Paragon 28 Announces First Cases and Limited Market Release of the Bun-Yo-Matic™ – A Next Generation Clamp and Cut Guide System for Lapidus Bunion Procedures
17 Januar 2024 - 2:00PM
Business Wire
Paragon 28, Inc. (NYSE: FNA), is excited to announce the limited
market release of its Bun-Yo-Matic™ Lapidus Clamp System and
completion of the first surgical cases in Orange County, California
and Seattle, Washington. The Bun-Yo-Matic™ is the only bunion
solution on the market designed to intraoperatively simulate
weight-bearing and allow for compression prior to hardware
application. This unique approach provides surgeons a more
reproducible and efficient means to restore three-dimensional
alignment of the foot while accommodating each surgeon’s preferred
fixation methodology in a Lapidus procedure.
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Figure 1: Paragon 28 Bun-Yo-Matic™
Lapidus Clamp System (Graphic: Paragon 28)
The Bun-Yo-Matic™ Clamp remains fixed to the anatomy throughout
the entire procedure, ensuring surgeon-guided correction and
anatomic alignment are maintained through application of fixation.
The System is also equipped with cutting guides designed to
minimize bone removal from the base of Tarsometatarsal (“TMT”)
joint when preparing for fusion.
The Bun-Yo-Matic™ Clamp and accompanying cut guide system are
highly complementary to Paragon 28’s broad line of bunion and
forefoot solutions. The Clamp is a reusable surgical instrument
which will be used in conjunction with several of Paragon 28’s
existing implants and implant systems designed to treat bunions,
including:
- Gorilla® Precision™ Lapidus Plate
- Phantom® Small Bone Intramedullary Nail
- Phantom® MIS Lapidus System allowing medial access
- MIS Burr Guide used in preparing the 1st TMT joint
Paragon 28’s CEO, Albert DaCosta, commented, “The first clinical
cases with the Bun-Yo-Matic™ Clamp System went great, and we expect
this product to drive significant growth for Paragon 28. We believe
this clamp is a game changer in the bunion market and will result
in more reproducibility, streamlined procedural work flow, improved
accuracy, and ultimately improved patient outcomes in technically
demanding Lapidus arthrodesis cases. With the capability to hold
correction across all three planes throughout the entire procedure,
the system is unique and brings great value to our surgeons and
patients.”
The Bun-Yo-matic™ Lapidus Clamp System bolsters Paragon 28’s
bunion and forefoot solutions offering which includes the Gorilla®
Precision™ Lapidus Plate, Phantom® Small Bone Intramedullary Nail,
Phantom® MIS System, Gorilla® Precision MTP Plate, Phantom®
Metatarsal Shortening System, TenoTac™, Paratrooper™, and
HammerTube™. With this comprehensive portfolio, Paragon 28®
provides its customers with a single source to address their bunion
and forefoot 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
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
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