36 orthopedic & spine device companies to know | 2018

Spinal Tech

The medical technology landscape is changing, with orthopedic and spine device companies growing, developing new technologies and partnering for unique innovations.

Here are 36 orthopedic and spine device companies to know. The companies are listed in alphabetical order. Please contact Laura Dyrda at ldyrda@beckershealthcare.com with questions.

Astura Medical (Carlsbad, Calif.). Astura Medical received FDA clearance for its Bridalveil OCT system in October 2017, marking the launch of its 11th spinal implant and instrumentation system since the company was created in December 2014. After two years in business, Astura Medical completed its first portfolio of products with the Half Dome Posterior Lumbar Interbody Spacer, Olympic Posterior Spinal Fixation System, Alta Anterior Cervical Interbody Spacer and Zion Anterior Cervical Fixation System. Astura expects that suite of products to continue building on last year's 312 percent growth in annual revenue and plans to launch its MIS Platform later this year.

Camber Spine (Wayne, Pa.). Camber Spine accomplished 46 percent annual growth in 2017, a year that was kicked off with FDA clearance of its Siconus SI Joint Fixation System and defined by a 97 percent increase in active surgeon users. The year was bookended with FDA clearance of the Spira-C Open Matrix Cervical Interbody, which was successfully used in multilevel ACDF procedures for the first time in February. Building on those achievements, Camber Spine expects to launch three products — the second generation of ENZ MIS ALIF, SPIRA-L Open Architecture Lateral Cage and SPIRA V Open Matrix Corpectomy — and gain FDA approval for six.

Captiva Spine (Jupiter, Fla.). Founded in 2007, Captiva Spine has built a targeted portfolio of lumbar and cervical spine fusion products featuring screw systems, cages, morsels and putty and a plate system. In March, the company announced the first successful cases using its TransFasten Posterior SI Fusion System, which launched in October 2017, and plans to train surgeons on the posterior SI approach nationwide. The privately held company signaled further growth by hiring Daniel Abromowitz as vice president of sales and business development and launching its HyperLOX posterior cervical system, a solution for posterior stabilization and fusion of the cervical and thoracic spine.

Carl Zeiss AG (Jena, Germany). In 2017, Carl Zeiss achieved its most successful fiscal year in company history of more than 170 years: revenue rose by 10 percent to a record level of approximately $6.6 billion, and all four of the company's business segments reported positive returns, including about $1.8 billion in revenue for the medical technology segment. In the first quarter of 2018, Carl Zeiss Meditec continued the positive trend with 4.2 percent revenue growth in its ophthalmic devices business unit and 8.2 percent revenue growth in its microsurgery segment. Zeiss offers several spine visualization systems — the Kinevo 900, OPMI Pentero 800, OPMI Vario 700 and Surgical Loupes — that utilize a surgical microscope to improve patient outcomes in minimally invasive procedures.

Centinel Spine (West Chester, Pa.). Centinel Spine was born in 2008 out of the merger-acquisition of nucleus replacement devices leader Raymedica and integrated interbody trailblazer Surgicraft, and the company launched its cervical device the same year. In December 2017, Centinel re-acquired the prodisc total disc replacement portfolio from DePuy Synthes Products, a line of products with the longest history of use globally, with intentions of focusing on the U.S. and Australian markets. Shortly after the deal closed, Centinel reported it pulled in $132 million from investors.

ChoiceSpine (Knoxville, Tenn.). Offering a regenerative and osteobiologics portfolio complete with synthetics, demineralized bone matrix putties, structural allograft and amnion allografts, ChoiceSpine lays claim to 18 patents. The 12-year-old, privately held company received FDA clearance for its TOMCAT standalone cervical device at the end of 2015 and in 2017 reported the 1,000th successful anterior cervical discectomy and fusion procedure using TOMCAT. Following that milestone, ChoiceSpine won FDA clearance for its Blackhawk integrated anterior cervical fusion device and Hawkeye Ti 3D-printed, titanium vertebral body replacement device, which achieved its first clinical use in December 2017.

