The Journey to Mainstream Rosemary Cunningham Thomas, CEO - - PowerPoint PPT Presentation

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Oct 30, 2023 283 likes •434 views

The Journey to Mainstream Rosemary Cunningham Thomas, CEO Serendipity Ixora AGM 8 June 2016 100 Surgeries 3 47/15/4 Patients > 1 year Patients > 2 years Patients > 3 years 5 0% Revision rate 6 with clinical results now

SLIDE 1 The Journey to Mainstream Rosemary Cunningham Thomas, CEO Serendipity Ixora AGM 8 June 2016

SLIDE 2

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100

3 Surgeries

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47/15/4

5 Patients > 1 year Patients > 3 years Patients > 2 years

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0%

6 Revision rate

SLIDE 7 …with clinical results now presented…

Clinical results now presented at two key

knee specialists meetings

In total, we now have 1 year data on 24

patients

Results show;

– Correct implant positioning – Joint space preserved – No adverse events – Significant improvements and very good scores 7 1. Australian Joint Registry 2014 2. Knutsen et al. JBJS (Am) 2007 ”SURVIVAL”2 ”SURVIVAL”1 ”FAILURE MONTH” ”FAILURE MONTH” FKA 73% 75% 100% 100%

SLIDE 8 8 Episurf Medical’s goals and objectives are to mainstream patient-specific treatment options as a new standard within the orthopaedic industry Our ambition is to achieve 10% market penetration of the treatment market for Grade III-IV cartilage lesions

SLIDE 9 9 1. The Orthopaedic industry annual report 2015, publish by Orthoworld 2. The Orthopaedic industry annual report 2015, publish by Orthoworld The treatment options and the players Individuals suffering from knee joint injuries are referred to one of several existing treatment methods, however all suffering from one or several weaknesses or limitations Lesion size Age of patient Larg e Medium Small 30 70 50 Total knee replacement Mosaic- plasty Micro- fracture surgery Partial knee replacement ACI Existing treatment methods based o n biological interventions Often referred to non- surgical treatment methods Highly invasive and – “something you only do once” Knee 49% Hips 41% Extremities 10% Zimmer Biomet 34% Stryker 22% DePuy Synthes 19% Smith & Nephew 11% Other 14% The joint reconstruction market, $16.5bn1 Market shares – knee reconstruction market, $8.0bn2 ~50,000 ~250,000

SLIDE 10 Advancing on the Technology Adoption Curve 10 What we achieve during the early adoption phase will give us access to 85% of the remaining market We are commercialising a novel technology, in a previously untreated patient group, in a traditionally conservative sector – orthopaedic implants. Innovators 2,5% Early adopters 13,5% Early majority 34% Late Majority 34% Laggards 16% Episurf Medical is exactly at the correct point of advancing through the initial stages of the technology adoption curve » Clinical evidence – 1 year data » Credibility with early adopters » Generating early revenue » 5 CE-approved products » 100 implants First implant in human December 2012 û û First sales people started Q3 2014 û The “tipping point” û

SLIDE 11 Leif Ryd, Associate Professor Orthopaedic surgeon with a long career in clinical research, focusing on osteoarthritis (OA). Former professor at Karolinska Institutet in Stockholm Clinical Advisory Board 11 Episurf has an active KOL-strategy, and in 2015 the company formed an experienced and international Clinical Advisory Board Johannes Holz, Dr Med Specialist in

rthopaedics and trauma

surgery at OrthoCentrum in Hamburg and Park- klinik in Manhagen Karl Eriksson, Associate Professor Department of Orthopaedics at Sophiahemmet and Södersjukhuset, Stockholm Tim Spalding, Associate Professor Specialist Knee Surgeon, University Hospitals Coventry and Warwickshire NHS Trust and Honorary Associate Professor, Warwick Medical School, University of Warwick Seppo Koskinen, Professor Professor in Medical Radiology at the Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm and Senior Consultant, Karolinska University Hospital, Huddinge Mats Brittberg, Professor Professor at the Cartilage Research Unit, Gothenburg University and orthopaedic surgeon, Department of Orthopaedics, Kungsbacka Hospital, Kungsbacka

SLIDE 12 A global strategy 12 Episurf is currently executing its European commercialization strategy while also preparing a US entry strategy Europe

100 implants across Europe
Direct sales force focusing on Germany, the

UK, Belgium and the Nordics

Current focus towards Germany and the UK
Re-imbursement
IP and patent portfolio

The US

Regulatory analysis pending
510(k) vs PMA
Market access options are being evaluated
Re-imbursement
IP and patent portfolio

SLIDE 13 2016 Strategic Initiatives

» Consistent commercial execution » Continued product and service innovation via our

proprietary technology platform

» Producing scientifically robust clinical evidence » Pursue the relevant regulatory and reimbursement

pathways to support geographical expansion including an entry strategy into the US 13

SLIDE 14 14 The status quo The future

Thank you!