Globus Medical, Inc. and its subsidiaries (‘Globus’) operates as a medical device company that develops and commercializes healthcare solutions for patients with musculoskeletal disorders.
Globus is committed to medical device innovation and delivering service to hospitals, ambulatory surgery centers, and physicians to advance patient care and improve efficiency. With several product launches in 2024 and operations across multiple countries worldwide, the company offers a comprehensive portfoli...
Globus Medical, Inc. and its subsidiaries (‘Globus’) operates as a medical device company that develops and commercializes healthcare solutions for patients with musculoskeletal disorders.
Globus is committed to medical device innovation and delivering service to hospitals, ambulatory surgery centers, and physicians to advance patient care and improve efficiency. With several product launches in 2024 and operations across multiple countries worldwide, the company offers a comprehensive portfolio of innovative and differentiated technologies that are used to treat a variety of musculoskeletal conditions. Although the company manages its business globally within one reportable segment, it separates its products and services into two major categories: Musculoskeletal Solutions and Enabling Technologies.
Market
The primary market for the company's products is the United States (‘U.S.’), where it sells its products through a combination of direct sales representatives employed by the company and sales representatives employed by its exclusive independent distributors, who distribute the company's products on its behalf for a commission that is generally based on a percentage of sales.
During the year ended December 31, 2024, international sales accounted for approximately 20.6% of the company's total sales. Internationally, the company sells its products through a combination of direct sales representatives employed by it and exclusive international distributors.
Strategy
The company’s business strategies are to leverage its integrated product development engine, continue to expand into international markets, and continue to expand into international markets.
As of December 31, 2024, the company had an existing direct or distributor sales presence in various countries outside the U.S.
The Globus Solution
The company's focus on actively listening and responding to the needs of its customers with quality solutions separates it from its industry peers. The company has introduced many products, including multiple products in 2024, designed for the treatment of musculoskeletal disorders.
The company's innovative Musculoskeletal Solutions products, combined with its ability to provide world-class service through a trained and exclusive sales force and corporate account management, create significant value for its customers.
Product and Service Categories
While the company groups its products and services into two categories, Musculoskeletal Solutions and Enabling Technologies, they are not limited to a particular technology, platform, or surgical approach.
Musculoskeletal Solutions
The company’s Musculoskeletal Solutions consist primarily of implantable devices, biologics, accessories, unique surgical instruments, and neuromonitoring services, used in an expansive range of spinal, orthopedic, and neurosurgical procedures. Musculoskeletal disorders are a driver of healthcare costs worldwide. Disorders range in severity from mild pain and loss of feeling to extreme pain and paralysis. These disorders are primarily caused by degenerative and congenital conditions, deformity, tumors, and traumatic injuries. Treatment alternatives for musculoskeletal disorders range from non-operative conservative therapies to surgical interventions depending on the pathology. Conservative therapies include bed rest, medication, casting, bracing, and physical therapy. When conservative therapies are not indicated, or fail to provide adequate quality of life improvements, surgical options become necessary.
The company's broad spectrum of spine products addresses the vast majority of conditions affecting the spine, including degenerative conditions, deformity, tumors, and trauma. With 20 years in this competitive market, the company provides comprehensive solutions that facilitate both open and minimally invasive surgery (‘MIS’) techniques. This includes traditional fusion implants, such as pedicle screw and rod systems, plating systems, intervertebral spacers, and corpectomy devices. The company has also developed treatment options for motion preservation technologies, such as dynamic stabilization, total disc replacement, and interspinous distraction devices, as well as interventional solutions to treat vertebral compression fractures. The company's biologic solutions include regenerative biologic products, such as allografts and synthetic alternatives that are adjunctive treatments typically used in combination with stabilizing implant hardware.
The company’s orthopedic trauma solutions are designed to treat a wide variety of orthopedic fracture patterns and patient anatomies in the upper and lower extremities, as well as the hip. The company's orthopedic trauma and extremity products cover four major segments of the orthopedic trauma market: fracture plates, compression screws, intramedullary nails, and external fixation. Fracture plating includes proximal humerus, distal radius, proximal tibia, distal tibia, distal fibula, distal femur, small fragment, mini-fragment, and clavicle plates. Intramedullary nailing includes tibial, trochanteric, and femoral nail systems. Regenerative biologic products, such as bone void fillers and allograft struts are used in orthopedic procedures where applicable.
