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Brett G. Zani, Ph.D. Department Head - Applied Sciences

Intramedullary Bone Stabilization Device Using a Light-Curable Monomer. Brett G. Zani, Ph.D. Department Head - Applied Sciences Concord Biomedical Sciences and Emerging Technologies Lexington, MA. Society for Biomaterials 2014. 1. Conflict of Interest. No conflicts

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Brett G. Zani, Ph.D. Department Head - Applied Sciences

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  1. Intramedullary Bone Stabilization Device Using a Light-Curable Monomer Brett G. Zani, Ph.D. Department Head - Applied Sciences Concord Biomedical Sciences and Emerging Technologies Lexington, MA Society for Biomaterials 2014 1

  2. Conflict of Interest • No conflicts • Waiting on response if this slide is required Society for Biomaterials 2014 2

  3. The Beginnings – 16th Century • Bernardino de Sahagun, a Spanish Anthropologist, traveled with Cortez to Mexico • Aztec physicians placing wooden sticks into medullary canals of broken bones Society for Biomaterials 2014 3

  4. Middle 19th Century • Ivory pegs were inserted into the medullary canal to repair fractures. Society for Biomaterials 2014 4

  5. Present Day Standards of Care Society for Biomaterials 2014 5

  6. Aging Population • Growing number of fracture incidences • Need method of fracture repair to successfully mend osteoporotic bone • Traditional bone fixation: high overall complication rates and not effective for osteoporotic patients Society for Biomaterials 2014 6

  7. IlluminOss Concept Balloon Angioplasty Catheter Light Cured Polymer Similar in Concept to Dental Cement Patient Customized, Minimally Invasive Orthopedic Implants Society for Biomaterials 2014 7

  8. New Class of Orthopaedic Implants • Intramedullary biologic fixation of fractured bones • Patient customized, form contouring polyethylene terephthalate (PET) balloon • Monomer infused into/polymerized within balloon • Inflate, trial fit, adjust as many times as needed, until polymerization initiated by light source Society for Biomaterials 2014 8

  9. IlluminOss Polymer • Comparable or stronger vs. standard bone cement (PMMA) • Remains liquid until activated by visible light (436 nm) source • Light causes fragmentation of photoinitiator = polymerization • Ductile and does not fracture under load • ~ Mimics bone, no stress shielding (cause of bone loss) • Complete polymerization in 200 – 800 seconds (dependent upon implant size), no risk of over curing • Biocompatible cross-linked, thermoset polymer: • stable up to very high temperatures • chemical resistance • retains strength and shape extremely well • well suited for long-term, permanent products Society for Biomaterials 2014 9

  10. Make small passageway into the bone to access the canal • IlluminOss Photodynamic Balloon Stabilization System (PBSS) Society for Biomaterials 2014 10

  11. Attach infusion syringe, introduce balloon catheter into canal IlluminOss PBSS Procedure Society for Biomaterials 2014 11

  12. IlluminOss PBSS Procedure Check balloon position under fluoroscopy, inflate balloon with the syringe Society for Biomaterials 2014 12

  13. IlluminOss PBSS Procedure Balloon conforms to medullary canal Society for Biomaterials 2014 13

  14. IlluminOss PBSS Procedure Activate visible light (blue, 436 nm) source achieving fracture stabilization Society for Biomaterials 2014 14

  15. IlluminOss PBSS Safety & Healing I • Sheep tibia implanted with PBSS • Evaluated at 30, 90, 180 days (n=6) • No significant macroscopic or microscopic observations • Implants conformably filled medullary space • Complete cortical bone apposition • Active cortical bone remodeling Society for Biomaterials 2014 15

  16. IlluminOss PBSS Safety & Healing II Mid-shaft tibial osteotomy in sheep (n=36) External fixators vs. external fixators with PBSS Evaluated at 8, 12, 26 weeks (eg, radiography, µCT, histopathology) Society for Biomaterials 2014 16

  17. IlluminOss PBSS Safety & Healing II No significant toxic effects with PBSS Foamy macrophages at PBSS implant site, in local lymph nodes both in controls and PBSS-treated animals. No inhibition of endosteal bone remodeling and/or vascularization were observed with PBSS Society for Biomaterials 2014 17

  18. Translating to the Clinic and Marketplace 500 + patients treated in the following indications: Radius + Ulna Radius Clavicle Metacarpal Ulna Humerus Pelvis Femur Fibula Tibia + Fibula Society for Biomaterials 2014 18

