Paragon 28 Introduces a Novel Right-Angle Drill for the APEX 3D™ Total Ankle Replacement System

Rhea-AI Summary

Paragon 28 (NYSE: FNA) has introduced a novel Right-Angle Drill for its APEX 3D™ Total Ankle Replacement System. This new tool is designed to improve tibia preparation before implanting the APEX 3D™ tibia implant. The drill uses a linear guide to precisely create vertical holes in the tibia, ensuring ideal peg placement and a stable implant interface.

This addition is part of a series of instrumentation enhancements to the APEX 3D™ system, including recently released Polishing Blocks, Square Tip Drill, and next-generation Off-Set Impaction Handle. These improvements aim to enhance tibia preparation, contributing to the long-term success of ankle replacements and improving surgeon experience and patient outcomes.

Positive

• Introduction of a novel Right-Angle Drill for improved tibia preparation
• Potential for improved long-term outcomes in total ankle replacements
• Continued advancement of the APEX 3D™ Total Ankle Replacement System
• Addressing tibia implant loosening, the primary cause of total ankle replacement failure

Negative

• None.

Insights

Medical Device Expert

The introduction of the Right-Angle Drill for the APEX 3D™ Total Ankle Replacement System represents a significant advancement in ankle replacement surgery. This novel tool addresses a critical challenge in the field: tibia implant loosening, which is the primary cause of total ankle replacement failure. By enabling more precise tibia preparation, the Right-Angle Drill aims to create a more stable implant-bone interface, potentially leading to improved long-term outcomes for patients.

The drill's design, utilizing a linear guide for vertical hole drilling, suggests a focus on accuracy and consistency in the surgical process. This could translate to reduced variability in outcomes and potentially lower revision rates. However, it's important to note that while the technology is promising, long-term clinical data will be necessary to confirm its effectiveness in improving ankle replacement durability.

Orthopedic Surgeon

As an orthopedic surgeon, I find the Right-Angle Drill to be a valuable addition to the APEX 3D™ system. The emphasis on tibia preparation is crucial, as it directly impacts the longevity of the ankle replacement. The drill's ability to create precise vertical holes for peg placement should lead to a more stable tibia implant interface, which is essential for the implant's long-term success.

Moreover, the series of recent instrumentation enhancements, including Polishing Blocks and a Square Tip Drill, demonstrates Paragon 28's commitment to continuous improvement in their total ankle replacement system. These tools collectively aim to refine the surgical technique, potentially reducing operative time and improving overall outcomes. However, surgeons will need time to adapt to these new instruments and their learning curve should be considered when evaluating initial results.

Financial Analyst

From a financial perspective, Paragon 28's continuous innovation in the APEX 3D™ system positions the company well in the competitive orthopedic device market. The introduction of the Right-Angle Drill and other recent enhancements could drive adoption of their total ankle replacement system, potentially increasing market share and revenue.

The timing of this announcement, coinciding with the AOFAS Annual Meeting, is strategically sound. It provides an immediate platform to showcase the new technology to key decision-makers in the field. However, investors should note that while innovation is crucial, the true financial impact will depend on clinical outcomes and adoption rates over time. The company's focus on addressing a primary cause of ankle replacement failure could lead to reduced revision surgeries, potentially improving the cost-effectiveness of their system and attracting more healthcare providers and payers.

ENGLEWOOD, Colo.--(BUSINESS WIRE)-- Paragon 28, Inc. (NYSE: FNA) is pleased to announce the addition of a novel Right-Angle Drill to the APEX 3D™ Total Ankle Replacement System designed to improve tibia preparation prior to the implantation of the APEX 3D™ tibia implant. The Right-Angle Drill utilizes a linear guide to precisely drill vertical holes into the tibia for ideal peg placement and a highly stable tibia implant interface.

Figure 1: Image of the APEX 3D Right-Angle Drill as a standalone unit. (Graphic: Business Wire)

The release of the Right-Angle Drill continues a series of instrumentation enhancements to the APEX 3D™ Total Ankle Replacement System, which includes the recently released Polishing Blocks, Square Tip Drill, and next-generation Off-Set Impaction Handle. These recent enhancements were primarily designed to improve tibia preparation, thereby contributing to the long-term success of ankle replacements and ultimately improving surgeon experience and patient outcomes.

“The preparation of the tibia prior to placing the implant is paramount for long-term success. Successful total ankle surgery is characterized by an implant bone interface, prepared tibia bone and the tibia implant, which combine into one structure that works together,” says Dr. Mark Myerson, a design surgeon of the APEX 3D™ system. “The Right-Angle Drill precisely prepares the tibia to create the appropriate interface for the APEX 3D™ implant to allow for long-term survival.”

“We are thrilled to continue advancing our APEX 3D™ Total Ankle Replacement System with the launch of our novel Right-Angle Drill,” says Albert DaCosta, CEO and Chairman of Paragon 28. “The Right-Angle Drill is a critical step towards addressing tibia implant loosening, the primary cause of total ankle replacement failure. This drill enables surgeons with a more precise preparation and promotes better implant integration, which we believe will result in improved long-term outcomes for foot and ankle patients.”

Paragon 28 will be showcasing the APEX Right-Angle Drill at the American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting this week in Vancouver, British Columbia. Additionally, Paragon 28 will be showcasing the recently launched R3FLEX™ Stabilization System, SMART28℠ Case Management Portal, SMART Bun-Yo-Matic℠, FJ2000™ Power Console and Burr System, and PRECISION® MIS Bunion System throughout the meeting. Surgeons may visit booth 625 or schedule a hands-on introduction to these technologies with P28 product experts who will be on-site throughout the meeting.

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/A for the fiscal year ended December 31, 2023 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. Myerson 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240910193295/en/

Investor Contact

Matthew Brinckman

Senior Vice President, Strategy and Investor Relations

Phone: (720) 912-1332

Source: Paragon 28, Inc.

FAQ

What is the new product Paragon 28 (FNA) has introduced for its APEX 3D™ Total Ankle Replacement System?

Paragon 28 has introduced a novel Right-Angle Drill for its APEX 3D™ Total Ankle Replacement System, designed to improve tibia preparation before implanting the APEX 3D™ tibia implant.

How does the new Right-Angle Drill by Paragon 28 (FNA) improve the ankle replacement procedure?

The Right-Angle Drill uses a linear guide to precisely drill vertical holes into the tibia, ensuring ideal peg placement and a highly stable tibia implant interface, which is important for long-term success of the ankle replacement.

What other recent enhancements has Paragon 28 (FNA) made to its APEX 3D™ Total Ankle Replacement System?

Recent enhancements include Polishing Blocks, Square Tip Drill, and a next-generation Off-Set Impaction Handle, all designed to improve tibia preparation and contribute to long-term success of ankle replacements.

Where is Paragon 28 (FNA) showcasing its new Right-Angle Drill in 2024?

Paragon 28 is showcasing the APEX Right-Angle Drill at the American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting in Vancouver, British Columbia.