Paragon 28
NYSE:FNA
$
13,09
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$0,00 (0,00%)
13,09
$
$0,00 (0,00%)
End-of-day quote: 04/21/2025
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Paragon 28 Company Info
EPS Growth 5Y
0,00%
Market Cap
$1,10 B
Long-Term Debt
$0,11 B
Short Interest
0,00%
Quarterly earnings
05/02/2026 (E)
Dividend
$0,00
Dividend Yield
0,00%
Founded
2010
Industry
Country
ISIN Number
Website
Analyst Price Target
There are currently no price targets available for this stock.
In the last five quarters, Paragon 28’s Price Target has risen from $16,00 to $16,00 - a 0,00% increase. Seven analysts predict that Paragon 28’s share price will fall in the coming year, reaching $0,00. This would represent a decrease of -100,00%.
Top growth stocks in the health care sector (5Y.)
What does Paragon 28 do?
Paragon 28, Inc. is a leading medical device company. The company exclusively focuses on the foot and ankle orthopedic market. The company is dedicated to improving patient lives. The company’s innovative orthopedic solutions, procedural approaches and instrumentation cover a wide range of foot and ankle ailments including fracture fixation, forefoot, ankle, progressive collapsing foot deformity (PCFD) or flatfoot, charcot foot and orthobiologics. To treat these painful, debilitating or even lif...
Paragon 28, Inc. is a leading medical device company. The company exclusively focuses on the foot and ankle orthopedic market. The company is dedicated to improving patient lives. The company’s innovative orthopedic solutions, procedural approaches and instrumentation cover a wide range of foot and ankle ailments including fracture fixation, forefoot, ankle, progressive collapsing foot deformity (PCFD) or flatfoot, charcot foot and orthobiologics. To treat these painful, debilitating or even life-threatening conditions, the company provides a comprehensive portfolio of solutions that includes surgical implants and disposables, as well as surgical instrumentation. As of December 31, 2023, the company’s broad suite of surgical solutions comprises nearly 80 product systems to help fit the specific needs of each patient and procedure. The company designs each of its products with both the patient and surgeon in mind, with the goal of improving outcomes, reducing ailment recurrence and complication rates, and making the procedures simpler, consistent and reproducible. The company’s passion, expertise, and exclusive focus in the foot and ankle market has allowed the company to better understand the needs of its patients and physicians, which has enabled it to create innovations and enhanced solutions that disrupt and transform the foot and ankle market. As a result, the company has experienced significant growth and momentum in its business.
The company strives to disrupt and transform the market by focusing exclusively on the foot and ankle to develop and commercialize differentiated, high quality orthopedic solutions, advanced procedural approaches and instrumentation that are collectively designed to enable surgeons to provide consistent, reproducible and effective outcomes. The company’s development strategy integrates all aspects of the procedure and the company seek to enhance support systems beyond implants. The company develops procedure specific solutions featuring meaningfully improved and purpose-built designs for implants and instrumentation, enhanced surgical techniques and clinical support. The company relies on an unbiased, clinical, research-first approach to developing new products, which allows the company to create disruptive technologies. Each of its systems is designed to deliver the surgeon an enhanced user-experience throughout the procedure, while improving patient outcomes and increasing the reproducibility of results. The company couples this innovation and advancement with a dedication to medical education to support surgeons, patients and stakeholders within its organization, while also delivering its products through a clinically focused sales force.
The company has developed a comprehensive portfolio of foot and ankle surgical systems and procedural techniques designed to address many of the conditions requiring surgery in the foot and ankle, including fracture fixation; forefoot; ankle; PCFD or flatfoot; charcot foot; and orthobiologics. Each system typically includes numerous plates, screws, staples, nails, advanced joint and bone replacements, orthobiologics, and other implantation instruments and disposables. Except for its total talus spacer, which is authorized for marketing under a Humanitarian Device Exemption (HDE), its marketed products are either Class II medical devices cleared by the U.S. Food and Drug Administration (FDA) for specific indications or they are Class I exempt for general orthopaedic use. The company has no products that are Class III medical devices.
The company’s development pipeline is driven by its passion and commitment to designing products aimed at improving patient outcomes and creating surgical efficiencies. The company has a dedicated team of design and development engineers that have embodied its research philosophy to drive continual innovation and a system of collaboration that allows the company to harness and rapidly respond to customer feedback to drive development of new concepts and product iterations. The foregoing has helped the company to expand its portfolio quickly and consistently, having launched nearly 80 product lines since 2011 including four product lines launched in 2023. The company has more than 30 product and system offerings in its development pipeline and expects the majority to launch commercially in the next 24 months. The company has also enhanced its offerings through licensing agreements and tuck-in acquisitions, such as its recent acquisitions of Additive Orthopaedics, LLC (Additive Orthopaedics) and Disior Oy.
