CARLSBAD, Calif., March 01, 2021 — 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 successfully launched its proprietary SiLOTM Posterior SI Joint Fusion System (SiLO), which was designed specifically for posterior sacroiliac joint fusion.
Sacroiliac joint (SI Joint) fusion is a surgical procedure which fuses the iliac bone (pelvis) to the spine (sacrum) for stabilization. The SiLOTM Posterior SI Joint Fusion System is a single graft Posterior SI-Fusion System made of human cortical bone and was developed to provide a simple, safe, and reproducible method of stabilizing and fusing the sacroiliac joint.
The SiLO graft was designed specifically for posterior sacroiliac joint fusions and consists of three levels of ridges along its circumferential solid body to increase implant retention and stability through its unique “Dowel Anchorage Design.” The SiLO graft is shaped for enhanced 360-degree bone incorporation and includes vertical side-channels that allow for additional bone graft material during insertion for enhanced stability. The SiLO graft is implanted with custom designed, patent pending instrumentation.
Trent Northcutt, President and Chief Executive Officer of Aurora Spine, commented, “We are pleased with the recent commercial launch of Aurora’s proprietary SiLOTM Posterior SI Joint Fusion System, which we expect to be a key growth driver for Aurora into a market that has gained acceptance among key surgeons and pain interventionalists alike. Also, conducting SI Joint Fusion posteriorly is a procedure that is expected to grow immensely in the coming years, as it can be done through minimally invasive surgery (MIS) and has quicker recovery times for patients.”
In a recent BONEZONE article titled “SI Joint Fusion Market Has Rapid Growth Potential“ author Mike Evers wrote, “Minimally invasive sacroiliac (SI) joint fusion is an increasingly common treatment for patients with low back pain due to SI joint dysfunction. Therefore, it represents a high-growth potential niche in the orthopedic spine market.”
The article goes on to state, ” we see the market growing significantly in the medium-term once surgical volumes normalize to pre-COVID levels. The 2019 SI joint fusion market ranged between $150 million to $250 million globally, with double-digit annual growth according to our estimates.”1
Technical Summary
In conjunction with the launch, the company issued a cadaver-based biomechanical investigation whitepaper on the performance of the SiLO graft, which is circular, against a rectangular-shaped graft. The rectangular-shaped graft was placed in the left sacroiliac joint and tested. The SiLO graft was placed in the right sacroiliac joint and tested. The experiment was conducted in a cadaver-based multi-directional bending model. The results showed that the SiLO graft immobilized the sacroiliac joint at the graft site and was more effective at doing so because it interlocks with the sacral and iliac bones. The SiLO graft also had a more effective interlock because it is larger, and its round reamer cuts a precise, highly congruent channel.
In addition, the flexion-extension centers were located posterior and caudal to the joints in the intact samples. The centers of motion moved towards the location of the grafts for both the SiLO graft placement and the rectangular-shaped graft placement. The center of motion moved directly over the SiLO graft after placement, which is optimal for bony fusion; while the center of motion failed to move over the rectangular-shaped graft, indicating less effective fixation.
Laszlo Garamszegi, Chief Technology Officer and Aurora Spine, added, “We are also happy to share the results of the work conducted by industry professionals and Aurora’s engineering team in our recent biomechanical whitepaper, which had very positive results. Part of the exercise was to test the simplicity of applying the SiLO to the sacroiliac joint, but at the same time were also able to see how its ability to be precisely placed performs against a more traditional SI Joint Fusion graft. The SiLO performed extremely well during the testing and we look forward to sharing this data with surgeons and pain interventionalists.”
To access the whitepaper in its entirety, go to: https://aurorapaincare.com/s/F220149_A-SILO-Biomechanics-Whitepaper.pdf.
About Aurora Spine
Aurora Spine is focused on bringing new solutions to the spinal implant and pain management markets 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.
1For the full article: https://www.bonezonepub.com/2770-si-joint-fusion-market-has-rapid-growth-potential
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
