now available by mazor robotics · market opportunity: over 2,500 hospitals in the us alone...
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Robotic Spine Surgery?
Ori Hadomi, CEOSeptember 2011
MZOR:TA
Now available byMAZOR ROBOTICS
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Forward Looking Statement
Any forecast and/or forecasting statement, included in this presentation, is based on the Management's assessment at its discretion. However, these forecasts and/or statements are based on the Company's expectations at the time of this Presentation and do hold in store a number of uncertainties and risk to consider.
It is important to emphasize that actual results may differ substantially from expectations in these forecasts and/ or forecasting statements, resulting from various factors. The Company does not make any representations regarding the accuracy and achievement of the forecasts and/or forecasting statements.
In addition, forecasts and/or forecasting statements relate to the date of this Presentation only and the Company is not under any obligation to update or correct any of the forecasts and/or forecasting statements to reflect events or circumstances after the date of this Presentation.
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Robotic Spine Surgery: Enabling MISThe Renaissance – latest technology generation launched Q3/11
Regulatory status: FDA & CE cleared
User base: Over 30 units in leading clinical sites; over 2,000 live cases
Market opportunity: Over 2,500 hospitals in the US alone
Business model: Capital ($750K) + disposable ($1,200) + service
Sales team: Blue chip sales, Ex ISRG team
Competition: The only FDA cleared robotics technology for spine surgery
ROI for customers: Strategic investment – differentiator10 -15 months (subject to incremental volume)
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Mazor Robotics• Corporate Structure
• Global company - 50 employees world wide• Offices: US, Germany & Israel• US team expansion (12 and growing)• YTD financing: $49M; Cash balance : $20M• Publicly traded at TASE (MZOR)
• Mature Technology• Clinical effectiveness proven (>2,000 cases)• 7 CE & FDA cleared products• Strong IP • Over 20 systems in Europe & 6 in USA
• Global Business Plan • Expansion in Europe, Asia and USA• Capital + recurrent revenues business model
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Spine (Multi Level) Fixation with Pedicle Screws
The Need For Robotics In Spine Surgery
Misplaced Pedicle screw
Revision
Pedicle Screws Inserted Free-Hand Are Misplaced in 10% of Cases
Pedicle Screw Placement Accuracy: a Meta-AnalysisKosmopoulos V, Schizas C.; Spine 2007 Feb 1;32(3):E111-20
The Need For Robotics In Spine Surgery
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Misplaced Pedicle screw
Revision
The Need For Robotics In Spine Surgery
Major medical complications were reported in 5.2% of complex fusion procedures.
Trends, Major Medical Complications, and Charges Associated With Surgery for Lumbar Spinal Stenosis in Older Adults. JAMA April 2010
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CT-based 3D Planning Software
• CT-based 3D planning
• Guided instrumentation
• 1 mm accuracy
Computing Workstation
Robotic Guidance Unit
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Step 1:Plan
Step 4:Operate
Step 2:Mount
Step 3:3D Sync
Preoperative blueprint of the ideal surgeryis created in a virtual 3D environment
Spine Surgery with
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Step 1:Plan
Step 4:Operate
Step 2:Mount
Step 3:3D Sync
Rigid attachment to the patient assures maximum surgical accuracy throughout the procedure
Spine Surgery with
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Step 1:Plan
Step 4:Operate
Step 2:Mount
Step 3:3D Sync
Two fluoroscopy images are automatically synchronized with the CT based surgical blueprint (independent of anatomy)
Spine Surgery with
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Step 1:Plan
Step 4:Operate
Step 2:Mount
Step 3:3D Sync
Tools and implants are guided to theplanned trajectory with 1 mm accuracy
Spine Surgery with
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Clinically validated by surgeons’ experience:• Over 2,000 procedures worldwide• Over 12,000 implants• No cases of permanent
nerve damage
Powered by Mazor Robotics Technology
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Complete Solution to the Spine Surgery Market
Procedures• Pedicle screws (Cervical to Sacrum)• Obese patients• Revisions and Osteoporotic bones• Scoliosis & Deformities • Variety of Trajectories:
• Transfacet and translaminar-facet screws
• Sacroiliac screws• Tumor evacuation and removal• Percutaneous Spine stabilization (GO-LIF)
Surgical Approaches• Posterior:
• Open• MIS• Percutaneous
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Soon to come to the US: Brain ApplicationApplications• Brain biopsies• DBS placements• Shunt placements
Advantages• Accuracy• Frameless• Surgical speed
Regulatory Status: • CE cleared• Expect FDA clearance by
Q1/12
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Mazor Robotics Clinically Validated Technology:Clinical Evidence
98.3% Accuracy of 3,271 implants in 635 cases in 14 medical centerswith 49% of implants placed percutaneousely(typically 10%-20% of spine surgeries are MIS)Devito DP, Kaplan L, Dietl R, et al. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine. 2010;35(24):2109-2115.
