Episurf Medical Ab Class B · OMXSTO:EPIS_B
Episurf Medical Ab Class B — Pareto 15th Annual Healthcare Conference 2024
32 slides from Episurf Medical Ab Class B's conference presentation, Sep 19, 2024
Slide 1: Pareto 15th Annual Healthcare Conference
Stockholm, September 2024 Pareto 15th Annual Healthcare Conference Pål Ryfors, CEO episurf.com
Slide 2: The middle-aged patient
The-middie-aged patient | Ses cePINGYOU = Y \\ weALTHY y~ al Medical
Slide 3: Challenging patient group
Challenging patient group ! Middle-aged active patients ! Highly challenging patient group to surgeons - importance of addressing the pain ! Heavy pressure on joints – many times body weight
Slide 4: Common enemy: End-stage procedures
Common enemy: End-stage procedures
Slide 5: Original idea: Early intervention technology
Original idea: Early intervention technology ! A typical “hole in the cartilage” ! Inspired by dental industry ! As patients’ age – healing/re-generation capacity decreases significantly
Slide 6: Company milestones since start
✓ First scientific backed sales ✓ First 510(k)-clearance ✓ First time speakers invited Pre-clinical studies to ESSKA, WAC, EFFORT, published ✓ First time +10m revenues ICRS and AAOS ✓ First US sales ✓ Second 510(k) application ✓ Clinical results published IPO Nasdaq 2014 Company started ~2009 - 2010
Slide 7: Original idea: Early intervention technology
Original idea: Early intervention technology 1. What we thought: The typical “hole in the cartilage” 2. What we did: An implant technology based on targeted damage assessments and fully individualized solutions 3. What we learned: Highly successful solution – but joints often slightly more damaged t
Slide 8: Alternative treatment vs Episealer clinical gaps
Alternative Invasive arthroscopy or eye- Standardized off-the shelf Free-hand surgery with Cartilage lesions are often Stem and hat construction treatment balling on MRI scans implants and instrumentation standardized instruments related to underlying bone has led to failures lesions Challenge to tr
Slide 9: Alternative treatment vs Episealer clinical gaps
Alternative Invasive arthroscopy or eye- Standardized off-the shelf Free-hand surgery with Cartilage lesions are often Stem and hat construction treatment balling on MRI scans implants and instrumentation standardized instruments related to underlying bone has led to failures lesions Challenge to tr
Slide 10: Alternative treatment vs Episealer clinical gaps
Alternative Invasive arthroscopy or eye- Standardized off-the shelf Free-hand surgery with Cartilage lesions are often Stem and hat construction treatment balling on MRI scans implants and instrumentation standardized instruments related to underlying bone has led to failures lesions Challenge to tr
Slide 11: Alternative treatment vs Episealer clinical gaps
Alternative Invasive arthroscopy or eye- Standardized off-the shelf Free-hand surgery with Cartilage lesions are often Stem and hat construction treatment balling on MRI scans implants and instrumentation standardized instruments related to underlying bone has led to failures lesions Challenge to tr
Slide 12: Alternative treatment vs Episealer clinical gaps
Alternative Invasive arthroscopy or eye- Standardized off-the shelf Free-hand surgery with Cartilage lesions are often Stem and hat construction treatment balling on MRI scans implants and instrumentation standardized instruments related to underlying bone has led to failures lesions Challenge to tr
Slide 13: Medical
© EPISURF Medical
Slide 14: PROMs in published studies
✓ PROMS (Patient Report Outcome Score) now available in several published studies (knee) ✓ Significant improvement in clinical scores and fast return to weight-bearing ✓ Strong implant survivorship – results last over time
Slide 15: Swedish prospective and European multicentre studies
Swedish prospective study European multicentre study • Stålman, A., et al., No implant migration and good subjective outcome of a • Holz, J., et al., Patient-specific metal implants for focal chondral and novel customized femoral resurfacing metal implant for focal chondral lesions. osteochondral le
Slide 16: Rehabilitation duration and survival rates by treatment
Duration (weeks) of rehabilitation according to established postoperative protocols Illustration of survival rates for various treatment alternatives Unloaded full Range-Of-Motion Knutsen MFX 2 Knutsen ACI 2 HemiCAP 3 Episealer 3 Full Weight-Bearing UniCAP 4 Agili-C 5 UKA age <55 6 UKA age 55-64 6 S
Slide 17: Company milestones since start
