Aurora Spine receives IRB approval to commence registration for Multicenter Study of its SiLO™ Device for SI Joint Pain

Rhea-AI Summary

Aurora Spine Corporation (OTCQB: ASAPF) announced IRB approval for a multicenter study of its SiLO^TM SI Fusion System, aimed at patients needing sacroiliac joint fusion surgery. The study will involve up to 11 investigative sites in the U.S., focusing on up to 60 subjects. The SiLO system is designed to stabilize the SI joint with bone allograft implants. The primary outcomes will evaluate changes in pain levels and quality of life for patients. This clinical evidence is intended to support the system's efficacy and safety in treating SI joint pain.

Positive

• IRB approval obtained for the SiLO SI Fusion System study.
• Multi-center study involving up to 60 subjects across 11 sites.
• Potential for improved patient outcomes and quicker recovery times with the SiLO procedure.

Negative

• None.

CARLSBAD, Calif., May 06, 2021 (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 that it has received Institutional Review Board (IRB) approval for its new multicenter study of its SiLO^TM 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 SiLO^TM 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 Northcutt
President and Chief Executive Officer
(760) 424-2004

Chad Clouse
Chief Financial Officer
(760) 424-2004

www.aurora-spine.com
www.aurorapaincare.com

Adam Lowensteiner
LYTHAM PARTNERS, LLC
Phoenix | New York
Telephone: 646-829-9700
asapf@lythampartners.com

FAQ

What is the significance of the IRB approval for ASAPF?

The IRB approval allows Aurora Spine to conduct a multicenter clinical study on the efficacy and safety of the SiLO SI Fusion System for sacroiliac joint fusion surgery.

What are the expected outcomes of the SiLO study by ASAPF?

The primary outcomes will assess changes in patients' self-reported pain, quality of life, and disability over time.

How many subjects will participate in the ASAPF SiLO study?

The study will involve data from up to 60 subjects across 11 investigative sites in the U.S.

When was the IRB approval for the SiLO study announced by ASAPF?

The IRB approval was announced on May 6, 2021.