Compared to freehand surgery, in 112 cases Mazor Robotics-guided surgery significantly:• Improved implant accuracy• Reduced X-ray dosage• Reduced complication rates, re-operations,• and postop opoids• Reduced average length of stayKantelhardt SR, Martinez R, Baerwinkel S, Burger R, GieseA, Rohde V. Perioperative course and accuracy of screwpositioning in conventional, open robotic-guided andpercutaneous robotic-guided, pedicle screw placement.Eur Spine J. 2011;20(6):860-868.
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Mazor Robotics Clinically Validated Technology:Clinical Evidence
98.9% Accuracy of 365 implants in 7 medical centersHardenbrook M, Knoller N, Barzilay Y, Zilberstein B,et al. Clinical experience with miniature robot for spinalsurgery: 89 clinical cases. E-Poster presented at 14thInternational Meeting on Advanced Spine Techniques(IMAST); July 2007; Paradise Island, Bahamas.
“…a reliable tool for exact pedicle screw placement”Pechlivanis I, Kiriyanthan G, Engelhardt M, et al.Percutaneous placement of pedicle screws in the lumbar spine using a bone mounted miniature robotic system, first experiences and accuracy of screw placement. Spine. 2009;34(4):392–398.
99.6% Accuracy of 1,815 implants in 120 scoliotic adolescentsDevito DP, Gaskill T, Erikson M, Fernandez M. Robotic based guidance for pedicle screw instrumentation of the scolioticspine. Presented at Pediatric Society of North America (POSNA); May 2011; Montreal, Canada.
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Mazor Robotics Systems in Daily Clinical Use Worldwide
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Revenue Model
4OperateRenaissance™
Surgical System$759K
Robot disposable$1.2K per procedure
Service agreement$76K per year
Implantable devices$6-8K per procedure
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Mazor Robotics Value Proposition Equation
Patient• Safety• Speed of rehabilitation• Risk of complications• Aesthetics• Radiation
PV = Precision Invasiveness
• Surgeon• Patient Value (PV) +
• Ease of use• Prestige• Marketing tool• Cutting edge
technology
= Surgeon Value (SV)
• Hospital Admin• (PV) + (SV) +
• Revenues • Differentiation• Market share• Reputation
= Hospital Value (HV)
MAZOR ROBOTICS OFFERS VALUE TO ALL THE PLAYERS IN THE HEALTHCARE SPECTRUM
PrecisionInvasivenessPatient Value (PV) =
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Mazor Robotics Clinically Validated Technology:Surgeon Testimonials
“If you do spine surgery for a living,this will come naturally to you...This is the future of spinal surgery.”--Isador H. Lieberman, MD, MBA, FRCSC, Plano, Texas, USA
“Once I tell my patients about this technology, they all want me to use it in their operations.”--Dale S. Horne, MD, PhD, Cincinnati, Ohio, USA
“The value of preoperative evaluation of the vertebral anatomy in these [scoliotic] pediatric patients cannot be over emphasized and has been an unexpected and enlightening outcome of the detailed analysis provided by the planning software.”--Dennis P. Devito, MD, Atlanta, Georgia, USA
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Hospital Marketing Kit
Adverts PostersBillboards
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In the PipelineProduct Renaissance Brain Surgery Implantable Devices
Intended USE • Advanced platform + 3D Imaging
• Cervical application
• Precise positioning for brain surgery (DBS,biopsy, shunt placement)
• Robotic enabled MIS spine stabilization procedures
Regulatory Status (Forecast)
FDACE
Q2/2011Q2/2011
2012Q1/2011
Emerald: Q2/2011GO-LIF: CE cleared
Launch Plan H2/2011 2012 2012
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Mazor On The Runway: Sales Channels
USA– Introduction - H2 2010
– Ramping up sales with clear and validated business plan
– Direct sale headed by Mr. Chris Sells, Ex VP Sales, Intuitive Surgical
– CEO relocated to the USA to support activities
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Mazor On The Runway: Sales Channels
• Europe:• Direct Sale:
• Germany, Austria, Switzerland• Started sales in 2008• Over 15 active systems installed• > 800 clinical cases
• Active Distributors since H2/2011• Holland• Russia• Czech Republic• Targeting: Spain, Portugal, GB & France
• Asia:• Korea – Distributor • Targeting: Taiwan, India, Singapore, China,
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Summary
• Mature technology with promising new products pipeline
• Proven business model and aggressive sales strategy
• Global company - experienced management team
• Expanding sales in Europe, Asia and the US
• Mazor Robotics Ticker in TASE: MZOR
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Thank YouYour questions are welcome
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