The company has dedicated substantial resources to building a leading commercial organization that consists of sales, marketing and medical education. The company’s entrepreneurial and clinically-oriented culture has allowed it to build a leading sales force which includes an estimated 266 producing U.S. sales representatives as of December 31, 2023. The company defines producing sales representatives as those sales representatives' logging revenue, for at least one case, in all three months of each quarter. The company’s U.S. sales force consists primarily of independent sales representatives, the majority of whom are exclusive. During 2023, substantially all of its U.S. revenue was produced by its producing sales representatives. The company began selling outside the United States in late 2016. As of December 31, 2023, the company sells its products in 22 countries, and in 2023, its international business contributed approximately 15% of its revenue. The company has a significant opportunity to continue to capture market share in existing and new territories both in the United States and internationally.
Growth Strategy
The key elements of the company’s strategy are to continue to invest in research and development to further improve outcomes and expand itsaddressable market; transform the foot and ankle market by leveraging its smart 28 initiatives to advance the foot and ankle surgical experience and clinical outcomes.; continue to invest in its commercial infrastructure globally to capture market share.; advance medical education and targeted marketing campaigns; and actively evaluate and pursue business development opportunities.
Market
The company defines its market as the market for surgical implants and devices used in foot and ankle procedures across all major indications, which include fracture fixation, forefoot, ankle, PCFD or flatfoot, charcot foot and orthobiologics. The company’s each of these subsegments and orthobiologics represents its own market opportunity with varying growth rates. The company estimates the global market for surgical implants and devices used in foot and ankle procedures was approximately $4.9 billion in 2023 and is expected to grow at approximately 7% annually, representing one of the fastest growing markets within orthopedics.
Solutions
The company has built a comprehensive, full-line foot and ankle orthopedic device company. The company lets the needs and limitations of the procedure dictate the systems and technologies that it develops in order to identify the best solution to overcome and improve the entire surgical and patient experience. The company approaches each type of procedure from both the patient’s and the surgeon’s perspectives. The company respects that no two patients are the same, and with that in mind it develops its solutions with a range of optionality. Since its first internally developed product, the Preserve bone wedges, launched in 2011, the company has commercialized nearly 80 product systems. Additionally, the company has more than 30 product and system offerings in its development pipeline the majority of which it expects to launch commercially in the next 24 months which represents its continued dedication to enhancing its product portfolio with novel and disruptive solutions. The company has also rapidly expanded its global intellectual property portfolio and will continue to focus on only patenting what it views as truly unique.
Smart 28 Ecosystem
The company expects to continue to invest in Smart 28 with the intent of developing post-operative solutions, while further bolstering its capabilities and offerings within the preoperative and intraoperative stages.
Procedurally Focused Systems
The company has developed a comprehensive portfolio of foot and ankle surgical systems. Each system typically includes one or more of the following: plates, screws, staples, nails, advanced joint and bone replacements, orthobiologics, and other implantation instruments and disposables specifically designed for the particular surgical system. The company focuses its engineering efforts equally on each component of its surgical systems, from the implants to the procedural approach and instruments. Since inception, the company has designed and markets nearly 80 product systems. The company’s products are available in a variety of sizes and configurations to best suit the individual patient’s anatomical and surgical requirements.
Plating Systems
The company offers three plating systems: Gorilla Plating System, Baby Gorilla Plating System and Silverback Ankle Fusion Plating System. These plating systems are used in all major procedural segments within the foot and ankle industry. The company’s plates were created with the patient and surgeon in mind and designed to eliminate hardware irritation and the need for plate manipulation to help enhance surgical outcomes. The company’s plates are generally optimized to be procedure-specific with varying degrees of thickness to best suit the anatomical requirements of each patient and surgery. To complement its plates, drive clinical value, and enhances reproducibility, the company offers complete all-in-one caddies containing the implants and procedure-specific instruments that surgeons will likely utilize in the procedure. Several of its plating systems include many patented features.
The company’s leading plating system is the Gorilla Plating System (Gorilla). Gorilla is one of the most comprehensive foot and ankle plating systems with over 290 plating options and a wide variety of plate-specific screws.
Gorilla Plate-Specific Screws: One of the most comprehensive product offerings with 14 systems, 61 styles, and 293 plate options with unique, customizable instrumentation. Offers 2.7 mm, 3.5 mm, and 4.2 mm locking or non-locking variable angle plate screws, R3CON and TUFFNEK screws options. Variable angle plate screws are designed to allow greater surgical flexibility and accommodate up to 15° off-axis locking placement. The company’s reinforced screw neck, known as TUFFNEK, increases the bending strength of the construct at the point of highest stress.
The company’s Gorilla Plating System includes, among others, the following systems:
Lisfranc (midfoot) Plating System: 5 anatomically contoured designs. 28 total offerings. Designed to minimize soft tissue irritation.
