1. COMPREHENSIVE “PRIMARY CARE” VERTEBROPLASTY CLINIC IN A FREE-STANDING, RADIOLOGIST OWNED DIAGNOSTIC IMAGING CENTER-DIAGNOSTIC, TREATMENT, PREVENTION AND FOLLOW-UP OF VCFs BY H. PAUL HATTEN, Jr., M.D. INDIAN RIVER RADIOLOGY VERO BEACH, FLORIDA, USA

2. DISCLOSURE

3. INDIAN RIVER COUNTY Full Time Population 141,667 (est. 2009) Seasonal Population 163,531 (est. 2009)

8. INDIAN RIVER RADIOLOGY Free Standing Diagnostic Imaging Center (DIC) 6,268 square feet 4 Board Certified Radiolgists

9. EQUIPMENT CT – Marconi MX 8000 Fluoro DEXA – GE Lunar Plain Films Ultrasound – Sequoia Acuson MRI – 1.0 Tesla Philips Open

10. OFFICE PROCEDURES SI Joint Injections ESI’s - CT Guidance Bone Biopsies Soft Tissue Biopsies - CT - Ultrasound

11. VERTEBROPLASTIES HPH – CAQ Neuroradiology Started Vertebroplasties 2000 951 Vertebroplasties as of 8/31/2010

12. AMBULATORY SURGERY CENTER (ASC) Radiolgist helped organize and design Siemens 23” C-Arm

17. New Technologies: Novel Vertebroplasty Materials

18. CERAMENT™ Bi-Phasic Ceramic Bone Substitute:- Enhances the bulk of cancellous bone:- - Biologically - Biomechanically

19. Bio-Material Characteristics 60 wt % α-calcium sulfate hemihydrate (CaS) 40 wt % hydroxyapatite (HA)  High injectability allows for minimal invasive delivery and ensures good intraosseal spread Iohexol-based radio-opacity enhancing component (liquid)  Makes the material visible under fluoroscopy Short term strength Resorbable during 6- 12 months CaS Long term support Highly osteoconductive HA

20. CERAMENT™ U.S.A. Pilot Results 90% of 20 patients treated have complete pain relief Pain improved from VAS 8.5 av. pre-op to 1.8 av. at one week 17 patients at 6 months with av. VAS of 1.2 16 patients at 12 months with av. VAS of 0.6 One adjacent level fractures to date 11 months post-surgery

21. At 12 weeks, there is extensive new bone formation, cement resorption, and cement incorporation in the bi-phasic ceramic-filled defect CRITICAL DEFECT IN RABBIT Empty Bi-Phasic Ceramic C C nB

22. Progression of Resorption of Cerament™ and Bone Incorporation beyond 1 year Axial CT Scan, L1: Day 1 Axial CT Scan, L1: 13 Months

23. Professional Bowler: Levels L3 & L4 Treated Post Operative CT Scan Pre Operative MRI Returns to Professional Bowling in Las Vegas Tournament 14 days Post Cerament™ Vertebroplasty.

24. “PRIMARY CARE” VERTEBROPLASTY CLINIC Osteoporosis Counseling - Reclast Infusion Center - Calcium & Vitamin D Vertebroplasty Pain Management (no pain meds)

25. REQUEST Imaging Pain Treatment - Vertebroplasty - ESI’s - SI Joint Injection - Facet Injections

28. PATIENT FOLLOW-UP RN Nurse Coordinator calls all pain management patients day following procedure. All Verterbroplasty patients called by Dr. Hatten evening of procedure. Any new pain and/or VCF call RN Nurse Coordinator.

30. OSTEOPOROSIS COUNSELING Vitamin D Calcium Bisphosphonate Treatment (Reduces risk of VCF’s by 50%)

31. RECLAST INFUSION CENTER Initiated February 2009 Reclast (Zoledronic Acid – Novartis Pharaceutical) Annual Infusion

33. “PRIMARY CARE” VERTEBROPLASTY CLINIC VCF - Verebroplasty - Prevention - Follow-up - New VCF’s Spine Interventional Procedures - ESI’s - SI Joint Injections General Radiology Procedures