CTL Medical Corp. (Dallas). Founded in 2015, CTL Medical scooped up RF Precision and AccelSpine in 2016 and has established itself as a major player in the pedicle screw systems market with more than 10 full-time engineers and in-house manufacturing capabilities. In July 2017, CTL entered an agreement to co-market the bone cement, kyphoplasty and vertebroplasty technologies of G-21, a biomaterials company, building on its 2016 partnership with Firehouse Medical to sell its spinal implants and devices to the U.S. government. The company has already secured FDA clearance for two systems in the first quarter of 2018: the Seurat Universal Pedicle Screw System and the Matisse Ti-Peek ACIF Cage System with TiCro.

DePuy Synthes Spine (Raynham, Mass). Johnson & Johnson integrated the DePuy and Synthes businesses in 2012 to create an orthopedic and neurological powerhouse, DePuy Synthes Co. DePuy Synthes Spine made one of the biggest orthopedic device company acquisitions of 2017, scooping up a nerve localization technology company known as Sentio for an undisclosed amount. DePuy secured a $260 million contract from the Department of Defense last year for its orthopedic products, which comprise a portfolio the company claims is one of the world's most comprehensive.

Elliquence (Baldwin, N.Y.). Elliquence has earned its status as a pioneer in endoscopic spine products and continues expanding its product line. To accommodate high demand for its endoscopic decompression procedures, the company is adding members to its team, and growing and constructing training facilities. Elliquence's patented radiofrequency technology — developed nearly five decades ago — helps surgeons preserve healthy tissues by utilizing high frequency, low temperature radio waves in traditional scalpel, scissor, electrosurgical and laser assisted procedures.

Globus Medical (Audubon, Pa.). Globus Medical is a force in the orthopedic and spine surgery device markets with a product line of more than 100 spine products — it launched nine in 2017. After launching its Excelsius GPS robotic surgical system in August 2017, the 15-year-old musculoskeletal solutions company posted a 16.1 percent increase in fourth quarter sales worldwide, and hit $636 million in global sales for the year. Globus Medical has now splashed into the orthopedic trauma market with FDA clearance on 11 new products in the segment.

Implanet (Martillac, France). Implanet's flagship product for treatment of spine pathologies resulting in vertebral fusion, the Jazz implant, generated $1.47 million in revenue in the fourth quarter, with the number of units sold increasing 16 percent to 2,821. Implanet presented studies showing the system offers a safe alternative to traditional techniques and concluding the system appears to lower hospital costs for spinal fusion surgeries for adolescent idiopathic scoliosis. In February, Implanet finalized an agreement to work with L&K Biomed's U.S. subsidiary Aegis Spine to expand Jazz distribution.

K2M (Leesburg, Va.). K2M is known for developing minimally invasive solutions for complex spinal disorder correction. A trailblazer in the 3-D printing of spinal devices, K2M launched a system for restoring cervical sagittal balance through posterior fixation in March and helps surgeons achieve 3-D spinal balance across the axial, coronal and sagittal planes through its Balance ACS platform. The company's comprehensive offerings boosted it to between $257.5 million and $258.1 million in preliminary reported revenue for fiscal year 2017, a 9 percent year-over-year increase. In March, the company committed to researching the outcomes of operative and nonoperative treatment for adult symptomatic lumbar scoliosis patients in collaboration with the Scoliosis Research Society and other organizations.

Life Spine (Huntley, Ill.). Life Spine has created more than 60 solutions for addressing spinal pathology from the occiput to the sacrum and launched 21 products in 2017 alone, building out its portfolio focused on fusion and minimally invasive surgeries. Driven by a 493 percent boost over 2016 in revenues for its ProLift Expandable Spacer System with reduced graft subsidence, the company posted 36 percent year-over-year growth overall in 2017. While pushing additional micro-invasive technologies, Life Spine unveiled clinical advancements to its procedural solutions; earned FDA clearance for its Plateau-Lo Insert and Rotate Spacer System; and announced the first clinical use of SENTRY 2 Lateral Plating System in the first quarter of 2018.