Lapidus Plating System: Anatomically contoured. Guide allows for placement of cross-screw while maintaining on-axis placement of plate screws.
Lateral Column Plating System: Anatomically contoured. Plate and screw construct designed to maintain anatomic alignment of the lateral column.
Calcaneus (heel bone) Slide Plating System: Angled screw accommodates a locking screw for added dimension of stability. May result in less hardware removal cases. Designed to not violate growth plate of the calcaneus in pediatric patients.
NC Fusion Plating System (fusion of two bones on the inside middle of the foot): Anatomically contoured. Designed to achieve compression across multiple joints. Built-in alignment templating.
The Baby Gorilla Plating System is a comprehensive foot and ankle specific plating system that includes 26 distinct plating styles and 92 distinct plating options with unique, customizable instrumentation. Similar to Gorilla, the Baby Gorilla system incorporates modularity, optionality and specificity with plates designed for procedures that require narrower plates and smaller screws to match the anatomy and size of the smaller bones within the foot. Additionally, while the Baby Gorilla system was created to primarily address a full range of trauma fixation procedures, it also includes a variety of compression plates for reconstructive procedures in the foot and ankle.
Baby Gorilla Plate-Specific Screws: Offers 2.0 mm and 2.5 mm locking or non-locking variable angle plate screws. Variable angle plate screws are designed to allow greater surgical flexibility and accommodate for up to 15° off-axis locking placement.
The company’s Baby Gorilla Plating System includes, among others, the following systems:
System provides fracture- and procedure-specific options
Navicular Fracture Plates: 4 total offerings. Hole pattern designed around common forms of navicular bone (a bone in the ankle) fractures.
5th Metatarsal Hook Plates: Designed to anatomically fit the 5th metatarsal bone. Contains sharp hooks allowing the plate to grab the proximal fragments and secure them back to the bone.
The Gorilla Plating System and Baby Gorilla Plating System are cleared for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The systems can be used in both adult and pediatric patients. The Gorilla Plating System and the Baby Gorilla Plating System received 510(k) clearance in April 2014. The Gorilla Plating System and the Baby Gorilla Plating System are cleared as Class II medical devices for the above indications and the associated instrumentation are cleared as Class I medical devices.
The company’s Silverback Ankle Fusion Plating System (Silverback) offers 62 unique, low profile, anterior, lateral, and posterior plate designs, five screw diameters, and a robust offering of joint preparation instrumentation to address tibiotalar (TT), tibiotalocalcaneal (TTC), or tibiocalcaneal (TC) arthrodesis. The plating system is engineered from Type II Anodized Titanium Alloy for improved fatigue performance and allows for multiple points of fixation with contoured and flat options.
Silverback Plating System: The Silverback plate options were designed specifically for the varying anatomy when addressing an ankle arthrodesis. Offers 3.5 mm and 4.2 mm locking and non-locking screws, 4.5 mm and 5.2 mm locking and non-locking Silverback screw options and a 4.7 mm Compact Silverback screw option. Compact Silverback screw is designed for dense bone commonly found in the proximal tibia.
The Silverback Gorilla Plating System are cleared for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The system can be used in both adult and pediatric patients. The Silverback Gorilla Plating System received 510(k) clearance in September 2018. The Silverback Gorilla Plating System is cleared as a Class II medical device for the above indications and the associated instrumentation are cleared as Class I medical devices.
Precision Guide Technology
Precision Guide is its patented instrument technology that the company created with the goal of improving surgical outcomes and allowing surgeons of all skill levels and experience to perform consistent and reproducible procedures utilizing its implants. This technology also saves time in the operating room and reduces the amount of fluoroscopy, a type of medical imaging, used.
Many foot and ankle procedures require cross-screws in addition to plates. For certain procedures, when a surgeon implants a cross-screw they can either insert the screw freehand or use its Precision Guide. Freehand screw placement may result in intra-operative hardware collision or multiple attempts to redirect the screws to avoid collision, which may result in unwanted revisions, longer surgical times, and slower patient recovery.
Each Precision Guide variation is uniquely attuned to work in tandem with its corresponding procedurally focused plate or implant. Once plate screws are inserted, the surgeon attaches the Precision Guide to the plate with a simple hand screw. The Precision Guide arm provides the surgeon with a drill guide that is positioned at a pre-calculated, three-dimensional angle designed to avoid collision with the existing plate and plate screws and optimize orientation for ideal construct strength.
The company has six variations of Precision Guide that are tailored to specific procedures where one or more cross-screws or implants are required. The company’s Precision Guide technology is available for the following procedures: MTP fusion (a procedure to address bunion deformities that fuses two bones on the big toe), first tarsometatarsal arthrodesis (Lapidus plate) and metatarsal osteotomy for bunion correction, medial column beaming for charcot foot reconstruction, ankle fusion plating, and naviculocuneiform (NC) joint arthrodesis.
