Apifix presentation english version

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Short fixation followed by Specific Physiotherapy Program ApiFix® New minimal invasive method to treat Adolescent Idiopathic Scoliosis Nikos Karavidas, MSc, PT

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Short fixation followed by Specific Physiotherapy Program

ApiFix

New minimal invasive method to treat Adolescent Idiopathic ScoliosisNikos Karavidas, MSc, PT

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Treatment SeverityNowadays, there is a missing step between conservative treatment and spinal fusion. This gap can be covered by Apifix, which offers the internal brace option.25- 402550

Treatment Severity

ApiFix The internal braceApiFix

Treatment process

Scoliotic deformityApiFix Implant attaches to the pedicle with 2 screws peri apical and a relative correction of the deformity is achieved

A miniature ratchet mechanism allows the elongation of an expandable rod

The implant gradually elongates by specific Physiotherapeutic exercises, enlarging the distance between the two screws. This gradual correction targets to bring the curvature into the safe zone , below 35

Spinal fusion Vs ApiFix Spinal fusionSurgical incision approx. 30- 45 cmDuration of operation 6-8 hoursHospitalization 6-7 daysBlood loss 800-1500cc ApifixSurgical incision approx. 10 cmDuration of operation 45-60 minHospitalization 1-2 daysBlood loss 50 ccNo fusion, no effect on growth plates, does not affect growthNormal range of motion of spine after surgeryPotential option to remove the device after maturityOption for spinal fusion in the futureStatistically significant lower rate of surgical complications

ApiFixTypical Long Fusion CaseApiFix Concept

Apifix acts like an internal brace, which combines a minimal invasive surgical procedure with Physiotherapeutic Scoliosis Specific Exercises (PSSE) with Schroth method

Fatigue Test per ASTM F 1717

Testing JigTest Sample- Test performed by EndoLab GMBH (Germany)- ApiFix Run-out load at 5,000,000 cycles was 1000N - Standard fusion systems of good quality holds around 300N* * Multiaxial Pedicle Screw Designs: Static and Dynamic Mechanical Testing. Ralph E. Stanford et al, Spine Vol. 29, No. 4 , 2004

Run out load [N] of standard fusion systems* and the ApiFix systemFatigue test

Spherical joint between the Implant and the Screw.No moments can be transferred, only pure axial loads.The Nut firmly holds the spherical ring but the joint is still free to move 3D. Risk reduction

Risk AnalysisOutcomeRisk MitigationMain Risks IdentifiedProper safety factor identifiedFinite Elements AnalysisImproper design leading to early failureSystem was able to withstand 1,000N loading for 5MCFatigue test per ASTM F1717Fracture of system under long term fatigue loadingLow wear of 0.01 mg/MCWear test of 10 MCWear of ratchet mechanismLow steady state wear of 0.02 mg/MC per joint Wear test of 10 MCWear of poly-axial jointFor properly indicated patients, the system was able to reduce the curve to below 35 degreesClinical trial in EuropeFailure of system to reduce scoliotic curve below 35 degreesNo device related adverse event in 37 patients with up to 2.5 years follow up (438 patient-months)Clinical trial in EuropeUnexpected adverse events

Indications for ApiFixApifix is not applied to every type of scoliosisLenke type 1 (Main Thoracic), Lenke type 5 (Thoracolumbar)Cobb angle 40 60 Moderate rotationFlexible curve( significant correction in side-bending x-rays)

The most suitable patients for the program are aged 11-12 with 90% risk of progression and aged 13-14 with 70% risk of progression, to bring them to the age of 16 with only 10% risk of progression Age1920-2930-59601045%100%100%100%11-1223%61%90%95%13-148%37%70%90%160%10%30%70%

Risk of curve progression 5 , by age

Indications for ApiFix

Pre-operationScoliosis classification by LenkeX-ray evaluation and estimation of Cobb angleEvaluation of flexibility by lateral bending x-raysRadiological and clinical assessment also by the Certified PhysiotherapistCommencement of the exercises 1 month prior to the operationDetailed information to the patient and their family, expectation management

Post-operationExit of the hospital 1-2 days after the operationCommencement of exercises 2 weeks after the operationRadiological assessment at 1,3 and 6 monthsContinuation of the exercises for at least 6 monthsDetailed information to the patient and their family about the results of the treatmentLong follow-upTreatment protocol

Pre-operationCommencement 1 month prior to the operation, (3-4 sessions)

Expectation management, body awareness, principles of correction, main goals of treatment

Improvement of spinal mobility and flexibility by manual therapy techniques, massage and exercises

Teaching of the 5 basic ApiFix exercises

Post-operation2 weeks - 8 weeks, (6 sessions) : Relief of post-operative pain and stiffness ApiFix exercises8 weeks 6 months, (6 sessions) :ApiFix exercisesAuto-correction exercises based on Schroth method and Barcelona Scoliosis Physical Therapy School (BSPTS) principles, which consist a holistic approach to treat the whole spine in AIS, and stabilize the result Physiotherapeutic Scoliosis Specific Exercises (PSSE)

5 basic ApiFix exercises1234

5These 5 exercises are applied only for the purpose to expand the device, they are designed only for thoracic curves and do not consist a holistic approach to treat scoliosis.The ApiFix exercises developed by Dror Levi and Lior Neuhaus Sulam.

