Aurora Spine receives IRB approval to commence registration for Multicenter Study of its SiLO™ Device for SI Joint Pain
06 May 2021 - 10:15PM
Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV:
ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative
medical devices that improve spinal surgery outcomes, today
announced that it has received Institutional Review Board (IRB)
approval for its new multicenter study of its SiLOTM SI Fusion
System, which is intended for use on patients who require
sacroiliac joint fusion surgery. The system implants a bone
allograft into the SI joint to stabilize and fuse the joint.
The IRB is an FDA registered constituted group that has been
formally designated to review and monitor biomedical research
involving human subjects. In accordance with FDA regulations, an
IRB has the authority to approve, require modifications (to secure
approval), or disapprove research. This group review serves an
important role in the protection of the rights and welfare of human
research subjects.
The SiLO registry will be conducted at up to 11 investigative
sites in the United States and is anticipated that data from up to
60 subjects will be entered into the registry.
Trent Northcutt, Aurora’s President, CEO and co-founder stated,
"In the past few months, Aurora has been conducting advanced
training sessions and cadaver labs that introduced leading
neurosurgical, orthopedic and pain management physicians to the
SiLOTM SI Fusion System. With many procedures already completed,
the SiLO system has been safe and effective in an outpatient
setting. The IRB approval allows Aurora to launch a multicenter,
prospective clinical study to investigate the efficacy of the SiLO
device managing low back pain and improving quality of life in
patients suffering from SI Joint pain."
“This registry aims to provide interventional pain physicians in
the United States with clinical data that supports the safety and
effectiveness of the SiLO sacroiliac fixation technique. I am
excited to be part of the study and to train others so that we can
continue to advance therapies that relieve pain and restore
function,” said Jack Diep, M.D., a Pain Medicine Specialist in Lake
Havasu City, AZ. Dr Diep has adopted this therapy with his patients
as a minimally invasive alternative approach. Dr. Diep stated, "The
launch of this registry will give the ability to produce published
clinical outcomes utilizing a minimally invasive option to treat
sacroiliac pathology."
"SiLO carries features within the implant design and
instrumentation that leads to a congruent fit of the graft within
the sacroiliac joint allowing proven biomechanical stability with a
single graft approach to posterior fixation,” said Steven Falowski,
M.D., Director of Functional Neurosurgery at Argires-Marotti
Neurosurgical Associates of Lancaster, PA . “The IRB approval to
start the registry will now allow Aurora to obtain real world
clinical evidence in its patients to demonstrate the efficacy and
utility of this truly minimally invasive approach."
“SiLO is an efficient posterior approach procedure which results
in quicker post-op recovery times and better patient outcomes,”
said Dr. Michael Stoffman, a Neurosurgeon at University at Buffalo
Neurosurgery. “The SiLO study is an important milestone for the
physician community as we are committed to helping patients
experiencing chronic SI Joint pain by advancing the benefits of the
SiLO procedure through vigorous clinical research.”
“The SiLO Registry will provide valuable clinical data regarding
the safety and effectiveness of the SiLO system and its minimally
invasive approach,” said Anish S. Patel, MD, MBA, managing partner
at National Spine & Pain Centers. “The IRB approval for Aurora
Spine’s study is a key step in gathering clinical evidence of the
benefits of the SiLO system and its treatment of sacroiliac pain
and better patient outcomes.”
The primary outcomes for this analysis will be change in
patients’ self-reported pain, quality of life, and disability over
time. Pain, quality of life, and disability will be assessed using
the Visual Analog Scale in both the numerical and facial scales,
the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), and the
Oswestry Disability Index (ODI).
About Aurora Spine
Aurora Spine is focused on bringing new solutions to the spinal
implant market through a series of innovative, minimally invasive,
regenerative spinal implant technologies.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Forward-Looking Statements
This news release contains forward-looking information that
involves substantial known and unknown risks and uncertainties,
most of which are beyond the control of Aurora Spine, including,
without limitation, those listed under "Risk Factors" and
"Cautionary Statement Regarding Forward-Looking Information" in
Aurora Spine's final prospectus (collectively, "forward-looking
information"). Forward-looking information in this news release
includes information concerning the proposed use and success of the
company’s products in surgical procedures. Aurora Spine cautions
investors of Aurora Spine's securities about important factors that
could cause Aurora Spine's actual results to differ materially from
those projected in any forward-looking statements included in this
news release. Any statements that express, or involve discussions
as to, expectations, beliefs, plans, objectives, assumptions or
future events or performance are not historical facts and may be
forward-looking and may involve estimates, assumptions and
uncertainties which could cause actual results or outcomes to
differ unilaterally from those expressed in such forward-looking
statements. No assurance can be given that the expectations set out
herein will prove to be correct and, accordingly, prospective
investors should not place undue reliance on these forward-looking
statements. These statements speak only as of the date of this
press release and Aurora Spine does not assume any obligation to
update or revise them to reflect new events or circumstances.
Contact:
Aurora Spine Corporation
Trent NorthcuttPresident and Chief Executive Officer(760)
424-2004
Chad ClouseChief Financial Officer(760) 424-2004
www.aurora-spine.comwww.aurorapaincare.com
Adam LowensteinerLYTHAM PARTNERS, LLCPhoenix | New
YorkTelephone: 646-829-9700asapf@lythampartners.com
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