Xtant Medical Holdings, Inc. (‘Xtant’), a global medical technology company, focuses on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal implant fixation systems to facilitate spinal fusion in complex spine, deformity, and degenerative procedures.
The company’s products are used by orthopedic spine surgeons and neurosurgeons to treat a variety of spinal disorders in the cervical, thoracolumbar, and interbody spine.
The company promotes it...
Xtant Medical Holdings, Inc. (‘Xtant’), a global medical technology company, focuses on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal implant fixation systems to facilitate spinal fusion in complex spine, deformity, and degenerative procedures.
The company’s products are used by orthopedic spine surgeons and neurosurgeons to treat a variety of spinal disorders in the cervical, thoracolumbar, and interbody spine.
The company promotes its products in the United States through independent distributors and stocking agents, supported by direct employees. It has an extensive sales channel of independent commissioned agents and stocking distributors in the United States representing some or all of its products. The company also maintains a national accounts program to enable its agents to gain access to integrated delivery networks (‘IDNs’) hospitals and through group purchasing organizations (‘GPOs’). It has biologics contracts with major GPOs, as well as extensive access to IDNs across the United States for both biologics and spine hardware systems. While the company’s focus is primarily the United States market, it promotes and sells its products internationally through direct sales representatives and stocking distribution partners in Europe, Canada, Mexico, South America, Australia, and certain Pacific region countries.
The company’s strategic focus is currently on digesting and growing the products and businesses it has acquired, producing its own stem cells, growth factor, amnio, and synthetics biologics products, and continuing to focus on the following four key growth initiatives: introducing new biologics products, including its Cortera Spinal Fixation System, viable bone matrix, OsteoVive Plus, and amniotic membrane allografts, SimpliGraft and SimpliMax; leveraging its distribution network; penetrating adjacent markets; and leveraging its growth platform with technology and strategic acquisitions.
During the fourth quarter of 2024, the company entered into a license agreement with a distributor, granting an exclusive, nontransferable, non-sublicensable, royalty-bearing right and license to manufacture and commercialize in the United States its SimpliMax product and the trademarks associated therewith during the term of the agreement and subject to certain limitations, as set forth therein.
During the first quarter of 2025, the company entered into a manufacture and license agreement with a distributor, pursuant to which it agreed to manufacture and supply to the distributor its SimpliGraft product under the distributor’s name and brand. The company appointed the distributor as the exclusive seller of its SimpliGraft product to end-users located in the United States during the term of the agreement and in accordance with the terms and conditions thereof, and granted the distributor the right to use its related trademark in connection therewith.
The Centers for Medicare and Medicaid Services recently issued a Local Coverage Determination implementing significant changes to reimbursement for cellular and tissue-based products, which would impact its SimpliMax and SimpliGraft products and constitute a CMS Policy Change under its license agreements.
Orthobiologics Products
The company’s biomaterial products include OsteoSponge, OsteoSelect DBM putty, OsteoSelect Plus DBM putty, OsteoWrap, OsteoVive, OsteoFactor, its line of 3Demin products, and its nanOss family of products, as well as other allografts:
OsteoSponge is a form of demineralized bone matrix (‘DBM’) made from 100% human bone. Derived from trabecular (cancellous) bone, OsteoSponge is designed to provide a natural scaffold for cellular in-growth and expose bone-forming proteins to the healing environment. The malleable properties of OsteoSponge are intended to enable it to conform to, and fill, most defects. OsteoSponge’s mechanical and osteoconductive properties, in tandem with its osteoconductive potential, are designed to make OsteoSponge an ideal bone graft for use in various orthopedic practices, including spine, neurology, cranial/maxillofacial, trauma, plastic/reconstruction, and general procedures where new bone growth is needed.
OsteoSelect DBM Putty is designed to be easily molded into any shape and compressed into bony voids. The company has validated a low-dose, low-temperature gamma sterilization process designed to provide maximum osteoinductive potential while still affording device-level sterility.