The company's hip and knee joint solutions for the treatment of degenerative conditions or failed previous reconstruction have a long history of clinical use. Over 16 different implants have been marketed to date, including modular hip stems and acetabular cups for total hip arthroplasty, as well as posterior stabilizing and cruciate retaining knee arthroplasty implants.
The company's neuromonitoring services utilize proprietary software that employs hunting algorithms and graphical user interfaces to provide surgeons with an enhanced and intuitive nerve avoidance system. Through the company's IONM platforms, it gives surgeons the option to connect certain instruments to a computer system that provides discrete, real-time, surgeon-directed, and surgeon-controlled feedback about the directionality and relative proximity of nerves during surgery. The company's systems analyze and then translate complex neurophysiologic data into simple, useful information to assist the surgeon’s clinical decision-making process. The company provides onsite and remote monitoring of the neurological systems of patients undergoing spinal and brain-related surgeries.
Enabling Technologies
The company’s Enabling Technologies comprise imaging, navigation, and robotics (‘INR’) solutions for assisted surgery, which are advanced computer-assisted intelligent systems designed to enhance a surgeon’s capabilities, and ultimately improve patient care and reduce radiation exposure for all involved, by streamlining surgical procedures to be safer, less invasive, and more accurate. The market for the company’s Enabling Technologies in spine, cranial, and orthopedic surgery is still in the infancy stage and consists primarily of imaging, navigation, and robotic systems. In spine, a majority of these technologies are limited to surgical planning and assistance in implant placement for increased accuracy and time savings with less intraoperative radiation exposure to the patient and surgical staff. As the company’s Enabling Technologies become more fully integrated with its Musculoskeletal Solutions, a continued rise in adoption is expected.
The company’s INR solutions include the ExcelsiusGPS platform, which is a robotic guidance and navigation system that supports minimally invasive and open procedures with screw and interbody spacer placement applications. The ExcelsiusGPS platform has a modular design. The company also acquired Nemaris Inc., the company that developed and marketed Surgimap, a surgical planning software platform. Surgimap’s intuitive, patient-specific surgical planning and cloud-based infrastructure includes predictive algorithms and visual guides that enable healthcare professionals to plan and simulate surgical treatment of complex deformities. The software also enables medical professionals to share medical imaging technology globally to improve procedural workflow and patient care. The company had launched Excelsius3D, which when combined with the ExcelsiusGPS robotic navigation system, provides a superior intraoperative, image-guided robotic navigation solution that is designed to improve implant placement accuracy, lower radiation exposure, and shorten operative times. This maneuverable and intuitive imaging platform offers few imaging modalities, position memory, and a field of view. In 2024, the company launched the ExcelsiusHub and the ExcelsiusFlex to further expand its Excelsius ecosystem. The ExcelsiusHub provides real-time patient array monitoring, tissue-sparing drills, and registration flexibility to elevate the safety of spine navigation. The ExcelsiusFlex is a total knee arthroplasty robotic solution with imageless and computed tomography-based registration workflows. It was designed to give ergonomic control to the surgeon with enhanced feedback and visibility.
The company’s innovative Enabling Technologies products offer surgeons more information about patient anatomy and surgical options to help them make well-informed preoperative and intraoperative surgical decisions.
Sales and Marketing
The company markets and sells its products primarily through its exclusive global sales force. As of December 31, 2024, the company had a direct or distributor sales presence in the U.S. and in various other countries. The company has dedicated spinal implant, orthopedic trauma, and Enabling Technologies sales teams in place. It sells its hip and knee products primarily through independent sales agents.
The company’s implant sales representatives are present in the operating room during most surgeries in the U.S. and in many, but not all, of the other countries in which its products are sold. These representatives have the responsibility to confirm that all of the items needed in the surgery are available and are provided sterile, or are capable of being sterilized at the hospital. An assortment of sizes and quantities of implants are made available to be able to satisfy varying surgical requirements and patient anatomy, along with numerous surgical instruments and cases needed to safely perform the surgery and implantation. As products are used in surgeries, replacement items are shipped to the company’s sales representatives and hospitals to replenish their supply.