Schroth methodGoals of treatment by Schroth method:

Personalized exercises based on the curvature type (Physiotherapeutic Scoliosis Specific Exercises-PSSE)3D auto-correction of scoliosis and active self elongationAngle Trunk Rotation (ATR) improvement and prevention of flatbackActivities of Daily Living (ADL ) trainingImprovement of Vital Capacity (VC) and breathing functionImprovement of posture and clinical appearanceReduction or elimination of painImprovement of spinal mobility and flexibilityReduction of mechanical forces that promote progression

The exercises are prescribed only by Schroth Certified Therapists

6m post op1m post oppre opCase study 1 Cobb 45 Cobb 23 Cobb 19

6m post oppost op 1 monthpre op

Case study 1

Case study 2

Pre- Op2 W6 W3 MCobb Angle53302626

Age13Risser1SexF

Case study 3

Pre-OpPost-Op6 weeks3 M52323030

Age15Risser4SexF

Follow upPre-OpPost-Op12 weeksCobb angle473330

Case study 4Age15Risser2SexF

Case study 4Spinal flexibility is maintained after the operationGradual expansion of the ApiFix mechanism after exercises

Pre-opTh (R) 54 Lu (L) 44 Immediately after operation Th (R) 30 Lu (L) 33

1 month after operation (before starting exercises)Th (R) 37 Lu (L) 39

3 months after Schroth exercises Th (R) 35 Lu (L) 39

Case study 5Age14Risser0SexF

Before exercisesOpening the device 3 months after Schroth exercises

Case study 53 months after exercises

Before exercises3 months after exercises

Case study 5Sagittal plane improvement 3 months after Schroth exercises

Before exercises3 months after exercises

Case study 5Improvement of clinical appearance, ATR, shoulder and pelvic asymmetries 3 months after Schroth exercises

Benefits from Schroth method after the ApiFix operation:

Halt progression of scoliosis, even after the marked progression the first month after operation and before starting the exercisesFurther opening of the deviceThoracic Cobb angle improvement from 37 to 35Halt progression of the lumbar curvatureRemarkable improvement of posture, with better symmetry for shoulders and pelvisSlight improvement of ATR, 14 to 13 for the thoracic curve, and 9 to 7 for the lumbar curveSagittal plane improvement, with more harmonic kyphosis and lordosisPain eliminationPsychological improvementImproved breathing function and VCADL training Case study 5

Difficulties faced during treatment with Schroth method:

No indication for treatment, double major scoliosis, Lenke type 3No slight or moderate rotation (ATR 14 9 )Delayed commencement of exercises (4 weeks after operation)Not flexible curvatureProgression of both curves, thoracic and lumbar, 1 month after operation Risser 0, pre-menarche when starting exercises, so the risk for proggression was higherLack of trust for the result of the treatment by the family environmentCase study 5

Pre-operation Lu (L) 36 After operation Lu (L) 22

Case study 66 months after Schroth exercises Lu (L) 18

Age19Risser5SexF

Cobb angle improvement and better balance for shoulders and pelvis 6 months after Schroth exercises

Pre-operationKyphosis 51 After operationKyphosis 57

Case study 66 months after Schroth exercises Kyphosis 49

Posture and sagittal plane improvement 6 months after Schroth exercises

Benefits from Schroth method after ApiFix operation:Cobb angle improvement from 22 to 18 Further opening of the deviceSignificant improvement of posture and better balance for shoulders and pelvis Significant improvement of Kyphotic angle from 57 to 49 Better clinical appearance and psychological support Activities of Daily Living (ADL) trainingPain eliminationDifficulties faced :No indication for ApiFix, Lumbar ScoliosisDelayed commencement of exercises, 4 weeks post-operationLow compliance with exercises for the first 3 monthsNo chance to perform side-bending exercises to open the deviceCase study 6

Conclusions- RecommendationsThe main goal of treatment with ApiFix is to bring the scoliosis into the safe zone, below 35 ,and avoid progression in adult lifeThe treatment targets to ensure a good quality of life for the patient, without movement restrictions and pain, and posture improvementIt is crucial to follow the indications for ApiFix treatment, because it is not applied for every type of scoliosisThe exercise program must be designed exclusively by a Certified Schroth Therapist, who is a specialist in scoliosis treatmentExercises must start before the operation according with the clinical assessment, in order to improve the final result of treatmentA long follow-up is required to state the long-term results and there is an imperative need for good quality research to present the effect of ApiFix treatment

THANK YOUNIKOS KARAVIDAS, MSc, PTPhysiotherapistCertified Schroth TherapistCertified SEAS TherapistMcKenzie Therapist

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Sheet1AssumptionsFDA as HUD - 2016China and SA penetration in 2016WW case load 70,000Clinical evidence critical mass 2016First exit point 2016, if not large raise of $5-10MASP - $7000 - Europe and ROW, $15,000 - USDevice COGS $1100RevenueHR - CEO, VP Sales, R&D manager,Operations manager, Clinical specialists, sales people allocated over time annual cost $120,0001-Jan-142-Jan-153-Jan-164-Jan-175-Jan-1810% of fixed costs for overhead and other expnsesEurope500,0001,200,0002,400,0007,000,00018,000,000US001,125,0005,250,00012,000,000ROW00700,0003,150,0008,400,000Total Revenue500,0001,200,0004,225,00015,400,00038,400,000ExpensesHR480,000600,000840,0001,080,0001,200,000COGS78,571188,571605,2622,156,0005,330,286US Regulation and reimbursement250,000150,000100,000100,000100,000Marketing200,000250,000300,000350,000350,000Overhead and other48,00060,00084,000108,000120,000NPV19,581,065Total expnses1,056,5711,248,5711,929,2623,794,0007,100,286Profit-556,571-48,5712,295,73811,606,00031,299,714

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Total Revenue

Sheet21000332299224208ApiFixTenorSynergyXiaMoss MiamiMoss MiamiSynergyTenorXiaApiFix

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