10.03.2014 18:00:00
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VEXIM : A Retrospective Study of 178 Patients Followed over 5 Years Confirms the Excellent Long Term Results of SpineJack® for Treating Vertebral Compression Fractures
Regulatory News:
Vexim (Paris:ALVXM) (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 literature2,3 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”.
2014 preliminary financial agenda*:
FY 2013 results:
March 18, 2014
Q1 2014 sales: April 15, 2014
H1 2014 sales:
July 22, 2014
*Indicative dates, subject to potential modifications
About VEXIM, the innovative back microsurgery specialist
Based
in Balma, near Toulouse (France), VEXIM is a medical device company
created in February 2006. The Company has specialized in the creation
and marketing of mini-invasive solutions for treating traumatic spinal
pathologies. Benefitting from the financial support of its longstanding
shareholders, Truffle Capital4 and Banexi Venture, 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 50 staff. It
has its own sales teams in France, Germany, Italy, Spain, Switzerland
and the United Kingdom, as well as distributors notably in Argentina,
India, Taiwan, Belgium, South Africa and in the following countries
where the product is currently being registered: Mexico, Brazil,
Colombia, Venezuela, Chile, Ecuador and Peru. VEXIM has been listed on
NYSE Alternext Paris since May 3rd 2012.
For further information, please go to www.vexim.com
SpineJack®5, a revolutionary implant for
treating Vertebral Compression Fractures
The revolutionary
aspect of the SpineJack® lies in its ability 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 mini-invasive
surgery, guided by X-ray, in approximately 30 minutes, enabling the
patient to be discharged shortly after surgery. The SpineJack® range
consists of 3 titanium implants with 3 different diameters, thus
covering 95% 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 until 2029.
- Name: VEXIM
- ISIN code: FR0011072602
- Ticker: ALVXM
1 1st and 2nd generation of the
SpineJack®
2 Lindsay R, Silverman SL, Cooper C et al.
(2001) Risk of new vertebral fracture in the year following a fracture.
JAMA 285(3):320-323.
3 Fribourg D, Tang C, Sra P,
Delamarter R, Bae H. Incidence of subsequent vertebral fracture after
kyphoplasty. Spine. 2004;29:2270–6
4 Founded in 2001 in
Paris, Truffle Capital is a leading independent European private equity
firm. It is dedicated to investing in and building technology leaders in
the IT, life sciences and energy sectors. Truffle Capital manages €550m
via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked
during 7 to 10 years). For further information, please visit www.truffle.fr
and www.fcpi.fr.
5
This medical device is a regulated health product that, with regard to
these regulations, bears the CE mark. Please refer to the Instructions
for Use.
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