PARIS — Vexim (Toulouse, France) reported it has signed an exclusive distribution agreement with Stryker EMEA (Montreux, Switzerland) for its novel SpineJack implant covering Germany, the UK, Austria and Ireland.

The agreement confirms a deal reported earlier in Medical Device Daily and represents a significant break-through for the French start-up as it prepares to take on Medtronic (Minneapolis), which holds a lock on the expanding market for vertical compression fracture (VCF), estimated at $600 million globally, thanks to the acquisition of Kyphon (Sunnyvale, California), the pioneer in VCF treatment, for $3.9 billion in 2007. (Medical Device Daily, July 1, 2009)

"This exclusive contract gives us access to one of the largest and best sales forces in the market, notably in Germany," said Vincent Lefauconnier, chief commercial officer at Vexim.

Stryker will be responsible for SpineJack sales, marketing and customer training in the target territories.

The companies said SpineJack should start to become available in the markets cited through Stryker's sales network from August 2009.

Vexim will distribute SpineJack directly in France.

SpineJack goes beyond the current procedure for kyphoplasty by restoring post-trauma vertebral height using an adjustable titanium implant inserted into a patient's vertebra in a minimally invasive procedure.

The vice president for spine and biotech with Stryker EMEA, David Halliday, said "SpineJack allows us to extend our footprint in the expanding market for the treatment of VCF with a new, innovative product.

He added that initial study results and the response from surgeons "leads to the expectation that this concept will have significant market impact."

In July Vexim released the first-year follow up results for a pilot study of 20 patients and said it had enrolled another 100 patients 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.

Vexim received an initial investment of €5.5 million ($6.6 million) in February 2006.

Vexim's chairman/CEO Bruce de la Grange told MDD and he had just closed on provisional financing of €12.5 million ($3.5 million) and is preparing for a final financing round in 2010.

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

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