Aurora Spine Corporation Announces Positive Interim Results from Clinical Study using ZIP™ MIS Interspinous Fusion System

Rhea-AI Summary

Aurora Spine Corporation recently announced positive interim results from the REFINE Study on its ZIP™ MIS Interspinous Fusion System. The study, involving 54 patients, showed that 82% of participants experienced improvement after 3 months, with 65% reporting significant enhancements in pain and function. This data, published in Pain and Therapy, highlights the device's effectiveness and safety. Conducted by 11 doctors, the study aims to address the significant unmet need in treating lumbar spinal stenosis. Further results are expected at the 12-month follow-up.

Positive

• 82% of patients reported improvement after using ZIP device.
• 65% of patients showed significant enhancement in pain and function.
• Study demonstrates both effectiveness and safety of ZIP device.
• Ongoing patient enrollment for further data collection.

Negative

• None.

Initial results show ZIP device to be effective and safe

CARLSBAD, Calif., Oct. 27, 2022 (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 positive interim results from a clinical study using the ZIP™ MIS Interspinous Fusion System. The results were published in an abstract posted in Pain and Therapy, titled "A Prospective, Observational, Open-Label, Non-Randomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Fusion Device in Subjects with Low Back Pain: REFINE Study".

The publication discussed the results of the interim 3-month analysis, which included 54 patients, of which 82% reported improvement as a result of the procedure, while 65% of the patients demonstrated clinical meaningful improvement in their pain and function. The publication also demonstrated that the use of the ZIP device was both effective and safe at the 3-month follow-up. This study remains active and enrollment is continuing, with more follow-up data expected in the future as more patient data is compiled.

The study included results gathered from 11 doctors and was conducted on behalf of Aurora Spine to determine the utility of using interspinous fusion devices as a fusion therapy for the treatment of lumbar spinal stenosis. The treatment of lumbar spinal stenosis has a large unmet treatment need that bridges the gap between conservative measures and invasive surgical procedures.

Dr. Steven Falowski, a Functional Neurosurgeon in Lancaster, PA and lead investigator in this study stated, “The 3-month clinical data in the Prospective multicenter REFINE Study is landmark in demonstrating the safety and effectiveness of a minimally invasive interspinous fusion with the Aurora ZIP implant. This opens access to more patients, who otherwise may not have had treatment options or wanted to avoid larger open spinal procedures, to receive innovative care to restore their quality of life. It is the first of its kind to collaborate with surgeons and interventional pain physicians, and also bridges the gap between conservative measures and larger open spinal procedures. I am excited to continue to follow these patients for their long-term outcomes in the study."

Trent Northcutt, President and Chief Executive Officer of Aurora Spine, commented, "This publication is an exciting validation of Aurora Spine’s ability to provide safe and effective outcomes by utilizing the Aurora Zip product line. We look forward to additional results published at the 12-month collection point and believe it will continue to trend positively for our physicians and their patients.”

In addition to Steven Falowski, other participants in the study are Drs. Louis J. Raso, Jupiter Medical Center, Jupiter, FL; Vip Mangal, National Spine and Pain Centers, Oxon Hill, MD; Ali Narizi, Reno Tahoe Pain Associates, Reno, NV; Denis G. Patterson, Nevada Pain Specialists, Reno, NV; Michael D. Danko, Premier Pain Treatment Institute, Loveland, OH; Rafael Justiz, Oklahoma Pain Physicians; Rainer S. Vogel, Comprehensive and Interventional Pain Management, Henderson, NV; Sebastian Koga, Koga Neurosurgery, Covington, LA; Yousseff Josephson, National Spine and Pain Centers, Voorhees, NJ; and Jason E. Pope, Evolve Restorative Center, Santa Rosa, CA.

Dr. Raso will be presenting this data at the upcoming American Society of Pain & Neuroscience (ASPN) Innovation Summit on December 9-10 at The Bellagio Hotel in Las Vegas.

A copy of the full publication can be accessed at: https://rdcu.be/cXY1C.

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 were the key findings of the REFINE Study for ASAPF?

The REFINE Study found that 82% of patients using the ZIP device experienced improvement, with 65% achieving significant enhancements in pain and function.

What is the significance of the interim results for ASAPF?

The interim results validate the safety and effectiveness of Aurora Spine's ZIP device, potentially impacting its market position in spinal surgery.

When will further results from the REFINE Study be available for ASAPF?

Additional results are expected at the 12-month data collection point following the ongoing enrollment of patients.

Who conducted the REFINE Study for the ZIP device associated with ASAPF?

The study was conducted by 11 doctors specializing in spinal treatments.

What does the REFINE Study aim to address for ASAPF?

The REFINE Study aims to address the treatment needs of lumbar spinal stenosis between conservative and invasive surgical options.