VEXIM: ANVISA Approves SpineJack® Implants in Brazil

VEXIM: ANVISA Approves SpineJack® Implants in Brazil

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May 29, 2017

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News:

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces it has received the regulatory approval from ANVISA1, Brazil’s National Health Surveillance Agency, in order to commercialize the SpineJack® in Brazil.

The approval from ANVISA is a key achievement opening a new opportunity for VEXIM in this important international market with untapped potential. This clearance will provide us with new growth opportunities in this key Latin American market. VEXIM estimates that Brazil alone today represents a €15 million market in the vertebral compression fractures field.

This approval will enable us to have substantial growth in our international business. The Company is expecting to initiate export to Brazil in the coming months, after the conclusion of the product’s evaluation process and of distribution partnerships”, said Vincent Gardès, CEO of VEXIM.

Financial reporting schedule:
2nd quarter sales: July 11th, 20172

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 Capital3, 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 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 66 employees, including its own sales teams in Europe and a network of international distributors. VEXIM has been listed on NYSE Alternext Paris since May 3rd 2012. For further information, please visit www.vexim.com

SpineJack®4, an innovative implant for treating Vertebral Compression Fractures
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 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.

Nom : VEXIM
Code ISIN : FR0011072602
Code mnémonique : ALVXM

1 Agência Nacional de Vigilância Sanitária.
2 Indicative date, subject to changes.
3 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.
4 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.

Contacts

VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
Tel.: +33 5 61 48 48 38
investisseur@vexim.com
or
PRESS RELATIONS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tel.: +33 1 44 54 36 66
Tel.: +33 6 48 82 18 94
vexim@alizerp.com

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