Vexim, a company focused on the minimally invasive treatment of vertebral fractures, is announcing 2014 annual sales of €10.3m ($11.14 million), reflecting a jump in sales by a factor of 1.7 over 2013. The company indicates that this increase is due to the continued adoption of the SpineJack technology, with more than 8, 000 implants sold in 2014.
A major 2014 milestone was the June opening of a Vexim subsidiary in the United States; commercial activities began in December 2014. In May 2014, Vexim launched a new generation of its SpineJack product and expanded its indications to all types of vertebral compression fractures. In 2015, Vexim will also launch a clinical study to support its planned 510(k) for the SpineJack in the U.S.
Vexim published the results of three clinical trials in 2014. According to the March 24, 2015 news release, there was a five year retrospective study published on March 20 that included 178 patients and found that “the reduction-stabilization of vertebral fractures through a combination of SpineJack implantation and cement injection resulted in immediate and sustained improvement of the patient’s pain and functional capabilities. Then there were the one-year results of an international study, published on May 19, 2014, confirming that SpineJack resulted in major improvement was shown in pain, functionality and quality of life for 103 patients one year after implantation. Six-month results of comparative study of SpineJack versus Balloon Kyphoplasty, published on September 30, 2014, demonstrated that SpineJack is highly effective in treating vertebral compression fractures and resulted in near-perfect restoration of vertebral height, greater, faster relief of vertebral pain and shorter intervention period.”
Asked how the international distributor business more than doubled its sales in 2014, Vincent Gardès, CEO of Vexim, told OTW, “Our business operations in Emerging Markets are growing fast and represent together with Europe and the U.S. the third pillar of our geographic expansion. The good results in 2014 are the consequence of promotional and educational efforts realized in Latin America and South East Asia. We expect this platform to keep growing in the near future in new markets like Brazil, South Africa or Australia.”
Regarding the U.S. launch, Gardès noted, “Things are going extremely well! In September 2014, we opened the U.S. subsidiary and hired a VP of sales for the U.S., Christopher Staubly. In December, the FDA approved the marketing in the United States of the Masterflow Injection System for mixing and injecting orthopedic cement. The Masterflow Injection System is revolutionary in terms of its simplicity, accuracy and control of the injection of ultra-high-viscosity cement to treat vertebral fractures where reducing and stabilizing the fracture is the priority.”
“In February 2015, we announced the success of 15 surgeries carried out with the Masterflow Injection System at Oklahoma Spine Hospital, one of the preeminent American hospitals specializing in spine surgery. We also announced the appointment of Dr. Douglas Beall to Vexim’s Board of Directors. Last month we also announced extensive IP protection of our new high performance cement delivery system, Masterflow. As many as 18 patent applications were filed across the world to protect these innovative features. A number of those are now being granted in key European countries, the United States and China, as well as in Japan, Canada, Australia, Korea and Russia.”
Looking into the future, Gardès told OTW, “In 2015, Vexim will continue to expand its footprint across the vertebral augmentation space, notably in the United States but also in new regions, including Asia and Latin America. The company also expects to see adoption rates of its products increase in Europe with dedicated marketing and clinical programs. The company expects to reach profitability during the course of 2015. We will also initiate a 510k clinical study for future registration in the U.S.”
