Aurora Spine Receives IRB Multi-Site Selection Approval for its DEXA-C™ Cervical Interbody System

Rhea-AI Summary

Aurora Spine has announced the approval for a multicenter study of its DEXA-C™ Cervical Interbody System, aimed at improving spinal surgery outcomes. Seven sites have been selected, three are pending approval, with patient enrollment anticipated soon. The clinical trial will involve 80 subjects, assessing the system's effectiveness in anterior cervical discectomy and fusion procedures. Aurora's patented DEXA™ technology targets varying bone densities to enhance fusion success. Key outcomes will be monitored at multiple post-surgery intervals, focusing on fusion assessment and patient-reported results.

Positive

• IRB approval received for multicenter study.
• Study includes 80 subjects, providing significant data potential.
• Use of patented DEXA technology tailored for patients' bone density.

Negative

• None.

Patient enrollment to commence

Carlsbad, Calif., April 04, 2023 (GLOBE NEWSWIRE) -- 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

FAQ

What is the purpose of Aurora Spine's multicenter study of DEXA-C?

The study aims to evaluate the effectiveness of the DEXA-C Cervical Interbody System in improving outcomes for patients undergoing anterior cervical discectomy and fusion.

How many sites are involved in the DEXA-C study?

The study has selected seven sites for participation, with three sites currently pending approval.

What are the primary outcomes being measured in the DEXA-C study?

Primary outcomes include fusion assessment through follow-up visits at 3, 6, 12, and 24 months post-surgery.

What is the significance of the DEXA technology for spinal surgery?

DEXA technology allows for implants that match varying bone densities, which is designed to enhance the success of bone fusion.

When is patient enrollment expected to begin for the DEXA-C study?

Patient enrollment is expected to commence soon after site approvals are finalized.