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6/19/2018INNOVATIONS IN SPORTSMEDICINETO INFINITY AND BEYOND ERIC GIFFORD MDDISCLOSURE THIS PRESENTATIONHIGHLIGHTS TWO CURRENT, EVIDENCE-BASEDPROCEDURES AVAILABLE AS TREATMENT MODALITIES AND THEY WILLBE REFERRED TO BY THEIR COMMERCIAL NAMES.BOTH OF THESEPROCEDURES ARE ONE-OF-A-KIND, WITHOUT DIRECT COMPETITORS.ALL EFFORTWILL BE TAKEN TO PRESENT MODALITIES WITHOUT BIAS. DR. ERIC GIFFORD HASNO FINANCIAL RELATIONSHIPS WITH ANYCOMMERCIAL INTERESTS.CHRONIC TENDINOPATHIES MAKE UP A LARGE PERCENTAGE OF CHRONIC PAIN AND DISABILITY SIMILAR TO DEGENERATION OF CARTILAGE OF A JOINT – INSTEAD IT IS DEGENERATION OFMUSCLE TENDONS AROUND JOINTS DIFFICULT TO TREAT PHYSICAL THERAPY-SOFT TISSUE WORK, ECCENTRIC EXERCISES, STRETCHING, SCRAPING, ETC REST, BRACING, SPLINTING NSAIDS, INJECTIONS-STEROID, PROLOTHERAPY PRP SURGERY1

6/19/2018CHRONIC TENDINOPATHIESWHAT ELSE CAN BE DONE?TENEX PERCUTANEOUS TENOTOMYULTRASOUND GUIDED TENDON TREATMENTProblem1. Conservative measures are oftenineffective2. Surgery is fairly invasive and often stillresults in prolonged recovery and downtime as well as continued painSolutionReplicate surgical approach but through aminimally invasive manner using an ultrasoundguided Ultra-sonic needle tip.DISEASE yDegenerativeChronicTendinopathyNeurovascular ReparativeMediationProcess ?INSULTHealed62

6/19/2018BURDEN OF DISEASE – CHRONIC TENDONOSIS20 Million Patients per Year in USELBOW7MM PATIENTS / YEARSHOULDER1.8MM PATIENTS / YEARKNEE2.5MM PATIENTS / YEARPLANTAR FASCIA3.1MM PATIENTS / YEARACHILLES5.6MM PATIENTS / YEAR* Based on 2013 ICD - 9 diagnosis codeUNMET CLINICAL NEEDConservativeRest / IceOTC MedicationPhysical TherapyUse of cortisone injectiondeclining due topublishedreports of damagingeffects on tendon Minimally InvasiveTENEX System to cut and remove paingenerating tissue Local Anesthesia only Single Treatment Relatively quick recoveryand return to activityFully InvasiveOpen/Arthroscopic Surgery Goal is to cut & removedamaged tissue – paingenerator General anesthesia Prolonged recovery withrehab protocol/PTWhen patients fail conservative treatment and experience chronic pain3 months6 months 12 monthsThe TENEX system provides the goals of surgery but with the invasiveness of an injection8“MICRO-JACKHAMMER”TENEX delivers optimizedultrasonic energy to tip ofthe instrument thatprecisely cuts diseasedtendon tissue whilesparing healthy tissue –harmonic resonance ofdiseased tissue (necrotic)is different from healthytissue (elastic)Cutting of targeted tissue isachieved throughlongitudinal movement ofneedle at the speed ofsound (ultrasonic) – tissueis cut via “jack-hammereffect”Continuous salineirrigation cools theMicrotip to controlunwanted heat andalso simultaneouslyremoves target tissue93

