Greg Lucier, Chairman and CEO
Rajesh Asarpota, Exec. VP and CFO
Skip Kiil, Exec. VP, Global Commercial
Pete Leddy, Exec. VP, People and Culture
Matt Link, Exec. VP, Strategy, Technology, and Corporate Development
Steve Rozow, Exec. VP, Global Process Transformation
Nathaniel Sisitsky Esq., Sr. VP, General Counsel, and Corporate Secretary
NUMBER OF EMPLOYEES: 2,600
GLOBAL HEADQUARTERS: San Diego, Calif.
Bruce VanDam, M.D., caught a glimpse of the future 15 years ago.
The Southern California orthopedic surgeon was in Brazil at the time, observing a rather unconventional procedure by a most unconventional physician. Even with his limited knowledge of the surgery (and physician), VanDam knew he was witnessing something extraordinary that steamy July day.
“...it was very clear to me that—bingo, this is the way to do it,” he said.
The “it” in VanDam’s memory is spine surgery, or more precisely, lateral interbody fusion, a minimally invasive approach in which a physician accesses the intervertebral disc space from the side (lateral) rather than the front (anterior) or back (posterior). Such an approach spares major back muscles, bones, and ligaments, helping to reduce pain, blood loss, and swelling, as well as minimize hospitalization. Recovery is also quicker compared with conventional techniques.
The lateral approach was pioneered by Luiz Pimenta, M.D., Ph.D., a São Paulo neurosurgeon frustrated by the medical complications associated with invasive procedures. Determined to find a safer, more effective alternative to traditional spinal fusions, Pimenta first began considering “unconventional” surgical methods in the late 1990s after completing a thoracoscopy course in Germany.
“The course sparked a significant interest in looking at the spine in unconventional ways. Therefore, after returning to Brazil, I started applying these new techniques with the aim of providing better results for patients,” Pimenta, now 71, told Spinal News International in a 2014 interview. “At that point, I started what has since become my life’s professional passion of device/procedural development—from that day, improving spinal surgery has been my core professional challenge.”
Pimento successfully met that clinical challenge through the lateral approach to spinal fusion, which at the turn of the millennium, was largely a foreign concept. Pimento admits he was considered crazy back then for straying from convention, but he ultimately found an equally mad (and willing) partner in NuVasive Inc., a fledgling firm (at the time) looking to differentiate itself in the global spinal market.
NuVasive worked with Pimento to bring the revolutionary technique to the United States, eventually debuting the unique approach via its XLIF technology in 2003. XLIF (eXtreme Lateral Interbody Fusion) incorporates two systems developed by the company: MaXcess and NVJJB/M5.
The MaXcess System customizes surgical access according to patient size and shape. It features a split three-blade design that can be positioned to maximize patient anatomy visualization, and fiber optic lighting for enhanced intraoperative imagery. MaXcess enables doctors to perform surgeries using instruments similar to those necessary for open procedures, but with a significantly smaller incision.
The NVM5 System is an intraoperative nerve monitoring platform that helps improve both surgical technique and safe implant placement. The system combines electrically stimulated EMG (eletromyography) and spontaneous EMG activity to assess possible nerve root irritation or injury in the operating room.
“In partnering with Dr. Pimenta, we were able to bring in technology—specifically, neurophysiology—that ultimately became part of this assembly of technology into a procedure that created a more predictable clinical experience for surgeons,” Matt Link, executive VP of Strategy, Technology, and Corporate Development for NuVasive, said in an XLIF 15th anniversary tribute video on the company’s website. “What started off as a simple procedure for a minimally invasive approach for degenerative disc disease grew rapidly in its evolution and application across a wide range of indications.”
Those indications now span lumbar, thoracic, and cervical applications, with more than 80 Maximum Access Surgery (MAS) products available to treat degenerative spine conditions.
Last year, the company expanded its MAS portfolio with the release of 3D-printed fully porous titanium implants and solutions for single-position lateral surgery from T6 (thoracic) to S1 (sacral).
The Modulus XLIF titanium implants were developed with additive manufacturing technology to create a porous architecture that mimics bone porosity and stiffness for reduced stress shielding. The devices’ optimized architecture reportedly has better imaging characteristics than other titanium interbody products.
The new additions to NuVasive’s lateral solutions lineup, meanwhile, allow surgeons to perform lateral single-position operations. The company strategically launched the solutions—Lateral ALIF, XLIF Crestline, and Lateral MAS—shortly before the North American Spine Society’s annual meeting last fall in Orlando, Fla.
The Lateral ALIF approach features a new retractor system that gives surgeons direct access to L5-S1 in patients assuming a lateral decubitus position; the solution is intended to save procedural time and improve OR efficiency.
Similarly, XLIF Crestline is a supplemental solution that provides side access to challenging L4-L5 levels where XLIF procedures are virtually impossible (i.e., high crest, anterior psoas, or an anterior plexus). The off-angle technique allows access to disc space traditionally reached through a posterior approach, and uses NuVasive’s NVM5, MaXcess, and XLIF implants.
The Lateral MAS Fixation, on the other hand, is an adapted technique using Reline, a fixation system designed to preserve and restore spinal alignment.
