drainage Device
STARflo PLUS: Drainage + Monitoring
STARflo MINIject Drainage Device
1st in Human
Market Entry
Market Entry
![Page 8: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/8.jpg)
© 2014 iSTAR Medical S.A. -‐ CONFIDENTIAL
Unmet need
Bleb-‐free drainage mechanism for paQents at high risk of failure with convenQonal filtering surgery
Benefits • Augments physiological ouklow pathways
• Sustained Drainage performance (no formaQon of fibroQc cap)
• No Bleb leading to lower re-‐intervenQon rates
• No need for anQ-‐fibroQc meds STARfloTM
STARfloTM Glaucoma Drainage Device
![Page 9: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/9.jpg)
STARfloTM: Glaucoma Drainage Device designed for long term efficacy
STARfloTM precision-‐pore geometry
• 100% medical grade silicone
• AnQ-‐fibroQc
• Safe and effecQve bio-‐integraQon
• Maximized Qssue interface
10 years of R&D with precision-‐pore geometry (University of Washington & Healionics)
• © 2014 iSTAR Medical S.A. -‐ CONFIDENTIAL
10 µm
![Page 10: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/10.jpg)
© 2014 iSTAR Medical S.A. -‐ CONFIDENTIAL
Drainage mechanism
10
Head secHon
Body secHon
• Augments natural uveoscleral ouklow • Bleb-‐free soluQon
![Page 11: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/11.jpg)
STARfloTM Mechanism of acTon
• AnT-‐fibroTc
Minimal fibrous capsule (6M results) without use of anQ-‐fibroQc meds
• OpTmized bio-‐integraTon Choroidal and scleral Qssue ingrowth within the porous structure
• © 2014 iSTAR Medical S.A. -‐ CONFIDENTIAL
![Page 12: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/12.jpg)
© 2014 iSTAR Medical S.A. -‐ CONFIDENTIAL
Ongoing Studies
US Study
Regulatory approval study supports FDA 510k product clearance
EU Study
Designed to support product adopQon under CE mark indicaQon
• Open angle glaucoma refractory
to convenQonal surgery
• ReducQon in IOP, ReducQon in meds, Success rate/survival analysis, Safety, QoL
• 60 paQents 1 Year follow up
• Open angle glaucoma not controlled by max medicaQon
• ReducQon in IOP, ReducQon in meds, Success rate/survival analysis, Safety, QoL
• 50 paQents 2 Years follow up
![Page 13: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/13.jpg)
© 2014 iSTAR Medical S.A. -‐ CONFIDENTIAL
The remote ECG concept…
![Page 14: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/14.jpg)
© 2014 iSTAR Medical S.A. -‐ CONFIDENTIAL
…is spreading fast
![Page 15: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/15.jpg)
© 2014 iSTAR Medical S.A. -‐ CONFIDENTIAL
iSTAR Product Pipeline
1st in Human
2014 2015 2016 2017
STARflo Glaucoma Drainage Device
STARflo PLUS: Drainage + Monitoring
STARflo MiniJect Drainage Device
IOP is the key measure to control glaucoma
progression
![Page 16: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/16.jpg)
© 2014 iSTAR Medical S.A. -‐ CONFIDENTIAL
Intra-‐ocular Pressure Measurement
![Page 17: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/17.jpg)
STARflo PLUS™ concept
STARflo PLUS™ -‐ Glaucoma Management System
• €3.6m R&D Grant Award • 1st preclinical completed
![Page 18: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/18.jpg)
© 2014 iSTAR Medical S.A. -‐ CONFIDENTIAL
Remote PaTent Management Challenges to overcome
• PaQent-‐physician relaQonship • Liability • ConfidenQality • Business model • Healthcare system Reimbursement
![Page 19: ICT meets BioWin - Glaucoma & Remote par iSTAR Medical](https://reader034.vdocuments.net/reader034/viewer/2022042522/55a73c3a1a28abe6258b46ff/html5/thumbnails/19.jpg)
Thank you for your adenTon!