6/19/2018TENEX TX SYSTEMTX1 Console User interface with circuitry forprecise & targeted tissue cutting andremoval Targeted diseased tissue is removedwhile sparing healthy tissue with builtTX1 Microtip Percutaneous (18 gauge) pen-likefunction Pre-assembled w/foot pedal activation Single use – entirely disposablein safety featuresPERCUTANEOUS TENOTOMY / FASCIOTOMYDISEASED TENDON TISSUEUltrasound Imaging used to identifydiseased tissue and guide TenexTX Microtip during procedureTX1 MICROTIP PLACED INTOHYPOECHOIC REGION1. VISUALIZE DAMAGEDTENDON (DARK REGION)VIA ULTRASOUND2. GUIDE TENEX MICROTIPTO DAMAGED TISSUEWITH ULTRASOUNDGUIDANCECUTS & REMOVES TARGETDAMAGED TISSUEREMOVAL OFHYPOECHOIC REGION11TARGETED TISSUE CUTTING AND REMOVALHarmonic resonance – ultrasonicenergy only cuts pathology basedon density of degenerated tissueUltrasonic energy optimized fordense degenerated tissuedoes not affect healthy elastictissueHealthy Tendon UltrasonicEnergy4

6/19/2018CHRONIC TENDONOSIS TREATMENTS2%Elbowtennis golfers elbowShoulderOver-use workers/athletes33%Skin8%TendonPlantar Fascia25% “foot” visitsBone38%19%Kneebasketball, volleyballAchilles10% of runnersWHO’S A CANDIDATE?CHRONIC PAIN ( 3 MONTHS) AT THE AFFECTED JOINT AND NOTRESPONSIVE TO CONSERVATIVE MEDICAL TREATMENT (REST,ICE, BRACE, PHYSICAL THERAPY, ETC.)POINT TENDERNESS – POINT OF MAXIMUM PAIN TYPICALLYCORRESPONDS TO THE LOCATION OF THE DAMAGED TISSUEULTRASOUND CONFIRMATION – PLACEMENT OF ULTRASOUNDTRANSDUCER ON THE SITE OF MAXIMUM TENDERNESS SHOULDIDENTIFY A REGION OF DEGENERATED TENDON TISSUEVISUALIZED AS A HYPOECHOIC REGION DUE TOIRREGULAR/DISORGANIZED FIBERS AND THICKENED TENDONTISSUE.5

6/19/2018HOWS IT DONE? NO RESTRICTIONS BEFORE PROCEDURE PREP AREA WITH SIMPLE ANTISEPTIC LOCAL ANESTHETIC APPLIED UNDER ULTRASOUNDGUIDANCE 4-5MM INCISION MADE DOWN TO THE TARGET TISSUE TENEX NEEDLE IS ADVANCED TO THE TARGET TISSUEAND ULTRASOUND GUIDED TENOTOMY IS PERFORMED TOTAL CUTTING TIME USUALLY LESS THAN 5 MINUTESPOST OP PROTOCOL ALLOWED TO GO HOME IMMEDIATELY FOLLOWINGPROCEDURE LIGHT ACTIVITY WITH MINIMAL WALKING, LIFTING,PUSHING, PULLING FOR 2 WEEKS FOOT AND ANKLE USUALLY IN A BOOT FOR 2 WEEKS GRADUAL PROGRESSION BACK TO NORMAL ACTIVITYOVER NEXT 4-6 WEEKS PHYSICAL THERAPY TO AUGMENT HEALING PROCESSIN CERTAIN CASESEPICONDYL / ELBOW TENDONOSISEpicondylHealthyTendonEpicondylBlue strip marks placement ofultrasound transducerHypoechoic/DamagedTendon6

6/19/2018PATELLAR TENDONOSISPatellaHealthyTendonOrange strip marksplacement of ultrasoundtransducer on inferior pole ofpatellaPatellaHypoechoic/DamagedTendon54ACHILLES TENDONOSISCalcaneusHealthyTendonOrange strip (a) marks placement ofultrasound transducer on Achillesand (b) shows cross section view toidentify mid-substance tendonosisCalcaneusHypoechoic/DamagedTendonPLANTAR FASCIITIS/FASCIOSISOrange strip marks theplacement of ultrasoundtransducer on plantar fascia –typically on medial aspect.7

