Orthofix Announces 510k Clearance and Full Commercial Launch of OsteoCove, an Advanced Bioactive Synthetic Graft for use in Spine and Orthopedic Procedures
12 Outubro 2023 - 8:00AM
Business Wire
Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and
orthopedics company, today announced the 510k clearance and full
commercial launch of OsteoCove™, an advanced bioactive synthetic
graft. Available in both a putty and strip configuration, OsteoCove
was carefully formulated to provide superior bone-forming
capabilities with best-in-class handling characteristics for a wide
range of spine and orthopedic procedural applications.
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Image of OsteoCove putty and strip, an
advanced bioactive synthetic graft formulated to provide superior
bone-forming capabilities with best-in-class handling
characteristics for a wide range of spine and orthopedic procedural
applications. (Photo: Business Wire)
“Using the same disciplined R&D approach we have
historically taken with our internally processed demineralized bone
matrix solutions, we created a product that challenges the
performance expectations of typical synthetic bone graft
substitutes,” said Dr. Frank Vizesi, Chief Scientific Officer for
Orthofix. “OsteoCove is another prime example of leveraging our
strengths in product development in combination with our vertically
integrated manufacturing expertise.”
Made of biphasic ceramic granule comprised of β-tricalcium
phosphate (ß-TCP) and hydroxyapatite (HA) combined with type-I
bovine collagen, OsteoCove features a specialized granule surface
topography designed to elicit a bone-forming response, as evidenced
by its ability to grow bone in a challenging muscle pouch model.
This specialized surface chemistry and microporosity are shown to
promote superior bone formation when compared to other commercially
available advanced synthetic grafts.1
“Orthofix is a leader in both the demineralized bone matrices
(DBM) and cellular allograft markets, and the launch of OsteoCove
significantly strengthens our biologics portfolio and builds on our
mission to deliver best-in-class products in every major bone
grafting category,” said Tyler Lipschultz, President, Orthofix
Global Biologics. “With the introduction of OsteoCove, we expect
strong growth in this large market segment as we continue to
deliver on our commitment to provide surgeons a comprehensive
offering of biologic solutions to meet the needs of their
patients.”
The U.S. synthetic bone graft market is estimated to be $300
million.2
Orthofix invites those attending the North American Spine
Surgeon Annual Meeting in Los Angeles, October 18-21, 2023, to
visit booth #1711 to learn more about the Company’s portfolio of
biologic solutions.
1,2 Data on file
About Orthofix
Orthofix and SeaSpine merged in January 2023 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, where it
conducts general business, product development, medical education
and manufacturing, 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 São Paulo,
Brazil. To learn more, visit Orthofix.com.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231012672479/en/
Media Relations Denise Landry DeniseLandry@orthofix.com
214.937.2529
Investor Relations Louisa Smith, Gilmartin Group
IR@orthofix.com
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