  19. Fibula Fixation in the Clinic Society for Biomaterials 2014 19

  20. Fibula Fixation in the Clinic Society for Biomaterials 2014 20

  21. END Society for Biomaterials 2014 21

  22. Photodynamic Polymer • Material Properties • Tensile Strength at break = 4600 psi • Elongation at break = 35% • Modulus = 85,700 psi • Load required to yield = 228 lbs • Tensile strength at yield = 6500 psi • Photodynamic Polymer is a ductile material and will yield before breaking. Society for Biomaterials 2014 22

  23. IlluminOss Polymer Temperature • All polymers exhibit an exothermic response • PMMA long term response at elevated temperature • Peak temperature ~ 100 ⁰ C, ~ 27 minutes duration • IlluminOss max temperature ~ 62 ⁰C, ~ 4 minute duration • ~ 2% shrinkage upon cure • Thermal excursion substantially reduced in bone due to the mass of the surrounding body and its thermal conduction – STUDIES HAVE SHOWN NO NECROSIS, etc… Society for Biomaterials 2014 23

  24. Rotational Fracture Stability Balloon full surface contact with the circumference of the intramedullary canal , providing rotational stability compared to traditional rods BENEFIT: broad contact area distributes load, as opposed to focal load concentration of traditional rods Society for Biomaterials 2014 24

  25. Tissue Response I Society for Biomaterials 2014 25

  26. Tissue Response II Society for Biomaterials 2014 26

  27. Left ulna fracture (91 yr old female) Society for Biomaterials 2014 27

  28. Implant Curing Society for Biomaterials 2014 28

  29. Success!! Society for Biomaterials 2014 29

  30. IlluminOss: Faster Procedural Speed Physicians Faster workflow: rapid procedure No requirement for locking screws no targeting quick access closure 30 to 40 Minute Rapid Procedure Time Society for Biomaterials 2014 30

  31. IlluminOss: Fewer ComplicationsCostly and Time Consuming to Manage Note: based upon comparative sized studies between literature and IlluminOss EU Registry Society for Biomaterials 2014 31

  32. Clinical Summary • Since June of 2011 500+ clinical cases have been performed on Long Bones, accelerating daily • Radius, Distal Radius, Radial Head, Ulna, Fibula, Clavicle, Humerus, and others • All patients had: • Successful procedures, with clinical restoration of function • There were no device related complications • No failed implant attempts • No intra-operative or post-operative adverse device effects. • No local or systemic adverse device effects. • No device migrations or removals. • No infections. Society for Biomaterials 2014 32

  33. IlluminOss: Fewer ComplicationsCostly and Time Consuming to Manage • No Intra-operative adverse events • No local or systemic infections • No device-related complications • No implant removals • No special or ancillary equipment required • Used successfully alone and with standard orthopaedic screws or plates and screws • Used for primary fixation and to revise failed index treatments • Rapid procedure time • Training Simplicity: See One, Do One, Train One Society for Biomaterials 2014 33

  34. Platform Progression TODAY Tomorrow Future Craniomaxillofacial Spine Wrist Radius Ulna Humerus Clavicle Hip Fibula Femur Tibia Sports Medicine Society for Biomaterials 2014 34

  35. Today’s Distribution Economics TODAY: High Capital Cost Kits, $35,000 to $50,000, Reprocessing + Consignment Society for Biomaterials 2014 35

  36. Minimal Instrumentation Required to Perform an IlluminOss Procedure Society for Biomaterials 2014 36

  37. Simplicity is the ultimate sophistication! Leonardo da Vinci IlluminOss PBSS Flexible Delivery Catheter Visible Light Source Liquid Monomer Society for Biomaterials 2014 37

  38. Locking Screw Flexibility ILLUMINOSS Implant can have locking screws delivered anywhere along the implant and in any orientation, versus nails which require targeted locking. Freedom in the placement of screws allows for faster procedure, with less fluoroscopy exposure. Society for Biomaterials 2014 38

  39. Screw Pull-out forces with PBSS Society for Biomaterials 2014 39

  40. Polymer Implant Anchoring Plate In Poor Quality Bone Screws holding plate pull-out Screws re-anchored into polymer

  41. Contact • Brett G. Zani, Ph.D. • Department Head - Applied Sciences • Concord Biomedical Sciences and Emerging Technologies • Lexington, MA • Office: 781-541-5588 • Mobile: 603-682-4546 • email: bzani@cbset.org • Abstract: 354 • In-Situ Formed Biomaterials Translating to the Clinic & Marketplace • Presentation: Saturday, April 19th at 9:30 am, Four Seasons 1 Society for Biomaterials 2014 41

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