Toulouse, March 10, 2014 ‐ VEXIM (FR0011072602 ‐ ALVXM), a medical device company specializing in the minimally‐invasive treatment of vertebral fractures, announces today that the results of a long term retrospective study of 178 patients confirm the effectiveness of SpineJack® for treating vertebral compression fractures.

 
This single‐center, retrospective, observational, consecutive study was conducted by Prof. David Noriega, orthopedic surgeon at the Hospital Clinico Universitario in Valladolid, Spain.The study included 178 patients suffering from vertebral fractures due to trauma, osteoporosis or cancer tumors who were studied over the course of five years after SpineJack® [1] implantation.

 
The intention of this retrospective analysis was to evaluate the morbidity, effect on pain and improvement of patient’s autonomy, as well as the sustainability of the correction achieved over time and the consequences of this restoration on development of adjacent vertebral fractures.

Vertebral pain was assessed using a Visual Analog Scale (VAS) and showed a statistically significant decrease of 75% at the end of the observation period.

 
Functional capacity was measured using the Oswestry Disability Index (ODI). Results showed a significant improvement of 92% at the end of the evaluation period.
In this study with an observation period of up to five years, and with almost 60% of osteoporotic fractures or fractures associated with osteoporosis, a very low rate of adjacent vertebral fractures (2.2%) was observed. These excellent results suggest a dramatic reduction in morbidity in vertebral fractures treated with the SpineJack®. The rate of adjacent fractures published in literature [2,3] on vertebroplasty and kyphoplasty is between 11% and 21%. It also confirms the excellent results from the previously disclosed international clinical study of 103 patients with vertebral fractures due to trauma, and the results of the first retrospective study on 77 patients performed last year in France.

Prof. David Noriega comments: “We believe that this very low rate of adjacent compression fracture is directly associated with the quality of fracture reduction and restoration of sagittal balance. As a result, it positively affects the quality and maintenance of our very good long term clinical outcomes especially when it comes to re-establishing independence and quality of life for every type of patients”.

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FY 2013 results: March 18, 2014*
Q1 2014 sales: April 15, 2014*
H1 2014 sales: July 22, 2014
*(Indicative dates, subject to potential modifications)