Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and
orthopedics company, today announced the presentation of multiple
clinical and scientific abstracts during the International Society
for the Advancement of Spine Surgery (ISASS) annual meeting in San
Francisco June 1-3, 2023.
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the full release here:
https://www.businesswire.com/news/home/20230601005376/en/
Illustration of the Orthofix M6-C
artificial cervical disc. (Graphic: Business Wire)
“We are pleased to support a wide range of abstracts and
clinical data during the annual ISASS meeting, including the first
presentation of the seven-year data from the M6-C artificial
cervical disc U.S. IDE study,” said Kevin Kenny, President of
Global Spine. “ISASS is an important opportunity for attendees to
learn from a distinguished surgeon panel that will provide their
insights about cervical disc replacement and long-term outcomes of
this therapy. Additionally, we are proud to support presentation of
data for our Bone Growth Therapy and Biologic solutions.”
At the ISASS annual meeting, Orthofix is presenting a variety of
industry abstracts and posters focused on the company’s M6-C™
artificial cervical disc, CervicalStim™ bone growth stimulator and
Trinity Elite™ Allograft with viable cells.
Motion Preservation
“M6-C Artificial Cervical Disc: Seven-Year Outcomes for
Single-Level Total Disc Replacement with a Novel Viscoelastic
Artificial Cervical Disc” – abstract presentation by Dr. Todd
Lanman.
This abstract is the first public presentation of specific
seven-year clinical results associated with the use of the M6-C
artificial cervical disc for the treatment of single-level
symptomatic cervical radiculopathy. The presentation will be on
Saturday, June 3 at 10:00 a.m. in Salons 10-12 by Dr. Todd Lanman.
Highlighted results include:
- Decreases in disability as measured by NDI and decreases in
Neck and Arm Pain Scores that were observed at prior follow-up
periods and were retained through seven-years post-op
- Eleven Secondary Surgical Interventions (SSI) were observed
among the M6-C disc cohort (6.9%). This rate is comparable to
seven-year SSI rates reported for other commercially available
artificial cervical discs
- Annual follow-up of this cohort will continue through 10-years
post-op
“Cervical Disc Arthroplasty Expert Panel: Osteolysis and
Periprosthetic Bone Changes in Cervical Disc Replacement” –
academic program session with moderator Dr. Gunnar Andersson and
speakers Dr. Josh Jacobs, Dr. Armen Khachatryan, Dr. Todd Lanman,
Dr. Steven Kurtz and Dr. Sophia Sangiorgio.
This multidisciplinary panel of clinicians and researchers will
discuss the assessment of bone changes around artificial cervical
disc implants, leveraging prior research in hip and knee
arthroplasty. Panel will be conducted on Friday, June 2 at 1:20
p.m. in Salons 10-12. Topics covered include:
- Categorization and classification of radiographic
observations
- Clinical management of observed bone changes post-cervical disc
replacement
“Proposed Classification System of Radiographic Bony Changes
after Cervical Disc Replacement” – poster by Dr. Armen
Khachatryan.
Poster will be located in the Exhibit Hall. Content highlights
include:
- Introduction of classification system for post-cervical disc
replacement radiographic observations
- Analysis of system reliability
Bone Growth Therapy
“CervicalStim Bone Growth Therapy: Electrical Stimulation
Used as an Adjunct to Cervical Spine Fusion in Patients at Risk for
Pseudarthrosis” – podium presentation with Dr. Ilyas Aleem.
This presentation will cover the results of a prospective
multicenter study that evaluated the adjunct effect of PEMF in
subjects undergoing cervical spinal surgery who presented with risk
factors for pseudarthrosis (multilevel fusion, prior failed
cervical spine fusion, diabetes, osteoporosis, or nicotine use).
Presentation will be conducted on Saturday June 3, at 10:32 a.m. in
Salons 13-15. Highlights include:
- Out of 160 subjects, 144 (90.0%) were graded as fused (all
levels) at the 12-month visit
- Fusion success was 91.7% (n=55/60) for subjects with a single
risk factor, 89.0% (n=89/100) for subjects with two or more risk
factors, and 90.9% (n=20/22) for subjects with three or more risk
factors
- Significant improvements in NDI, VAS (arm and neck), SF-36, and
EQ-5D were observed compared to baseline scores (p<0.001)
“CervicalStim Bone Growth Therapy: Adjunctive Use of Bone
Growth Stimulation in Cervical Spine Fusion in Patients at Risk for
Pseudarthrosis” – poster by Dr. Ilyas Aleem.
