Enabling technology was the story of the North American Spine Society 2019 Annual Meeting (NASS), with top spine players heavily featuring their robotic-assisted surgery ecosystems. These players are becoming clearer in their messaging about how their technologies integrate into an efficient workflow. We also spoke to companies excited about advances in surface technologies, 3D printing and new clinical trials for biologics.
Before we jumped into the new products and technologies, we polled executives on their thoughts about the spine market in general.
Spine Market Growth Expected to Remain in Low Single-Digits
Many of the executives we spoke to, including Camber Spine, NuVasive, SeaSpine and Spinal Elements, agreed that spine market growth would remain in the low single-digits, and gave figures in the range of flat to +3%. Several players noted increased case volumes over the first half of 2019, but did not sense an influx of new patients. We believe the observed volume increases largely to be the result of players entering competitive accounts (NuVasive) or selling in new product spaces due to portfolio expansion (SeaSpine).
Price pressure has remained consistent in the spine segment at about 2%, with aggressive pressure on commoditized products like conventional fixation, open pedicle screws, cervical plates and disposables. Executives noted that financial pressures continue to drive hospital consolidation. As hospitals scale and gain additional leverage in purchasing power, device companies are pursuing aggressive new product release cadences to stave off commoditization.
Companies like Alphatec Spine and SeaSpine highlighted rapid overhauls of legacy-heavy portfolios. SeaSpine once derived “most” of their revenue from products that were at least seven years old, and now generate 55% of their revenue from products launched within the last three years. At the halfway mark of 2019, Alphatec Spine saw 32% of their revenue come from new products after none the prior year.
Enabling Technology and Robotics
Enabling technology figured heavily in the messaging and booth presentations of the large- and medium-sized players in that space. It is easy to be swept up in the near-future potential and slick presentations of these technologies (Brainlab’s dramatic choreographed countdown for the Loop X launch comes to mind), but in general we felt most of these technologies iterated on existing features and capabilities. For spinal robotics, transformative advances remain over the horizon. Robotics utilization in spine is low (around 10% of all spinal procedures, based on our conversations), creating plenty of runway over which players will compete in the coming years.
Globus Medical introduced an update to their ExcelsiusGPS platform that includes Interbody Solutions, which offers navigation and real-time feedback during dilation, disc preparation and implant insertion. Globus is the only company offering an interbody placement with its robotic system. They also debuted the Globus Imaging System that is expected to launch in 2020, comprising a mobile combination C- and O-arm that provides fluoroscopy, digital radiation and CT scan. GIS will be fully integrated into the company’s robotic and navigation tools.
Medtronic leadership shared usage and market share data for their enabling technology, calling out one million cases done with Stealth navigation, >40,000 cases done with Mazor and approximately 1,000 cases performed with Mazor X Stealth Edition. Medtronic estimates that it has 60% market share in navigation and a 66% share in spinal robotics with 270 units placed in the U.S.
NuVasive unveiled the robotic component of Pulse, but somewhat surprisingly the system won’t launch until 2021. Its first application will be for pedicle screw placement, with bone cutting and retractor management to follow. The arm and cart design is similar to ExcelsiusGPS but includes seven points of articulation, as opposed to six for ROSA Spine and five for ExcelsiusGPS. The highly versatile Pulse platform includes neuromonitoring, global alignment, rod-bending, imaging and navigation. It promises to be a strong contender with the coming addition of the LessRay image enhancement platform and robotics modules.
Brainlab presented Cirq, a vendor-neutral robotic assistance arm, and an automated intraoperative imaging robot called Loop-X. Cirq is a lightweight arm (around 11kg) that mounts to an O.R. table rail and features modular support for spinal drilling and pedicle screw placement. Loop-X is an automated mobile imaging robot that can wirelessly position itself around the patient for 2D and 3D scans.
Zimmer Biomet’s spine robot is rolled into their existing brain systems as ROSA ONE, planned for launch in 1Q20. While it doesn’t break new ground in terms of functionality, Rosa Spine has the advantage of an existing install base in an increasing competitive market. The company also showed the WalterLorenz Surgical Assist Arm meant for both stand-alone use and ROSA integration. Zimmer Biomet hopes these two technologies play key roles in the turnaround of a spine business that has struggled in 2019.
Integration and Optimization
As players introduce more enabling technology across their portfolio, integration and workflow quality become important differentiators. Minimally invasive single-position surgery is an opportunity for companies to bring many of their technologies to bear with great effect, and the top players emphasized that they are working to hone their surgical approaches.
Medtronic walked us through their Surgical Synergy workflow for SynergyOLIF360 Single-Position Workflow that features StealthStation navigation, O-arm imaging and navigated Stealth-Midas instruments. Meanwhile, NuVasive estimates their X360 system has saved 5,300 hours and $25.4 million in hospital costs across 7,100 cases performed. The ecosystem of technologies that comprise Pulse are a cornerstone of the X360 system. Both Globus Medical and DePuy Synthes have integrated their technologies into single position lateral approaches to compete with X360.
Our conversations at NASS reinforced that as the playing field for enabling technologies levels out among the top players, workflow efficiencies will likely play a large role in driving surgeon adoption. While robotic system placements are an interesting metric and nice capital sale, time and a more crowded market will eventually force prices down. Players that can successfully drive high adoption rates will benefit from product pull through over the long term.
Surface Technology and Biologics
Not all of the NASS conversations centered on robotics, of course. Surface technology and biologics remain a crucial component to the spine narrative.
The members of Medtronic’s management team we spoke to were very excited about the addition of Titan Spine’s nanoLOCK surface technology for titanium interbody devices that achieves a proprietary blend of macro, micro and nano surfaces through subtractive manufacturing. Medtronic completed its acquisition of Titan Spine in June.
Additive manufacturing and 3D printing have been widely adopted by spine players. An executive from a small, well-established spine company told us that 3D-printed products need to be part of a company’s bag, just like titanium and PEEK.
Among small players, Camber Spine showed they continue to innovate in this space, announcing their SPIRA-O open matrix OLIF interbody. The company’s SPIRA technology features 3D-printed open architecture and roughened titanium arches to promote bone growth. Of larger companies, DePuy Synthes highlighted the launch of its CONDUIT Interbody Platform based on EIT Cellular Titanium Technology that was acquired in 2018. The implants have 80% porosity to mimic the 50% to 90% porosity of natural bone.
Players of all sizes continue to invest in clinical research to back biologic products. During the conference, Medtronic announced a new clinical trial to study Infuse Bone Graft in TLIF procedures. Infuse has been used since 2002 in certain spine, oral-maxillofacial and trauma surgeries.
Biologics comprise about half of SeaSpine’s revenue, and the company is conducting pre-clinical and clinical studies focused on their OsteoStrand and OsteoStrand Plus demineralized bone fibers. Management believes leveraging their place in the DBM market can drive adoption and premium pricing in the segment.
In all, we covered nearly 50 spine company announcements leading up to and during NASS.