Aurora Spine Receives IRB Multi-Site Selection Approval for its DEXA-C™ Cervical Interbody System
April 04 2023 - 7:30AM
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 it has received Institutional Review Board (IRB)
multi-site selection approval for its new multicenter study of
DEXA-C™ Cervical Interbody System. The study has selected seven
sites with three submitted for approval. After approval, patient
enrollment is expected to begin. The study will initially include
data from 40 single level and 40 multiple level subjects.
The DEXA-C system is indicated for anterior
cervical interbody fusion procedures and is the first in a series
of implants based on Aurora’s patented DEXA™ technology platform.
Based on the DEXA T-score for measuring a patient’s bone density,
the DEXA technology platform includes implants that are of varying
densities to match a patient’s bone density. DEXA-C is intended for
use on patients who require anterior cervical discectomy and fusion
surgery. The DEXA-C system implants an interbody spacer(s) into the
cervical intervertebral body space(s) to stabilize and fuse the
level(s). Allograft will be used in the spacer and the spinal
segment(s) are fixed with an anterior cervical plate.
Mr. Trent Northcutt, Aurora’s President, CEO,
and co-founder, stated, "We are pleased to move forward with the
next step of the multicenter study for DEXA-C by having several
sites approved and ready for enrollment. We’ll be sure to make
periodic updates of this study, with the next steps being the
enrollment of patients at these locations. The data from this study
will be very important to doctors’ thinking about using the DEXA-C
series of implants and will help build out our DEXA franchise.”
Principal Investigator Dr. Sebastian Koga said:
“This prospective trial is the first clinical study in a decade to
address a new biomaterial in spine. I am excited to participate in
a landmark project and look forward to elucidate the role of softer
materials in the biology of bone fusion.” Dr. Koga is a
neurosurgeon at Forrest Health Institute of Neuroscience and
Director of Koga Neurosurgery and has the largest experience
nationally with this new biomaterial.
Dr. Steven Falowski, a Functional Neurosurgeon
in Lancaster, PA, commented, “This is the next step in spinal
fusion surgery to assure improved patient outcomes and counter some
of the common limitations with graft implants such as subsidence. I
am glad to move forward with this study to demonstrate its utility
with clinical data."The primary outcomes of interest for this study
will be fusion assessment with patient follow-up visits at 3
months, 6 months, 12 months, and 24 months post-surgery. Included
in the data collection will be fusion assessment from Static and
Dynamic X-Ray (AP/LAT/Flex/Ex) using the following criteria:
bridging bone inside or outside of graft; no lucencies at the
graft-vertebral body junction; and motion < 1mm.
The secondary outcome measures will include
subsidence and alignment assessments. Patient reported outcomes
(NDI and VAS) will be collected at follow up visits and assessed
compared to baseline.
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. Additional information can be accessed at
www.aurora-spine.com or www.aurorapaincare.com.
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 Northcutt
President and Chief Executive Officer
(760) 424-2004
Chad Clouse
Chief Financial Officer
(760) 424-2004
www.aurora-spine.com
Adam Lowensteiner
LYTHAM PARTNERS, LLC
Phoenix | New York
Telephone: 646-829-9700
asapf@lythampartners.com
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