Paragon 28, Inc. (NYSE: FNA), is pleased to announce the launch of the Mister Tendon™ System which allows surgeons to perform a distal cut of the flexor hallucis longus (“FHL”) or flexor digitorum longus (“FDL”) tendon through a minimally invasive incision, harvesting a working length of tendon suitable for tendon transfer procedures. Use of this instrumentation through a minimally invasive approach, is designed to allow for better healing and quicker recovery time in flatfoot reconstruction. In addition to the harvester, an accessory dilator instrument is provided to help bluntly dissect soft tissue, improving harvester access without causing additional damage.

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Figure 1: Paragon 28 Mister Tendon™ Harvester and Blunt Dissection Probe (Graphic: Business Wire)

Paragon 28’s CEO, Albert DaCosta, commented, “We are thrilled to add the Mister Tendon™ Harvester to our comprehensive and novel offering of flatfoot solutions. We are committed to addressing the unmet needs of foot and ankle surgeons and the launch of a minimally invasive tendon harvester fulfills a promise we have made to our customers to develop less invasive instrumentation and implants for the most common procedures in the foot and ankle.”

Surgeon designer Thomas San Giovanni, MD, commented, “As surgical procedures change with a noted trend towards minimally invasive surgery, so must instrumentation to facilitate the task at hand. In the words of Miyamoto Musashi, the famous Japanese master samurai and philosopher, 'Do nothing that is of no use.' There would be no use to carry out the typical open dissection of the patient's soft tissue structures and neurovascular structures if tendons could be harvested of the same length desired by using well thought out innovative instrumentation that facilitates minimally invasive harvest technique. In doing so, the same goal would be achieved all while sparing the anatomical region from needless dissection, avoiding surgical disruption of the soft tissue structural anatomy and microvasculature...do nothing that is of no use. The Mister Tendon Harvester™ was created based on this principle.”

The Mister™ Tendon Harvester System bolsters Paragon 28’s flatfoot solutions offering which includes the PRESERVE™ Cotton, Evans, and STJDA Wedges, Titan 3-D™ Cotton and Evans Wedges, Grappler™ Interference Screw System, Grappler™ Suture Anchor System, Gorilla® Calc Slide Plate, Gorilla® BOW & ARROW Plates, Gorilla® HEvans™ Plate, Gorilla® NC Fusion Plating System, Gorilla® Medial Column Plating System, Gorilla® Universal Plating System, JAWS Great White™ Staple System, and Monster® Hindfoot Screw System. With this comprehensive portfolio, Paragon 28® provides its customers with a single source to address their flatfoot 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. San Giovanni 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.

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