Poster highlights results of a study that evaluated cervical
spine fusion rates for subjects with one or more risk factors for
pseudarthrosis; subjects that received PEMF treatment were compared
to matched subjects that did not receive PEMF treatment. Poster
will be located in the Exhibit Hall. Results include:
- At 12 months post-op, subjects in the PEMF treated group
(n=161) had a 90.1% fusion rate, compared to a 65.4% fusion rate
for the control group (n=26) (p<0.001)
- Subjects in the PEMF treated group had a significantly higher
number of risk factors for nonunion (1.8 for treated group vs. 1.1
for control, p<0.001), and significantly higher number of
surgical levels (2.8 for treated group vs. 2.0 for control,
p<0.005)
- When compared to control subjects that did not use PEMF
stimulation, treated subjects had improved fusion outcomes despite
being older, having more risk factors for pseudarthrosis, and
undergoing more complex surgeries
Biologics
“Trinity Elite Allograft: Radiographic and Clinical Outcomes
in Subjects that Underwent Single-Level or Multilevel Anterior,
Posterior or Lateral Lumbar Interbody Fusion with a Cellular Bone
Allograft” – podium presentation by Dr. Pierce Nunley on behalf
of Dr. Todd Lansford.
This study investigates the effectiveness of cellular bone
allograft in lumbar spinal fusion by surgical approach (e.g.,
anterior, lateral, and posterior). Presentation of data will be on
Saturday, June 3 at 10:30 a.m. in Salons 13-15. Highlights
include:
- Analysis of 252 subjects treated via anterior, lateral, or
posterior approaches reported fusion success by bridging bone
assessment, as well as bridging bone and Quantitative Motion
Analysis (QMA) assessment, at time of study closure.
- At 12 months, the overall fusion success rate for bridging bone
was 98.5%; fusion success was 98.1%, 100.0%, and 97.9% for
anterior, lateral, and posterior approaches, respectively. Fusion
success for bridging bone and QMA assessment was 83%, 94.6%, and
93.8% for anterior, lateral, and posterior approaches,
respectively.
- At 24 months, the overall fusion success rate for bridging bone
was 98.9%; fusion success was 97.9%, 100.0%, and 98.8% for
anterior, lateral, and posterior approaches, respectively. Fusion
success for bridging bone and QMA assessment was 85.4%, 96.1%, and
92.9% for anterior, lateral, and posterior approaches,
respectively.
- Significant improvements in quality-of-life, pain, and
disability scores were also noted, irrespective of the surgical
approach.
“Trinity Elite Allograft: Twenty-Four-Month Interim Results
from a Prospective Clinical Trial Evaluating the Performance and
Safety of Cellular Bone Allograft in Patients Undergoing Lumbar
Spinal Fusion” – podium presentation by Dr. Daniel Park.
This abstract reports on the outcome measures from a
prospective, multicenter center clinical study that assessed the
efficacy and safety of cellular bone allograft when used as an
adjunct to lumbar arthrodesis out to 24-months follow-up. This data
will be presented on Friday, June 2 at 11:02 a.m. in Salons 10-12.
Highlights include:
- At the time of interim analysis, 86 subjects reported data
necessary to evaluate both fusion and disability through 24-months
postoperative
- Fusion rate, based on bridging bone assessment and QMA, was
reported to be 95.3% (N=86)
- ODI and VAS Leg and VAS Back Pain scores all reported
significant improvements from baseline (p<0.001)
To learn more about the full portfolio of Orthofix solutions,
please visit us at booth #100 at the ISASS meeting.
About Orthofix
The newly merged Orthofix-SeaSpine organization is 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 São Paulo, Brazil.
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version on businesswire.com: https://www.businesswire.com/news/home/20230601005376/en/
Media Relations Denise Landry DeniseLandry@orthofix.com
214.937.2529
Investor Relations Louisa Smith, Gilmartin Group
IR@orthofix.com
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