BioWin  Namur,  16  Dec  2014  

©  2014    iSTAR  Medical  S.A.    -­‐  CONFIDENTIAL    

Mission  Statement  

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Help  the  millions  suffering  from  eye  diseases  and  disorders  with  implants  made  from  STAR®  Biomaterial  

Primary  focus:  GLAUCOMA  

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  

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>$4.0  B  care  costs  

Drug  Therapy  (drops)  

Laser  &  Surgical  

Glaucoma  Drainage  Devices  

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  

©  2014    iSTAR  Medical  S.A.    -­‐  CONFIDENTIAL    

Glaucoma  treatment  algorithm  

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  

 

©  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  

©  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    

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    

©  2014    iSTAR  Medical  S.A.    -­‐  CONFIDENTIAL    

Drainage  mechanism  

10  

Head  secHon  

Body  secHon  

•  Augments  natural  uveoscleral  ouklow  •  Bleb-­‐free  soluQon  

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    

©  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  

©  2014    iSTAR  Medical  S.A.    -­‐  CONFIDENTIAL    

The  remote  ECG  concept…  

©  2014    iSTAR  Medical  S.A.    -­‐  CONFIDENTIAL    

…is  spreading  fast  

©  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  

©  2014    iSTAR  Medical  S.A.    -­‐  CONFIDENTIAL    

Intra-­‐ocular  Pressure  Measurement  

STARflo  PLUS™  concept  

STARflo  PLUS™  -­‐  Glaucoma  Management  System    

•  €3.6m  R&D  Grant  Award  •  1st  preclinical  completed  

©  2014    iSTAR  Medical  S.A.    -­‐  CONFIDENTIAL    

Remote  PaTent  Management    Challenges  to  overcome  

•  PaQent-­‐physician  relaQonship  •  Liability  •  ConfidenQality  •  Business  model  •  Healthcare  system  Reimbursement  

Thank  you  for  your  adenTon!