Brazil Green Lights VEXIM’s SpineJack
Elizabeth Hofheinz, M.P.H., M.Ed. • Fri, June 9th, 2017
VEXIM, a medical device company based in Toulouse, France, has just received the green light to commercialize SpineJack in Brazil. Approval came from ANVISA, Brazil's National Health Surveillance Agency.
SpineJack is indicated for reduction of spinal fractures resulting from osteoporosis, trauma fractures, malignant lesions myeloma or osteolitic metastasis. It is intended to be used in combination with validated bone cement, and to be placed, using a transpedicular approach, through a vertebra pedicle with a minimum internal diameter, as verified with a pre-operative CT scan.
“The approval from ANVISA is a key achievement opening a new opportunity for VEXIM in this important international market with untapped potential,” says the May 29th, 2017 news release. “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.
Gardès told OTW, “As part of our international expansion strategy we have selected countries with high market potentials. Brazil is considered as a sizable market opportunity for Vexim with its 15M€ market. We also believe this market will grow substantially in the upcoming decades based on economy development, aged population and better access to medical treatments.”
“We initiated our regulatory process for Brazil in 2010. The ANVISA process is made of multiple steps and control procedures that are required to register medical devices. We received a GMP (good manufacturing process) approval already in 2015 that a first good signal for our regulatory process.”
“From a Brazilian standpoint, we are thrilled to bring our SpineJack product and concept to the country and we strongly believe this will be a game changer in the way we treat vertebral fractures going forward. We have been experiencing success in Latin America for several years but Brazil is definitely the most important opportunity there. To the orthopedic surgeon community around the world, we would like to reaffirm our commitment and dedication to bring them world-class innovation when dealing with spine trauma diseases where ever those surgeons are working.”