Mazor Robotics (Caesarea, Isreal). In 2017, Mazor Robotics hit $64.9 million in revenue and saw purchase orders soar: it clinched 27 in the fourth quarter alone. With Medtronic's $40 million investment in 2017 to assume global spine market commercial responsibility for the Mazor X Surgical Assurance Platform and accessories, Mazor received 64 robotic system orders for the Mazor X system for the year, out of 73 total. The company plans to emphasize synergy with Medtronic and procedure growth this year, riding the momentum of accelerating adoption of robotics for spine surgeries.

Medacta (Castel San Pietro, Switzerland). The first European-based international hip and knee manufacturer, Medacta has an average growth of 25 percent compared to the global market's 3 percent growth. Through the Medacta for Life Foundation, the company opened the My Baby nursery school and the My Child preschool in 2011 and 2015, respectively, which offer bilingual curricular and extracurricular activities for local children and continued expanding in 2018. When One World Surgery sent a team of 22 medical professionals to Honduras between Hurricanes Harvey and Irma in September 2017, the Medacta for Life Foundation provided 20 joints and surgical instrumentation the professionals needed to perform 15 total knee replacements and five total hip replacements in just four days.

Medicrea (Rillieux-la-Pape, France). Medicrea has designed, manufactured and distributed more than 30 FDA-approved spinal implant technologies for use in more than 150,000 procedures. The company's U.S. sales for the first quarter of 2018 amounted to $4.4 million, a 7 percent increase over the first quarter of 2017. A 60 percent increase in the number of personalized surgeries drove a 40 percent boost in sales for Medicrea's UniD ASI patient-specific technology platform, which represents 55 percent of total sales.

Meditech Spine (Atlanta). As part of its vision to make a positive difference in the marketplace, Meditech Spine partners with the nonprofit organization Cure International and sponsors children in developing countries to undergo spinal surgery. A portion of proceeds from the each sale of Meditech's CURE LP plate will help Cure International treat young patients in underserved areas, the company announced when its CURE Lumbar Plating System received FDA clearance in June 2017. Meditech also won FDA clearance that month for its Talos Lumbar (HA) Peek IBF for lumbar fusion procedures.

Medtronic (Minneapolis). Medtronic is a medical device manufacturer operating in more than 160 countries with more than 370 locations worldwide; the company employs more than 84,000 people. In early 2018, Medtronic released a restructuring plan expected to save $3 billion by 2022 while keeping the total employee count steady. A few months prior, Medtronic completed its $40 million investment in Mazor Robotics for exclusive distribution rights to the Mazor X Surgical Assurance Platform and accessories for robotic assisted spinal procedures. Medtronic reported $7.3 billion in third quarter 2018 revenue, a 1 percent increase over the same period last year.

Mesoblast (Melbourne, Australia). Mesoblast is a regenerative medicine company with a proprietary technology platform based on mesenchymal lineage adult stem cells. The company aims to have the first industrially manufactured allogeneic stem cell product approved in the U.S. with its product candidate remestemcel-L (MSC-100-IV) for the treatment of acute Graft Versus Host Disease in pediatric patients. As of December 31, 2017, Mesoblast had cash reserves of $47.4 million. Mesoblast recently completed enrollment for its Phase 3 mesenchymal cell therapy trial to treat chronic low back pain due to degenerative disc disease.

