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Addressing a global health problem Aktiedagen Stockholm 6 March 2017

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Page 1: Addressing a global health problema-bid.com/sites/default/files/Episurf-Medical-6-March-2017... · ... Global Industry Analysis, size, ... Millennium Research Group, Inc. Estimated

Addressing a global health problem

Aktiedagen

Stockholm 6 March 2017

Page 2: Addressing a global health problema-bid.com/sites/default/files/Episurf-Medical-6-March-2017... · ... Global Industry Analysis, size, ... Millennium Research Group, Inc. Estimated

Introduction

Focus of today

1. The problem

2. Our solution

3. Our results

4. Company

Today’s presenter

Pål Ryfors• Acting CEO and CFO from Jan 17. CFO Dec 15 – Jan 17

• Background from the banking industry, most recently CFO

at Marginalen Bank and previously Head of Group

Controlling at Hoist Finance

This document has been prepared by EPISURF MEDICAL AB solely for information purposes. The document and all information contained herein may not be reproduced, in whole or in part, for any purpose except as authorized by EPISURF MEDICAL AB. Although the information contained herein is believed to be accurate in all material respects, no expressed or implied representation or warranty as to the accuracy or completeness of such information is made by EPISURF MEDICAL AB, nor by any other party. This document has not been audited or independently verified. Nothing contained herein shall be relied upon as a promise or representation as to the future. No responsibility or liability (express or implied) is accepted for any errors, omissions or misstatements herein. The contents of this document are subject to corrections or change at any time and you will not be notified of such corrections or change.

2

episurf.com

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The problem

• Several hundred million individuals are suffering from

severe knee pain leading to significant loss off quality of life

3

Negativeimpact onquality of

life

Severe painand weakmobility

Lack of treatmentmethods

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The problem (cont.)

4

• A lengthy, degenerative and often very painful process is preceding the full development of osteoarthritis, incurring

significant costs to the society

• Today there is no cure for osteoarthritis – Joint cartilage has

poor capacity to regenerate

• There is a significant number of patients in a pre-OA stagewhich are difficult to treat

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Targeting the GAP patient

5

30 50 70

L

M

S

TKA

UKA

Epiealer®

Synthetic grafts

Age

Lesion size

Mosaicplasty

Episealer®

The treatment of knee joint disease for the

middle-aged patient is challenging

Cell treatments

Micro fracture

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Targeting the GAP patient (cont.)

61. Source: Transparency Market Research: Arthroscopy Procedures and Products Market – Global Industry Analysis, size, share, growth, trends and forecast 2015 - 2023

2. Source: European Markets for Orthopedic Soft Tissue Solutions 2010, Millennium Research Group, Inc. Estimated # of procedures in 2014

3. Includes TKR and UKR. Source: National Joint Registry for England, Wales, Northern Ireland and the Isle of Man Annual Report 2015 (Surgical data to 31 December 2014)

>5million

knee arthroscopies

>2million

knee replacements

128

39

3

70 67

Kneearthroscopies

Debridement& Microfracture

Other (incl.ACI)

Kneereplacements

of which OA(96%)

Continued establishment of the Episealer® technology within the treatment algorithm for early focal cartilage and bone marrow lesions represents significant global market potential

Market example1

2

3

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A growing market

• The GAP-patient: Too old for biology – too young for TKA

– Your best years

– Demand for an active life style

• Osteoarthritis occurs earlier in the middle age and increases following an ageing population and increased obesity

• The healthcare system has a growing preference for

shorter recovery time and minimally invasive procedures

7

200 million patients worldwide

suffer from knee osteoarthritis

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Scratching on the surface…

Knee49%

Hips41%

Extremities10%

81. The Orthopaedic industry annual report 2015, publish by Orthoworld2. The Orthopaedic industry annual report 2015, publish by Orthoworld

Z B34%

DePuy19%

S & N11%

Other14%

Market sharesjoint reconstruction market, $16.5bn1

Market sharesknee reconstruction market, $8.0bn2

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The unique solution

9

SimplifiedMinimallyinvasive

Patientspecific

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Market validation

�Clinical results

�Generating revenues

�Strong user adoption

10

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Our technology

11

STEP 1

Collecting MRI

STEP 3

Patient-specificimplants

STEP 4

The uniquesurgical kit

STEP 2

3D damage assessment

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Epioscopy 3D damage marking

12

• Digital, 3D based analysis of the knee joint

• Analysis of the cartilage quality and

underlying bone quality through creation of a

digital replica of the knee joint

• Non-invasive

• Simple communication and approval process

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The Episealer family

13

• An implant portfolio for various parts of the knee joint• Each implant is customized to fit the unique anatomy of each

individual patient• Using Hydroxiapatite and Titanium coating for long- and short-

term bone fixation

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Epiguide – surgical tools

14

• Just-in-time delivery – no inventory at hospitals• Simplified procedure• 20 – 30 minutes “skin-to-skin”

