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Neocement® - Bone Cement with Chitosan Neocement® is a calcium phosphate cement with chitosan, combining antimicrobial protection and stable integration with natural bone. Available in two formats: Neocement® – manual preparation, moldable paste for precise filling of small defects. Neocement® Inject P – pre-filled syringe, ready-to-use injectable cement for minimally invasive procedures. Both formats harden within 8–12 minutes, forming hydroxyapatite to support stable bone re

Fractures with bone loss End fractures Orthopedic Trauma Cavity filling (tumors, cysts) Pseudoarthrosis / Non-unions Arthrodesis (foot, ankle, hand, calcaneus) Reconstruction of the hip cavity Medullary bone lesions (knee) Note: similar devices available on the market are used in these applications. Neocement® Inject

Neocement® Preparation Videos Neocement® Inject P - www.youtube.com/watch?v=2BhF-tLd2pU Neocement® - www.youtube.com/watch?v=5Gmuj6gA9Kc

Setting Time At room temperature (20–24°C), the setting time is typically 8–12 minutes, starting from the beginning of mixing. At temperatures below 20°C, the setting time increases (e.g., up to 25 minutes at 18°C), while at temperatures above 24°C, it decreases (e.g., as short as 6 minutes at 28°C). Neocement® Mix liquid phase and chitosan for 2 min Wait for it to become pasty for 2 – 5 min

Chitosan and calcium phosphate based cement

Case #01 Patient information Female Diagnosis: Left calcaneus fracture Surgical Procedure: Open reduction with plate fixation Details: Bone substitute implanted in direct contact with cancellous tissue.

• Stable implant; • Minimal resorption. • Partial weight-bearing initiated; • Neocement® helped prevent articular collapse and improved stability. • Patient walking pain-free with full range of motion; • No visible interface with surrounding bone tissue; • Evident new bone formation.

Case #02 Patient information Male Diagnosis: Comminuted tibial plateau fracture. Surgical procedure: Open reduction and internal fixation (ORIF) with cannulated screw and washer. Details: Bone substitute implanted in direct contact with cancellous bone tissue. Immediately after surgery

• Implant radiopacity confirmed. • Low implant resorption observed. • New bone formation observed. • Patient underwent a secondary surgery to remove the osteosynthesis material. • Very good progress. BA: 0°, 125°. • Stable knee with good mobility and adequate muscle strength. • Significant new bone growth and fracture consolidation observed.

Chondroblastoma Affecting the Apophysis of the Greater Trochanter in a Child Rare primary bone tumors. Most cases are managed with intralesional curettage, with or without local adjuvants. We report a case of chondroblastoma of the greater trochanter in a 12-year-old boy, successfully treated with intralesional curettage and calcium phosphate bone cement grafting (Neocement® Inject). • Patient experienced resolution of pain and gradual restoration of hip function. • Lost to follow-up after one month, limiting long-term outcome assessment.

Injectable hydroxyapatite paste (35% nanoparticles), fully resorbing within ~6 months. Acts as a scaffold for vascularization and new bone formation, while maintaining a soft gel-like consistency • Non-hardening paste; • Injectable, particle size <100 nm; • Radiopaque (detectable in x-rays). • Preclinical studies: complete resorption observed in ~6 months (CER, 2023). • Clinical studies: 94% bone consolidation at 12 months and 100% at 18 months (PMCF 2020.09).

Possible Indications for Use Fractures with bone loss Orthopedic Trauma End fractures Cavity filling (tumors, cysts) Pseudoarthrosis / Lack of consolidation Arthrodesis (foot, ankle, hand, calcaneus) Hip reconstruction / Bone lesions (knee) Maxillary sinus lift Alveolar ridge augmentation Interbody fusion (e.g., cages) Scoliosis Note: similar devices available on the market are used in these applications.

n-IBS® combination (granules or 3D shapes) In spinal surgery, autologous bone obtained during resection can be manually combined with n-IBS® and used to fill the cages.

n-IBS® combination (granules or 3D shapes) n-IBS® can also be used to fill the internal space of the resected intervertebral disc.

Non-hardening paste

Patient information Adult patient Symptoms: Paresthesia, decreased strength, and discopathy. Surgical procedure: Two-level spine arthrodesis at C5-6 and C6-7. Cages filled with n-IBS were used to achieve fusion. Follow-up 4 months after surgery • Complete bone consolidation. • No adverse events reported.

Neobone® is a synthetic bone graft (75% hydroxyapatite, 25% (3-TCP) designed for long-term bone regeneration. Its composition ensures biocompatibility, osteoconductivity, and stable integration with natural bone. • High hydroxyapatite content to enhance osseointegration; • Greater stability compared to p-TCR promoting osteoblast adhesion and growth.

Neobone® porosity Total porosity calculated using formula (3) in ISO 13175-3: 50 - 60 % Results Lot: 22B008 Mean total porosity: 52,75 ± 2,47 % Lot: 22B012 Mean total porosity: 57,77 ± 2,06 % Lot: 22B015 Mean total porosity: 54,46 ± 2,47 % Mean interconnected porosity by mercury intrusion porosimetry: 22,2349 ± 2,4645

Neobone® pore sizes Pore size was investigated through microstructural analysis of SEM images, using the mean equivalent circle diameter method (according to ISO 13383-1). For Neobone®, the mean equivalent diameter of micropores is below 10 µm. The mean equivalent diameter of macropores is greater than 500 µm. Fluid absorption and ion release contribute to the mechanical stability of the material. Support vascularization and large-scale cellular migration.