Leading the Spine Industry in Making Surgery Safer for Patients, Surgeons and OR Staff. Canaccord Musculoskeletal Conference Orlando March 1 st, 2016

Transcription

1 Leading the Spine Industry in Making Surgery Safer for Patients, Surgeons and OR Staff Canaccord Musculoskeletal Conference Orlando March 1 st, 2016

2 SpineGuard leadership Pierre Jérôme Co-founder, CEO and Board Director Alan Olsen Chairman of the Board 24 years of experience in the medtech industry (Europe and USA): Medtronic Sofamor Danek, Boston Scientific, SpineVision sales & marketing, business development, general management Master degree in Management from the INSEEC School of Business Bordeaux, France Founder of Danek (now Medtronic Spine) 25 years experience Investor and Board director in MedTech Stéphane Bette Co-founder, CTO, US GM and Board Observer Maurice Bourlion Board Director and SAB Member 20 years of experience in spine (Europe and USA): Sofamor Danek R&D, SpineVision founding employee, VP R&D and US GM Master degree in Mechanical Engineering (ENSAM), Post-graduate in Biomechanics (LBM) Co-invented Dynamic Surgical Guidance and Electro-Conductive Shock Wave Lithotripsy Extensive experience in R&D, international marketing and business development in the medtech industry Steve McAdoo VP Business Development Pierre Guyot Board Director Joined SpineGuard in January 30 years of experience in the international healthcare industry, 27 years of experience in the US medtech industry: Medtronic, Biomet, Smith & Nephew, Cerapedics, Danek Medical, SURx sales, marketing, and business development Until 2014, Pierre was the CEO and a member of the board of directors of Mölnlycke Health Care 2

3 SpineGuard core technology: Dynamic Surgical Guidance (DSG ) Enabling technology to secure implant placement in bony structures External electrode Local electrical current Bipolar sensor Internal electrode The bipolar sensor: local real-time measurement and transcription of electrical conductivity 3

4 PediGuard : Single use drilling probes for Spine surgery Cervical Straight Curved Cannulated Threaded Thoraco Lumbar Pre-launching now in Europe Shapes & tips addressing adult & pediatric indications from sacrum to high cervical in open & MIS 4

5 Screw placement traditional technique Drilling of a pilot hole using manual instruments Frequent checks via x-rays (fluoroscopy) A tedious technique lacking in precision (15-20% misplacement) and implying substantial x-ray exposure 5

6 Complications due to poorly-placed screws Biomechanical Neurological Hemorrhagic Cost implication Poorly-positioned screws may require a 2 nd surgical procedure Pseudarthrosis: poor fusion 15-32% screw misplacement Paralysis if the spinal cord is breached Neurologic consequences if the nerve roots are touched Complication rate: 2 to 11% Fatal hemorrhaging if the aorta is punctured Complications that are difficult to detect Revision rate due to screws at risk for the aorta: 2-6% Based on 3 US economic studies, the additional cost for revision surgeries to correct misplaced screws ranges from $17,650 to $27,677 OR teams exposed to excessive radiation doses and aware of its danger Long-term biological effects Spine surgery 10 to12x more exposure to X-ray than with other surgical procedures A well documented unmet clinical & safety need Data resulting from systematic review of the specialized scientific literature with all references listed at the end of SpineGuard s clinical brochure 6

7 Fusion: the gold standard and main market in Spine Surgery Pedicle screw market split CAGR Annual number of procedures Open degenerative Minimally-invasive surgery 62% 12% +3% +10% >700,000 Deformities Trauma & tumors 8% 8% +5% +2% >80,000 >80,000 ~1 million procedures Posterior cervical 8% +7% >80,000 Dynamic stabilization 2% +15% ~ 20,000 Orthopedic surgery > $40 billion Spine surgery ~$10 billion Vertebral fusion ~$6.6 billion (2/3 are screws) ~400 comparable screw systems on a mature and ultracompetitive market A large addressable market in need of innovation and differentiation Sources : William Blair, Spine Technology Summit and I-DATA 7

8 Clinical value established via 8 peer reviewed publications Alternative techniques Rate of poorly positioned screws Sensitivity 1, PediGuard vs. EMG Conventional method Surgical navigation max 32% Significant benefits in terms of accuracy 84% 50% 98% High reliability EMG (Electromyography) 15% min max 6% 5% min max 5% 1% min PediGuard Lumbar EMG Thoracic EMG Thoracic & Lumbar PediGuard Best in class accuracy 25-30% reduction in radiation exposure 15% less time inserting screws Data resulting from systematic review of the specialized scientific literature with all references listed at the end of SpineGuard s clinical brochure 8