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15

https://www.youtube.com/watch?v=AkylltFd_PM&t=1s

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The patient

16

“FOR THE FIRST TIME IN 25 YEARS I COULD RUN AGAIN WITH NO PAIN OR SWELLING”

“FOR THE FIRST TIME IN 25 YEARS I COULD RUN AGAIN WITH NO PAIN OR SWELLING”

…41-year-old Nicklas from Sweden has suffered

from knee pain for more than 2 decades. Prior to

asking for the Episealer treatment he had

undergone 6 procedures with no lasting effect,

resulting in decreasing life standard with

constant pain. Last summer, he finished a 10 km

race, without feeling any pain or swelling…

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A lengthy and painful process

Pre-OA OA

The lengthy degenerative process leading up to OA often starts with a trauma leading to a small damage in early age

Biologics Synthetic grafts / Re-surfacing UKA TKA

Episurf Medical’s goal is to

mainstream patient-specific treatment options

as a new standard within the orthopaedic industry

17

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How Episurf is solving the failure rate

18

What Episurf avoids What Episurf do

� Lack of defined indication and/or weak bones/surrounding cartilage

• Pre-surgical assessment to find correct indication – addressing the pain

� Edges from “almost perfect” fit creates damages on opposing cartilage

• Patient specific to adjust to individual anatomy

� Difficult surgery which easily can lead to errors in angle and depth, which create edges

• Using patient specific guide instruments in order to achieve correct positioning and depth

� Screwing the implant into the bone through a 2-step methodology without bone assessment

• Press-fit methodology by drilling a hole and subsequent insertion of the implant

� Risk of detachment of hat & peg• A one-piece implant with HA and titanium

coating to create bone fixation

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Clinical results

19

We are commercializing a novel technology, in a previously difficult to treat patient group, in a

traditionally conservative sector – orthopaedic implants

2

4

10

15

24

48

75

107

171

> 4,0 yrs

> 3,5 yrs

> 3,0 yrs

> 2,5 yrs

> 2,0 yrs

> 1,5 yrs

> 1,0 yrs

> 0,5 yrs

Performed

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Clinical results (cont.)

20

0

25

50

75

100

Pre-op 3m 12m0

25

50

75

100

Pre-op 3m 12m0

25

50

75

100

Pre-op 3m 12m0

25

50

75

100

Pre-op 3m 12m

KOOS - Pain KOOS – Function daily living KOOS – Quality of Life VAS

• Correct implant positioning

• Joint space preserved and no adverse events

• Significant improvements and very good scores

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From idea to concept to commercialization

• Associate Professor Leif Ryd: Career within knee surgery and knee arthroscopy

• ”How do we treat early, focal cartilage

lesions? ... and in what way might this impact the development of osteoarthritis?”

• Episurf Medical…

21

?

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

IncorporationDecember 2012

first implant

Listed on OMX Nasdaq Small Cap

Commercializationand preparation for

US market entryFirst clinical

data presented

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Strong value proposition to stakeholders

22

• Safe procedure and short recovery time

• Clinically superior pain and function improvement

• Predictable results and increased durability of treatment

Patients

Physicians

Payers

• Superior technology for pre-surgical decision-making

• Minimal procedure length and fewer re-ops and revisions

• Simplified administration

• Safe procedure

• Fewer re-ops and revisions

• Short rehabilitation time & expense

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Episurf company

• Headquartered in Stockholm, Sweden

• 27 employees

• Highly experienced Clinical Advisory Board

• 5 CE approved products

• Listed on Nasdaq Stockholm since June 2014

23

0

5

10

15

20

25

SE

K

EPIS B, Nasdaq Stockholm

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Summary

• At the forefront of the trend of patient specificity in

med-tech

• An unique and successful solution for a global health problem

• Addressing an enormous and partly un-tapped market with a growing track-record of clinical results

24

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25

IR ContactPål Ryfors, Acting CEO and CFO

[email protected]+46 (0) 709 62 36 69

Q&A

Current rights issueTerms in summary

• New shares: 1:1

• Amount: SEK 120 million

• Subscription price: SEK 7.50

• TERP discount: 37.5%

• Guarantee: SEK 100 million

• Other: Commitments from key shareholders and management

Timetable in summary

• Extra General Meeting on February 20 2017

• Last day of trading with right to participate in the rights issue: February 21 2017

• Prospectus: ~February 23 2017

• Subscription period: February 27 – March 13 2017

Current rights issueTerms in summary

• New shares: 1:1

• Amount: SEK 120 million

• Subscription price: SEK 7.50

• TERP discount: 37.5%

• Guarantee: SEK 100 million

• Other: Commitments from key shareholders and management

Timetable in summary

• Extra General Meeting on February 20 2017

• Last day of trading with right to participate in the rights issue: February 21 2017

• Prospectus: ~February 23 2017

• Subscription period: February 27 – March 13 2017