Mizuho OSI (Union City, Calif.). Mizuho OSI is known for its surgical tables designed for spinal surgery, hip replacement, knee replacement and orthopedic trauma procedures. However, the company is expanding to become a full-OR solution; Mizuho OSI is the nation's second-largest supplier of over-bed traction equipment, patient care and pressure management products. In October 2017, Mizuho OSI unveiled the Levó Head Positioning System at the North American Spine Society annual meeting; the system uses electro-mechanical technology to give physicians control and precision in head positioning for all spine procedures.

NuVasive (San Diego). NuVasive develops minimally disruptive and procedurally integrated spinal surgery solutions. The company is best known for its eXtreme Lateral Interbody Fusion (XLIF) procedure and also offers the Maximum Access Surgery platform for minimally invasive spine surgery. NuVasive employs 2,300 people at more than 25 locations across the globe, and reported $1.03 billion in full year 2017 revenue. NuVasive recently unveiled its Anterior Lumbar Interbody Fusion Access, NuVasive's first Maximum Access Surgery ALIF retractor platform for both lateral and supine spine surgery.

Orthofix (Lewisville, Texas). Orthofix has approximately 900 employees worldwide developing orthopedic and spine products and regenerative tissue forms. In 2017, Orthofix's net sales hit $116.9 million; its spine fixation segment reached net sales of nearly $82 million. Orthofix recently acquired artificial disc company Spinal Kinetics for up to $105 million.

Paradigm Spine (New York City). Paradigm Spine is a non-fusion spinal implant technology company, offering the coflex Interlaminar Stabilization device, the coflex-F and the DSS stabilization system. In January, Paradigm Spine published two-year trial results of its European Study of coflex And Decompression Alone in the Journal of Neurosurgery Spine. Paradigm Spine also commissioned a 2015 Milliman study into the economic value of colfex, which found reduced costs compared to primary lumbar fusion.

SeaSpine (Carlsbad, Calif.). SeaSpine develops orthobiologics and spinal fusion technologies. The company markets it products in the U.S. and in more than 30 countries worldwide. SeaSpine reported revenue of $131.8 million for 2017, an increase of 2.3 percent over 2016, and U.S. revenue of $118.4 million for 2017, a 4.4 percent increase over the previous year. The company recently expanded its Ventura NanoMetalene posterior interbody device to accommodate a wider range of posterior procedures and patient anatomies.

SI-Bone (Santa Clara, Calif.). Founded in 2008 as Inbone, a spin off from Wright Medical, SI-Bone developed a patent for the minimally invasive sacroiliac join fusion implant system, iFuse. Since then, more than 30,000 minimally invasive SI joint fusions have been performed with the device by more than 1,500 surgeons worldwide. The device has been gaining coverage determinations since 2009, most recently announcing Blue Cross Bleu Shield Association increased its clinical evidence rating for minimally invasive SI joint fusions in January.

Spinal Elements (Carlsbad, Calif.). Spinal Elements develops spinal implants and instruments and offers cervical, lumbar, thoracolumbar and biologics products. Amendia acquired Spinal Elements, forming one company under the "Spinal Elements" name in April 2017 to yield a portfolio of titanium-coated PEEK interbody technology. Spinal Elements develops Ti-Bond porous titanium coating, complementing Amendia's Overwatch pedicle screw system, Syzygy reduction screw system and Ceres cervical product lines.

Spineart (Irvine, Calif.). Spineart markets a portfolio combining traceable bar-coded sterile packed implants with compact instrument sets. The privately held company offers minimally invasive surgery, motion preservation, fusion, biologics and fracture treatment solutions. Spineart offers an alternative to pedicle screw fixation with its 360° P-Screwless platform for minimally invasive circumferential fusion. The company is represented in over 55 countries and has 15 ongoing projects in its research and development pipeline.

SpineCraft (Westmont, Ill.). SpineCraft develops products for spine deformities and complex spine problems, minimally invasive spine surgery, cervical and thoracolumbar degenerative conditions, non-fusion applications, orthobiologics and bone substitutes. In February 2017, SpineCraft entered into an agreement with Mighty Oak Medical to use the FireFly Mechanical Surgical Guidance System with SpineCraft Astra & Apex Spine Systems for complex spine and deformity correction. SpineCraft also offers systems for minimally invasive spine surgery.

