Agostinho Almeida

Bruno Santos

João Ferreira

João Claro

Eusébio Gomes

João Gomes

Research  &  Development    Business  Development  

Company:  Servitus-­‐Inves;gação  

INTRODUCTION  

 Balance    Flexibility    Quality  of  life  

Cervical  

Lumbar  

Thoracic  

Spinal  curvature  

Normal  spinal  curvature  

Abnormal  spinal  curvature  

rota;on  

↑  angle  

PROBLEM  

Adolescent  Idiopathic  Scoliosis  (AIS)  

Musculoskeletal  disorder  of  unknown  causes  that  affects  adolescents  between  10-­‐16  years  of  age.  

Idiopathic  scoliosis  affects  2-­‐4%  world  popula6on  Economic  burden  (Hosp.  costs,  USA,  2004):  $689  million  

PROBLEM  

The  Burden  of  Musculoskeletal  Diseases  in  US  

Adolescent  Idiopathic  Scoliosis  (AIS)  

Long-­‐term  complica;ons  

Reduced  quality  of  life  

•   Chronic  pain  •   Altered  posture  and  movement    

•   Psychological  distress  •   May  require  spinal  fusion  

surgery  

PROBLEM  

7  

What  do  

pa;ents  need?  

-­‐Control  progression  

-­‐Comfortable  solu4on  

-­‐Aesthe4cs  

-­‐Correct  deformi;es  

Pa;ents  need:  

NEEDS  

Adolescent  Idiopathic  Scoliosis  (AIS)  

What  are  the  

current  solu;ons?  

<20º  

Pa;ent  monitoring  

Standard  of  care  for  AIS  

>45º  

Spinal  surgery  

1st  line  of  therapy    

CURRENT  SOLUTIONS  

Richards,  B.S.,  et  al.  Standardiza6on  of  Criteria  for  Adolescent  Idiopathic  Scoliosis  Studies.  2005.  Spine,  18;2068-­‐2075.  

20º-­‐45º  

Orthopaedic  brace  

11  

CURRENT  SOLUTIONS  

Boston   Milwaukee  

Late  1950’s  

“Hard  braces”  Triac  Spinecor  

Late  1990’s-­‐2000  

“So`  braces”  

Do  not  correct  the  spinal  deformity  

Stop  progression  of  the  disease  

window  of  opportunity  (10-­‐16  years  old)  Scoliosis  Braces:  

Is  there  a  beaer  

solu;on?  

Mainly  composed  of  tex2les  and  

thermo  moldable  plas2c    

PORTO.DOT  –  THE  NEW  SOLUTION  

Porto.Dot  

Before treatment 30 days after starting treatment

 12º  correc;on  

 Corrects  3  curves!  

 Results  in  6  months  

Improved  quality  of  life!  

PORTO.DOT  –  THE  UNIQUENESS  

• Displacement of the upper and lower trunk in opposite directions.

• Contrary to existing solutions, forces derrotation/detorsion of trunk in the corrective direction.

4 point pressure system!  

PORTO.DOT  –  TECHNOLOGY  

IP,  REGULATORY,  AND  PAYER  STRATEGY  

IP  Strategy  •  Patent  filed  in  2008  (PCT/PT2008/000046)  •  Interna;onal  publica;on  number:  WO/2010  053391  A1  

•  Trademark  (Porto.Dot)  

•  Future  patents  

Regulatory  Strategy  

•  Class  1  medical  device  

•  Collec;on  of  clinical  data      Submission  of  Class  2  medical  device  (2014)  

Payer  Strategy  

•  Payment  codes:  

-­‐  PT:  ISSO  060309  

                           and  ISSO  060318        

the  new  standard  

of  care  for  AIS  

Porto.Dot  

Market  Size  

Poten;al  Addressable  Market  

Es;mated  #  of  pa;ents  with  AIS  

3%  of  children  between  10  and  16  

AIS  MARKET  

ROADMAP  

1995-­‐2010   2011   2012   2013   2014   2015   2016  

Sales  PT,  SP  &  EU  Licensing  Br  

Licensing  USA  

Marke;ng  &  Sales  

Scien;fic   Marke;ng  

R&D  

Manufacturing  

Subcontracted  FPD   Porto.Dot  available  for  sales  

IP  and  Regulatory  approval  Patent  protec;on  and  CE  Marking  

Reimbursment  Patent  filed   Clinical  trials   • 3  Healthcare  Org.  

• Fac.  Engineering  70  pa6ents   Par;ally  funded  

Manufacturers  

Distributors  

Manufacturers  &  Distributors  

Sellers  

TARGET  MARKETS  

Revenue  streams:  •  Porto.Dot  sales    •  Licensing  

Porto.Dot  

Buyers  

Orthopedic  Osteopath  Physiatrist  

Cer;fied  Prosthe;st-­‐Ortho;st  

Public/private  hospitals  

Insurance  companies  

Payers  

KEY  SUCCESS  FACTORS  

Scien;fic  and  clinical  credibility  

Buying  decision  

New  standard  of  care  for  AIS  

Porto.Dot  corrects  the  spinal  deformity  in  AIS  pa;ents  

Peer-­‐reviewed,  conference  Support  from  opinion  leaders  

Partnerships   Market  expansion  

Market  conversion  

Sales:  €8.1    M  

EBITDA:  €4.0  M  

FINANCIALS  

2017:  

Porto.Dot    -­‐  a  new  standard  of  care  for  AIS  Market  entry  in  2013  

Payback  in  5th  year  of  sales  

Funding:  €  3.5  M  

Porto.Dot    a  correc6ve  solu6on  for  AIS  

Acknowledgments:  COHiTEC,  class  and  faculty  COTEC  EGP-­‐UPBS