Carlsbad, Calif., April 17, 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 that initial surgeries using its proprietary SiLO TFX™ MIS Sacroiliac Joint Fixation Device have been performed in recent weeks. Over a dozen patients were implanted with the newly FDA-approved device and all procedures using the device were successful.
The patented, minimally invasive SiLO TFX MIS Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The SiLO TFX MIS Sacroiliac Joint Fixation System includes a Transfixing-Cone, an ilium screw, a sacrum screw and associated instrumentation. The SiLO TFX implants are designed to transfix the sacrum and ilium, providing stability for bony fusion.
The market opportunity for the SiLO TFX is sizable, as over 30 million people suffer from lower back pain in the U.S. alone, of which, approximately 4.7 million are SI joint pain patients and treated with non-surgical treatments. One treatment are therapeutic injections, of which there are 1.2 million administered per year. The SiLO TFX was designed for ease of implantation and uses similar approach of the injection, making the implantation seamless for doctors that already know how to administer an injection in the SI join. Longer-term suffers of SI joint pain now have minimally invasive surgical options, including the SiLO TFX, of which approximate in excess of 250,000 cases per year or more than $2.3 billion market opportunity per year in the U.S. alone.
Mr. Trent Northcutt, Aurora’s President, CEO and co-founder, stated, "We are pleased with these initial surgeries using our SiLO TFX, which is a game changing device for the industry. These surgeries will enable us to enter into the next phase of commercialization, whereby we’ve begun to build inventory and kits to gear up for a full launch of the product by mid-year.”
Dr. Michael Stoffman, Neurosurgeon at the University at Buffalo Neurosurgery, said “SiLo TFX is a seamless, precise and efficient method to safely transfix the SI joint. I believe the SiLO TFX will result in superior clinical outcomes based on our positive biomechanical data with head to head testing of other transfixing SI joint devices.”
Dr. Steven Falowski, a Functional Neurosurgeon in Lancaster, PA, commented, “The SiLO TFX marks the next chapter in treating patients safely and effectively with a minimally invasive option for sacroiliac joint fixation. It incorporates two well-known techniques of graft placement into the joint, and transfixation across the sacrum and ilium. The instrumentation allows for a smooth placement with a single small incision improving both the physician and patient experience."
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.
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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
Adam Lowensteiner
LYTHAM PARTNERS, LLC
Phoenix | New York
Telephone: 646-829-9700
