Treace Medical Announces Publication of Additional Positive Clinical Data Supporting Lapiplasty® 3D Bunion Correction™

Treace Medical Concepts, Inc., a medical device company focused on
advancing the standard of care for hallux valgus (bunion) surgery,
announces publication of additional positive clinical data supporting
Lapiplasty® 3D Bunion Correction™ in The Journal of Foot & Ankle
Surgery. The objective of the study was to evaluate bone healing
with an accelerated weightbearing protocol in patients undergoing
fusions of the tarsometatarsal joint (“3-plane Lapidus fusion”) or
fusions of the great toe (“MTP joint fusion”) with biplanar plating
fixation, the implant fixation construct used in the Lapiplasty®
Procedure. Highlights of the study:

• 195 patients were included in the study with a mean follow up of 9.5
  months (19.5% of the patients had comorbidities known to compromise
  bone healing including tobacco use and controlled diabetes).
• Patients were allowed to begin weightbearing on their operative foot
  at approximately 5 days following surgery.
• 97.4% of the patients demonstrated a successful bony fusion of the
  joint and 98.9% of the patients maintained a stable joint position
  over the course of the study.

Paul Dayton, DPM of the Midwest Bunion Center (Des Moines, IA) and lead
author on the publication stated, “This study demonstrated positive bone
healing rates over progressive timepoints when utilizing biplanar
plating without a cross-joint compression screw in procedures used to
treat bunions or arthritis of the big toe joint. The bone healing rates
were quite encouraging given this unique fixation approach allowed
patients to undergo an accelerated recovery protocol and to initiate
weightbearing in a post-operative boot within their first week of
surgery. Additionally, there were 29 smokers and 9 controlled diabetics
in the cohort; comorbidities known to negatively impact bone healing.
Further, implant removal rate was a very low 3.1% compared with
conventional plate implants where published removal rates can be upwards
of 17% for tarsometatarsal¹ and 20% for MTP joint fusion
procedures². Overall, I’m very pleased with these results as
they reinforce that I can offer this fixation option to my patients with
a high level of confidence that they will experience reliable bone
healing under an accelerated weightbearing protocol.”

“The outcomes of this new study are noteworthy in that they closely
mirror those reported in our 13-month multicenter dataset presented at
the 2018 American Orthopaedic Foot & Ankle Society’s (AOFAS) annual
meeting in Boston,” said Robert Santrock, MD of West Virginia University
and co-author on this new publication. “In the AOFAS dataset, the 61
feet treated with Lapiplasty® 3D Bunion Correction™ showed low 1.6%
symptomatic non-union rate and 3% radiographic recurrence rate³.
Patients in the AOFAS study initiated weightbearing in a post-operative
boot at an average of 10.5 days, which is consistent with this new
study.”

“The rapid time to weightbearing, high rate of bone healing, and low
implant removal rate reported in this study further highlight the
patient benefits of biplanar plating - the fixation method used in the
Lapiplasty® Procedure,” says John T. Treace, CEO of Treace Medical. “The
study represents the 9^th peer review publication supporting
the Lapiplasty® Procedure, another important milestone for our company
which was recently recognized as the industry leader in
advancing the science of bunion surgery. With a pipeline of studies
underway, we continue to build upon the robust clinical dossier
supporting the Lapiplasty® Procedure so that patients, practitioners,
and payors can make treatment decisions based on clinical evidence.”

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.

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 get back to
their active lives quickly.

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.

1. Cottom JM, Vora AM. J Foot Ankle Surg 52:465–469, 2013.
2.
Wanivenhaus F, et al. J Foot Ankle Surg 56:50-53, 2017.
3. Santrock
R, et al. AOFAS Annual Meeting, Boston, MA, 2018.

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