K2M Highlights Global Expansion at NASS

During this year’s North American Spine Society (NASS) annual meeting in Dallas, Texas, executives at K2M Inc. were focused on the global release of the company’s Rail 4D system.

Rail 4D is stabilization technology featured in the K2M’s Mesa Rail Deformity and Mesa Rail Small Stature spinal systems, which are used to help complex spinal curves. The Rail 4D product first debuted this summer during the International Meeting on Advanced Spine Techniques in Istanbul, Turkey. The news from NASS in Dallas was that the company now has continued to expand its global sales of Rail 4D, most recently in Denmark, Germany and Holland. The technology has already been introduced in the United Kingdom, Switzerland, Spain, Sweden, Ireland, and the United States.

“The European expansion of Rail 4D Technology signals the rapid uptake of this technology and marks another important milestone for the K2M global strategy,” said Eric Major, K2M’s president and CEO. “Establishing a strong European presence with this unique technology is critical to our commitment to offering the best solutions for physicians and patients around the world.”

The Leesburg, Va.-based company claims to be the largest privately held spinal device company developing devices for the treatment of complex spinal pathologies and minimally invasive procedures.

Inspired by structural I-beam geometry, the uniquely shaped and proprietary Rail is an alternative to the traditional round spinal rods offered with other products. According to the company, the Rail provides enhanced structural rigidity, while maintaining a lower-profile than set screw-based systems. Compared to a standard 5.5 millimeter cobalt chrome rod, the company’s cobalt chrome Rail of the same size is 210 percent stronger in flexion-extension and 46 percent stronger in lateral bending, according to company data. This technology is exclusive to K2M, as it has been designed to complement the company’s existing Mesa Locking and Cricket Reduction technologies.

“Rail provides the surgeon the ability—in conjunction with state-of-the-art screw technology – to optimally correct the scoliotic spine in the coronal and, more importantly, the sagittal plane. This presents significant short and long term advantages to the scoliotic patient,” said Stewart Tucker, MBBS, FRCS (Eng), FRCS (Orth), of the United Kingdom’s Royal National Orthopaedic Hospital.

According to the company, the design offers fixation options for surgeons by helping to apply forces during axial correction of difficult spinal curvatures and has the potential to reduce intraoperative rod “flattening” dreaded by surgeons. The Rail may decrease the need for over-bending the construct and give surgeons more predictability and direct control over sagittal balance, officials noted.

Lane Major, senior vice president of global marketing for K2M, told Orthopedic Design & Technology that 2012, despite market conditions, pricing and reimbursement pressures, has been another growth year for the company and that additional expansion is expected for 2013.

“We continue to expand globally,” he said. “We’ve got a direct sales force in the United Kingdom and Germany and we’re doing the same thing. There is a lot of potential in European markets for us. We also continue to expand in the United States. We’ve had a lot of new 510(k) clearances recently—pediatric clearance for MESA system and Rail 4D, the Serengeti retractor system. We’re building a compliance program that’s as good or better as any company on the show (NASS exhibit) floor. We continue to innovate; that’s most important.”

When asked if market conditions make the task of innovating more difficult, Major told ODT it isn’t easy but that’s the “name of the game” lately in medical devices and in the spine market, in particular.

“We’ve got a great team, and our people will have to maintain that entrepreneurial spirit. It come down to hard work and prioritizing,” he said, adding that the device tax is another curve ball. “The tax is huge for us. It’s real. We will continue to grow, but there will be some new employment opportunities we won’t be able to pursue if we’re going to maintain profitability.”

Other goals, according to Major, in 2013 include expansion of the company’s biologic product line as we as the evaluation of new product categories.

“We don’t have an artificial disc, for example,” he said. “That’s not by accident. We did buy some intellectual property, but it’s a space we continue to look at. It is important than any new product innovations fit with our portfolio and our long-term growth strategy. We now have a competitive portfolio and it shows in sales.”