Monster, Mini Monster, and Joust Beaming Screw Systems
To complement its plating systems and provide surgeons with the full suite of products, the company created a variety of innovative standalone screw systems. The company’s screw systems are utilized in all major procedural segments within the foot and ankle industry. Every detail was scrutinized in the design of its screws, from thread distance and pitch to neck tapering angle (precompression taper), with the goal of providing differentiated screws that address the needs of patients and surgeons. To support its 510(k) submission, the company conducted engineering analyses in which its screws were uniquely attuned and well-balanced for optimal strength and insertion sharpness, all while maintaining superior implantation represented by greater predicted pull-out strength compared with predicate devices.
The company’s Monster and Mini Monster Screw Systems are cannulated and solid screw systems with a wide variety of size and feature options. The company offer a variety of length increments and multiple thread length options that allow versatility for the fixation of osteotomies, fractures, and joint arthrodesis. The company’s screw offerings are supported by a robust portfolio of tools and instruments designed to help improve consistency and accuracy of surgical outcomes.
The company’s Joust Beaming Screw System of cannulated and solid beams with a variety of sizes and features optimized to accommodate varying patient anatomy and allows surgeons greater flexibility in final placement. Compared to its Monster screw systems, Joust screws are longer in length and are primarily utilized in procedures that require stabilization that extends beyond one joint, such as charcot foot. Additionally, its Joust screws are constructed from Type II Anodized Titanium that have been proven in third-party clinical studies to provide improved fatigue strength, which may result in better patient outcomes.
The company’s screws can be used as a standalone implant, with other screws, or in tandem with a plating system, depending on the procedural demands and surgeon preference. The company designed its screws with the mindset of being inclusive and cognizant of individual surgeon preferences, knowing that there is more than one way to a successful outcome. The company offer surgeons one of the broadest arrays of screw options, including headed and headless screws, fully and partially threaded, all at various sizes. Other key features of its screws include reverse cutting flute threading, which are self-tapping reverse threads that help facilitate screw removal, and forward cutting flutes, which creates thread pattern during screw insertion and allow the screw to be self-tapping.
The Monster Screw System is cleared for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device. The Monster Screw System, including the Joust Beaming Screw System, can be used in both adult and pediatric patients. The Monster Screw System received 510(k) clearance in April 2013. The Monster Screw System is cleared as Class II medical devices for the above indications and the associated instrumentation are cleared as Class I medical devices.
The Joust Beaming Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device. The Joust Beaming Screw System received 510(k) clearance in April 2019. The Joust Beaming Screw System can be used in adult patients. The Joust Beaming Screw System is cleared as Class II medical device for the above indications and the associated instrumentation are cleared as Class I medical devices.
APEX 3D Total Ankle Replacement System (TAR)
The APEX 3D is its total ankle replacement system that was initially cleared by the FDA in July 2020. The company’s the APEX 3D System marks the next generation in total ankle arthroplasty, or replacement, with advanced technologies such as porous 3-D printed implants and Vitamin E infused highly cross-linked polyethylene. The APEX 3D implant is available in varying sizes and design configurations, including a universal polyethylene locking mechanism that provides surgeons versatility in implant sizing to best fit the needs of the patient. The APEX 3D System is based on over a century of combined clinical experience, cutting-edge biomechanical research, and is designed to address the inherent challenges associated with total ankle joint replacement clinical outcomes, including tibial component loosening at a rate of between 12% and 38%, pathological wear, overly constrained articulation components in the presence of imperfect alignment, limited research to indicate the sensitivity of alignment, significant patient variation in gait, instability, and persistent pain. In addition, the APEX 3D System was designed to address the factors the company believe contribute to loosening and stress of components.
The APEX 3D total ankle replacement system is cleared for use as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. The APEX 3D total ankle replacement system can be used in both adult and pediatric patients. The APEX 3D total ankle replacement system received 510(k) clearance in July 2020. The APEX 3D total ankle replacement system is cleared as Class II medical device for the above indications and the associated instrumentation are cleared as Class I medical devices.
Smart 28 for Total Ankle Replacement
To complement its APEX 3D total ankle replacement implant and further distinguish its total ankle replacement procedure, the company developed two advanced technologies, FasTrac and MAVEN, to utilize intra-operatively. Depending on physician preference and surgical needs, FasTrac or MAVEN is designed to ensure optimized implant positioning to enhance post-procedural surgical outcomes. FasTrac and MAVEN represent its first TAR-specific Smart 28 tools. The company intends to further develop tools and capabilities across the entire continuum of TAR care to further enhance clinical outcomes for its APEX 3D patients.
