The study will assess the safety and effectiveness of SpineJack® compared with conservative orthopedic management in 100 patients in France
TOULOUSE, France--(BUSINESS WIRE)--Regulatory News:
VEXIM (Paris:ALVXM) (FR0011072602 ‐ ALVXM / PEA-PME), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announced the initiation of a new clinical study in France.
The Company developed a new comparative study protocol with the Coordinators Pr Jean-Marc Vital and Pr Olivier Gille (Bordeaux, France).
This prospective, multicentric, randomized study will compare the safety, efficacy and cost-effectiveness at 1-year and 2-years follow-up of the SpineJack® device with conservative orthopedic management (bracing) on 100 patients suffering from acute traumatic vertebral compression fractures.
This study takes place at four sites in France and will reinforce the existing clinical data and good results of SpineJack® previously communicated last year in the treatment of both indications, osteoporotic and traumatic vertebral fractures, which have led in 2015 in four accepted major publications in peer scientific journals.
For further information, these two studies are registrered on the US National Institute of Health: ClinicalTrials.gov
«Vexim confirms its clinical strategy to become the preferred treatment of reference in both osteoporotic and traumatic fields by means of the already ongoing comparative FDA study (SpineJack® vs Balloon Medtronic) and this new cost-effectiveness study in order to collect best in class healtheconomics data for strategic market », commented Vincent Gardès, CEO of VEXIM.
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 minimally-invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital1 and from BPI 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 also developed the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 60 employees, including its own sales teams in Europe and a network of international distributors.
VEXIM has been listed on Alternext Paris since May 2012. For further information, please visit www.vexim.com
SpineJack®2, a revolutionary implant for treating Vertebral 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 minimally-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 fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spinal surgery and worldwide patent protection through to 2029.
MasterflowTM 2, a high-performance orthopedic cement delivery system
The MasterflowTM is an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure for treating vertebral compression fractures. The device provides a better control of the injection of biomaterials into the spine. A complement of the SpineJack®, the MasterflowTM stands out for being both easy to use and precise, particularly in its ability to stop the cement delivery instantly without inertia. The MasterflowTMcontributes to reducing pain in patients. Its first sales were recorded in the U.S. in February 2015, and the system has also received the CE marking in February 2015, a mandatory conformity mark for products marketed in Europe.
1 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.frand www.fcpi.fr.
2 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.