Minimus Spine has announced that it has successfully secured ISO 13485 certification of its quality management system and also the CE mark for its TrioJection system for delivering ozone to a herniated spinal disc. The company reports that TrioJection offers a sterile and accurate means of delivering ozone.
“These are obviously two very important milestones and keep the company on track with its strategy to provide a safe, effective, non-surgical treatment for disc herniation.” said David Hooper, Minimus Spine’s founder and chief executive officer. “Specifically, their achievement gives us the ability commercialise TrioJection in Europe and to initiate a user validation study there by the end of the year. We are now identifying clinical sites to participate in the study and welcome investigators to contact us to learn more about the study protocol. These data will play a key role in supporting the launch of TrioJection.”