OsteoSelect PLUS DBM Putty combines the cohesive characteristics of OsteoSelect DBM Putty with demineralized cortical chunks. OsteoSelect PLUS is designed to deliver differentiated handling properties and ensure patient safety through validated, terminal sterilization.
3Demin is a family of allografts that maximizes osteoconductivity and the osteoinductive potential of human bone. They consist of 100% demineralized cortical bone with malleable handling characteristics and are distributed as a sterile allograft. The company’s 3Demin products are easily hydrated with any biocompatible liquid, making them an option for various bone grafting applications. They are most commonly used in spinal fusion procedures.
OsteoFactor is a processed allograft that contains retained growth factors found within the endosteum layer of allograft bone. Unlike many of the various growth factor-based products on the market today, OsteoFactor is not limited to a single growth factor but contains a wide array of naturally occurring proteins and peptides that support bone formation and remodeling.
OsteoVive Plus is an aseptically processed, viable bone allograft created through a proprietary processing method. The graft offers an alternative to autograft through its osteoconductive, osteoinductive, and osteogenic potential. The company’s proprietary processing methods protect the native elements of bone, including growth factors and viable cells, while its PurLoc fiber technology creates beneficial handling characteristics.
The nanOss family of products provides osteoconductive nano-structured hydroxyapatite and an engineered extracellular matrix bioscaffold collagen carrier to provide a natural bone growth solution.
The company recently launched two biologics products for the wound care market. SimpliGraft and SimpliMax are dehydrated, terminally irradiated, single and dual-layer amniotic membrane sheets intended to serve as a barrier and provide protective coverage from the surrounding environment when topically applied to chronic and acute wounds.
The company also processes and distributes sports allografts, which are processed specifically for anterior and posterior cruciate ligament repairs, anterior cruciate ligament reconstruction, and meniscal repair, milled spinal allografts, which consist of cortical bone milled to desired shapes and dimensions, and traditional allografts for multi-disciplinary applications, including orthopedics, neurology, podiatry, oral/maxillofacial, genitourinary, and plastic/reconstructive.
During 2025, the company plans to release FibreX next-generation advanced DBM Fiber, OsteoFactor Pro internally produced solubilized allogenic growth factor cocktail stabilized by native human collagen, and TriviumFX, designed for bone regeneration, combining advanced science with practical application. Its unique formulation combines its PurLoc Fiber Technology and superior handling properties and is designed to deliver dependable performance for reliable outcomes.
The company’s Spinal Implant Products
The company offers a comprehensive line of products that are used to treat a variety of spinal and sacroiliac conditions, including trauma, degeneration, deformity, and tumor, including the use of minimally invasive surgery techniques. Some of the company’s key spinal implant product lines include:
Cervical Products
The Spider Cervical Plating System consists of simple, single-step locking with three forms of locking feedback providing confidence in the Spider System construct and performance.
The Streamline OCT System allows a rigid construct to be created in the occipito-cervico-thoracic spine by offering a broad range of implants. These implants provide the ability to tailor treatment to a specific patient.
The CervAlign System is a comprehensive anterior cervical plate system designed to meet the varying clinical needs of surgeons performing anterior cervical discectomy and fusion procedures. The system is able to accommodate semi-constrained, constrained, and hybrid constructs.
Thoracolumbar Products
The Axle-X Interspinous Fusion System is an internal fixation device for spinal surgery in the non-cervical spine (T1 - S1 inclusive). It is a minimally invasive, modular interspinous fusion system with angled spikes that allows for adequate L5 - S1 engagement and other variations in patient anatomy. The Axle-X Interspinous Fusion System is designed to provide spinal stability for lumbar fusion procedures, including the treatment of degenerative disc disease, spinal tumors, and trauma.
The Streamline MIS Spinal Fixation System allows a rigid construct to be created in the thoracolumbar spine via a percutaneous or mini-open approach using cannulated pedicle screws, set screws, and rods. The system offers a broad range of implants and instruments, providing the ability to tailor treatment to a specific patient.
