Excellent Long Term Performances of SpineJack® Supported by a 24-Month Follow-up Clinical Study

Regulatory News :

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM / PEA-PME eligible), a medical device company specializing in the minimally-invasive treatment of vertebral fractures, announces today that the 2-year results of a study on 103 patients confirm the already demonstrated excellence of SpineJack®¹ at the 1-year follow-up in treating acute fresh traumatic vertebral compression fractures.
This prospective, observational and consecutive study involved 14 clinical investigating sites located in France, Germany, Switzerland, Spain, Italy and Austria. 103 patients were recruited in this study with a high rate of complex fractures (59%). These results revealed statistically significant advantages of SpineJack® in terms of patients’ pain, function and quality of life over 1 and 2 years post-surgery.

Vertebral pain was assessed using a Visual Analog Scale (VAS), and showed a significant 82% average decrease in pain at 1 year (79% at post op). This improvement was sustained over the 2-year follow-up period with a decrease of 85% at 2 years. A recent publication² in the Spine Journal showed a 68% decrease for balloon kyphoplasty and 67% for the KIVA device at 1 year.

In addition, the decrease in pain allowed a strong reduction in the consumption of analgesics. 2 years after the surgery, 98.3% of patients were using no medication at all or mild analgesics.

Functional capacity was measured using the Oswestry Disability Index (ODI). A sustained progressive improvement was noted over the 2-year follow-up period, with significant decrease in ODI score reaching 86% at 1 year and 89% at 2 years. A recent publication² in the Spine Journal reported a score of 58% for balloon kyphoplasty and 50% for the KIVA device respectively at 1 year.
The radiological outcomes were assessed using X-rays. All X-ray images were treated by FXA™ software developed by the company ACES Ing.-GmbH, a Radiographic Core Lab (Filderstadt, Germany). All results provided below were performed by the software and assessed independently from Vexim or the surgeons.

The FXA method is 510(k) cleared, approved by the Food and Drug Administration in the US.
A reduction of vertebral kyphotic angle of 5.35° was seen postoperatively. At the 1-year follow-up the reduction was 4.44°. For the A3 fracture group the reduction was 7.18° postoperatively and at 1 year the reduction was 5.72°. All the results at each time point are statistically significant.
Neither device-related adverse event nor device removal was reported over the 2-year follow-up period.

The overall adjacent fracture rate up to 2 years after surgery was 2.9%. The adjacent fracture rate observed in our study is much lower than the 10% - 22% rate reported in the literature for vertebroplasty and kyphoplasty techniques³, thus suggesting a direct link between optimal endplate restoration by SpineJack^® and a significant reduction of the risk of further fractures.
These long-term results confirm the stability of the correction over time. The SpineJack® allows an effective, low-risk procedure for patients with vertebral fractures of traumatic origin with a significant reduction in pain and analgesic consumption achieved immediately after surgery and maintained over time. Additionally, this procedure allows a fast and sustainable improvement in quality of life.

Vincent Gardès, CEO of VEXIM, concludes: «We are very pleased with the outcome of these 2-year follow-up results on this key European trauma study. SpineJack® continues to demonstrate its ability to treat complex fractures with impressive patient outcomes using a safe and minimally invasive procedure. These results support our confidence in becoming the new reference and best approach to vertebral fractures treatment in the near future. »

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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 Capital⁴ 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, the United Kingdom and United States, as well as distributors in Turkey, Argentina, Taiwan, Belgium, Estonia, Poland, Portugal, South Africa, Saudi Arabia, Colombia, Panama, Venezuela, Chile, Peru and Ecuador and in the following countries where the product is currently being registered: Mexico, Brazil. Vexim has been listed on NYSE Alternext Paris since May 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.

• Name: VEXIM
• ISIN code: FR0011072602
• Ticker: ALVXM

¹ SpineJack® 2^nd generation
² Korovessis P et al. Balloon Kyphoplasty Versus KIVA Vertebral Augmentation—Comparison of 2 Techniques for Osteoporotic Vertebral Body Fractures - A Prospective Randomized Study. SPINE Volume 38, Number 4, pp 292–299
³ - 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. - 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.

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