$509 Million ($1.47B total)
Prior Fiscal: $468 Million
Percentage Change: +8.7%
No. of Employees: 4,500
Global Headquarters: Plainsboro, N.J.
Peter Arduini, President and CEO
Carrie Anderson, Corp. VP and CFO
Glenn G. Coleman, Corp. VP and COO
Kenneth Burhop, Corp. VP, Chief Scientific Officer
William Compton, Sr. VP, Chief Information Officer
Robert T. Davis, Jr., Corp. VP and President, Orthopedics and Tissue Technologies
Dan Reuvers, Corp. VP and President, Codman Specialty Surgical
Paul Gonsalves, Sr. VP, Chief Commercial Officer
Michael McBreen, Sr. VP and President, International
John Mooradian, Corp. VP, Global Operations and Supply Chain
Judith E. O’Grady, R.N., M.S.N., R.A.C., Corp. VP, Global Regulatory Affairs
Integra is a company that could be seen as in a state of flux, at least when viewed from an orthopedic perspective. With the Codman acquisition in 2017, the firm seemed to move much more into the neurosurgical space than the orthopedic arena. The organization was notably absent from last year’s Top Company list and only returned this year due to the acquisition of DJO and its subsequent lack of an annual report. This status is counter to the direction the company was taking back in 2011 when it acquired SeaSpine—a provider of spinal fusion products. Of course, only a short four-years later, Integra completed the spinout of that same entity to stand on its own once again.
Integra President and CEO Peter J. Arduini might disagree with that assessment, though. “With the integration of Codman Neurosurgery nearing completion, important channel investments in place, and exciting new product introductions on the horizon, we expect to reap the benefits of a comprehensive product portfolio, a larger and more focused sales team, and a broader global footprint,” he said in his letter to shareholders in the company’s 2018 annual report.
Within that same letter, Arduini notes the company is living up to the vision of its founder, Dr. Richard Caruso, in providing medical technologies and products that make it a leader in regenerative medicine, which includes extremity orthopedics.
Although the company is lopsided in where revenue is generated between its two divisions—Codman Specialty Surgical, and Orthopedics and Tissue Technologies—by an almost 2:1 split, the orthopedics and tissue segment is still a vital component that has enjoyed favorable growth in recent years. The $508.5 million in 2018 sales was an 8.7 percent increase over 2017’s tally of $467.9 million. In the specific area of Extremity Orthopedics, the firm reported low-single digit revenue losses due to declines in its lower fixation portfolio, but those dips were mostly offset by growth in shoulder and ankle offerings.
In comparison, Integra’s Codman Specialty Surgical unit posted $963.9 million in 2018, which represented a 33.8 percent rise over the $720.3 million the segment brought in during 2017. The most direct (and obvious) reason for the increase was the enjoyment of a full year of revenues from the absorption of Codman Neurosurgery, which only offered partial contributions to the company during the previous fiscal in which it was purchased.
Taking a global look at the company’s financials reveals the firm’s sales are well established in the United States. The overall revenue for the entire organization topped $1 billion in 2018 ($1.046 billion) in the U.S.—an increase of 17 percent over the prior year. Integra’s growth internationally, however, is gaining in significant chunks. The European market added just over $200 million to the firm’s total in 2018, a 34 percent gain over 2017. Asia Pacific contributed $144 million, which represented a 79 percent expansion over the previous fiscal. Even the Rest of World, which was a modest $63 million in 2017, rose 28 percent to finish 2018 just shy of $81 million.
Taking a year off from M&A activity, Integra instead focused on ensuring organic growth was still a focus for the firm. With that in mind, it launched its XT Revision Total Ankle Replacement System late in the year. According to a company statement, the system represents one of the first FDA-cleared devices indicated exclusively for revision ankle arthroplasty and can be used to revise any commercially available primary total ankle replacement system. Further, the augmented posterior sloped talus addresses subsidence by rebuilding posterior talar height. The anatomic design mimics the natural kinematics of the ankle, designed to promote a more normal gait and better overall function postoperatively.
“The launch of the Integra XT Revision Total Ankle Replacement System represents Integra’s commitment to further advance ankle arthroplasty solutions,” said Robert T. Davis Jr., corporate vice president and president, Orthopedics and Tissue Technologies. “Many of our surgeons have expressed their excitement for the XT system and our approach for ankle revision surgery. With this addition to our ankle reconstruction portfolio, Integra now offers comprehensive care for end-stage ankle arthritis patients.”
Unfortunately, the company did come under the dark cloud that has been looming over the entire medical device industry during the last 18 months. Whether the “60 Minutes” story about Boston Scientific’s transvaginal mesh product, “The Bleeding Edge” documentary that was distributed via Netflix, or the Implant Files investigations organized by the International Consortium of Investigative Journalists that highlighted an array of problem devices that were impacting patients worldwide, the medtech industry certainly faced a PR nightmare during the year. In late November, Integra was caught up in it as well.
An NBC News feature titled “Exporting pain: U.S.-made medical devices cause serious injuries, pain overseas” shared the story of Australia’s Wolfgang Neszpor who had received Integra’s PyroTITAN shoulder implant. The technology was an “export-only” device, which means it did not face the standard FDA regulatory oversight. The article went on to share both the pros and cons of the policy, and how it came to be. Regardless of where one stands on the ethics of legislation that permits devices to be sold to other countries while the products are not approved in the U.S., being featured so prominently in the NBC News report could not have been the message Integra wanted going out to the public. According to the report, the company suspended two clinical trials for the device and had planned a new one that was set to close in 2020.
Whether Integra will seek approval of the device in the U.S. will remain to be seen, but the firm did offer a written statement to NBC News regarding the implant. “Today, the PyroTITAN device meets all regulatory, safety and performance requirements…[and] has enabled many patients to regain the mobility of their shoulders.” There was no indication, however, whether the device had been modified, according to NBC’s report.