FasTrac is its proprietary distal tibia alignment system that features laser technology developed to provide a precise visual reference point during component alignment, a critical step in establishing optimal implant placement during TAR. In addition to expediting and visually enhancing alignment, the system streamlines the surgical technique by eliminating the need to insert an additional pin into the tibia or conduct CT scans. The FasTrac system is designed to be used to verify varus/valgus alignment as well as internal external alignment. FasTrac is cleared for use for the same use as its APEX 3D total ankle replacement system and can be used in adult patient populations. The FasTrac received 510(k) clearance in November 2020. FasTrac is cleared as Class II medical device for the above indications and the associated instrumentation are cleared as Class I medical devices.
MAVEN is its proprietary patient-specific instrumentation offering that provides an accurate and simple-to-use surgical planning technology to surgeons. It utilizes an advanced CT-based coordinate system designed for reproducible alignment and accurate implant placement critical for long-term survivorship of the implant. MAVEN advances patient-specific technologies with its anatomical design features, which promote alignment accuracy, stability, and ideal implant placement. MAVEN is compatible with both weight-bearing CT and traditional CT scanning technologies and features one continuous scan from the knee through the base of the foot to capture biomechanically accurate data. The combination of patient-specific CT information, contoured guides, and APEX 3D implant designs provide the surgeon with exceptional technology engineered to optimize patient outcomes. The company’s MAVEN patient-specific instrumentation is intended to be used as patient specific surgical instrumentation to help position total ankle replacement components intraoperatively and guide bone marking before cutting. MAVEN can be used in adult and pediatric patients. MAVEN received 510(k) clearance in January 2021. MAVEN is cleared as Class II medical device for the above indication and the associated instrumentation is cleared as Class I medical devices.
Patient Specific Total Talus Spacer
The company has the first and only patient-specific total talus spacer authorized for marketing pursuant to an approved HDE application. The implant is designed to replace the talus, the bone in the ankle that connects the leg and foot. This distinct product offering allows patients to maintain a more active lifestyle and provides its surgeons access to a novel alternative to amputation or traditional ankle fusion therapies. The company utilizes its advanced technologies to create the patient-specific implant shape based on CT scan imaging data, bolstered with AI. The imaging data is then processed in its proprietary software applications to automatically create a design to match the patient’s specific anatomy. The design is then additively manufactured with laser sintering technology, a technique to harden the material, utilizing a cobalt chromium metal alloy.
Patients who received the Patient Specific Talus Spacer in an independent clinical study showed a reduction in pain compared to baseline visual analogue scale pain scores, a standard unidimensional measure of pain, improvement in range of motion, and improvement of functional outcomes based on all Foot and Ankle Outcome Score (FAOS) subscales, including pain, other symptoms, function in daily living, function in sports and recreational activities, and foot and ankle-related quality of life. This study evaluated 32 cases in 31 patients. The primary safety endpoint was the proportion of patients who underwent a secondary subsequent surgical intervention (SSSI). Other safety endpoints assessed included adverse events, device or procedure related adverse events, adverse events by severity, and serious adverse events. The probable benefit endpoint, which is an endpoint used in HDE applications to demonstrate the probable benefit of health from use of the device outweighs the risk of illness or injury from its use, was the reduction in baseline level pain following surgery using the Visual Analog Scale (VAS) for pain. The secondary probable benefit endpoints assessed included ankle range of motion (ROM) and FAOS. FAOS subscales, pain, symptoms (stiffness, swelling), activities of daily living (ADL), ability to perform sports and recreational activities (Sport/Rec); and foot/ankle-related quality of life (QoL) were also assessed. The patients who were implanted with the patient specific talus spacer in the above study received a clinically meaningful probable benefit from the device. The study demonstrated that baseline VAS pain score was reduced by -2.8 cm postoperatively, from 6.9 cm (moderate to severe pain) to 4.1 cm (mild pain). ROM also improved on average, especially when limiting the analysis to those patients who had at least a year of follow-up and thus had adequate time to rehabilitate. Functional outcomes based on FAOS subscales also improved, with average improvement on all subscales exceeding the associated MIC threshold except Sport/Rec. Moreover, the rate of reoperation was low, with 9.4% of cases resulting in reoperation. Improvement in pain and function measures, accompanied by a low rate of reoperation, is particularly meaningful to AVN talus patients who have limited options and high risk of needing to undergo fusion or amputation. No serious adverse events were reported and there were only three adverse events reported, one for scarring and two for pain related to the implant. The study was not powered for significance.
The total talus spacer is marketed pursuant to an approved HDE application to treat avascular necrosis of the ankle joint. The anatomical landmarks necessary for the design and creation of the patient specific talus spacer must be present and identifiable on a CT scan. The total talus spacer system can only be used in adult patients. Additive Orthopaedics began development on the total talus spacer in the first quarter of 2016 and the original HDE application was approved in February 2021.
