VEXIM: another major step towards the SpineJack® commercialization in the US

VEXIM: another major step towards the SpineJack® commercialization in the US

21 February 2017 / 8 h 00

- Completion of patient enrollment in the international clinical trial to support 510(k) submission for the SpineJack® in the US.
- FDA 510(k) filing is planned by year-end leading to potential US launch in the first half of 2018, a market worth €500 million per year.
- This trial evaluates safety & effectiveness of the SpineJack® in comparison with balloon kyphoplasty in 152 patients with vertebral fractures.

Toulouse, February 21st, 2017 (8:00AM CET) – VEXIM (FR0011072602 – ALVXM), a medical device company specializing in the minimally-invasive treatment of vertebral fractures, today announces enrollment completion of its FDA clinical trial.
The VEXIM FDA trial is a European, prospective and randomized multicenter study. It aims to compare safety and efficacy of the SpineJack® vs balloon kyphoplasty on 152 patients with osteoporotic vertebral compression fractures. It is being conducted in 12 centers in Germany, France, Italy, Spain and Switzerland. The study is intended to provide clinical data to support a 510(k) submission in the United States, which is expected to be filed by the end of 2017.

« Vertebral Compression Fractures (VCF) represent a true concern in aging population with more than 1.5 million osteoporotic VCF reported each year globally, » explains Professor David Noriega, one of the study investigators.
« Those fractures are very crippling because patients experience acute and chronic back pain, as well as a progressive deformation of the spine that can lead to additional pathologies. Thanks to its jack mechanism, which is designed to restore vertebra from the inside through a mini invasive surgery, the SpineJack® is intended to provide a quick and efficient way of treating those fractures and to restore spine balance [1]. »

VEXIM’s clinical trial compares improvements in terms of back pain, functional and physical capability, quality of life, device safety, analgesic usage and vertebral height restoration, on patients suffering osteoporotic vertebral compression fractures and treated with the SpineJack® and balloon kyphoplasty. Trial’s success will be defined by showing the SpineJack®’s non-inferiority to balloon kyphoplasty on a primary endpoint which is a composite measure of pain reduction, maintenance or improvement in function and absence of device related serious adverse event.

As of today, all 152 patients planned have been randomized. Half of them within SpineJack® treatment group, the other half in the balloon kyphoplasty group. The finalization of patient enrollment represents an important milestone in the trial’s schedule. SpineJack® 510(k) file is planned to be submitted to the FDA [2] before the end of year 2017.

« The finalization of our FDA clinical study enrollment is a key milestone on the path to commercialize the SpineJack® in the United States. We keep our target to submit our 510(k) in 2017 that would lead, subject to FDA clearance, to a SpineJack® commercialization in the US during the first half of 2018. This is also a demonstration of VEXIM’s capacity to run a large international trial. In the name of VEXIM, I want to thank warmly all our site investigators and coordinators for their active participation that allowed us to achieve this phase of the trial, » concludes Vincent Gardès, VEXIM’s CEO.

Financial reporting schedule
2016 Full-Year Results: March 22nd, 2017*
*(Indicative dates, subject to modifications)

  1. D. C. Noriega & R. H. Ramajo & I. S. Lite & B. Toribio & R. Corredera & F. Ardura & A. Krüger (2016) Safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study. Osteoporos Int 27:2047-2045. Clinical data on SpineJack® second generation
  2. Food and Drug Administration