France-Based Vexim Plans New Trial to Support U.S. Clearance of its Primary Technology

Vexim, a Toulouse, France-based medical device company specializing in the minimally invasive treatment of vertebral fractures, is kicking off a new clinical study to support its planned application for U.S. Food and Drug Administration (FDA) 510(k) regulatory clearance for its SpineJack device.
The company expects to complete the study in two years to with FDA submission in 2017.

Following recent and ongoing discussions with the FDA, the company will conduct a prospective multi-center, randomized study that will compare the safety and effectiveness at one year follow-up of the New Generation SpineJack device with Medtronic Spine’s kyphoplasty balloon on 150 patients suffering from vertebral compression fractures due to osteoporosis.

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 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 centers to treat with SpineJack and those surgeons are expected to begin patient recruitment in the first quarter of 2015.

“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,” said Vincent Gardès, Vexim’s CEO. “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 U.S. 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.”

According to the company, the difference with SpineJack is its ability to restore a fractured vertebra to its original shape, restoring the spinal column’s optimal anatomy and, as a result, removing pain to allow the patient to recover functional capabilities. Specialized instruments and guided by X-ray allow the implants into the vertebra to be carried out by minimally-invasive surgery in approximately 30 minutes enabling the patient to be discharged shortly after surgery. The SpineJack system line consists of three titanium implants with three different diameters, covering 95 percent of vertebral compression fractures and all patient morphologies.

Founded in 2006, Vexim is based in Balma, near Toulouse. The company focuses on the minimally invasive treatment of vertebral fractures.

European authorities recently expanded SpineJack’s indications for use.