6/19/2018CLINICAL PUBLICATION SUMMARYIn Print/Accepted Koh – American Journal Of Sports Medicine (Elbow) Hackel – Orthopaedics Today (Procedure Overview / Mixed Tendons) Morrey – Techniques In Elbow And Hand Surgery (Elbow) Elattrache – Operative Techniques In Sports Medicine (Knee) Barnes – Operative Techniques In Sports Medicine (Procedure Overview) Khanna – Am Academy Of Physical Med & Rehab Poster (Mixed Tendons) Traistor – Am Medical Society Of Sports Medicine (Mixed Tendons) Barnes – Journal Of Shoulder And Elbow Surgery (Elbow) Patel – Journal Of Orthopedics (Plantar Fascia) Sanders – American Journal Of Sports Medicine (Epidemiology Study) Stuhlman – Journal of Sports Medicine (Patellar Tendon) Kamineni – Journal of Orthopedic Research (Basic Science) Patel – Austin Journal of Orthopedics and Rheumatology (Plantar Fibroma) Koh – Three Year Clinical Follow-up/American Journal of Sports Medicine (Elbow) Ellis – American Journal of American Podiatric Medical Association (Achilles)Submitted/In Preparation Razdan – Plantar Fascia Study Moore – Tenex Vs Open Surgery (Elbow) Noyes – Elbow Study Hackel – Tenex vs Endoscopic Surgery (Plantar Fascia)Study revealed 90% 0f patients pain free within weeks of treatment Cost Effective Intervention – Less expensive ( 11,000) and quicker recovery time vssurgery Sustained Pain Relief With Long Term Follow-up (6 – 36 Months) Strong Safety ProfileKOH ET AL (SINGAPORE/MAYO) - ELBOW Prospective study of 20 pts with chronic epicondylitis who failednon-surgical treatment (medical, PT, cortisone) Single treatment with TX1 Post-procedure care - no PT, OTC pain control, activitymodification for 2 weeks Patient follow-up: 2 weeks, 1, 3 , 6 ,12, 24* and 36* months- Adverse events- Pain score (VAS)- Quality of life (DASH/Disability of the Arm, Shoulder and Hand)- Diagnostic ultrasound at baseline, 3, 6 and 36 monthsAmerican Journal of Sports Medicine Vol 41, 636-644, 2013* In print, Am Journal of Sports Medicine, 2015SENG ET AL (3 YR) – ELBOW TENDONOSIS & USEXAMResolution of Tendon Thickness &3 mo13/206 mo18/2036 mo20/20HypoechogenicitySeng, et al; Am Journal of Sports Med, 20158

6/19/2018BARNES, BECKLEY, AND SMITH (MAYO)- ELBOW PROSPECTIVE STUDY INVOLVING 19 PATIENTS – SYMPTOMATIC 7 MEDIAL AND 12 LATERALTREATMENT (REST,6 MOPT, ICE, SINGLE CORTISONE) SINGLE TREATMENT TOTALFOR AT LEASTTENDONOSIS PATIENTS WHO FAILED CONSERVATIVEWITHPROCEDURE TIMETX1 & NO ADDITIONALINTERVENTION 15 MINUTES WITH MEANENERGY TIME 38 SECONDS NO COMPLICATIONS CLINICAL OUTCOMES ATBASELINE,6 WEEKS, 3 MO, 6 MO AND 12 MO VAS (PAIN) MAYO ELBOW PERFORMANCE SCORE / MEPS (RANGEOF MOTION) DISABILITY OF THE ARM, SHOULDER AND HAND/DASH (QUALITYOF LIFE)Barnes et al, Journal of Shoulder & Elbow Surgery, 2014MOORE ET AL (IA) – TENEX VS SURGERY (ELBOW) PROSPECTIVE 45 PATIENTSSTUDY RANDOMIZING TENEX VSOPEN SURGERY FOR ELBOWWITH CHRONIC EPICODYLOSIS NOT RESPONSIVE TO CONSERVATIVE CARE 23 TREATED WITH TX1 22 TREATED WITH OPEN SURGICAL REPAIR OUTCOMES MEASURED AT 1 WEEK, 1 MONTH AND 6 MONTHS POST-TREATMENTTENEX VS. SURGERY EFFICACY/PAIN RELIEF91%77% POST-TREATMENT VISITS2.54.25(P 0.001) AVG WORK WEEKS MISSED1.18.2(P 0.001) TOTAL COST/SAVINGS PER PTTENEXWAS 11,753(P 0.01)LESS THAN SURGERYManuscript submitted for publicationELATTRACHE (KERLAN JOBE) - KNEE PROSPECTIVE STUDY INVOLVING 16 PATIENTS – SYMPTOMATIC FOR ATLEAST 6 MO 10 COLLEGIATE-LEVEL ATHLETES FAILED CONSERVATIVE TREATMENT SINGLE TREATMENT WITH TX1 & NO ADDITIONAL INTERVENTION NO COMPLICATIONS CLINICAL OUTCOMES 15/16 (93%) REVEALED RESOLUTION OF SYMPTOMS AT 3 MONTHS SUSTAINED EFFECT AT 12 MONTHS ALL 10 ATHLETES RETURNED TO THEIR PRIOR LEVEL OF COMPETITIONOperative Techniques in Orthopedics Vol 23, 2: 20139

