For Release: 7:00 am EST on October
Facet Solution’s ACADIA™ implant demonstrates
positive clinical results after one year follow up
LOGAN, UTAH (October 15, 2007) – Facet Solutions, Inc.
announced today that it has completed one year follow-up on the
first cohort of patients to receive its ACADIA™ Facet Replacement System (ACADIA™). The clinical outcomes for these patients
at one year include a significant decline in leg and back pain;
improved motion and function; and no post-operative complications.
Additionally, the first patient in the ACADIA™ study has
completed the two year follow up evaluation with similarly positive
The ACADIA™ has been developed by Facet Solutions, Inc.
to provide patients with lumbar spinal stenosis and facet degeneration
a motion preserving alternative to lumbar spinal fusion. The
ACADIA™ procedure includes replacing the diseased facet joint
with an anatomic implant that restores the natural motion, stability,
and balance to the lumbar spine.
An international team of Orthopedic surgeons began the initial
ACADIA™ study at the Hospital Servidor Publico Estadol in
São Paulo in late September 2005. The team included Dr.
Allen Carl of Albany Medical Center in Albany, New York and Dr.
Carlos Oliveira of São Paulo, Brazil.
“I believe that the early clinical results for the ACADIA™ clearly
demonstrate that this new Treatment option is improving the quality
of life for my patients who would otherwise lose significant
motion using current fusion or dynamic stabilization devices,” Dr.
Oliviera stated. "In fact, many of my patients were having
fusions and would come back four and five years later needing
a subsequent fusion at adjacent levels as a result of the reduction
in motion at the original fused level of the spine. I anticipate
that this technology will ultimately become the surgical standard
of care for spinal stenosis patients in the future.”
“Facet Solutions is very pleased with the early clinical
experience”, added Eric Bannon, VP of Clinical Affairs. “The
company looks forward to expanding this clinical outcome data
with results from an ongoing FDA approved IDE Study which was
recently expanded to eight sites within the United States.”
The summary findings from this evaluation will be presented
a the Science of Facet Joint Repair and Total Posterior Arthroplasty
Symposium which will be held in Austin, Texas at the Omni Hotel
on Monday, October 22, 2007 at 6:30 PM.
*Note: ACADIA™ is an investigational device in the United
States. It is limited by United States (U.S.) Federal Law for
investigational use only.
About Facet Solutions
Facet Solutions, Inc. is a privately held, venture backed company
that is focused on developing and commercializing surgical devices
for the Treatment of facet related spinal disorders. Facet Solutions
has received venture capital from its partners De Novo Ventures,
Pequot Ventures, and Spray Venture Partners. Facet Solutions
is FDA registered and is certified to ISO 13485.
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VP of Sales and Marketing
Facet Solutions, Inc.