Despite the COVID-19 pandemic's effect on the spine industry, innovation and mergers and acquisitions activity continues to pick up steam among medtech companies in 2022.
Robotics, navigation, augmented reality, 3D printing and artificial intelligence-based technologies are expected to continue to make noise in the spine industry.
Twenty-three spine companies to watch in 2022:
1. Medtronic (Dublin, Ireland): Medtronic kicked off 2022 with the approval of its Intellis and Vanta spinal cord stimulators for treating chronic pain associated with diabetic peripheral neuropathy. Harry "Skip" Kiil, who previously led global orthopedics at Smith+Nephew, became head of Medtronic's cranial and spine business in January. His responsibilities include driving innovation and delivering therapies to global markets more effectively. Arguably Medtronic's biggest development of 2021 was the clearance of its patient-specific UNiD Rods with the company's CD Horizon, Solera, Voyager and Infinity OCT spinal systems. The rods are bent before surgery to match a preoperative plan created with AI. Medtronic's acquisition of Medicrea is designed to help the company leverage data and artificial intelligence in preoperative planning, which is a central focus for the medtech giant, CEO Geoff Martha said.
2. Johnson & Johnson — DePuy Synthes (West Chester, Pa.): Johnson & Johnson has around 16 percent of the spine market, just behind Medtronic, which has about 29 percent, according to a report from The Spine Market Group. Despite the pandemic's effect on the spine market, sales in the company's "spine, sports and other" segment hit $2.9 billion in 2021, a 7.2 percent increase year over year. Johnson & Johnson CEO Alex Gorsky said the company is "just starting to unlock the full potential and benefits of robotic and digital technologies," which will play a central role in the future of the company.
3. Stryker (Kalamazoo, Mich.): Stryker kicked off 2022 with a definitive agreement to acquire Vocera Communications for $3.1 billion. The acquisition, expected to close in the first quarter, will help the company address the increasing need for hospitals to connect caregivers and disparate data-generating medical devices. Last year, Robbie Robinson was appointed president of Stryker's spine division after 17 years with the company. Robotics continues to be a key element in Stryker's total joint business, but CEO Kevin Lobo has yet to provide a timeline on when the company will have a robot for spine surgery.
4. Zimmer Biomet (Warsaw, Ind.)/ZimVie (Westminster, Colo.): Zimmer Biomet's spine spinoff ZimVie, which will be completed March 1, is expected to earn $1 billion in revenue in 2022. Vafa Jamali, a former Medtronic executive, is tasked with leading ZimVie out of the gates in March alongside a newly appointed team of executives. ZimVie will focus on key growth areas of the spine and dental markets, including implants, surgical tools, bone grafts, spinal fusion implants, nonfusion alternatives and digital care technologies.
5. Globus Medical (Audubon, Pa.): Globus Medical's market-leading spine robot, ExcelsiusGPS, continues to be adopted by spine surgeons and is the primary factor driving growth in the company's enabling technologies business, which increased 100.3 percent year over year to $958.1 million in 2021. ExcelsiusGPS has been used in almost 30,000 spine surgeries and robotic utilization — the number of cases performed per installed robot — was at an all-time high in 2021, according to CEO Dave Demski.
6. NuVasive (San Diego): Highlights of NuVasive's 2021 include the $150 million acquisition of Simplify Medical, which includes the Simplify artificial disc, and the launch of Pulse — an integrated platform designed to increase safety and efficiency in spine surgery. Reports of a potential acquisition by Globus Medical saw NuVasive's stock spike late last year, but financial analysts projected that deal would not come to fruition.
7. SeaSpine (Carlsbad, Calif.): SeaSpine's $110M acquisition of 7D Surgical was a significant coup for the company last year. 7D Surgical's flagship technology, the Flash navigation system for spine and cranial surgery, is designed to replace standard fluoroscopy and offers surgeons a radiation-free tool to place spinal implants. The system costs about $450,000, which is less than half the price of traditional imaging systems, according to the company. Including results from the May acquisition, SeaSpine expects full-year revenue for 2021 to be around $191 million, reflecting 24 percent year-over-year growth, and is well positioned to carry that growth through 2022.
8. Alphatec (Carlsbad, Calif.): Alphatec will look to see the benefits of its $116.9 million acquisition of EOS imaging on its books this year. The company is integrating EOS technology into its Alpha Informatix platform, adding spinal imaging and anatomical modeling. Recent product launches include the ALIF standalone interbody system and the OsseoScrew. Alphatec also continues to grow adoption of its prone transpsoas technique in spine surgery.
9. Augmedics (Chicago): Interest in augmented reality has spiked in spine over the last decade, stemming from a desire to limit complications associated with instrumented spine surgery and improve procedural efficiency. In January, Kevin Hykes took over as president and CEO of Augmedics, which he said aims to "continue to fundamentally disrupt the way that surgery is practiced with the groundbreaking Xvision system." The AR system, which gives surgeons a 3D visualization of the spine intraoperatively, has been adopted at multiple hospitals and practices in the past two years. In 2020, it was named one of the best inventions of the year by Time magazine.
10. Surgalign Holdings (Deerfield, Ill.): Surgalign was formed in 2020 after RTI Surgical sold its original equipment manufacturer business to a private equity firm for $480 million. RTI Surgical rebranded as Surgalign Holdings and is using the capital to bolster its spine portfolio. In January, the company received FDA clearance for its Holo Portal AI-driven augmented reality guidance system for lumbar spine surgery. The company is also developing the ARAI surgical navigation system. Spine surgeon and CMO Kris Siemionow, MD, PhD, is overseeing the development of the ARIA system.