6/19/2018STUHLMAN, STOWERS & STOWERS (FL STATE) - KNEE PROSPECTIVE STUDY INVOLVING 8 PATIENTS – SYMPTOMATIC FOR ATLEAST 6 MO ACTIVITY LIMITING TENDINOPATHY 3 PTS WITH BI-LATERAL PAIN FAILED CONSERVATIVE TREATMENT SINGLE TREATMENT WITH TX1 & NO ADDITIONAL INTERVENTION 12 MONTH FOLLOW-UP NO COMPLICATIONS CLINICAL OUTCOMES 8/8 PATIENTS REPORTED NO PAIN (VAS 1) I MPROVEMENT IN SYMPTOMS BETWEEN 3 DAYS AND 6 MONTHS AFTER TREATMENT SUSTAINED AT 12 MONTHSManuscript accepted, Journal of Sports MedicineRAZDAN & VANDERWOUDE (NE) – PLANTAR FASCIA PROSPECTIVESTUDY INVOLVING100 PATIENTS – SYMPTOMATIC FOR ATLEAST 6 MO ALL FAILED CONSERVATIVE TREATMENT: PT, ORTHOTICS, OTC MEDICATION SINGLE TREATMENT WITH TX1 & NO ADDITIONALINTERVENTION 12 MONTH FOLLOW-UP NO COMPLICATIONS CLINICALOUTCOMES PAIN (VAS) AND DISABILITY INDEX (FADI) MEASURED AT 2 WEEKS, 6 WEEKS, 6 MO AND 12 MO SIGNIFICANT IMPROVEMENT IN PAIN AND DISABILITY INDEX BY 2 WEEKS AND SUSTAINED AT 12 MO 91/100 (91%) PATIENTS PAIN FREE AT 6 MONTHS AND SUSTAINED AT 12 MONTHSPodium Presentation, Society for Interventional Radiology Annual Meeting 2015Manuscript submitted for publicationPATEL (ORTHO INDY) – PLANTAR FASCIA PROSPECTIVESTUDY INVOLVING12 PATIENTS – SYMPTOMATIC FOR ATLEAST 6 MO ALL FAILED CONSERVATIVE TREATMENT: PT, ORTHOTICS, EXTRA-CORPOREAL SHOCK WAVE, CORTISONE 4 PTS FAILED OPEN OR ENDOSCOPIC FASCIOTOMY SINGLE TREATMENT WITH TX1 & NO ADDITIONALINTERVENTION 12 MONTH FOLLOW-UP NO COMPLICATIONS CLINICALOUTCOMES 11/12 (92%) PATIENTS PAIN FREE AT 3 MONTHS AND SUSTAINED AT 12 MONTHS SIGNIFICANT IMPROVEMENT IN QOL BY 6 MONTHS AND SUSTAINED AT 12 MONTHSMEAN BASELINE AOFAS 30.1MEAN 12 MOAOFAS 88.1American Journal of Orthopedics, 201510