The Streamline TL Spinal Fixation System allows a rigid construct to be created in the thoracolumbar spine using pedicle screws, set screws, rods, and Streamline TL Crosslinks. The system offers a broad range of implants and instruments, providing the ability to tailor treatment to a specific patient.
The Cortera Spinal Fixation System is a comprehensive posterior thoracolumbar fixation solution. Featuring innovative implants and multi-functional instrumentation, Cortera provides surgeons with a safe and effective solution that is designed to improve surgical workflow and deliver value when navigating complex procedures.
HPS 2.0 Hybrid Performance System is a universal system for the stabilization of the spine. The aim is to shorten the length of fusion and thus reduce the risk of degeneration in the adjacent segments. The dynamic coupler controls the movement of the spine in all directions. The HPS 2.0 is not currently sold in the United States.
Sacroiliac Joint Products
The Silex Sacroiliac Joint Fusion System is a sacroiliac fixation system that actively compresses across the SI joint. Sacroiliac dysfunction is increasingly recognized as a frequent contributor to chronic low back pain.
Interbody Products
Calix is a family of polyetheretherketone, or PEEK, interbody spacers and precision instruments for both cervical and thoracolumbar applications. Calix PC is a frictional titanium plasma-coated PEEK implant that provides additional biomechanical performance and end-plate visualization.
The Irix-C Cervical Integrated Fusion System consists of an integrated titanium ring, surrounded by an outer PEEK ring and two screws. It is intended for spinal fusion procedures at one level (C3 - T1 inclusive) in skeletally mature patients for the treatment of degenerative disc disease.
The Irix-A Lumbar Integrated Fusion System consists of an integrated titanium ring, surrounded by an outer PEEK ring and three screws. It is intended for spinal fusion procedures at one or two contiguous levels of the lumbosacral spine (L2 - S1 inclusive) in skeletally mature patients for the treatment of degenerative disc disease.
Fortilink is a family of implants used in a variety of fixation procedures. Fortilink implants with TiPlus Technology are manufactured with selective laser melting and are built from implant-grade titanium alloy. Open mesh structure and graft windows are designed to allow bone ingrowth and facilitate fusion.
Fortilink implants with TETRAfuse 3D Technology maintain bone-like mechanical properties. The unique features of the 3D printed nano-rough surface have been shown to allow bone cells to attach to the implant, increasing the potential for fusion.
Interlaminar Stabilization Products
The Coflex device is a single-piece, U-shaped, titanium implant intended for the treatment of moderate to severe lumbar spinal stenosis in conjunction with decompression. It provides minimally invasive, motion-preserving stabilization. The Coflex device is the first and only posterior lumbar motion preservation solution with Level I evidence, the highest possible level of clinical data, from two prospective, randomized studies against two treatment options—decompression alone and decompression with fusion—across two countries, the United States and Germany. The Coflex device has demonstrated long-term clinical outcomes for durable pain relief and stability.
The CoFix implant allows minimally invasive, segmental stabilization after microsurgical decompression and serves to support posterior fusion as an alternative to fixation with pedicle screws. It is intended for use on all levels of the lumbar spine for back pain and intervertebral disc-related pain due to degenerative processes of the lumbar spine with the occurrence of instability.
Sales and Marketing
The company distributes its products in the United States through an extensive distribution network of commissioned independent sales agents and stocking agents. As of December 31, 2024, it had over 670 independent sales agents and stocking agents. The company also maintains a national accounts program to enable its agents to gain access to IDN hospitals and through GPOs. It has biologics contracts with major GPOs, including Vizient, Premier, and HealthTrust Purchasing Group, as well as extensive access to IDNs across the United States for both biologics and spine hardware systems.
The company’s international footprint includes direct sales representatives and distribution partners in Canada, Mexico, South America, Australia, and certain Pacific region countries. Additionally, as a result of the company’s August 2023 Surgalign Holdings asset acquisition, it gained distribution partners in the European Union. The company’s European Union business is based in Wurmlingen, Germany.
