VEXIM Completes Enrollment in Clinical Trial

VEXIM, a medical device company specializing in the minimally-invasive treatment of vertebral fractures, has completed enrollment in its U.S. Food and Drug Administration (FDA) clinical trial.
 
VEXIM’s 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 represent a true concern in aging population with more than 1.5 million osteoporotic VCF reported each year globally,” explained 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. The 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.
 
Currently, 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.
 
“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 U.S. 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,” said Vincent Gardès, VEXIM CEO.
 
The SpineJack is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally-invasive surgery, guided by X-Ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack range consists of three titanium implants with three different diameters, thus covering 95 percent of vertebral compression fractures and all patient morphologies. SpineJack technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.
 
Based in Balma, near Toulouse (France), VEXIM was founded in February 2006. The company develops and markets minimally-invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital, and from OSEO public subsidies, VEXIM has designed and developed the SpineJack, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company currently has 60 members on its staff. It has its own sales teams in France, Germany, Italy, Spain, Switzerland and the United Kingdom, as well as distributors in Turkey, Argentina, India and in the following countries where the product is currently being registered: Mexico, Brazil, Colombia, Venezuela, Chile, Ecuador and Peru.
 
Founded in 2001 in Paris, Truffle Capital is an independent European private equity firm that invests companies within the IT, life sciences and energy sectors. Truffle Capital manages 550 million euros via FCPRs and FCPIs.
 
Reference:
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