9 Substantial benefits for all those involved Patients Surgeons Hospitals Avoids wrong screw placement and all the resulting complications Works on all levels of the spinal column (lumbar, thoracic & cervical) Less exposure to radiation (young patients) Less risk of infection Decreased operating time Less exposure to x-rays The only real-time guidance and anticipation technology No change in the surgical procedure Allows to train new surgeons Compatible with all anesthetics No investment in specialized personnel or equipment Reduces operating time and the use of operating theatres Minimizes risk of patient litigation resulting from medical error No maintenance no sterilization, instruments available on the shelf ACA: financial accountability of hospitals when corrective surgery is required US Code 270 for surgical supply A compelling value proposition for the entire healthcare system 9

10 Marketing leaning on KOLs, clinical data & education SAB 10

11 Commercial focus on key geographies USA & France: HQ in Paris & San Francisco - Direct through independent sales agents and strong field presence Rest of the world: Indirect via national stocking distributors, focus on top 10 countries 30+ regular users in France, good momentum in Germany, UK & Switzerland Education effort toward Russian surgeons mitigated by economic turmoil Direct organization 3 regions led by a sales manager and product specialist 15 employees primarily in sales & marketing Tools in place to answer changes driven by HC reform Coverage 75+ agencies 120+ accounts National and regional contracts signed with US Hospital systems Significant adoption in Mexico & Chile, difficult economic situation in Brazil Large tender in Saudi Arabia Intensive company presence and support in Japan CFDA registration obtained for straight PG, short list of distributors Clearance in major countries 11

12 A qualitatively steady growth of adoption Around 300 users worldwide 35 US and 15 French teaching institutions have adopted PediGuard in their curriculum 6,3M revenue in 2015, growing 43% over ,000 + surgeries performed worldwide (half in the US) US Unit Sales Trajectory 12

13 A new chapter of the story: From PediGuard probes to integrated DSG devices Foundation DSG inside Strategic Inflection IPO Completion of the PediGuard product line Building clinical evidence & KOL network Setting-up international sales coverage Investment in marketing Extending registrations & IP Miniaturizing the sensor 43% growth for FY M debt financing First DSG screw surgeries PediGuard, drilling instruments to make spine surgery safer Expanding DSG scope OEM Partnerships for advancing other DSG applications Poised to accelerate market penetration 13

14 DSG Screw: the game changer TODAY and TOMORROW 1 Find Entry Point 6 Insert Screw 7 Check 1 Find Entry Point 2 Prepare Hole 5 Check 2 Insert SmartScrew Check Tap Check Single-step insertion of pedicle screws 14

15 DSG Screw unmatched value Clinical value Economic value Strategic value Ultimate accuracy improved success rates Enhanced screw purchase/anchorage Minimizes radiation exposure Fits with existing reimbursement landscape for pedicle screws Clinical workflow efficiency skip steps save time and cost More defensible price vs. legacy screws in a >1m procedural market in Spine alone Adaptable to various pedicle screw instrumentations 510kable clear pathway to commercialization Highly differentiated scope to capture market share aggressively CE mark obtained First surgeries performed with NFI screws 510k in process with Zavation 15

16 DSG Powered Drill: the entry to non Spine applications DSG Technology Procedural Capabilities Smart k-wire Guide wire or drill bit with DSG bipolar sensor Cervical SPINE Robotic Smart drill bit Modified motor with embedded DSG electronics Concept validation through animal & cadaveric labs NON SPINE Trauma Maxillo-Facial Large Joints SpineGuard is seeking co-development partnerships 16

17 Broadening our technology scope X-RAY FREE NAVIGATION Novel ultrasound technology Complete DSG for a full guidance solution in MIS and open surgery 100% X-ray free approach 2 patent applications filed Partnership with a leading ultrasonic transducer manufacturer BONE QUALITY MEASUREMENT Assess precisely the local bone quality / density Overcome DEXA scans lack of accuracy Allow surgeons to make intra-op decisions on treatment 2 patent applications filed Opportunities not only in Spine 17

18 Wrap up DSG has a broad scope beyond the existing PediGuard line Multiple new applications accessible via partnerships TRAUMA GENERAL ORTHOPEDICS MAXILLO-FACIAL Breakthrough in an innovation-lite area New Functionalities 1 ROBOTICS 1 1 X-RAY FREE NAVIGATION BONE QUALITY MEASUREMENT DSG POWERED DRILLS DSG SCREWS PEDIGUARD THREADED PediGuard In house OEM Partnership development strategy A clear strategy to establish DSG as standard of care, drive growth and create shareholders value 18