Forefoot Correction Systems
The company has developed a variety of products and systems to treat bunions. There is no one size fits all approach to such a complex confluence of soft tissue and bone deformities, and the company developed a portfolio of surgical options to treat bunions of varying degrees of severity and other patient-specific considerations, such as weight, age and level of desired activity. When choosing a bunion procedure, it is important to match the procedure to the severity and type of deformity, while considering factors, such as medical co-morbidities, soft tissue, age, and activity level. Improper choice of procedure could lead to under correction, recurrence, complications or altered biomechanics of the foot. The company’s broad portfolio allows the surgeon to provide patients with a solution to address the appropriate level of intervention for their individual deformity, from mild and moderate to severe and end stage.
The below section highlights two of its various bunion correction systems, the PROMO Triplanar Hallux Valgus Correction System and the Phantom Intramedullary Nail System
More than 100 surgical techniques exist for the treatment of bunions. Bunion post-operative recurrence rates vary between different publications from 3% to 70%, representing significant variability and procedural limitations amongst conventional treatments. The company designed its proximal rotational metatarsal osteotomy or PROMO Triplanar Hallux Valgus Correction System (PROMO) to consistently and effectively treat all three planar dimensions contributing to bunion deformity without requiring a fusion of the joint. The company also developed its PROMO system to provide surgeons the flexibility to tailor the procedure to match the specific deformity and allow the opportunity to correct a wide range of bunion deformities. In addition, the company has developed tools and instruments specific to the PROMO procedure, providing the surgeon with procedural reproducibility and accuracy. Additionally, in cases with healthy joints or with patients that are not hypermobile, its PROMO procedure does not require fusion of the TMT joint, or the tarsometatarsal joints in the foot, while still addressing all planes of deformity.
The PROMO system is indicated for use for stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The PROMO system can be used in both adult and pediatric patients. The company began developing the PROMO system in the second quarter of 2017 and received initial 510(k) clearance in December 2017. The PROMO system is cleared as Class II medical device for the above indications and the associated instrumentation are cleared as Class I medical devices.
Phantom Intramedullary Nail System for Treatment of Severe Hallux Valgus
The company’s Hallux Valgus (bunions) portfolio also features its Phantom Intramedullary Nail system which is a novel dedicated intramedullary device designed specifically for correcting hallux valgus deformity by fusing the first TMT joint. Offered in a variety of lengths to accommodate variations in patient anatomy, the nail and threaded peg construct is positioned below the bone with zero profile to minimize soft tissue disruption during a Lapidus procedure. This design is intended to lessen pain associated with hardware prominence of traditional plating systems while minimizing disruption to the periosteum (blood supply). The system exerts a proportionate amount of force in all anatomic planes to resist recurrent hallux valgus and plantar gapping. The nail and threaded peg construct offer crossed screw fixation proximally and distally, providing for stability across the fusion site and allowing early weight bearing. Instrumentation provided in the system also allows the surgeon to dial in the appropriate amount of compression specific to each patient, with this compression being applied directly through the center of the anatomy, which is the ideal location.
Additionally, as part of this system, the company offers unique instrumentation that provides targeting guides for precise placement and positioning of the nail and pegs.
In a clinical study designed to analyze the efficacy of different fixation devices in relation to such devices ability to prevent plantar gapping, its Phantom Intramedullary Nail demonstrated improved performance as compared to a medial wall plate construct and crossing screw constructs while avoiding soft tissue irritation. A study published in Foot & Ankle Orthopaedics in 2019 compared its 4-Hole Phantom Intramedullary Nail, 3-Hole Phantom Intramedullary Nail, Gorilla Lapidus Plate, and a two-crossing screw construct in cadaveric tissue in cyclic loading, simulating repeated loading of the foot that would occur with walking. The study found that the 3-Hole and 4-Hole Phantom Intramedullary Nails, as well as the Gorilla Lapidus Plate all had statistically significant less plantar gap widening than crossing screws and may provide a better environment for bone healing than screw fixation.
The Phantom Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudoarthroses and malunions by revision, joint fusion or reconstruction procedures. Phantom Intramedullary Nail System can be used in both adult and pediatric patients. The Phantom Intramedullary Nail System received 510(k) clearance in June 2017. The Phantom Intramedullary Nail System is cleared as Class II medical device for the above indications and the associated instrumentation are cleared as Class I medical devices.
Orthobiologics
The company offers a variety of different orthobiologics, including bone wedges, grafts, demineralized bone matrices, bone void fillers, synthetic materials, amniotic products, and a biocompatible collagen matrix. The company’s flagship orthobiologic product is its patented PRESERVE Bone Graft System, which features eight procedure-specific shapes with more than 40 size variations, significantly reducing the need for potential graft shaping. PRESERVE is complemented with a variety of sizer instruments that allow surgeons the ability to determine ideal graft size and position to achieve the desired correction.
