VEXIM : SpineJack®’s CE Mark Expanded to All Types of Vertebral Compression Fractures

Regulatory News:

VEXIM (Paris:ALVXM) (FR0011072602 - ALVXM / PEA-PME eligible), a medical device company specializing in the minimally-invasive treatment of vertebral fractures, announces that it has obtained the approval in Europe to extend the SpineJack® system’s indications.

The extension of the SpineJack® minimally-invasive system’s use to all types of vertebral compression fractures was driven by the SpineJack®’s excellent performances in 3 studies whose results were recently published:

• two retrospective studies on a total of 255 patients with osteoporotic, traumatic or tumor-related vertebral fractures, who were followed over a 5-year period,
• an international clinical study on 103 patients suffering from traumatic vertebral fractures.

Vexim is thus strengthening its positioning in the treatment of unstable complex fractures that are often the result of trauma, which account for more than 42% of vertebral compression fractures¹,². This approval significantly broadens VEXIM’s potential market and enables a minimally-invasive solution to be provided to patients suffering from highly-debilitating fractures by easing their pain and improving their autonomy.

Vincent Gardès, CEO of VEXIM, comments: "We are pleased with this extension of the SpineJack®’s indications to all vertebral compression fractures. It will allow us to treat a greater number of patients, and notably those who were thus far unable to benefit from our minimally-invasive approach. This strengthens our strategic positioning on the minimally-invasive back surgery market and provides us with new growth prospects for our activity.”

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 Capital³ 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 57 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, Colombia, Panama and in the following countries where the product is currently being registered: Mexico, Brazil, Venezuela, Chile, Ecuador and Peru. VEXIM has been listed on NYSE Alternext Paris since May 3, 2012.
For further information, please go to www.vexim.com

SpineJack®⁴, 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 Results of the Trauma Register, 103 patients, 14 centers in Europe, 2014
² Magerl - A comprehensive classification of thoracic & lumbar injuries, Eur Spine J, 1994 , 3: 184-201
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.