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Treace Medical Announces Presentation of Positive Clinical Data Supporting Lapiplasty® 3D Bunion Correction™ for the Surgical Management of Bunion Deformities

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Clinical data presented at the 2018 annual meeting of the American
Orthopaedic Foot & Ankle Society (AOFAS)

Study demonstrates 96.7% maintenance of 3-plane correction at 13.5
month mean follow-up with rapid return to weight-bearing

Treace Medical Concepts, Inc., a medical device company focused on
advancing the standard of care for hallux valgus (bunion) surgery,
announces presentation of positive 13.5-month follow-up results from its
retrospective, multicenter study with the Lapiplasty® 3D Bunion
Correction™ procedure in the surgical management of symptomatic hallux
valgus. The goal of the study, which involved multiple centers and 72
patients, was to evaluate maintenance of 3-plane correction and union
rates with rapid return to weight-bearing following surgery. Highlights
of the study:

  • 61 feet met the 1-year endpoint, with an average follow-up of 13.5
    months
  • Mean time for study patients to start weight-bearing on the operative
    foot was 10.5 days
  • 96.7% of study patients maintained their 3-plane correction:
    Intermetarsal Angle (IMA), Hallux Valgus Angle (HVA) and Tibial
    Sesamoid Position (TSP)
  • Symptomatic non-union rate of 1.6% (1 foot)

Robert Santrock, MD, Associate Professor and Chair of Foot and Ankle
Surgery at West Virginia University, presented the results on July 12th at
the annual meeting of the American Orthopaedic Foot & Ankle Society
(AOFAS) in Boston, MA. According to Dr. Santrock, "Traditional osteotomy
surgery has been associated with an unacceptably high rate of recurrence
on x-ray with studies citing a greater than 50% chance of the bunion
returning over time. In our study, only 2 feet (or 3.3%) treated with
the Lapiplasty® 3D procedure experienced a radiographic recurrence of
their bunion at 13.5 months. This low rate of recurrence represents what
we believe to be a very significant finding. Importantly, our patients
were able to start bearing weight within days of surgery in a
post-operative boot, versus 4-8 weeks in casts as with some traditional
surgical approaches."

The patented Lapiplasty® 3D Bunion Correction™ procedure represents a
new paradigm in the assessment and surgical management of hallux valgus,
a deformity of the foot which affects about 60 million Americans and
results in approximately 400,000 surgeries in the United States annually.

Paul Dayton, DPM, of the Midwest Bunion Center, a study enrolling site,
comments: "Traditional bunion surgery only addresses 1 (or 2) of the 3
planes involved in the complex bunion deformity. Studies demonstrate a
significant increase in the likelihood of the bunion returning if all 3
planes are not properly realigned in the surgical procedure. The
Lapiplasty® 3D Bunion Correction™ procedure offers novel instrumentation
and implants designed to reproducibly realign all 3 planes of the
deformity and, as importantly, stabilize an unstable joint in the middle
of the foot which is the root cause of the bunion. This allows patients
to start ambulating quickly and, as seen in our study, with a very low
chance of recurrence."

"This is exciting news for bunion sufferers. The low recurrence rate
demonstrated in this 13.5-month, multicenter study is highly
encouraging, particularly given how quickly these patients started
ambulating on their operative foot. With the Lapiplasty® 3D Bunion
Correction™ procedure, patients have a new alternative to the
inconsistent results of traditional osteotomy surgery, one designed to
deliver a comprehensive and lasting correction to this complex
deformity," says John T. Treace, Treace Medical's CEO and Founder.

About Treace Medical Concepts, Inc.

Based in Ponte Vedra, FL, Treace Medical Concepts, Inc. is a
privately-held medical device company focused on advancing the standard
of care for the surgical management of bunion deformities. The company's
patented Lapiplasty® 3D Bunion Correction™ procedure is designed to
reproducibly correct all 3 planes of the bunion deformity and address
the root cause of the bunion, while allowing patients to start
ambulating on the operative foot within days of surgery.

To learn more about Lapiplasty® 3D Bunion Correction™, or find a
Lapiplasty® surgeon in your area, please visit: www.alignmytoe.com or www.treace.com/patients.

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