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Swiss Ozics Group Announces CE Mark for the CompO6 (TM) Bone Reinforcement Composite
Ozics Group received the CE Mark for its CompO6™ Bone Reinforcement Composite, indicated for use in the bone augmentation procedures and to enhance the purchase of screws or similar osteosynthesis hardware in bone across the entire skeleton.
By: Ozics Group
First Sales Clearance of a Class IIb Medical Device Puts the Company on Commercial Track
St. Gallen, Switzerland
Ozics Group (www.ozics.com)
“for use in the bone augmentation procedures, such as treatment of compression fractures of vertebral bodies (VCF) and to enhance the purchase of screws or similar osteosynthesis hardware in bone across the entire skeleton”
Dr. Juha-Pekka Nuutinen, Director of Research and Development, said, "Treatment of fractures in osteoporotic bone remain a challenge from material science point of view, where efficacy features such as sufficient strength must be accompanied with safety features such as limited tissue necrosis due to exothermic heat generation during setting, shrinkage of the material during curing and visibility under standard x-ray to detect any seepage of the material into unwanted places without compromising handling characteristics. The CompO6™ Bone Reinforcement Composite was designed to address the currently experienced shortcomings in load-bearing bone and screw augmentation procedures."
Dr. Auvo Kaikkonen, President and CEO, commented, "This is the first Ozics Group product to receive a CE Mark for commercial sale. The Company's strategy is focused on commercializing exciting new technologies, such as CompO6™ Bone Reinforcement Composite, for orthopaedic and spine markets. Our focused development efforts include a number of advanced technology products that we plan to introduce worldwide following their progression through the clinical and regulatory clearance and approval processes."
The CompO6™ Bone Reinforcement Composite can be used as bone augmentation device to reinforce vertebral bodies after compression fractures and to secure screws or other metallic osteosynthesis hardware in bone with low mineral density or osteoporosis.
The Company received notification from Notified Body that it obtained approval for the CE Mark on October 28, 2011. CompO6™
Ozics vision is to develop a range of materials and implants that deliver the clinical benefits outlined above. The basic material is a composite of dimethylacrylate based polymer matrix and ceramic filler, containing silicateglass and hydroxyapatite (HA). The material can be administered by injection to provide a custom-made, intra-bony implant. Used primarily as a stand-alone device, it can also be used in conjunction with other fixation approaches and devices. Ozics’ first product offering, CompO6™ reinforced bone composite, is an injectable bone cement indicated for vertebral compression fractures and to aid screw purchase in trauma procedures throughout the entire skeleton. Ozics is determined to bring to the market a minimally invasive fracture fixation system to be used in load bearing fractures, such as hip, as a stand-alone device allowing immediate unassisted mobility.
Auvo Kaikkonen, CEO
+41 715 770 050
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Ozics’ products represent a transforming step in orthopaedic treatment using novel materials science and implant design. Ozics treatments are minimally invasive due to a unique delivery system which will reduce both treatment and rehabilitation time and costs. Ozics products will create a paradigm shift in the prophylactic treatment of osteoporosis, reducing significantly the incidence of osteoporotic fractures. The addressable market for Ozics is over USD 1bn p.a.