The company’s PRESERVE allografts are made of dense cancellous bone, which is the spongy portion typically found at the end of the bone. Studies have shown that cancellous bone is eight times more metabolically active than cortical bone, which is the dense outer surface of the bone, and has a higher union rate. Additionally, to enhance the quality and performance of its grafts the company applies an aseptic processing technique that helps preserve the biomechanical properties of the bone and this narrows the donor pool to only the highest quality bone.
The PRESERVE Bone Graft System is regulated as a Human Cell and Tissue Product (HCT/P) under Section 361 of the Public Health and Services Act (PHSA). The PRESERVE Bone Graft System is intended for homologous use only, which means repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with tissue-based product that performs the same basic function or functions in the recipient as in the donor. The company began developing the PRESERVE Bone Graft System in the first quarter of 2013.
Additional Products
In addition to the products, the company has a wide variety of other procedurally focused and differentiated systems.
Procedure: Hammertoe: Developed to provide surgeons an alternative soft tissue fixation option for hammertoes. Designed to rebalance top and bottom toe tendons with only a small incision – no bony cuts required.
Procedure: Hammertoe: Single piece titanium sprayed PEEK (Polyetheretherketone) implant intended for hammertoe correction. Allows for standard or retrograde technique and sterile or non-sterile instrument options.
Procedure: Bunions, Flatfoot: Superelastic nitinol with a simple insertion method to gain rigid compression across an osteotomy site. Robust optionality with staples ranging from 8 mm-25 mm in size and either straight or angled (for Akin sizes).
Procedure: Fracture Fixation: Designed so that if screw fracture occurs after the healing of the joint, the screw breaks cleanly at the notch point in the clear space. A case study involving three patients has shown when screws fracture in the clear space improved positioning may result and may reduce the need for hardware removal. R3ACT: Challenges of ankle fixation include: stabilization of syndesmotic ankle fracture is not well understood, little information to guide surgeon to proper alignment, high failure and revision rates, and a dynamic soft tissue environment with varying ankle pressures. Engineered screw to release initial rigid fixation where soft tissue has initiated healing; optimal range to best restore anatomic function of environment. R3LEASE screw head designed to fit perfectly in ankle fracture plating system. Procedure: foot fracture: Patented curved instrument designed to address procedural challenges. Screw offering features over 120 unique implants with unique size and solid/cannulated options.
Research and Development Expenses
The company’s research and development expenses included $30.1 million for the year ended December 31, 2023.
Clinical Overview
The company is committed to continued investment in clinical evidence and involving physicians who are recognized as thought leaders in foot and ankle. The company plans to continue investing in pre-clinical and post-clearance or post-certification studies to drive utilization of its products. As part of its clinical strategy, the company emphasizes and internally conducts performance testing of its products, including mechanical implant testing in an effort to substantiate the claims the company makes and supports marketing of its clinically meaningful systems.
Commercial Approach
The company has dedicated substantial resources to building a leading commercial organization that consists of sales, marketing and medical education. The company’s entrepreneurial and clinically oriented culture has allowed it to grow its commercial team.
To support its commercial expansion and awareness of the clinical benefits of its solutions, the company has made significant investments in its education and training programs.
The company’s U.S. sales forces consists primarily of independent sales representatives, the majority of whom are exclusive. For the year ended December 31, 2023, substantially all of its U.S. revenue was produced by 266 producing sales representatives. The company defines producing sales representatives as those sales representatives' logging revenue, for at least one case, in all three months of each quarter. As of December 31, 2023, its international sales force consists of several independent sales agents and direct sales representatives, 9 non-stocking distributors, 8 stocking distributors, and 5 direct sales market. The company began selling outside the U.S. in 2016.
Competition
Within the lower extremities market, the company’s primary competitors include multinational companies, such as Stryker Corporation (Stryker), Arthrex, Inc. (Arthrex), Smith & Nephew plc (Smith and Nephew), Johnson & Johnson (J&J) and Zimmer Biomet Holdings, Inc. (Zimmer Biomet) as well as with companies with one or a limited number of foot and ankle products such as Enovis Medical (Enovis), CrossRoads Extremity Systems, LLC (Crossroads), Medline Industries, Inc. (Medline), Conmed Corporation (Conmed), and Treace Medical Concepts, Inc. (Treace).
Intellectual Property
As of December 31, 2023, the company’s patent portfolio included 304 owned and issued patents. Of its patents:
Twenty-five patents relate to technologies used in its orthobiologics products. Of these, six are utility patents and nineteen are design patents, all of which relate to the associated tools and implants used; ten are U.S. patents, six are UK patents and nine are EU patents; and these patents begin to expire in 2028.