11. Bioventus (Durham, N.C.): This orthobiologics company made headlines last year after it acquired spine company Misonix for $518 million in a cash-and-stock transaction. The acquisition, which closed in October, is expected to accelerate growth, boost double-digit revenue and provide a significant opportunity for long-term market expansion, according to Bioventus CEO Ken Reali.
12. SI-Bone (Santa Clara, Calif.): Laura Francis, SI-Bone's former CFO and COO, assumed the role of CEO from Jeff Dunn last year. The company anticipates full-year 2021 revenue to be around $90 million, representing year-over-year growth of between 22 and 23 percent. SI-Bone's iFuse implant has been evaluated in 90 peer-reviewed publications and has become the standard of care for sacroiliac joint fusion. Last year, the company launched iFuse-Torq, a 3D-printed implant designed for pelvic trauma and minimally invasive sacroiliac joint fusion.
13. Spinal Stabilization Technologies (Westminster, Colo.): This spine company is preparing for an exciting future after its PerQdisc nucleus replacement system achieved the CE Mark and the FDA's "breakthrough designation" last year. PerQdisc is the only commercially available lumbar nucleus replacement system in the world. The device replaces the nucleus pulposus of the intervertebral disc in the L1-S1 spinal region in patients with single-level discogenic pain.
14. Camber Spine (King of Prussia, Pa.): Spine surgeon Edward Vresilovic Jr., MD, PhD, began 2022 as the new CMO of Camber Spine, which strengthened its sales team, launched several new products and introduced a set of devices and tools for its oblique lateral interbody fusion. The company plans to roll out spine surgeon education programs and bolster its portfolio this year.
15. Kleiner Device Labs (Incline Village, Nev.): Founded by spine surgeon Jeff Kleiner, MD, this startup has acquired 23 U.S. patents for its spine technologies. The company's initial product KG1, demonstrated an ability to increase spinal fusion success rates from 75 to 92 percent. The KG2, or Solid State Fusion Platform, received FDA clearance in September and is designed to provide up to three times the amount of bone-grafting material compared with traditional spinal surgery approaches.
16. Accelus (Palm Beach Gardens, Fla.): Formed last year through the merger of Integrity Implants and Fusion Robotics, Accelus' goal is to accelerate the adoption of robotic spine surgery as the standard of care in both hospitals and ASCs. More than 10,500 of the company's FlareHawk lumbar interbody fusion devices have been implanted in more than 8,000 patients and Fusion Robotics received FDA clearance for its initial system last year. Accelus plans to add training labs and R&D centers in Boulder, Colo., and San Diego.
17. Spineology (St. Paul, Minn.): Spineology has made a name for itself in the industry for its OptiMesh and Duo devices, which allow placement of anatomy-conforming interbody fusion devices through small incisions. The products are designed to expand in three dimensions to create large footprints, preserve the patient's anatomy and accelerate recovery. The company expanded its sales team and secured a $15 million venture loan last year.
18. Aesculap (Center Valley, Pa.): Aesculap made headlines last year when a study found that patients who had total disc replacement with its ActivL Artificial Disc had better outcomes than patients who received the ProDisc-L. Another study published in the Journal of Orthopaedic Surgery and Research found that ActivL patients had overall better sagittal alignment and experienced less pain three years post-surgery. In January, Aesculap wrapped up a mobile training program that introduced its products to spine and neurosurgeons across the country.
19. Barricaid (Woburn, Mass.): The Barricaid implant, developed by Intrinsic Therapeutics, is the first device clinically proven to reduce the incidence of reherniation and reoperation in patients with large annular defects, according to the company. Five year-data published in JAMA Network Open in December demonstrated high-risk lumbar discectomy patients treated with Barricaid are less likely to suffer reherniation and reoperation than those patients treated with discectomy alone. The device has been used in about 250 patients in the U.S. — where it was granted premarket approval in March 2020 — and in about 8,000 surgeries in Europe, Australia and Asia.
20. Esaote (Fishers, Ind.): Esaote has provided MRI systems to spine practices for more than 25 years. Spine imaging is the company's core business, from spine-specific coils and staff training to device installation and economics. Esaote's offerings include the S-scan open-concept MRI designed to scan the spine, extremities and the hips and shoulders. Over the next five years, in-office imaging will "continue to grow and is going to become more accepted," moving away from only being provided at hospitals and radiology departments, according to Stephen Gibbs, Esaote's MRI sales and marketing manager for North America.
21. Xtant Medical (Belgrade, Mont.): Xtant Medical's product portfolio of orthobiologics and spinal implant systems are designed to facilitate spinal fusion in complex spine, deformity and degenerative procedures. The company underwent some leadership changes at the start of 2022 with Scott Neils assuming the role of interim CFO. Despite the negative impact of the COVID-19 pandemic on nonurgent spinal procedures in recent months, Xtant president and CEO Sean Brown said the company continued to grow its distribution network, expand into adjacent markets and launch new products, "all of which are important pillars of our growth strategy."
22. BoneFoam (Plymouth, Minn.): Patient positioning is an area ripe for innovation in the spine industry, which is what Bone Foam set out to do with its Nextend Positioning System for anterior cervical cases. The technology is designed to optimize cervical spine positioning while providing a safe and stable operative surface. The system aims to help surgeons achieve more consistent and repeatable positioning while eliminating inefficiencies and complex tape configurations.
23. Mizuho OSI (Union City, Calif.): Mizuho OSI develops surgical tables and positioning devices for spine and orthopedic surgery, with its products designed to reduce physician fatigue and improve patient safety during procedures. Mizuho OSI recently acquired the Air Barrier System, an infection control device used in spine and hip surgeries, and received the California Awards for Performance Excellence last year.