Orthocell Ltd. is a leading Australian biotechnology company whose mission is to translate world-class research into commercially viable and life-changing products. The company specializes in regenerative medicine and is dedicated to the development of breakthrough products for the treatment of musculoskeletal disorders. Orthocell Ltd. has established a quality-controlled manufacturing facility at its headquarters in Perth, Australia. The facility is licensed by the Therapeutic Goods Administration (TGA) for the production of human tendon cells (tenocytes) and cartilage cells (chondrocytes) for the regeneration of damaged tendons and cartilage. The manufacturing facility is also approved according to ISO 13485 for the production of the CelGro™ collagen membrane. Under license from BioHorizons Inc., this membrane is marketed worldwide under the name Striate+™.* Orthocell Ltd. – over 15 years of experience Innovative products for regeneration therapy Histological structure of Striate+™ Striate+™ retains the ideal microstructure for cell attachment and proliferation, resulting in high-quality tissue repair. * Striate+™ is approved for sale in the European Union. ** The presence of residual cells and galactose-alpha-1,3-galactose (α-Gal) on the membranes was investigated by confocal laser scanning microscopy CLSM showing comparison between the unprocessed porcine peritoneum and Striate+. α-Gal is labeled with isolectin GS-IB4 (green) and the cell nucleus is labeled with DAPI (blue). CLSM images confirm that Striate+ contains no cellular components and has no detectable levels of α-Gal, evidenced by no fluorescence detected on both DAPI-stained and isolectin-/GS-IB4-stained images respectively. Success factor processing methods A breakthrough in the preparation of collagen membranes Optimized handling characteristics Biocompatibility and inflammation Integration and degradation Assessment and quality of tissue repair The SMRT™ manufacturing process 1 Orthocell Ltd's SMRT™ manufacturing process removes porcine DNA and cellular components, resulting in a highly purified, bio-compatible Type I collagen membrane. The complete removal of immunogenic impurities as well as the galactose-alpha-1,3-galactose (α-Gal) ensures high biocompatibility and full integration into the patient tissue during the healing process. The absence of inflammatory or foreign body reactions promotes a favorable clinical outcome. Preservation of the natural collagen architecture results in a more stable membrane with improved handling properties and an optimal degradation profile. Striate+™ porcine raw material with an abundance of cells Acellular Striate+™ SMRT™ manufacturing process 100 µm Porcine aortic valve (+ve control) Comparison between the unprocessed porcine peritoneum and Striate+. α-Gal is labeled with isolectin GS-IB4 (green) and the cell nucleus is labeled with DAPI (blue). Complete removal of the galactose-alpha-1,3-galactose (α-Gal) 100 µm 100 µm 100 µm The SMRT™ production process – an immunohistological demonstration**
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