IlluminOss Medical Inc's first orthopaedic De Novo device awarded approval by the US FDA.
M2 EQUITYBITES-January 24, 2018-IlluminOss Medical Inc's first orthopaedic De Novo device awarded approval by the US FDA
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Musculoskeletal Clinical Regulatory Advisers LLC (MCRA) stated on Tuesday that 0rthopaedic implants company IlluminOss Medical Inc will initiate the commercialisation of the first orthopaedic de novo in the US for the treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.
This initiation follows the role of MCRA in the successful granting of the first orthopaedic de novo bone stabilisation system by the US Food and Drug Administration (FDA) in December 2017.
According to MCRA, the orthopaedic de novo is a PET balloon infused with a photodynamic monomer, which when exposed to light, polymerises the monomer, resulting in a solid intramedullary (IM) rod. This is an important treatment option for the fixation and stabilisation of actual and impending pathological fractures of the humerus through a minimally invasive procedure.
MCRA is an adviser and clinical research organisation to the neuro-musculoskeletal and orthopaedic industry. With the integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance, it has an integrated approach to these key value creating initiatives, as well as orthopaedic specialisation.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Jan 24, 2018|
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