Surgeon Training and Education
The company devotes significant resources to training and educating surgeons regarding the safety and reproducibility of its surgical techniques and its procedurally integrated solutions. The company’s surgeon education and training program integrates surgical training with professional development and enables it to introduce surgeons to its comprehensive portfolio and patented approaches to spine surgery. The company offers educational and training courses globally through in-person formats and via virtual content, including virtual conferences and video and social channels, to demonstrate the benefits of its innovative products and procedures.
Manufacturing and Supply
The company, and its third-party manufacturers, are subject to the quality system regulations of the U.S. Food and Drug Administration (the FDA), state regulations (such as the regulations promulgated by the California Department of Health Services), and regulations promulgated by foreign regulatory bodies (such as in the European Union). For tissue products, the company is FDA registered and licensed in the States of California, Delaware, Florida, Illinois, Maryland, New York, and Oregon. For its device implants and instruments, the company is FDA-registered, California-licensed, Conformite Europeenne (‘CE’)-marked, and ISO-certified. CE, an acronym for ‘Conformite Europeenne’ or European Conformity, is the registration marking designating. The company’s facilities and the facilities of its third-party manufacturers are subject to periodic announced and unannounced inspections by regulatory authorities, and may undergo compliance inspections conducted by the FDA, state, and/or international regulatory agencies for, among other things, conformance to Quality System Regulations and Current Good Manufacturing Practice requirements, as well as separate foreign or international standards.
Surgical Instrument, Implant Sets, and Equipment Sales
For many of the company’s customers, it provides surgical instrumentation sets, including both implants and instruments, as well as its IONM systems in a manner tailored to fulfill its customer’s obligations to meet surgery schedules.
Intellectual Property
As of December 31, 2024, the company owned 2,859 issued U.S. patents (2,823 utility patents; 36 design patents) and had applications pending for 822 U.S. patents (all utility patents), and it owned 1,854 issued foreign patents and had applications pending for 464 foreign patents. The company’s issued patents expired or will expire between March 2015 and December 2044.
The company’s trademark portfolio contains 746 registered trademarks and 194 pending trademarks. The company’s portfolio includes domestic and foreign trademarks with associated logos and tag lines.
Government Regulation
The company’s products are medical devices and human tissue products subject to extensive regulation by the FDA and other regulatory bodies both inside and outside of the U.S.
The company’s products meet the FDA’s definition of medical devices (per Section 201(h)(1) of the Food, Drug, and Cosmetic Act) and human tissue products (under 21 CFR Parts 1270 and 1271 or Public Health Service Act Section 361), each subject to varying regulation(s) by the FDA and other federal, state, local, and foreign regulatory bodies.
The company is subject to both announced and unannounced inspections (device and tissue) by the FDA’s Office of Regulatory Affairs, Office of Compliance, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, and American Association of Tissue Banks, as well as other regulatory agencies overseeing the implementation and adherence of applicable state and federal tissue licensing regulations.
In the EU/European Economic Area (EEA), the company’s devices are required to comply with the essential requirements of the EU Medical Device Directive (Council Directive 93/42/EEC) (‘MDD’).
Further, the advertising and promotion of the company’s products in the EEA is subject to limited provisions under MDR and the laws of individual EEA Member States implementing Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEA Member State laws and industry codes governing the advertising and promotion of medical devices.
In addition to the presiding MDD and MDR outlined above, the company must also comply with EU / EEA laws, directives, regulations, and recognized standards as applicable to the devices it produces.
Below is a non-exhaustive list of requirements that apply to devices within the company’s portfolio and to which it must demonstrate some degree of compliance:
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization, and Restriction of Chemicals;
Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast);
Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment;
Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices;
Directive (EU) 2023/2413 of the European Parliament and of the Council of 18 October 2023 amending Directive (EU) 2018/2001, Regulation (EU) 2018/1999, and Directive 98/70/EC as regards the promotion of energy from renewable sources, and repealing Council Directive (EU) 2015/652;
Directive 2014/30/EU of the European Parliament and the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to electromagnetic compatibility;
Directive 2006/66/EC of the European Parliament and the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC; and
Directive 94/62/EC of 20 December 1994 on packaging and packaging waste.
The company is subject to announced and unannounced device inspections by Notified Bodies (an organization accredited by a Member State of the EEA to conduct conformity assessments), as well as other regulatory agencies overseeing the implementation and adherence of applicable regulations.
History
Globus Medical, Inc. was founded in 2003. The company was incorporated in Delaware in 2003.
