Vexim Releases Preliminary Data from Six-Month Trial

Vexim, a France-based medical device company specializing in the minimally invasive treatment of vertebral fractures, released preliminary six-month results of an investigator-initiated study comparing the safety and performances of the company’s SpineJack technology to the Medtronic kyphoplasty balloon in the treatment of vertebral compression fractures in patients with osteoporosis.

This pilot feasibility study was initiated by David Noriega, M.D., of the Hospital Clinico Universitario in Valladolid, Spain, supported by Vexim and after receiving approval from the hospital’s ethic’s committee to treat 30 patients. Of the 30 patients, 15 were treated with SpineJac and 15 were treated with the Medtronic balloon. Patients were monitored post implantation and results were assessed at six months and will be reassessed at 12 months.

The company reported “excellent near-term outcomes” compared to the Medtronic balloon at six months post implantation, according to a press release.

Patient groups treated with SpineJack achieved:

• Near-perfect restoration of vertebral height (evolution of anterior vertebral angle ratio: pre-op/post-op from 71 to 76 percent for the balloon and from 66 to 82 percent for SpineJack), as well as perfect restoration of the physiological angle of the spine (evolution of the treated vertebra angle pre-op/post-op: 5.4 degrees for Spinejack compared to 1.7 degrees for the balloon);
• A decline in pain (92 percent at six months for SpineJack compared to 81 percent for the Medtronic device);
• A shorter intervention period (23 minutes) compared with the balloon (32 minutes); and
• No serious device-related adverse events, and it was not necessary to re-operate on any of the treated vertebrae.

“This randomized clinical study which has been realized during the last months has allowed us to confirm the great potential of SpineJack implant compared to another well-known technique used for balloon kyphoplasty,” said Noriega. “The results obtained have allowed us to observe a greater fracture reduction capacity in the treated vertebra, as well as an improved segmental angular correction, providing better clinical benefits for the patients. The results obtained from patients with osteoporotic compression fractures confirm the results obtained in previous studies on traumatic fractures, increasing the use of this fracture reduction technique. This confirms that the vertebral reduction technique with SpineJack can be used independently of the quality of the bone.”

According to the company, the difference with SpineJack is its ability to restore a fractured vertebra to its original shape, restoring the spinal column’s optimal anatomy and, as a result, removing pain to allow the patient to recover functional capabilities. Specialized instruments and guided by X-ray allow the implants into the vertebra to be carried out by minimally-invasive surgery in approximately 30 minutes enabling the patient to be discharged shortly after surgery. The SpineJack system line consists of three titanium implants with three different diameters, covering 95 percent of vertebral compression fractures and all patient morphologies.

Founded in 2006, Vexim is based in Balma, near Toulouse. The company focuses on the minimally invasive treatment of vertebral fractures.

U.S. Plans

In September, the firm annouced Vexim Inc., which will serve as the company’s U.S. subsidiary for marketing its product portfolio in the United States. “It will support Vexim’s planned commercial launch in early 2015 of vertebroplasty and kyphoplasty solutions to serve the $500 million vertebral augmentation market,” according to a statement released at the time.

“We are pleased to have made such substantial progress to be in the position of readying the company for an opening of our U.S. operations,” said CEO Vincent Gardès. “Our plan is to develop a U.S.-based scientific and business team that can advance the understanding of the benefits of products that better treat vertebral compression fractures. Simultaneously, we are initiating U.S. approval process of SpineJack, our unique implant designed to repair fractured vertebra and restore anatomical balance to the spinal column, with the goal of bringing SpineJack to the U.S. as well.”

European authorities recently expanded SpineJack’s indications for use.