SYNTHETIC BONE SUBSTITUTES BONE VOID FILLERS

Benign bone tumors and cysts _ 10 Crest iliac defects after bone graft harvesting _ 16

PIONEER SINCE 1995 30 years of experience Since 1995, SBM has developed a unique material called BIOSORB, composed of pure* Beta-Tricalcium Phosphate (ß-TCP). SBM has created a specific line of products called BIO 1®, designed to safely and effectively fill bone voids or defects due to bone injuries or surgical procedures. SBM was one of the first manufacturers to offer ß-TCP implants, with CE marking in Europe (1998) and FDA 510K clearance in the United States (2003). Our commitment at every stage of the manufacturing process is supported by an environmental approach recognized by ECOVADIS certification....

Unique savoir-faire A WELL-KNOWN MATERIAL 10 years of clinical follow up [1 to 5] supported by in vivo studies and clinical data. [7 to 10] CONTROLLED MANUFACTURING PROCESSES With complete in-house control over every step of the BIO 1® manufacturing process, we ensure consistent reliability, safety and traceability of our products. Chemical synthesis Gamma ray sterilization (minimum dose 25kGy) completes the process. Advantages over therapeutic alternatives NO DONOR SITE MORBIDITY Unlike autografts, synthetic grafts eliminate the need for a second surgical site - reducing operative time, patient...

BIO 1® CHARACTERISTICS Biological properties ABSORBABLE Porous scaffold made of ß-TCP. Strong chemical link development: rapid bone ingrowth. Guide cells penetration. Improve bone graft integration. Good biocompatibility between ß-TCP and bone: no interposition of fibrous tissue [10] 3D electronic microscopy of the porosity of the ceramic (x 1000) [10] Mature bone Woven bone Ceramic implant Mature bone Woven bone Ceramic implant OSTEOINTEGRATION 95% pure* ß-TCP. Excellent cell resorption process. Physical properties BIOCOMPATIBLE Fully biocompatible with excellent tissue tolerance (ISO 10993-1)....

TYPES OF BIO 1® Sticks, blocks and cubes SEM* of macroporosity [11] Porosity: 45%. Mechanical strength: >15MPa. Internal porosity (micro- and macropores): d90 ≈ 300 μm macropores and 1.2 μm micropores. Porosity: >60%. Internal porosity (micro- and macropores): d90 ≈ 300 μm macropores and 1.2 μm micropores. Internal porosity (micro- and macropores): d90 ≈ 640 μm macropores and 0.5 μm micropores. *Scanning Electron Microscopy

TRAUMATOLOGY Trauma surgery for fractures ADULT Assess the size of the fracture and bone defect. Fracture reduction (surgical procedure independant of BIO 1®). Completely fill and pack the bone defect with the implant. For treatment of larger bone defects, BIO 1® can be mixed with autologous cancellous bone. Complete surgery with a rigid fixation system (such as plate and screws). Clinical case Tibial plateau fracture (28 years old female) [11] Post-op X-ray 12 months post-op X-ray Astragalus neck fracture (53 years old man) [11] 2.5 months post-op X-ray 9 months post-op X-ray

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BIO 1® is used to fill a bone void following the curettage of a benign bone tumor or a bone cyst. Shoulder, hand, lower limb and foot PEDIATRIC (>8 years old) References Reference Description Quantity

SPONDYLODESIS Postero-lateral fusion ADULT AND PEDIATRIC (≥8 years old) Prepare bone surface until bleeding. Place a rigid fixation system (surgical procedure independent of BIO 1®). Place granules with autologous cancellous bone and patient blood. Clinical case Instrumented Idiopathic Scoliosis. Postero-lateral bone graft after reducing the deformation (20 years old) [11] 3 months post-op X-ray 6 months post-op X-ray

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CHIN OSTEOTOMY Genioplasty ADULT AND PEDIATRIC (≥15 years old) Prepare bone site. Place a rigid fixation system (surgical procedure independent of BIO 1®). Place granules with autologous PRF (Platelet-Rich Fibrin) into the void to be filled. Complete the procedure by placing an autologous fibrin membrane to stabilize the granules at the bone site. Surgical case Chin wing genioplasty by Dr Saboye Dr. Saboye* Void before filling Mix of granules with autologous PRF *Clinical case by courtesy of Dr. Saboye Void filling with BIO 1® and autologous PRF mix Placing a PRF membrane to stabilize fixati

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Bone void created by a surgical procedure ADULT 1. Assess the size and bone defect. 2. Mix the macroporous cubes with the patient's blood to form a homogeneous coagulum. 3. Pack the mixture into the bone defect. References Reference Macroporous cubes for filling - 4 x 4 x 4 mm (5 cm3) Macroporous cubes for filling - 4 x 4 x 4 mm (15 cm3) Macroporous cubes for filling - 4 x 4 x 4 mm (30 cm3)

1. Blondel B, et al. Influence of screw type on initial coronal and sagittal radiological correction with hybrid constructs in adolescent idiopathic scoliosis. Correction Priorities. 2012 2. Blondel B, et al. Reciprocal sagittal alignment changes after posterior fusion in the setting of adolescent idiopathic scoliosis. 2012. 3. Bonnevialle P, et al. Kapandji pinning and tuberosities fixation of three- and four-part fractures of the proximal humerus. 2013. 4. Huitema GC, et al. Pulmonary function after less invasive anterior instrumentation and fusion for idiopathic thoracic scoliosis. 2013. 5....