Paragon 28 Launches the Mister Tendon™ Harvester System – The First and Only Minimally Invasive Harvesting System for FHL and FDL Tendon Transfer Procedures
January 26 2024 - 8:00AM
Business Wire
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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Investor Contact Matthew Brinckman Senior Vice President,
Strategy and Investor Relations Phone: (720) 912-1332
mbrinckman@paragon28.com
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