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 presented… • Clinical results now presented at two key ”SURVIVAL” 1 ”SURVIVAL” 2 knee specialists meetings 100% 100% • In total, we now have 1 year data on 24 patients FKA • Results show; 75% 73% – Correct implant positioning – Joint space preserved – No adverse events – Significant improvements and very good scores ”FAILURE MONTH” ”FAILURE MONTH” 1. Australian Joint Registry 2014 7 2. Knutsen et al. JBJS (Am) 2007
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 8
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 Highly invasive and – Existing treatment methods based o Often referred to non- The joint reconstruction market, $16.5bn 1 “something you only do once” n biological interventions surgical treatment methods Extremities 10% Larg Knee e 49% Total knee Hips replacement 41% Lesion size Medium Partial knee ~50,000 ACI Market shares – knee reconstruction replacement Micro- market, $8.0bn 2 fracture surgery ~250,000 Other Zimmer 14% Biomet 34% Smith & Small Mosaic- Nephew plasty 11% DePuy Stryker Synthes 22% 50 30 70 19% Age of patient 1. The Orthopaedic industry annual report 2015, publish by Orthoworld 9 2. The Orthopaedic industry annual report 2015, publish by Orthoworld
Advancing on the Technology Adoption Curve What we achieve during the early adoption phase will give us access to 85% of the remaining market Innovators Early adopters Early majority Late Majority Laggards 2,5% 13,5% 34% 34% 16% Episurf Medical is exactly at û the correct point of First sales advancing through the people started Q3 2014 initial stages of the The “tipping point” technology adoption curve First implant in human û December 2012 » Clinical evidence – 1 year data û » Credibility with early adopters û » Generating early revenue » 5 CE-approved products » 100 implants We are commercialising a novel technology, in a previously untreated patient group, in a traditionally conservative sector – orthopaedic implants. 10
Clinical Advisory Board Episurf has an active KOL-strategy, and in 2015 the company formed an experienced and international Clinical Advisory Board Leif Ryd, Associate Johannes Holz, Karl Eriksson, Tim Spalding, Seppo Koskinen, Mats Brittberg, Professor Dr Med Associate Associate Professor Professor Professor Professor Orthopaedic surgeon Specialist in Professor in Medical Professor at the with a long career in orthopaedics and trauma Radiology at the Cartilage Research Unit, Department of Specialist Knee Surgeon, clinical research, surgery at OrthoCentrum Department of Clinical Gothenburg University Orthopaedics at University Hospitals focusing on osteoarthritis in Hamburg and Park- Science, Intervention and and orthopaedic Sophiahemmet and Coventry and (OA). Former professor klinik in Manhagen Technology, Karolinska surgeon, Department of Södersjukhuset, Warwickshire NHS Trust at Karolinska Institutet in Institutet, Stockholm and Orthopaedics, Stockholm and Honorary Associate Stockholm Senior Consultant, Kungsbacka Hospital, Professor, Warwick Karolinska University Kungsbacka Medical School, Hospital, Huddinge University of Warwick 11
A global strategy Episurf is currently executing its European commercialization strategy while also preparing a US entry strategy The US Europe • • Regulatory analysis pending 100 implants across Europe • • 510(k) vs PMA Direct sales force focusing on Germany, the UK, Belgium and the Nordics • Market access options are being evaluated • Current focus towards Germany and the UK • Re-imbursement • Re-imbursement • IP and patent portfolio • IP and patent portfolio 12
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
Thank you! The future The status quo 14
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