✓ First scientific backed sales ✓ First 510(k)-clearance ✓ First time speakers invited Pre-clinical studies to ESSKA, WAC, EFFORT, published ✓ First time +10m revenues ICRS and AAOS ✓ First US sales ✓ Second 510(k) application Clinical results published IPO Nasdaq 2014 Company started ~2009 - 2010
Slide 18: Company milestones since start
✓ First scientific backed sales ✓ First 510(k)-clearance ✓ First time speakers invited Pre-clinical studies to ESSKA, WAC, EFFORT, published ✓ First time +10m revenues ICRS and AAOS ✓ First US sales ✓ Second 510(k) application Clinical results published IPO Nasdaq 2014 Company started ~2009 - 2010
Slide 19: Target market (USDbn)
Target market (USDbn) Joint Replacement 20,0 Spine 9,8 Knee: USD 10.5bn 2022 Trauma 8,0 +3.1% CAGR1 Episurf Medical near-term +55bn1 Sports Medicine 6,3 Extremities: targeted market segments +3.5% USD ~1.2bn Orthobiologics 5,3 USD 3.7bn +7.0% CAGR1 Enabling Technology 1,2 Other 4,8 1. Orthoworld - T
Slide 20: Target market
Target market Episealer® 510(k) cleared +USD 300m Patellofemoral System Knee Episealer® Knee CE-approved ~USD 400m 20,000 – 30,000 potential Episealer® Talus CE-approved ~USD 100m customers Foot & Ankle Episealer® MTP- In 510(k) process ~USD 400m system
Slide 21: Episealer Patellofemoral System
Episealer® Patellofemoral System 18% of Knee OA patients have OA isolated to the Patellofemoral Joint1 Existing devices plagued by problems with patient selection, ”overstuffing” and design challenges 1. Stoddart et. al., The compartmental distribution of knee osteoarthritis – a systematic review an
Slide 22: Episealer Patellofemoral System
Episealer® Patellofemoral System 18% of Knee OA patients have OA isolated to the Patellofemoral Joint1
Slide 23: US distributors and activation strategy
✓ ~25 distributors in 31 states. Working towards a nationwide coverage ✓ Activation strategy ✓ First users, first VAC, first case…
Slide 24: Cases performed or in near-term pipeline in US states
✓ Cases performed, or in near-term pipeline, in 15 states ✓ Excellent clinical and surgical outcomes – first podium presentation September 27th ✓ Several high-profile clinics involved
Slide 25: Agreement with J&J DePuy Synthes distributors
✓ Agreement with exclusive distributors of Johnson & Johnson DePuy Synthes in several states, totaling a population of +78 million ✓ ~200 reps ✓ First cases expected soon – activation strategy ongoing
Slide 26: Episealer MTP System
Episealer® MTP System ! Several million Americans suffering from OA in the 1st MTP-joint (big toe)1 ! Fusion relieves pain, but patients don't want it – industry is never going to stop aiming for a non-fusion solution ! Despite its clinical failures, Cartiva demonstrated surgeon willingness to quick
Slide 27: Episealer MTP System
Episealer® MTP System ✓ Highly differentiated solution to high volume clinical condition ✓ Can be revised into primary fusion; no bridges burnt; everything currently available remains available ✓ More anatomic variety than many appreciate – not just an oval shaped bone ✓ Can’t really be addressed wi
Slide 28: Distributor model in US market segments
✓ Distributor model in all US market segments ✓ Strategic shift towards hybrid model in OUS markets, with most countries being distributor markets
Slide 29: Distributor model and long-term product targets
✓ Distributor model in all US market segments ✓ Strategic shift towards hybrid model in OUS markets, with most countries being distributor markets ✓ Long-term target to launch additional products in OUS markets and focus on product development opportunities for (initially) the US market
Slide 30: ASP, customer base and activity
1. ASP 2. Customer base 3.Activity ~350 orthopaedic SEK ~46k 7.5 surgeries p.a. surgeons / orthopods SEK 150 – 200m target in the medium-term (cash flow positive) ~250 orthopaedic SEK ~28k 4.5 surgeries p.a. surgeons 1. ASP confirmed in multiple geographies incl. the US market 2. Already at ~150 cus
Slide 31: Strategy 2024-2026 and market opportunity
Market 2024 2025 2026 Key indicator opportunity Episealer® Growing ✓ Commercialization ~USD 0.3bn Patellofemoral S. order-intake 510(k) ✓ Episealer® MTP-System 510(k) Commercialization ~USD 0.4bn submission Strategy 2024 - 2026 + Episealer® Knee RoW Commercialization ✓ ~USD 0.4bn Growing order-intak
Slide 32: Pareto 15th Annual Healthcare Conference - Q&A
Stockholm, September 2024 Pareto 15th Annual Healthcare Conference Pål Ryfors, CEO episurf.com Q&A
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