Top 10 Orthopedic Device Firms

10. Wright Medical

August 9, 2016

$415 Million

KEY EXECUTIVES:
Robert J. Palmisano, President and CEO
David H. Mowry, Exec. VP, Chief Operating Officer, and Exec. Director
Lance A. Berry, Sr. VP & Chief Financial Officer
Robert P. Burrows, Sr. VP, Supply Chain
Terry M. Rich, President, Upper Extremities
Kevin D. Cordell, President, Lower Extremities and Biologics
Peter S. Cooke, President, International
William L. Griffin, Jr., Sr. VP and General Manager, BioMimetic

NUMBER OF EMPLOYEES: 2,295

HEADQUARTERS: Amsterdam, the Netherlands

Additive manufacturing—or, as it’s  colloquially known, 3D printing—stands to make an enormous impact on joint replacement. Many physicians are confident in 3D printing technology’s influence on orthopedics in particular. Patient-specific guides produced to facilitate surgery ensure that a template fits in place with precision—even with a difficult bone deformation.

Dr. Ryan Meineke, an orthopedic surgeon operating at Scripps Memorial Hospital in Encinitas, Calif., makes use of custom surgical guides like Wright Medical’s PROPHECY preoperative navigation guides to reduce surgery times for total ankle replacements, such as Wright’s INFINITY Total Ankle System. According to Meineke, the 3D model’s accuracy can reduce operating time by removing a number of the intricacies involved in total joint replacement.

“The shorter the amount of time you can be in the operating room, the safer it is for the patient,” he said in a July 2015 interview with The San Diego Union-Tribune. “Now, it’s cut the skin, put the guide on, and start cutting the bone. It really reduces the number of complexities we have to deal with.”

Using computed tomography scans, modeling software, and 3D printing to reduce surgery time is quite remarkable in its execution. Here’s how an ankle joint procedure might look, aided and abetted by 3D printing:
  1. A CT scan of the surgical site designs a 3D-printed guide to best fit the patient’s bone.
  2. Surgical pins are placed through the guide, into the bone.
  3. The guide lifts away, replaced by a template to direct cutting.
  4. A section is cut away, then the process is repeated for the joint’s other bone.
  5. The artificial joint fits neatly where the cuts were made into the bone. Surgery is quickened because time spent figuring out where to cut into the bone is removed.
It hasn’t been fully determined what benefit this translates to for patients, however. Increasing precision with 3D printing may reduce operating time, but could add about $1,000 to the surgery’s cost, according to Dr. Jason Koh, an orthopedic surgeon in Illinois at NorthShore University Health System. “It does seem like custom cutting guides can definitely improve implant position, but there is clearly some cost associated with it, and since our existing technologies do very well, it’s going to take some time to demonstrate long-term benefit,” Koh commented to the Union-Tribune.

Netherlands-based Wright Medical probably isn’t worrying too much about the cost of anything right now; the company generated $415.6 million in sales in fiscal year 2015 (ended Dec. 27), an impressive 39.4 percent growth from the year prior. The majority of this increase was attributed to a landmark merger with Tornier N.V., which officially closed Oct. 1, 2015, with the all-stock deal valued at $3.3 billion. The merger has ushered in a milestone that Wright President and CEO Robert Palmisano dubbed “the New Wright Medical.”

“The culmination of this merger marks a significant milestone for our company, creating the premier, high-growth Extremities-Biologics company uniquely positioned with leading technologies and specialized sales forces in three of the fastest growing areas of orthopedics—Upper Extremities, Lower Extremities, and Biologics,” Palmisano stated in the company press release announcing the merger’s completion.

Tornier brought an extensive portfolio of joint replacement and soft tissue repair technologies for the upper extremities. As expected, the merger with Tornier fortified Wright’s upper extremities business quite significantly in FY15. Though not the company’s main source of revenue, it’s certainly headed north—upper extremities sales in the United States totaled $58.7 million, and international sales totaled $24.8 million, respectively soaring a whopping 283.8 and 119.1 percent over the previous year. In total, the company’s upper extremities business gained $60.6 million from Tornier products acquired in the merger. U.S. Food and Drug Administration (FDA) clearance of Tornier’s Simpliciti Shoulder System in March 2015 further added to the product anthology. Simpliciti is a bone sparing total shoulder arthroplasty system with an ultra short-stem design without a metal implant extending into the distal humeral canal, which reduces risk of a mid-shaft humerus fracture following implantation.

Though somewhat dwarfed by the double and near tripling of the upper extremities business, the effects of the merger were still felt on the rest of Wright’s business divisions to a lesser—but still significant—extent. Sales for FY 2015 in the lower extremities business (the company’s main revenue source) reached $187.1 million in America and $51.2 million internationally, growing 25.9 and 8.9 percent respectively. Lower extremities assets gained in the merger were responsible for $9.2 million of the sales increase globally, but a number of new and established products featured during the 2015 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting had parts to play in the increase:
  • The INFINITY Total Ankle Replacement (TAR) System continued to reinforce Wright’s arsenal of Total Ankle replacement offerings with a lower profile design and straightforward surgical approach.
  • Product line extensions for the INBONE TAR System, which broaden options for surgeons with a smaller talar dome for patients with small anatomy. Uncoated tibia stems and a revision poly insert were also introduced.
  • The aforementioned PROPHECY Pre-Operative Navigation Alignment Guides, to precisely size, place, and align INFINITY and INBONE TAR components.
  • A flatfoot osteotomy solution, OTHOLOC 3Di Flatfoot plates feature 3Di medial displacement calcaneal osteotomy plating.
  • 510(k) clearance of the SALVATION External Fixation System—designed to address fractures, nonunions, and complex foot and ankle deformities.
The September, FDA approval of AUGMENT Bone Graft—an alternative to autograft to ankle and/or hindfoot fusion procedures—added another therapeutic option to Wright’s Biologics repertoire. According to Dr. Christopher DiGiovanni, lead U.S. investigator for AUGMENT’s North American pivotal trial and chief of the Foot and Ankle Service in the Department of Orthopaedic Surgery at Massachusetts General Hospital, Harvard Medical School, “...AUGMENT offers clear patient benefit by enabling a healing rate and safety profile equivalent to autogenous bone graft—while simultaneously avoiding the additional surgery required to harvest autograft bone graft tissue that can result in site-specific complications and/or prolonged harvest site pain in some patients.”

AUGMENT sales in the fourth quarter of 2015 contributed to an 11.2 percent growth in U.S. Biologics sales, producing $50.6 million in revenue. Although AUGMENT’s international sales performed admirably, they could not offset volatile foreign currency, which precipitated a 5 percent loss (Wright’s only segment reporting a decline) from the previous year with $19.6 million in sales. Sports medicine and other products drew $13.2 million globally in 2015, a 36 percent growth from 2014. Wright also added a new product category to its offerings in 2015 due to the merger with Tornier, in the form of a “large joint” segment. 2015 global sales of large joint products totaled $10.1 million.

As of Jan. 30, 2016, 1,126 lawsuits were pending in the MDL and JCCP pertaining to Wright’s metal-on-metal hip products, mostly in the company’s CONSERVE line. The first MDL bellwether trial began on Nov. 9, 2015, and culminated in favor of the plaintiff, who was awarded $11 million total in compensatory and punitive damages. However, the company believed “there were significant trial irregularities” and contested the result. Wright filed a post-motion for a new trial or reduction of damages, which is still pending.