Painful VCFs: How and When to Treat Them?

1. Painful VCFs: How and When to Treat Them?

2. Agenda Background on VCFs Diagnosis New Information on Treatment Options A New, Implant-based Approach Case Studies Summary and Conclusions

3. Background • 750,000 Vertebral Compression Fractures (VCFs) in US each year caused by osteoporosis • Osteoporosis causes twice as many spinal fractures than hip fractures • Yet VCFs often go undiagnosed and untreated • Estimated that two-thirds of VCFs are never diagnosed • Many patients dismiss their back pain as a sign of aging and/or arthritis

4. Similar Mortality in Hip Fracture and VCF Patients Source: International Osteoporosis Foundation: Vertebral Fracture Initiative

5. Force Transmission Force Concentration Balanced Biomechanics of Kyphosis:“Kyphosisbegets Kyphosis”

6. VCFs Increase Risk of Subsequent Fragility Fracture Source: International Osteoporosis Foundation: Vertebral Fracture Initiative

7. Consequences of Kyphosis • Deformity • Debilitation • Disability • Depression • Death Source: International Osteoporosis Foundation: Vertebral Fracture Initiative

8. Diagnosis • Patients may experience either: • Sudden onset of severe, “knifelike" back pain • Chronic or gradual onset of back pain that worsens when standing or walking • Additional symptoms of multiple VCFs: • Eventual loss of height, as much as six inches over time • Kyphosis (curved back), commonly called a dowager’s hump • Stomach complaints • Hip pain • Breathing problems Courtesy of Nucleus Medical Art, Inc.

9. Treatment of Symptomatic VCFs Treatment options: • Bed rest for severe pain • Prolonged pain and rest leads to loss of function and possible loss of independence • Analgesics and opoids • Physical therapy • Bracing • Steroid injections • Minimally Invasive Vertebral Augmentation • Vertebroplasty • Balloon kyphoplasty Source: International Osteoporosis Foundation: Vertebral Fracture Initiative

10. FREE Study Shows Benefits of BKP Treatment • FREE: Fracture REductionEvaluation Study • 300 patient, multicenter, randomized, controlled study designed to compare BKP to non-surgical care for acute VCF patients • Trial results were published in The Lancet and demonstrated • BKP patients had improved outcomes in terms of pain reduction, quality of life, function and mobility compared to non-surgical care • BKP had increased rates of new fractures (33%) compared to non-surgical care (25%) at one year Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE) Study, Wardlaw D, Cummings SR, Van Meirhaeghe J, et al. Lancet. 2009 Mar 21;373(9668):1016-24. Epub 2009 Feb 24.

11. FREE Study Shows Benefits of Earlier BKP Treatment • On average, the BKP patients in FREE were treated at 5.6 weeks • By one month post-treatment, compared to non-surgical patients, BKP patients experienced: • Greater improvement on most measures • Findings suggest that BKP may be considered earlier to provide faster pain relief and improved function.

12. Vertebral Augmentation: Room for Improvement Unmet needs: • Decrease: • New fracture risk • Cement leakage • Improve: • Kyphotic angle correction • Deployment predictability • 10 years of very little innovation in vertebral augmentation • Until Now: a new implant-based approach

13. About the Implant-based Approach • Structurally-supportive Implant • Stabilize the bone while using less cement • Predictable implant structure • Approximates natural bone characteristics • Made of medical polymer • Provides flexible, structural support • Implanted over removable guidewire, then filled with bone cement

14. Kiva in Action Insert Kiva Animation

15. Impressive Clinical Evidence Supports Implant • In three separate comparative studies, Kiva has been demonstrated to meet or exceed the performance of BKP 1 2 3. • In one or more of these studies, as compared to BKP, Kiva was shown to: • Reduce rate of adjacent level fractures • Improve kyphotic angle restoration • Reduce rate of cement leakage into surrounding tissue • Reduce cement volume 1 KAST IDE Study: The Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial 2 Otten, Pflugmacher, et al. Pain Physician Journal, October 2013 3 Korovessis et al. Spine, February 2013

17. Additional Implications of KAST • Patients in both the Kiva and kyphoplasty group showed substantial improvements over baseline • Although Kiva showed distinct advantages • Patients treated as early as 2 weeks post onset of pain demonstrated marked improvement by 7 days post intervention.

18. Kiva Case from KAST

19. Sample Kiva Case Courtesy of Wayne Olan, MD, Director of Interventional & Endovascular Neurosurgery George Washington University Medical Center

20. Summary: Vertebral Fractures… • Are the most common osteoporotic fractures • Increase the risk of subsequent VCFs by 5-fold and the risk of other fragility fractures (including hip) by 2- to 4-fold • Multiple VCFs: • Have similar mortality to hip fractures and so we need to be vigilant in diagnosis and treatment • Are associated with significant morbidity, even if they do not come to clinical attention Source: International Osteoporosis Foundation: Vertebral Fracture Initiative

21. Three Takeaways FREE study showed benefits of vertebral augmentation over non-surgical care. New clinically proven, implant-based approach to vertebral augmentation meets or exceeds the performance of BKP. There is clinical evidence showing the benefits of treating acute VCF patients earlier than 6 weeks with vertebral augmentation.

22. Questions?