Toulouse, February 19, 2015 - VEXIM (FR0011072602 - ALVXM), a medical device company specializing in the minimally-invasive treatment of vertebral fractures, today announces that Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária or ANVISA) has completed a successful GMP (Good Manufacturing Practices) inspection of the company without any non-compliance.
The approval of the Brazilian GMP certificate attests to the quality, safety and efficacy of all production steps, as well as the effective commitment of the company to establish and maintain a stage control system regarding the quality of the finished product.
This valuable achievement opens a new marketing opportunity for Vexim in Latin America. Vexim estimates that Brazil alone represents a 50 million € market in the vertebral compression fractures field.
Vincent Gardès, CEO of VEXIM, concludes: “This approval will enable us to have substantial growth in our international business. The Company is expecting to initiate export to Brazil by the end of 2015, after the conclusion of the product’s evaluation process.”
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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 Capital[1] 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. Vexim has been listed on NYSE Alternext Paris since May 3rd 2012. For further information, please visit www.vexim.com
SpineJack®, 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 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 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.
Contacts
VEXIM
Vincent Gardès
CEO
investisseur@vexim.com
Tel: +33 5 61 48 48 38
Alize RP
Relations presse
Caroline Carmagnol / Sophie Colin
vexim@alizerp.com
Tél : 01 44 54 36 66 / 06 64 18 99 59
LifeSci Advisors LLC
Investor Relations
Michael Wood
www.lifesciadvisors.com
+1 646 597 6983
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