Vexim has said it will initiate a new clinical study that will support its planned application for 510(k) regulatory clearance to market SpineJack in the USA. The Company expects to complete the study in two years’ time in support of a 510(k) submission in 2017. Following recent and ongoing discussions with the FDA, the company will conduct a prospective multicentre, randomised study that will compare the safety and effectiveness at one year follow-up of the new- generation SpineJack device with Medtronic’s balloon on 150 patients suffering from vertebral compression fractures due to osteoporosis.
A company press release reports that based on existing clinical data and the positive preliminary results of Vexim’s comparative study currently taking place in Europe, the company presented the current study design to FDA and sought FDA feedback on the design, sample size, and duration. In combination with the previously collected clinical data, FDA concurred that the new study conducted on 150 patients solely in Europe is appropriate to support 510(k) clearance, streamlining the study initiation and execution, as well as reducing the cost to the company. Vexim already has selected five European centres to treat with SpineJack and those surgeons are expected to begin patient recruitment in the first quarter of 2015.
Vincent Gardès, Vexim’s CEO, states: “Our discussions with the FDA have enabled us to make meaningful progress toward driving VEXIM’s future growth and development, as it relates to targeting the United States, which is the world’s largest market for vertebroplasty and kyphoplasty. Based on the excellent results obtained in clinical studies to date with SpineJack, particularly as evidenced by the 30 patients suffering from osteoporosis whose success we recently reported, we are fully confident in achieving a positive outcome from this new study, which once completed, will support our application for clearance to market our device in the USA. Furthermore, the fact that we will follow a 510(k) pathway, rather than PMA, combined with the possibility of only conducting the study in Europe, makes its timetable and cost very attractive for Vexim.”