VEXIM announced the results of an international clinical study on the clinical performance of SpineJack in treating acute traumatic vertebral compression fractures.
Here are five things to know about the study:
1. Functional capacity was measured using the Oswestry Disability Index, and according to study results, there was an improvement of 86 percent in ODI scores at one year after SpineJack implantation, following an improvement of 81 percent at three months. Also, The reported rate of adjacent fractures at one year was 2.9 percent.
2. The prospective observational study was conducted consecutively in 14 clinical sites across France, Germany, Switzerland, Spain, Italy and Austria, and it includes 103 patients. The study found that vertebral pain — assessed using a Visual Analog Scale —showed an average decrease of 82 percent at one year after implantation of SpineJack. Also, at one year, 98.7 percent of patients were using mild analgesics or no medication at all.
3. VEXIM's SpineJack is intended to restore a fractured vertebra to its original shape as well as the optimal anatomy of the spinal column. The company recently obtained the approval in Europe to extend the SpineJack system's CE Mark to all types of vertebral compression fractures. The approval broadens VEXIM's potential market.
4. In November 2013, VEXIM released the results of a study investigating the effectiveness of SpineJack for treating vertebral compression fractures. The retrospective study of 77 patients followed the device implantation to five years past surgery. Researchers found 100 percent of patients experienced a reduction in intervertebral pain immediately and one year later.
5. The SpineJack device will play a key role in the treatment of vertebral compression fractures, and according to a Transparency Market Research report, the global minimally invasive vertebral compression fracture repair market is expected to reach $2.82 billion by 2019. The market was valued at $1.58 billion in 2012 and is expected to grow at a compound annual growth rate of 8.7 percent from 2013 to 2019.
The spine surgery device market is expected to be worth $14.8 billion by 2017, according to a MarketsandMarkets report.
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