Plasmapore XP. Stability that Starts at the Surface

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1 Plasmapore XP Stability that Starts at the Surface

2 The Difference The Plasmapore XP Difference The unique structure, properties and processing of the Plasmapore XP coating results in early bone apposition and increased bone formation. Plasmapore XP : Osteoconductive Enhances implant stability Increases migration resistance In 1995, Aesculap expanded the application of its Plasmapore Coating from Orthopaedic implants to Titanium Spinal Implants to improve their primary and secondary stability properties. Today, Aesculap utilized its expertise to transform Plasmapore to Plasmapore XP, a pure porous titanium and osteoconductive surface applied to PEEK. Plasmapore XP increases migration resistance and maximizes surface area contact between the implant and the vertebral body endplate offering surgeons the ideal scaffold for a stable fusion. Plasmapore XP Pure Ti coating over PEEK-Optima Thickness: µm Porosity: 35-60% Tissue-compatible PEEK-Optima is a registered trademark of Invibio Biomaterial Solutions.

3 The experience Plasmapore XP is the culmination of 30 years of innovation in spinal technology and 20 years of experience with porous Titanium coatings First application of Plasmapore coating on Titanium hip prosthesis, BiContact Universal Hip System* 1995 First Plasmapore coated Titanium implant for the lumbar spine, PROSPACE Titanium* First PLASMAPORE XP coated PEEK lumbar spinal implant for the global market, Arcadius XP L Spinal System 2014 Plasmapore µ-cap coated total disc replacement for the lumbar spine, activl lumbar disc prosthesis** First PLASMAPORE XP coated PEEK posterior lumbar spinal implant for the global market, ProSpace XP Interbody System 2013 First PLASMAPORE XP coated PEEK cervical spinal implant for the global market, CeSpace XP Interbody System *Not available in the U.S. **Investigational use only

4 The Strength Plasmapore XP is a migration resistance surface enhancing technology that has been shown to provide an increased initial stability and long term stability when compared to traditional uncoated PEEK implants. AVERAGE PULLOUT STRENGTH RESULTS Uncoated Plasmapore XP Coated The pullout strength of both Plasmapore XP coated implants and PEEK implants was evaluated in ovine bone samples at several time points. The Plasmapore XP coated implants were found to have over six times the pullout strength at 12 weeks and over nine times the pullout strength at 24 weeks compared to the PEEK implants. 1 FORCE (N) WEEKS

5 The Visibility Excellent Visibility The Plasmapore XP coating improves visibility of PEEK interbody implants during imaging by providing a clear delineation of the implant contours and does not create any artifact in CT. CT MRI XP Tantalum Porous Titanium

6 The Histology Early Bone Apposition Enhanced stability, increased migration resistance, and an osteoconductive surface are combined to support all the factors that lead to bony ongrowth making Plasmapore XP coated devices the ideal choice. P XP B F P F B Histology Images Histology results at 12 weeks for representative (Fig. A) Plasmapore XP coated implant to (Fig. B) uncoated PEEK implant. There is increased bone formation and apposition (B) in the Plasmapore XP coated implant compared to the uncoated PEEK implant. Increased fibrous connective tissue (F) around the uncoated PEEK implant is evident. 1 Fig. A: Plasmapore XP coated implant Fig. B: Uncoated PEEK implant

7 A 2013 animal study, which examined comparative Histological results at multiple intervals, showed that implants coated in Plasmapore XP had a higher percentage of bony apposition early in the healing process when compared to traditional PEEK. The presence of early bone apposition is evidence of: A surface that has an ideal scaffold of micro/macro structures to enable bony on growth from the onset Early stability for long term success Increased Bone Formation When compared to traditional PEEK, Plasmapore XP coated implants support faster bone healing and minimize fibrous tissue formation throughout the healing process due to their unique properties. Plasmapore XP s optimal porosity and pore size also provide exceptional adherence strength and consistent, continual performance. C Uncoated Coated 80.0 * Mean Percent of Device Circumference Where Bone is Apposed (<0.1 mm) WEEKS C2 Graph 1. Bony apposition (%) by treatment group and time point *indicates significant difference compared to uncoated 12 week group

8 Histology Images Histology images at the 24 week period show that there is increased bone formation and apposition around the XP coated implant where conversely the uncoated PEEK implant shows an increase in fibrous connective tissue in the implants circumference. 1 Mean New Bone Foundation in Defect (0/0) WEEKS Uncoated Coated * Graph 2. Bone formation by treatment group and time point *indicates significant difference compared to uncoated 24 week group

9 1 Cheng, Boyle. Biomechanical pullout strength and histology of Plasmapore XP Coated Implants: Ovine multi time point survival study. Aesculap Implant Systems, Whitepaper, 2013 (ART129).

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