PARIS – On the heels of convincing clinical evidence for restoration of vertical compression fracture (VCF), Vexim SAS (Toulouse, France) said it will begin a soft release of its novel SpineJack implant this month, building to a formal European market launch at EuroSpine in Warsaw, Poland, in November.

With distribution deals in place for the major markets of Europe and a series of clinical trials underway, Vexim is the most advanced of three companies introducing a new generation of devices for treatment of VCF that push beyond the pain relief of balloon kyphoplasty with implants that can restore the vertical height of a crushed vertebrae and provide longer-term correction of this debilitating condition.

Medtronic (Minneapolis) holds a lock on the expanding VCF market, estimated at $600 million globally, thanks to the acquisition of Kyphon (Sunnyvale, California), the pioneer in VCF treatment, for $3.9 billion in 2007.

This week Vexim released the first-year follow up results for a pilot study of 20 patients and said it has enrolled another 100 patients, who received a total of 256 SpineJack implants, in a pan-European study that will measure clinical outcomes at 12 months.

The European study includes eight centers in Germany, France, Spain, Portugal and Turkey where the pilot study was conducted at six centers in France.

Vexim received the CE mark for SpineJack in May 2008, but said it delayed commercial release of the implant until it could gather clinical evidence to support the claim of efficacy for a controlled, morphological restoration of the cortical ring and endplates) while preserving the spinal joint.

"The evidence show we are not only treating the pain, we are treating the fracture," said Vincent Lefauconnier, the company's chief commercial officer. "All of us are after pain relief, which is the first measure of efficacy," he said.

"Our objective has been to develop a more comprehensive approach to treating these pathologies, with full anatomical restoration of the vertebra," Lefauconnier said.

To measure the restoration of the vertebrae, a critical competitive advantage in the coming competition with Medtronic/Kyphon, Vexim developed a tool to compare before-and-after computer tomographic (CT) scans with the Laboratoire de Physique Moléculaire of the prestigious Ecole Nationale Supérieure d'Arts et Métiers in Paris.

The software measures the displacement of the anatomical features of a crushed vertebrae and renders what Vexim CEO Bruce de la Grange called "a clear topographical map using color coding to show the movement from green, which mean no change, to red, which is really good. Orange and yellow are gradations of change in between.

"We say we can put it back to its original position in a controlled manner," unlike the balloon inflation technique used by Medtronic/Kyphoplasty, de la Grange told Medical Device Daily.

"It becomes important that SpineJack moves in one controlled direction," he said. "A compression fracture goes in one direction and the surgeon wants to counter that direction in order to correct the fracture."

"Kyphon/Medtronic has created a great awareness that VCF is a condition that can be addressed," de la Grange said.

"We are grateful for this pioneering work," he said, adding, "We feel SpineJack is taking treatment to the next generation."

The Vexim clinical evidence includes positive results in measures for pain relief and the safety of both the device and cement, as well as efficacy in restoration of the injured vertebrae.

SpineJack is a 5 mm, expandable titanium device measuring 25 mm in length that is implanted in a minimally invasive procedure, typically through two skin incisions.

Once inserted and expanded to the required height, bone cement is injected into the vertebra in order to fixate the restored structure, "like putting a cast on a broken arm," said Lefauconnier.

The procedure requires 20 to 30 minutes and patients report immediate pain relief, while surgeons report patients standing up within 24 hours without support.

Kyphon's pioneering work also includes seeking reimbursement as an implantable device in European countries, which has set the bar high enough for a titanium device to compete with a balloon-and-cement combination.

While Vexim will distribute SpineJack directly in France, it has negotiated distribution agreements for the other major markets of Europe.

Distributors include Stryker (Kalamazoo, Michigan) and DePuy (Warsaw, Indiana).

"We have sought the strongest possible partner in each market due to the highly variable reimbursement structures in the European Union," de la Grange said.

Vexim received an initial investment of €5.5 million in February 2006, valued at $6.6 million at that time.

"Our cash plan said we would be out of money by May of this year, but at that point we still had €1 million ($1.32 million)," said de la Grange, who told MDD he had just closed on provisional financing of 12.5 million ($3.5 million) and is preparing for a final financing round in 2010.

"We have had to beat back the interested parties in this latest financing," he said.

de la Grange said Vexim expects to receive a "substantial amount" from the French government's innovation funding agency, Oséo.

As for a potential trade sale to one of Vexim's distribution partners in Europe, he said, "nothing is going to happen before a 510(k) approval from the FDA, which is two years away, at the earliest."