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Paragon 28 Announces the Launch of the FJ2000™ Power Console and Burr System Designed Specifically for Foot and Ankle Procedures

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Paragon 28, Inc. (NYSE: FNA) has introduced the FJ2000™ Power Console and Burr System for foot and ankle surgery, designed to modernize procedures with its versatile and efficient features. The system offers pre-set options for reducing thermal necrosis, single-use hand pieces, and a variety of burrs and instruments in a sterile packed kit. The CEO highlighted the benefits of the system in terms of cost, efficiency, surgeon optionality, and patient outcomes, while a renowned surgeon praised its efficiency and flexibility. The new system complements Paragon 28's existing bunion and forefoot solutions portfolio.
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The introduction of the FJ2000™ Power Console and Burr System by Paragon 28 represents a significant advancement in foot and ankle surgical equipment. The system's design, emphasizing minimally invasive techniques, aligns with the ongoing trend in orthopedic surgery to reduce patient recovery time and postoperative complications. The low speed, high torque setting is particularly noteworthy, as it aims to minimize thermal necrosis, a condition where excessive heat from surgical instruments can damage surrounding tissue and impede healing. By preserving healthy bone during procedures, the FJ2000™ may contribute to improved patient outcomes, an essential metric for both surgeons and healthcare facilities. Additionally, the single-use aspect of the hand pieces and burrs could reduce the risk of infection, a common concern in surgical settings.

From a supply chain perspective, the FJ2000™ Power Console and Burr System's single-use model presents a shift in inventory management for healthcare providers. While single-use instruments can eliminate sterilization needs and reduce turnaround time between surgeries, they also require careful cost-benefit analysis. The impact on health system costs needs to be assessed in terms of the trade-off between the higher price of disposable items and the potential savings from reduced sterilization processes and decreased instrument wear and tear. However, the convenience and efficiency gains may justify the investment for high-volume surgical centers, leading to a potential increase in the adoption of these systems. Paragon 28's strategy to offer a comprehensive portfolio for bunion and forefoot surgeries could streamline procurement processes and enhance operating room efficiency, ultimately affecting the company's market share in the orthopedic sector.

Analyzing the market impact, the launch of the FJ2000™ Power Console and Burr System could position Paragon 28 as an innovator in the foot and ankle surgery market. The versatility and efficiency of the system address key concerns in the field, potentially leading to increased demand among surgeons. The emphasis on improved patient outcomes and operating room efficiency is likely to resonate with healthcare providers focused on value-based care. If the FJ2000™ delivers on its promises, Paragon 28 could see an uptick in sales, strengthening its financial position and potentially affecting its stock valuation. The company's comprehensive product portfolio for foot and ankle procedures may also lead to cross-selling opportunities, enhancing customer retention and long-term revenue growth. The medical device industry is highly competitive and continued innovation is crucial for maintaining a competitive edge.

ENGLEWOOD, Colo.--(BUSINESS WIRE)-- Paragon 28, Inc. (NYSE: FNA) is proud to announce a novel solution in modernizing foot and ankle surgery with the launch of its FJ2000™ Power Console and Burr System designed for a wide range of minimally invasive and open procedures in the foot and ankle.

Figure 1: Paragon 28 FJ2000™ Power Console (Graphic: Business Wire)

Figure 1: Paragon 28 FJ2000™ Power Console (Graphic: Business Wire)

The FJ2000™ Power Console and Burr System is highly versatile and designed for quick and efficient setup at the outset of each procedure. The System has three pre-set options, including a low speed, high torque setting designed to help reduce thermal necrosis during bone and joint preparation and preserve healthy bone healing.

The FJ2000™ offers single-use hand pieces and a substantial selection of burrs and instruments in a sterile packed kit prepared for immediate use. As a single-use option, the FJ2000™ brings greater flexibility and speed to the surgeon while preventing costly delays due to wear and tear and sterilization associated with traditional power systems.

Prof. Dr. med. Hazibullah Waizy, commented, “This system is very efficient from a workflow perspective. The combination of adjustable speed and power settings and drilling function allows surgeons to work precisely in a way most suitable for each unique procedure. The sterile packed, single-use hand pieces and burrs are dependable and allow me to turn cases quickly and effectively without waiting for other instruments to become available.”

Paragon 28’s CEO, Albert DaCosta, commented, “The FJ2000™ brings several benefits to the foot and ankle community, ranging from health system cost, operating room efficiency, surgeon optionality and ultimately improved patient outcomes. We are incredibly proud to bring a modernized approach to the market that is truly differentiated in so many ways.”

The FJ2000™ Power Console and Burr System bolsters Paragon 28’s bunion and forefoot solutions offering, which includes the Gorilla® Precision® Lapidus Plate, Phantom® Small Bone Intramedullary Nail, Phantom® MIS System, Gorilla® Precision® MTP Plate, Phantom® Metatarsal Shortening System, TenoTac®, Paratrooper™, and HammerTube™. With this comprehensive portfolio, Paragon 28® provides its customers with a single source to address their bunion and forefoot needs.

About Paragon 28, Inc.

Based in Englewood, CO., Paragon 28, is a leading medical device company exclusively focused on the foot and ankle orthopedic market and is dedicated to improving patient lives. From the onset, Paragon 28® has provided innovative orthopedic solutions, procedural approaches and instrumentation that 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. The company designs 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.

Forward Looking Statements

Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Paragon 28’s potential to shape a better future for foot and ankle patients. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward-looking statements are based on Paragon 28’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Paragon 28’s business in general, see Paragon 28’s current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and its Quarterly Reports on Form 10-Q, as updated periodically with its other filings with the SEC. These forward-looking statements are made as of the date of this press release, and Paragon 28 assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

Disclaimer

Prof. Dr. med. Waizy may report consulting and royalty fees from Paragon 28 in connection with the provision of product development services to Paragon 28.

Nothing in this material is intended to provide specific medical advice or to take the place of written law or regulations.

Investor Contact

Matthew Brinckman

Senior Vice President, Strategy and Investor Relations

Phone: (720) 912-1332

mbrinckman@paragon28.com

Source: Paragon 28, Inc.

FAQ

What is the new product introduced by Paragon 28, Inc. for foot and ankle surgery?

Paragon 28, Inc. has introduced the FJ2000™ Power Console and Burr System for foot and ankle surgery.

What are the benefits of the FJ2000™ Power Console and Burr System?

The system offers pre-set options for reducing thermal necrosis, single-use hand pieces, and a variety of burrs and instruments in a sterile packed kit. It brings greater flexibility and speed to the surgeon while preventing costly delays due to wear and tear and sterilization associated with traditional power systems.

What did the CEO of Paragon 28, Inc. say about the FJ2000™ Power Console and Burr System?

The CEO highlighted the benefits of the system in terms of cost, efficiency, surgeon optionality, and patient outcomes.

What is included in Paragon 28's bunion and forefoot solutions offering?

Paragon 28's bunion and forefoot solutions offering includes the Gorilla® Precision® Lapidus Plate, Phantom® Small Bone Intramedullary Nail, Phantom® MIS System, Gorilla® Precision® MTP Plate, Phantom® Metatarsal Shortening System, TenoTac®, Paratrooper™, and HammerTube™.

Paragon 28, Inc.

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