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Paragon 28 Launches PRECISION® MIS Bunion System Offering Surgeons a Guided Minimally Invasive Surgical Solution for Treating Patients with Bunions

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Paragon 28, Inc. (NYSE: FNA) has launched the PRECISION® MIS Bunion System, a minimally invasive surgical technique for distal metatarsal osteotomy. The system features an outrigger for controlled correction, instrumentation for free-hand technique, and cannulated chamfer screws for fixation. Surgeon designer David Gordon, MD, praised the system's three-dimensional correction and high functionality. Paragon 28's CEO, Albert DaCosta, highlighted the system's ability to treat a broader array of patients with Hallux Valgus, bringing benefits of minimally invasive surgery to patients and surgeons. The system will be debuted at the American College of Foot and Ankle Surgeons (ACFAS) Annual Meeting and will be showcased alongside other recent and upcoming product launches.
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The introduction of the PRECISION® MIS Bunion System by Paragon 28 represents a significant advancement in the field of orthopedic surgery, particularly in the treatment of hallux valgus, commonly known as a bunion. This new system facilitates a minimally invasive approach to correcting the deformity, which is likely to be well-received by both surgeons and patients due to the benefits of minimally invasive surgery (MIS), such as reduced recovery time, less postoperative pain and smaller scars.

From an investment perspective, the development of this system could potentially increase Paragon 28's market share in the orthopedic device sector. The emphasis on joint preservation and the design aimed at reducing soft tissue irritation are key selling points that align with current medical device trends. The system's ability to provide three-dimensional correction, including rotation, addresses a complex aspect of bunion surgery that can differentiate it from competing products.

Moreover, the company's decision to debut the system at the American College of Foot and Ankle Surgeons (ACFAS) Annual Meeting is a strategic move to generate industry buzz and facilitate early adoption through training sessions. The comprehensive portfolio that Paragon 28 offers for hallux valgus correction suggests a targeted approach to dominate this niche market.

Paragon 28's launch of the PRECISION® MIS Bunion System aligns with the broader trend in healthcare towards minimally invasive procedures. The system's potential to reduce hospital stays and improve patient outcomes could lead to cost savings for healthcare providers, which is particularly relevant in the context of rising healthcare costs and the push towards value-based care.

The company's presence at the ACFAS Annual Meeting provides an opportunity to directly engage with key opinion leaders and practitioners, which is essential for driving adoption in medical device markets. Training and education are critical components for the successful rollout of new surgical technologies and Paragon 28's mobile lab initiative is an innovative way to support this.

Investors should monitor the adoption rate of the PRECISION® MIS Bunion System post-launch, as it will be indicative of the system's impact on the company's financial performance. The success of the system could also lead to cross-selling opportunities with Paragon 28's other bunion-related products, potentially enhancing the company's overall revenue growth.

The orthopedic device market is highly competitive and Paragon 28's launch of the PRECISION® MIS Bunion System is a strategic move to capture a larger share of the bunion treatment market. The emphasis on a system that allows for tri-planar correction and the inclusion of cannulated chamfer screws for fixation suggests a focus on innovation and improved surgical outcomes.

Given the prevalence of hallux valgus and the demand for advanced treatment options, the market potential for this system is significant. It is important to assess how this product fits within the existing competitive landscape and how it might influence the market dynamics. The ability of Paragon 28 to leverage its comprehensive product portfolio could create a competitive advantage by offering a one-stop solution for bunion correction.

While evaluating the potential impact on the stock market, it is crucial to consider the system's reception by the medical community, the effectiveness of the company's marketing strategies and the scalability of production to meet potential demand. Any shifts in market share or revenue projections as a result of this launch would be of interest to investors and analysts alike.

