GENEVA, Switzerland — The long journey home to America for two companies with innovative products began in Geneva at the SpineWeek 2008 conference, which runs through Saturday.

Having recently received the CE mark for new spinal implants, Disc Motion Technologies (Boca Raton, Florida) launched sales and marketing efforts at SpineWeek for products it can only showcase, but not sell, in the U.S.

The same holds true for Pioneer Surgical Technology (Marquette, Michigan), which introduced two Europe-only products, the BacJac (Medical Device Daily, May 28, 2008) and NuNec systems.

It likely will be several years before either company can win approval from the FDA and hope to cash in on the world's largest medical device market.

Meanwhile, both companies have started on a well-worn and proven path to commercial success by setting up foreign offices, learning to tell their story in multiple languages, compiling clinical cases to demonstrate effectiveness, and hopefully pleasing investors with early sales revenues in euros, pound sterling and diverse other currencies.

Disc Motion Technologies received its CE mark in late March for a novel approach to total lumbar spine joint replacement.

Surgeons are trained for posterior interventions, yet total joint replacement has only been possible with an anterior arthroplasty surgery, for which few patients qualify, as it requires opening the entire front of the body to expose the targeted vertebrae hidden behind vital organs.

American surgeons are further intimidated by this procedure because, unlike Europe, there is no reimbursement for the procedure in the U.S.

Disc Motion's Europe-only approval is for a posterior approach to joint replacement with the True Total Spinal Motion Segment System (TSMS).

By replacing the joint with TSMS, the surgeon can address all potential sources of pain generation for the patient including the disc, facet joints and nerve roots.

"It has remained a small market because no one likes to go in to replace through an anterior approach," said Jud Carlson, managing director for Disc Motion, who estimated $150 million is spent annually on the procedure, more than half of that in Europe.

"Taking a posterior approach, we are going to grow this market, to make the pie larger," he said. "Where today only 5% of patients who could use a disc replacement actually undergo the surgery, with the posterior approach we believe 80% of these patients can be treated.

"Our goal is to be the first lumbar disc approved by Medicare for reimbursement," said Carlson. "To do this we will need to show them data, and plan to conduct a study on patients over 60."

Just days ahead of the opening of SpineWeek, Disc Motion reported the first implant procedure for a 46-year-old woman performed by a surgical team headed by Dr. Erkan Kaptanoglu at the Ankara Numune Education and Training Hospital (Ankara, Turkey).

The product still is in prototype development, and Carlson said, "We are now building kits for surgeries and have recruited more than the [number of] surgeons we need for the study. We have surgeons pounding on our door from Mexico, Korea, South Africa, Europe and South America."

He said Disc Motion is setting up for production of the complex joint replacement kit.

"We are working with manufacturers," he said. "It most likely will be with a company in Warsaw, Indiana. Where else?"

In the six months since Pioneer introduced its first CE-only product at EuroSpine in Brussels (MDD, Oct. 10, 2007), the company has filled out its European distribution network, expanded its offering by introducing existing products from the U.S. portfolio, and at SpineWeek introduced two new products that are only for the European market.

Formerly the head of European business for St. Francis Medical Technologies (Alameda, California), Dr. Lex Giltaij, the vice president for Pioneer charged with Europe, said most of his team followed him to Pioneer after St. Francis was acquired last year by Kyphon (Sunnyvale, California), which in turn was snapped up by Medtronic (Minneapolis) in a $4.2 billion deal.

In addition to quickly filling the offices of Pioneer BV, the European subsidiary based in Driebergen, the Netherlands, Giltaij said the team and experience has accelerated the company's footprint in Europe by quickly establishing distributor relationships that are essential in a market notorious for highly fragmented sales and marketing channels.

"We have almost full coverage in Europe now," he said, adding that sales are "perfectly on target, and we are quite ambitious for Europe."

Pioneer is direct to hospitals in Germany and has commissioned agents for the UK, thus covering two of Western Europe's biggest markets. Distributors handle France, the Benelux countries and all other markets.

Spain is the only blank in the landscape, Giltaij said, one he expects will be filled by the end of the summer.

In Italy, Pioneer is represented by 14 different distributors abandoned by Medtronic after it acquired Kyphon and adopted the direct relationships maintained in Italy by that company.

The experience of the former St. Francis team also paid off for Pioneer in product development, said Giltaij, holding up the star of the SpineWeek show, BacJac, an interspinous decompression system that received the CE mark in early May.

"Having worked on X-Stop with St. Francis, we had some strong ideas about where to improve that product," he said.

The success of X-Stop, a minimally invasive alternative procedure for the treatment of common degenerative spinal stenosis, was one of the reasons St. Francis was attractive to Kyphon and then Medtronic.

"X-Stop is a good alternative to invasive surgery, but requires a double-sided exposure of the targeted vertebrae and a significant fiddle factor,'" Giltaij said.

Like X-Stop, BacJac also provides a physical block in the space between the flexed spinous processes, but requires only an incision on one side of the vertebrae.

Once inserted the triangle-shaped implant is then "jacked" open into an "X" form that locks the implant in place to increase the dimensions of the spinal canal and intervertebral foramina.

BacJac is made of PEEK, a biologically inert material, compared to the titanium construction of the X-Stop, and also is radiolucent where titanium is radio-opaque, providing a sharper post-operative assessment of the positioning.

Another Europe-only product introduced to that market at SpineWeek is NuNec, a cervical total disc replacement device.

"This is going to be a big hitter for Pioneer," said Giltaij, citing the advantage of PEEK-on-PEEK construction and a unique fixation system.

Once implanted between two vertebrae, the surgeon turns a screw bristling with camming that bite into the bone and lock the implant in place.

This active fixation technology is supplemented by a more passive fixation of hydroxyapatite-coated PEEK surfaces that facilitate osteo-integration, or bonding to the bone.

The radiolucence of the PEEK construction will prove to be a competitive advantage, Giltaij said, as the surgeon "can perfectly see the cam fixation and the device's orientation markers. No competitor has this. Their radiology only shows a black shape around the implant."

Pioneer holds exclusive patents for PEEK-on-PEEK applications for the spine, he said, and the addition of the bio-compatible hydroxyapatite layer to PEEK is only a precursor to new products the company is developing.

In the past year Pioneer purchased two companies — Encelle (Raleigh, North Carolina) and Angstrom Medica (Woburn, Massachusetts) — that are developers of novel products using bio-friendly materials for tissue regeneration and osteoconductive chemistries, with potential applications for trauma, spine and orthopedic markets.

"Before the end of this year, you will be hearing the results of these combination product potentials," Giltaij said.