Paragon 28 Launches PRECISION® MIS Bunion System Offering Surgeons a Guided Minimally Invasive Surgical Solution for Treating Patients with Bunions
February 01 2024 - 8:00AM
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.
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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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240201226008/en/
Investor Contact Matthew Brinckman Senior Vice President,
Strategy and Investor Relations Phone: (720) 912-1332
mbrinckman@paragon28.com
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