Sixteen patents relate to technologies used in its nails; of these five are design patents and eleven are utility patents; two relate to surgical techniques and fourteen relate to the associated tools and/or implants used; six are U.S. patents, four are European patents, three are UK patents, one is a Swiss patent, one is a German patent, and one is a Japanese patent; and these patents begin to expire 2030.
One hundred and seventy-nine patents relate to technologies used in its plating systems; of these one hundred and twenty-five are design patents and fifty-four are utility patents; all of these patents relate to the associated tools with one also covering the surgical technique; seventy-one are U.S. patents, forty-two are EU patents, forty-six are UK patents, five are German patents, five are French patents, four are Spanish patents, four are Dutch patents, one is a Canadian patent, and one is an Australian patent; and these patents begin to expire in 2028.
Eighteen patents relate to technologies used in its screws; of these three are design and fifteen are utility patents; all of these patents cover the tools used; eight are U.S. patents, three are UK patents, two are EU patents, one is a German patent, two are Spanish patents, one is a French patent, and one is a Dutch patent; and these patents begin to expire 2035.
Fifty-five patents relate to technologies used in its other products including hammertoe implants, titanium wedges, soft tissue fixators; of these nineteen are design patents and thirty-six are utility patents; all of these relate to the associated tools, system, and/or implants used with two also covering the surgical technique; twenty-five are U.S. patents, eight are UK patents, six are EU patents, three are German patents, three are Spanish patents, three are French patents, three are Dutch patents, one is a Danish patent, one is an Irish patent, one is a Canadian patent and one is a Norwegian patent; and these patents begin to expire in 2033.
Eleven patents relate to technologies used in its total ankle arthroplasty system; all of these are U.S. utility patents that cover the implant system and the tools used; and these patents begin to expire in 2039.
In addition to its owned patents, the company has nine registered patents that are in-licensed pursuant to its agreement with Biedermann Technologies GmbH & Co. KG (Biedermann) and two registered patents that are in-licensed pursuant to its agreement with Extremity Medical, LLC (Extremity). Of the nine patents licensed from Biedermann, six are utility patents and three are design patents. All of the Biedermann patents relate to technologies used in its JAWs staple system. Of the patents licensed from Biedermann, six are U.S. patents, one is an EU patent, one is a Chinese patent and one is a Japanese patent. The patents licensed from Biedermann begin to expire in 2033. The two patents licensed from Extremity are utility patents and relate to technology used in its Phantom Lapidus Intramedullary Nail System. The patents licensed from Extremity begin to expire in 2030.
The company entered into the license agreement with Biedermann in July 2017 (Biedermann License Agreement). Pursuant to the Biedermann License Agreement, the company is required to pay a royalty of four percent (4%) of net revenue related to the licensed intellectual property for 15 years following the date of first sale. The term of the agreement is 20 years, and automatically renews for five-year periods thereafter.
As of December 31, 2023, the company had 265 pending patent applications globally, including 87 in the United States. In addition to these patent applications, the company has one pending patent application that is pursuant to its license agreement with Biedermann. The patent pursuant to its license agreement with Biedermann includes seven utility patents and three design patents that cover technology related to its JAWS staple system. Of these patent applications, eight are U.S. patents and two are EU patents. These patent applications will expire 20 years from their earliest filing date when issued. As a result, the earliest these patents could expire, if issued, would be 2035. The pending patent application is intended to exclude competitors from practicing the innovations of its currently marketed product offering, to protect potential future commercialization opportunities, and to strategically block potential workarounds by competitors.
The company has U.S. trademark registrations for several of its most material marks, including PARAGON 28, MONSTER, GORILLA and PHANTOM. The company also has pending U.S. trademark registrations on other material marks, including APEX 3D, MAVEN, SILVERBACK, and R3ACT.
Government Regulation
The company’s products, product candidates and operations are subject to extensive regulation by the FDA and other federal and state authorities in the United States, as well as comparable authorities in foreign jurisdictions. The company’s products are subject to regulation as medical devices in the United States under the Federal Food, Drug, and Cosmetic Act (FDCA) as implemented and enforced by the FDA, and to similar regulations as implemented and enforced by applicable regulatory authorities in foreign jurisdictions.
The majority of the company’s marketed products are Class II devices subject to 510(k) clearance, though it also markets certain Class I exempt devices that do not require 510(k) clearance and one Class III product that is marketed pursuant to an approved HDE application. To obtain 510(k) clearance, the company must submit to the FDA a premarket notification submission demonstrating that the proposed device is ‘substantially equivalent’ to a legally marketed predicate device.
Certain of the company’s products are regulated as Human Cell and Tissue Products (HCT/Ps). The company’s certificates have been granted and renewed under the Council Directive 93/42/EEC (EU Medical Devices Directive).
History
Paragon 28, Inc. was founded in 2010. The company was incorporated in 2011 as a Colorado corporation and reincorporated as a Delaware corporation in 2021
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