Stryker Spine (Allendale, N.J.). Stryker saw $12.4 billion in net sales for 2017, with spine sales reaching $2.2 billion. In March, Stryker Spine announced that its Tritanium C Anterior Cervical Cage was implanted by 311 surgeons since its October 2017 launch. Stryker Spine's spinal biologics offerings include traditional and proprietary spinal allografts, demineralized bone matrix products and a viable bone matrix. In 2017, Stryker reported employing 33,000 people across all of its service lines.

Titan Spine (Mequon, Wis.). Titan Spine was established in 2006 and focuses on designing and manufacturing titanium interbody cage devices that promote spinal fusion. Titan Spine's proprietary nanoLOCK surface technology is engineered to enhance bone growth response at the macro and nanosurface levels. In 2016, CMS created a new technology ICD-10 code for interbody fusion procedures using nano-textured interbody fusion devices; nanoLOCK is currently the only device with access to use the code. The surface technology company employs about 110 people and has been growing at over 40 percent per year for over 10 years.

TranS1 (Denver). TranS1 develops solutions designed to minimize the damage caused by surgical approaches to the spine. The company's foundational solution, the Axial Lumbar Interbody System — AxiaLIF+ — is manufactured to address spinal pathology at the L5-S1 vertebral bodies. TranS1 recently received three patents, two of which focus on presacral interbody fusion and one related to a new technique for sacroiliac fusion. Over the past three years, TranS1 has received 100-plus issued patents and has 50-plus new patent applications.

Vertiflex (Carlsbad, Calif.). Vertiflex offers treatments for lumbar stenosis. Its minimally invasive motion-preserving Superion Interspinous Spacer System is indicated for moderate lumbar spinal stenosis. In 2017, Vertiflex completed a $40 million financing round for the U.S. commercial expansion of the Superion Indirect Decompression System, an implant for treating lumbar spinal stenosis. The device is designed to reduce pressure on impacted nerves. Vertiflex's Totalis Direct Decompression System is designed for minimally invasive direct decompressions of the lumbar spine.

Wenzel Spine (Austin, Texas). Wenzel Spine provides minimally invasive solutions for the treatment of spinal disorders. In 2017, Wenzel Spine acquired the PrimaLOK SP Interspinous Fusion System and PrimaLOK FF Facet Fixation System from OsteoMed. Wenzel Spine's VariLift standalone expandable interbody fusion device expands in situ and provides lordotic correction.

Xenco Medical (San Diego). In 2017, Xenco Medical launched TraumaGPS, an on-demand trauma surgery delivery app, and expanded delivery for its ASC CerviKit, a compact storage platform for anterior cervical discectomy and fusion procedures in the ASC setting. Xenco Medical's surgical systems stand out from the crowd by ensuring every patient is operated on with single-use implant systems.

Zavation (Flowood, Miss.). Zavation is an employee-owned company offering biologics, spinal systems and kyphoplasty and vertebroplasty solutions. Private equity firm LongueVue Capital acquired Zavation Medical Products in 2017. Zavation has a network of more than 100 distributors across 35 states.

Zimmer Spine (Westminster, Colo.). Zimmer Biomet Spine offers solutions for differentiated complex and minimally invasive spine procedures; its MIS portfolio includes the PathFinder NXT Pedicle Screw System and Alpine XC Adjustable Fusion System. Zimmer and Biomet were separate orthopedic device companies that merged in a $14 billion transaction 2015 to create Zimmer Biomet. In 2016, the combined company acquired LDR Spine, the manufacturer of Mobi C and L artificial discs, for $1 billion. The company also acquired Medtech, which developed the ROSA robotic system for brain and spine surgery, for approximately $132 million.


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