“Using XLIF, XLIF Crestline, and Lateral ALIF provides the advantage of maintaining your patient in a single position. If you look, most of lumbar fusion surgery has really been done at L4 to S1, and so the ability to have these procedures available is tremendous,” Brian Kwon, M.D., orthopedic surgeon at New England Baptist Hospital in Boston, said when the solutions debuted. “NuVasive continues to take ownership of lateral surgery, making it better for us as surgeons and making it better for our patients.”
The financial benefits aren’t bad either: NuVasive’s inroads in the XLIF market have helped the company capture an 11 percent share in the global spinal sector, and cross the $1 billion sales threshold last year for the first time in its history. Its $1.03 billion haul represented a 7 percent increase over 2016’s total and a 27 percent spike compared to 2015’s sum. Executives attributed the solid gain to a 35.2 percent surge in international sales (to $176.2 million), strong U.S. demand for spinal hardware, and acquisitions.
The latter influence most likely stemmed from NuVasive’s 2016 purchases (Ellipse Technologies and Biotronic NeuroNetwork), as its 2017 investments occurred too late in the year (final quadrimester) to really impact sales. The 2016 purchases weren’t the company’s only growth dynamos, though they did play an integral role in raising Spinal Hardware revenue by 9 percent (to $723 million) and Surgical Support proceeds by 3 percent (to $297.4 million). The deals should continue to bear fruit this year as they meld with NuVasive’s more recent additions.
In purchasing Duke University/Georgia Institute of Technology startup Vertera Spine last September, NuVasive gainfully positioned itself as the only provider of porous interbody technology across both PEEK (polyether ether ketone) and titanium materials. Likewise, it became an instant leader in outsourced intraoperative neurophysiological monitoring services with the December pickup of SafePassage. The deal beefed up NuVasive’s neuromonitoring business line (formed after the Biotronic purchase), allowing it to reach key strategic U.S. markets and add significant new coverage, particularly on the East Coast.
“We invested further in building out our NuVasive Clinical Services business with the acquisition of SafePassage,” Chairman and CEO Gregory T. Lucier told investors in the company’s 2017 annual report. “As the only spine company in the world with dedicated neuromonitoring services, NuVasive is positioned to deliver greater value across our procedurally-integrated portfolio and expand our ability to transform how spine procedures are approached, measured, and valued from a clinical and economic perspective.”
That transformation also evolved last year through numerous FDA clearances and product launches. Many of those sanctions involved expanded or new indications for previously approved devices.
The CoRoent Small Interbody System, for example, received the FDA’s blessing in March 2017 for up to four contiguous cervical spine levels—just six months after the product was cleared for one level from C2-T1. The CoRoent system is an interbody cage made from PEEK-Optima that stabilizes the spine during fusion. The FDA’s clearance covered the CoRoent Small, CoRoent Small Lordotic, CoRoent Small Lordotic Plus, CoRoent Small Hyperlodotic, and CoRoent Small Contoured implants.
The same fate befell NuVasive’s PRECICE limb lengthening system and TLX interbody system. Inherited from Ellipse Technologies, the PRECICE product line was originally cleared for femur and tibia lengthening in patients with different limb lengths and deformities; the system now can be used in open and closed fracture fixation, pseudoarthrosis, malunions, nonunions, and bone transport.
The TLX system, meanwhile, received consent for a 20-degree expandable interbody as well as additional indications for use with allogeneic bone graft comprised of cancellous or corticocancellous bone graft to facilitate fusion. The FDA also cleared the TLX interbody system for use as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
Besides the expanded indications for its CoRoent, PRECICE, and TLX systems, NuVasive also won FDA clearance for its redesigned Magec magnetically controlled growth modulation system. The product is used to treat early-onset scoliosis, and features the company’s Reline small stature platform.
Reline’s adult options grew more diversified last spring with the debut of the brand’s Trauma spinal posterior fixation portfolio, designed to help preserve and restore patient alignment. The product line supports multiple approaches to spinal fixation procedures, including open, maximum access surgery, or hybrid approaches. The platform allows for controlled, dialed-in fracture correction through a dual rack system, with or without a rod present in the construct.
NuVasive targeted operating room safety with the September release of its LessRay software platform for reducing radiation exposure in hospital ORs. The LessRay system comprises a proprietary software algorithm and hardware components, and is initially focused on minimally invasive spinal surgeries.
“Innovation is in our DNA—it not only drives us to do what we do, it defines and distinguishes us,” Lucier said in the annual report. “As we evolve from a company focused on doing one spine procedure really well to an enterprise driving the industry with technological solutions and thought leadership, our management team and Board are evolving in tandem.”
Management’s evolution involved the promotion of three executives and the resignation of NuVasive’s chief financial officer. Lucier promoted Matt Link to executive vice president of Strategy, Technology, and Corporate Development; Skip Kiil to executive vice president, Global Commercial; and Steve Rozow to executive vice president, Global Process Transformation (a position he will hold in addition to his current duties as vice president of Global Operations).
The company also filed a lawsuit in October against its former vice chairman, who is now executive chairman at Alphatec Holdings Inc. The lawsuit accused Patrick Miles of scheming for more than a year to take business from NuVasive, but Alphatec denounced the complaint as a “frivolous PR stunt” and an attempt to damage the reputations of both Miles and the company.