Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and
orthopedics company, today announced the full U.S. commercial
launch and successful completion of the first cases with the Galaxy
Fixation Gemini™ system. The latest in the Galaxy product line,
this stable external fixation system is provided in several sterile
procedure kit configurations as a quick off-the-shelf solution for
treating fractures that result from trauma in the lower and upper
limbs.
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Image of the Galaxy Fixation Gemini
System for treating fractures that result from trauma in the lower
and upper limbs. (Photo: Business Wire)
“In trauma settings, it is critical that we respond quickly to
manage the damage to the impacted limb,” said Dr. Evengy Dyskin,
Clinical Assistant Professor of Orthopaedics, University of
Buffalo, in Buffalo, NY. “The all-inclusive nature of the sterile
kits eliminates spatial constraints, enabling application in a
trauma bay or intensive care unit setting, which would not be
possible with a traditional pin-to-bar system.”
Sterile kits eliminate the need for sterilization of trays which
takes an average of 139 minutes1 to process and adds cost to
healthcare facilities. Sterilization of trays also results in
increased operating room (OR) delays and costs due to packaging,
restocking and tray contamination. Average cost to a facility for
OR delays related to tray contamination is $1,0811 which can be
avoided through the use of prepacked sterile kits.
In particular, the Galaxy Fixation Gemini ankle kit is the only
pin-to-bar system with specific clamps available in a sterile kit
configuration giving surgeons more efficient solutions in lower
extremity trauma situations where time is an important factor. The
ankle kit, developed specifically to meet the needs of U.S.
surgeons, includes a double multiscrew clamp to facilitate rapid
insertion of tibial half-pins and is complemented by the foot
support and first metatarsal sterile kits when a more robust
construct is desired. It is estimated that ankle fractures occur in
187 per 100,000 persons per year in the U.S.2
“We are excited to expand our external fixation offerings in the
U.S. for trauma through the introduction of the Galaxy Fixation
Gemini System in several sterile packed configurations,” said Kim
Elting, President of Global Orthopedics. “This streamlined
pin-to-bar configuration is the latest example of our leadership in
sterile kit solutions, which improve OR efficiencies and
meaningfully decrease costs for the hospital and also for our
business.”
Orthofix further expanded its sterile kit offerings with the
global launch of the CalcFix Plus Calcaneal Minifixator™ System
earlier this year. The CalcFix Plus represents the latest version
of the original CalcFix Fixator device designed to treat calcaneal
fractures using a more minimally invasive external fixation
approach compared with internal fixation and includes updates to
the design that reduce the number of operative steps to apply.
The Galaxy Fixation Gemini and the CalcFix Plus Systems add to
Orthofix’s extensive portfolio of over 50 sterile kit procedural
solutions available globally and demonstrate Orthofix’s continued
investment in providing off-the-shelf solutions to meet the needs
in the acute trauma, military and humanitarian crisis settings.
Those attending the AOFAS Annual Meeting in Louisville, KY Sept.
20-22 can learn more about the Galaxy Fixation Gemini System and
the CalcFix Plus Calcaneal Minifixator System by visiting booth
613.
1 Ly JA, Wang WL, et al. Arch Bone Jt Surg, 2022 May; 10(5):
420-425. 2 Source (SmartTrack, 2023).
About Orthofix
On January 5, 2023, Orthofix and SeaSpine merged to form a
leading global spine and orthopedics company with a comprehensive
portfolio of biologics, innovative spinal hardware, bone growth
therapies, specialized orthopedic solutions, and a leading surgical
navigation system. Its products are distributed in approximately 68
countries worldwide.
The Company is headquartered in Lewisville, Texas and has
primary offices in Carlsbad, CA, with a focus on spine and
biologics product innovation and surgeon education, and Verona,
Italy, with an emphasis on product innovation, production, and
medical education for orthopedics. The combined Company’s global
R&D, commercial and manufacturing footprint also includes
facilities and offices in Irvine, CA, Toronto, Canada, Sunnyvale,
CA, Wayne, PA, Olive Branch, MS, Maidenhead, UK, Munich, Germany,
Paris, France and Sao Paulo, Brazil. A new name for the combined
entity will be announced at a future date; the Company will
continue to operate as Orthofix until said announcement.
Forward-Looking Statements
This news release may include forward-looking statements within
the meaning of Section 21E of the Securities Exchange Act of 1934,
as amended, and Section 27A of the Securities Act of 1933, as
amended. In some cases, you can identify forward-looking statements
by terminology such as “may,” “will,” “should,” “expects,” “plans,”
“anticipates,” “believes,” “estimates,” “projects,” “intends,”
“predicts,” “potential,” “continue” or other comparable
terminology. Orthofix cautions you that statements included in this
news release that are not a description of historical facts are
forward-looking statements that are based on the Company’s current
expectations and assumptions. Each forward-looking statement
contained in this news release is subject to risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statement. Applicable risks
and uncertainties include, among others: the ability of newly
launched products to perform as designed and intended and to meet
the needs of surgeons and patients, including as a result of the
lack of robust clinical validation; and the risks identified under
the heading “Risk Factors” in Orthofix Medical Inc.’s Annual Report
on Form 10-K for the fiscal year ended December 31, 2022, which was
filed with the Securities and Exchange Commission (SEC) on March 6,
2023. The Company’s public filings with the Securities and Exchange
Commission are available at www.sec.gov. You are cautioned not to
place undue reliance on forward-looking statements, which speak
only as of the date when made. Orthofix does not intend to revise
or update any forward-looking statement set forth in this news
release to reflect events or circumstances arising after the date
hereof, except as may be required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230920059213/en/
Media Relations Denise Landry DeniseLandry@orthofix.com
214.937.2529
Investor Relations Louisa Smith, Gilmartin Group
IR@orthofix.com
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