6/19/2018ELLIS ET AL (AZ) – ACHILLES TENDON PROSPECTIVE STUDY OF 26 PATIENTS – SYMPTOMATIC SINGLE TREATMENT MEANWITHCUTTING TIME OF PTS FOLLOWEDUPTX1 & NO ADDITIONALFOR AVERAGE OF18 MONTHSINTERVENTION4 MIN 24 SECONDS1 WEEK, 1 MONTH, 12 MONTHS AND 16 MONTHS POST NO COMPLICATIONS CLINICAL OUTCOMES 23/26 (88%)PATIENTS REVEALED PAIN RELIEF AT 24/26 (92%)PATIENTS WOULD HAVE THE PROCEDURE DONE AGAIN1 MONTH ANDSUSTAINED AT16 MONTHSManuscript accepted, Journal of APMAPATEL ET AL (IN) – PLANTAR FIBROMA PROSPECTIVE STUDY OF 8 PATIENTS SUFFERING FROM PLANTAR PATIENTS FAILED AVERAGETIME OF SYMPTOMS PERCUTANEOUS AVERAGEFIBROMACONSERVATIVE CARE INCLUSIVE OF ORTHOTICS– 15 MONTHSCUTTING AND REMOVAL OF LESION WITH SINGLE TREATMENT OFFOLLOW-UPTX1 2.5 YEARS CLINICAL OUTCOMES 8/8 PATIENTSPAIN FREE WITH AVERAGE TIME TO RESOLUTION OF SYMPTOMS - SIGNIFICANT IMPROVEMENT OF AOFAS NO RECURRENCE OFFIBROMAS ATSCORE FROM PRE-OP OF63 DAYS30.8 TO 90.1 AT 12 MO2.5 YEARSAustin Journal of Orthopedics and Rheumatology, Vol 2, Issue 2, 2015COOLIEFCOOLED RADIOFREQUENCY TREATMENT11

6/19/2018CHRONIC KNEE AND HIP PAIN DILEMMA RELIEVE PAIN FOR PATIENTS SUFFERING WITH CHRONIC JOINT PAIN UTILIZE INNOVATIVE NEW PROCEDURE FOR TWO CHALLENGING PATIENT POPULATIONSWITH HIP AND KNEE PAIN NON-SURGICALCANDIDATES OVERWEIGHT AGE – TOOYOUNG OR TOO OLD CO-MORBITITIES PATIENTSSTILL IN PAIN AFTER JOINT REPLACEMENT PATIENTSNOT RESPONDING TO OTHER CONSERVATIVE MEASURES VARIOUSINJECTIONS BRACING ACTIVITYMODIFICATION MEDICATIONSCOOLED RADIOFREQUENCYNEUROTOMY INTERVENTIONALPAIN SOLUTION COOLED RADIOFREQUENCY PROCEDURE PROVIDES UP TO 2 YEARS IN PAIN RELIEF PROVIDES LARGER LESIONS THAN STANDARD RF ALLOWING FOR TREATMENT OFMORE VARIABLE PERIPHERAL SENSORY NERVES12

6/19/2018RADIOFREQUENCY NEUROTOMY ELECTRODEWITH AN EXPOSED TIP, IS PLACED ONTO A PERIPHERALNERVE HIGH-FREQUENCY, ELECTRICAL CURRENT CONCENTRATES AROUNDTHE TIP; HEATS THE IMMEDIATELY SURROUNDING TISSUES; ANDCOAGULATES THEM, INCLUDING THE TARGET NERVE PAIN RELIEVED BY COAGULATINGTHE AFFERENT NERVE PREVENTINGTHE CONDUCTION OF NOCICEPTIVE (PAIN) IMPULSES PAIN RELIEF OCCURSBY ANESTHETIZING THE SOURCE OF PAINCOOLED RF SINGLE LARGER LESION COMPENSATES FOR VARIABLE NERVECOURSE. MORE EFFICIENT AND MORE PREDICTABLE THAN MULTIPLEPASSES WITH SMALLER GAUGE RF PROBE. DISTAL PROJECTION OF LESION PROJECTS HEAT IN AND AROUNDDIFFICULT ANATOMY, SCAR TISSUE, SURGICAL HARDWARE ETC. ANATOMIC TECHNIQUES PERFORMEDUNDER FLUOROSCOPY RELIESUPON EASILY VISUALIZED LANDMARKS. MAY ALSO USE ULTRASOUND IMAGING FOR NEUROVASCULAR BUNDLEIDENTIFICATION AND NEEDLE TIP PLACEMENT ELECTRICALSTIMULATION CAN BE USED TO VERIFY ABSENCE OFPROXIMITY TO MOTOR NERVE.IMPROVEMENT IN LONG EXISTING TECHNOLOGY, NOWWITH INTERNALLY WATER COOLED ELECTRODESLiver AblationCardiac ElectrophysiologyChronic spine and peripheraljoint pain13