ENGLEWOOD, Colo.--(BUSINESS WIRE)-- Paragon 28, Inc. (NYSE: FNA) is pleased to announce the launch of the PRECISION® MIS Bunion System, which allows surgeons to complete a distal metatarsal osteotomy using a minimally invasive (MIS) surgical technique.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240201226008/en/

Figure 1: PRECISION® MIS Bunion System (Graphic: Business Wire)

Figure 1: PRECISION® MIS Bunion System (Graphic: Business Wire)

The system features an outrigger designed for controlled tri-planar correction including translation and derotation of the metatarsal head and adjustment of the distal metatarsal articular angle. Instrumentation is also provided to facilitate a free-hand technique. The PRECISION® MIS Bunion System includes cannulated chamfer screws for fixation that allow alignment of the metatarsal head near the cortex of the first metatarsal. This minimally invasive technique is joint preserving, and screw placement is designed to reduce the chance of soft tissue irritation.

Surgeon designer David Gordon, MD, commented, “The PRECISION® MIS Bunion System by Paragon 28 really changes the landscape of minimally invasive hallux valgus correction, using a distal osteotomy. The design integrates all the elements essential for three-dimensional correction, including rotation. As the jig is fixed both distally and proximally, this gives it stability and the unique ability to apply compression across the osteotomy, to enhance healing. This jig has a high level of functionality and I am excited to see another thoughtful launch coming from Paragon 28.”

Paragon 28’s CEO, Albert DaCosta commented, “At Paragon 28, we have always been focused on matching solutions to the needs of the patient, and each patient is unique. We are adding a great new option to our suite of Bunion solutions with the launch of our PRECISION® MIS System that will help Paragon 28 and surgeons treat a broader array of patients with Hallux Valgus. I am proud of what our design surgeons and engineering team achieved in developing this system, which will bring benefits associated with minimally invasive surgery to our patients and surgeons in a reproducible way.”

Paragon 28 will debut the system at the American College of Foot and Ankle Surgeons (ACFAS) Annual Meeting this week in Tampa Bay, Florida and facilitate trainings on its mobile lab throughout the event. In addition to the PRECISION® MIS Bunion System, the Company will also be showcasing several other recent and upcoming product launches at ACFAS, including the FJ2000™ Power Console and Burr System, Mister Tendon™ Harvester System, Bun-Yo-Matic™ Lapidus Clamp, Grappler® Knotless Anchor System and Bridgeline™ Tape.

The PRECISION® MIS Bunion System bolsters Paragon 28’s hallux valgus solutions offering which includes the Phantom® Small Bone Intramedullary Nail System, Gorilla® Lapidus Plating System, PRESERVE® Lapidus Wedge, Gorilla® MTP Plating System, PRESERVE™ MTP Wedge, PROMO™ Plating System, Bun-Yo-Matic™ Lapidus Clamp, Mini-Monster® Screw System and JAWS™ Staple System. With this comprehensive portfolio, Paragon 28® provides its customers with a single source to address their bunion 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

Dr. Gordon 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.

The ticker symbol for Paragon 28, Inc. is FNA on the NYSE.

The PRECISION MIS Bunion System is a minimally invasive surgical technique for distal metatarsal osteotomy.

The PRECISION MIS Bunion System was designed by surgeon David Gordon, MD.

The system will be debuted at the American College of Foot and Ankle Surgeons (ACFAS) Annual Meeting in Tampa Bay, Florida.

In addition to the PRECISION MIS Bunion System, Paragon 28 will showcase several other recent and upcoming product launches at ACFAS, including the FJ2000 Power Console and Burr System, Mister Tendon Harvester System, Bun-Yo-Matic Lapidus Clamp, Grappler Knotless Anchor System, and Bridgeline Tape.
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About FNA

paragon 28 was established in 2010 as an orthopedic foot and ankle company. the name “paragon 28” was chosen to show that we are exclusively a foot and ankle company, with the “28” representing the number of bones in the foot. we will remain true to that vision. paragon 28 was started as a small, family-based company and we have kept those core ideals as we have grown. our mission is to strategically build a company around the core principles that drive innovation and quality. relentlessly working to advance the science behind foot and ankle surgery, paragon 28 is passionate about and committed to: - creation and innovation: blending different surgical philosophies from various global thought leaders to develop bio-mechanically and clinically relevant surgical solutions. - a focus on service: a customer service based, dedicated, and highly trained distribution network to the foot and ankle market. - efficient practices: meeting the needs of increasing pricing pressures and reimbursemen