Orthofix Announces First Cases and Full Commercial Launch of the 7D FLASH Navigation System Percutaneous Module 2.0 for Minimally Invasive Surgery
28 Agosto 2023 - 8:00AM
Business Wire
Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and
orthopedics company, today announced the full commercial launch and
successful completion of the first cases in the U.S. with the 7D
FLASH™ Navigation System Percutaneous Module 2.0. The Percutaneous
Module 2.0 provides new planning features and increased
functionality for the 7D FLASH Navigation System, allowing Orthofix
to further serve the Minimally Invasive Surgery (MIS) spine market,
estimated at approximately $1.8 billion in the U.S.1
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Image of the 7D FLASH™ Navigation System
with the Percutaneous Module 2.0 for minimally invasive surgeries.
The system uses visible light to create a three-dimensional image
for surgical navigation in seconds, enabling faster and more
efficient spinal procedures. (Photo: Business Wire)
“The 7D FLASH Navigation System provides a truly unique offering
for both open and MIS procedures enabling us to perform navigated
spinal fusion procedures without compromising safety, speed and
efficiency,” said Dr. Michael Hisey, an orthopedic surgeon at Texas
Back Institute in Dallas, Texas. “The planning features of the
Percutaneous Module 2.0 help optimize my navigation workflow and
allow me to minimize surgical incisions during MIS procedures.”
The 7D FLASH Navigation System uses visible light to create a
three-dimensional image for surgical navigation in seconds,
enabling faster and more efficient spinal procedures. The only
image-guidance system that utilizes novel and proprietary
camera-based technology, coupled with machine-vision algorithms,
the 7D FLASH Navigation System eliminates many of the long-standing
frustrations with other surgical navigation platforms. The speed,
accuracy, and efficiency of machine-vision technology is intended
to provide significant economic value and lower radiation exposure
for staff and patients during open procedures.
“We are excited to complete our first cases using the
Percutaneous Module 2.0,” said Dr. Beau Standish, President of
Global Enabling Technologies at Orthofix. "This launch expands the
clinical functionality and utility of the 7D FLASH Navigation
System by providing surgeons with a fully integrated procedural
solution for MIS, including implant planning and an expanded
offering of navigated tools. This new application addresses the
important MIS spine navigation market and further positions the 7D
FLASH Navigation System to be the navigation choice for a wide
range of institutions from teaching hospitals to ambulatory surgery
centers.”
To learn more about the 7D FLASH Navigation System, please visit
SeaSpine.com or 7DSurgical.com.
1. Source iData Research Inc. 2022.
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/20230828212653/en/
Media Relations Denise Landry DeniseLandry@orthofix.com
214.937.2529
Investor Relations Louisa Smith, Gilmartin Group
IR@orthofix.com
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