6/19/2018COOLED RF LESION LARGE VOLUME SPHERICAL LESION WITH DISTAL PROJECTIONCooled RF‐ 18Ga, 4mm40%10 mmAPPLICATIONS OF COOLED RFSACROILIAC PAIN OVERLAPPING AND FORWARD PROJECTINGLESIONS ARE MADE TO CAPTURE VARIABLEPATH OF LATERAL BRANCHES ON UNEVENSACRAL SURFACETHORACIC PAIN LARGE SPHERICAL LESION IS MADE TOACCOMMODATE VARIABLE NERVE PATH OFMEDIAL BRANCHES ESPECIALLY T5-T7LUMBAR PAIN FORWARD PROJECTING AND LARGESPHERICAL LESION ALLOW A PERPENDICULARAPPROACH TO MEDIAL BRANCHES IN ONENEEDLE PASS AND NOT MULTIPLE PASSES.ADDRESSES DIFFICULT ANATOMY ORPATIENTS WITH HARDWARE FROM PREVIOUSSURGERIESCERVICAL PAIN OFFERING RELIEF IN THE CERVICAL REGIONBY DELIVERING LARGE VOLUME LESIONSWHERE ANATOMY AND NERVE PATH AREVARIABLE.PERIPHERAL NERVE PROCEDURES14

6/19/2018Patients that are not candidates for surgery 29% of patients over the age of 65 with chronic knee pain nonresponsive to conservative medical management are notcandidates for surgery due to contraindicationsPatients with persistent post-surgical pain 53% of patients with TKA and 38% of patients with THA with chronicpain one year out of surgeryCOOLIEF COOLED RADIOFREQUENCYNEUROTOMY: A TREATMENT OPTION FORPATIENTS WITH CHRONIC KNEE AND HIPPAINPATIENT SELECTIONPatients that are not indicatedfor surgery: THA/TKA contraindications: Age BMI Comorbidities Patients that don’t want surgeryPatients that still have significantpain following surgery Patients still in pain after surgery due tonon-compliance Patients with past TKA/THAIMAGING GUIDANCE Provides up to 2 years pain relief, improved physical function,and reduced drug utilization Larger burn areas takes into account variable nerve course15

6/19/2018CLINICAL DATA FOR COOLED RADIOFREQUENCY1. Patel et al. “Twelve‐ Month Follow‐up of a Randomized Trial Assessing Cooled RadiofrequencyDenervation as a Treatment for Sacroiliac Region Pain”. Pain Practice. Jan 2015. “These 12‐month results illustrate the durability of effective CRF/LBN‐ mediated treatment ofSI region pain for selected patients2. Liu et. Al “A Cross Sectional Survey on Prevalence and Risk Factors for Persistent Post‐Surgical Pain 1Year after Total Hip and Knee Replacement”. Regional Anesthesia and Pain Management. Volume 37,Number 4, July‐ August 2012. “Persistent post‐surgical pain is common after THR and TKR and is associated with reducedhealth related quality of life.”3. Franco et. al. “Innervation of the Anterior Capsule of the Human Knee: Implications forRadiofrequency Ablation.” Reg Anesth Pain Med. 2015 Jul‐Aug;40(4):363‐8.QUESTIONS?16

ELBOW 7MM PATIENTS / YEAR KNEE 2.5MM PATIENTS / YEAR ACHILLES 5.6MM PATIENTS / YEAR PLANTAR FASCIA 3.1MM PATIENTS / YEAR BURDEN OF DISEASE – CHRONIC TENDONOSIS * Based on 2013 ICD - 9 diagnosis code 20 Million Patients per Year in US UNMET CLINICAL NEED 8 Rest / Ice OTC Medication Physical Therapy Use of

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