Competition
The company’s primary competitors include Medtronic plc, Johnson and Johnson, Zimmer Biomet Holdings, Inc., Stryker Corporation, Bioventus Inc., Globus Medical, Inc., OrthoFix Medical Inc., Alphatec Holdings, Inc., Highridgek Inc., SI-Bone Inc., as well as dozens of privately-owned companies. The company also competes with tissue banks that do not offer spinal fixation products, such as AlloSource International, Inc., LifeNet Health, and MTF Biologics.
Intellectual Property
Patents
As of December 31, 2024, the company’s biologics patent portfolio included 50 issued patents that expire between 2028 and 2041, 26 of which are issued U.S. patents. The company’s fixation portfolio is patent protected globally and includes 289 issued patents that expire between 2025 and 2043, 191 of which are issued U.S. patents, and 14 pending patent applications, 5 of which are U.S. patent applications.
Trademarks
The company has registered, and continues to seek registration of, trademarks and continuously monitors and aggressively pursues users of names and marks that potentially infringe upon its registered trademarks. It currently owns the following registered trademarks: OsteoSponge, OsteoVive, OsteoWrap, BacFast, OsteoSelect, 3Demin, Circle of Life, Coflex, CoFix, ARANAX, ASPECT, ATRIX-C, ATRIX-C UNION, BACJAC, BACFUSE, BIGFOOT, CLARITY, CONTACT, CROSS-FUSE, INTERLAMINAR STABILIZATION, INTICE, LAT-FUSE, NANOSS, NUNEC, PAC PLATE, QUANTUM, RELEASE, SLIMFUSE, STREAMLINE, X-LINK, XPRESS, XSPAN, ZYFIX, ELEMAX, UNISON, FORTILINK, TETRAFUSE, CERVALIGN, NANOSS 3D, DCI, DSS, HPS, PARADIGM SPINE, the Paradigm Spine design logo, THE MOVEMENT IN SPINE CARE, TIPLUS, FIBREX, MAXFUSE, BIOMAX, CORTERA, ELEVATE YOUR BONE GRAFT, and ELEVATED PROCEDURAL SOLUTIONS. Under the X-spine name, it owns the following registered trademarks: SILEX, IRIX, CERTEX, CALIX, H-GRAFT, SPIDER, X90, BUTREX, FORTEX, AXLE, FIXCET, XTANT, and X-spine’s square design logo.
Government Regulation
The company is ISO 13485 and MDSAP Certified and registered with the FDA as a manufacturer of human cellular and tissue products (‘HCT/Ps’), as well as medical devices. It is an accredited member in good standing of the American Association of Tissue Banks (‘AATB’). In addition, the company complies with all licensing requirements for distributing HCT/Ps in states with such regulations, including Florida, California, Delaware, Illinois, Louisiana, Maryland, Oregon, and New York.
The company’s stabilization and fusion products, along with its instrumentation systems, are classified as medical devices and are therefore subject to rigorous regulation by the FDA, as well as by other domestic and international regulatory authorities. These regulations apply to a wide range of activities carried out by the company and its suppliers, licensors, and partners both now and in the future. All products currently marketed by the company is regulated as HCT/Ps and/or have received 510(k) clearances from the FDA. The company’s Coflex product is its only PMA approved product.
The company markets Coflex Interlaminar Technology under the PMA approval pathway.
The company’s operations are also subject to the U.S. Foreign Corrupt Practices Act (‘FCPA’). It is required to comply with the FCPA, which generally prohibits covered entities and their intermediaries from engaging in bribery or making other prohibited payments to foreign officials for the purpose of obtaining or retaining business or other benefits.
The company is an International Organization for Standardization (‘ISO’) certified organization.
The Centers for Medicare and Medicaid Services recently issued a Local Coverage Determination implementing significant changes to reimbursement for cellular and tissue-based products, which would impact its SimpliMax and SimpliGraft products upon effectiveness.
The Center for Devices and Radiological Health oversees the clearance and approval of medical devices, including the company’s stabilization and fusion products, as well as certain HCT/Ps regulated as medical devices, such as its OsteoSelect DBM putty.
Research and Development
The company’s research and development expenses were $2.4 million for the year ended December 31, 2024.
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