Aurora Spine Announces FDA 510(k) Clearance for the AERO™ Facet Fusion System
Rhea-AI Summary
Aurora Spine (OTCQB: ASAPF) has received FDA 510(k) clearance for its new AERO™ Facet Fusion System, a minimally invasive solution for facet joint-related pain and instability. The patent-pending device is cleared for spinal levels C2 to S1 and can be used as a standalone procedure or alongside larger spinal fusion surgeries.
The system is specifically designed for patients with mechanical back pain, minor instability, or degenerative joint disease who haven't responded to conservative therapies. Initial surgeries with AERO are scheduled to begin in late Q3 2025, accompanied by a clinical study to validate outcomes and long-term benefits.
The AERO system features intuitive instrumentation and implant technology aimed at promoting bone fusion while minimizing soft tissue disruption, aligning with the company's focus on patient-first, surgeon-friendly innovations.
Positive
- FDA 510(k) clearance received for new AERO™ Facet Fusion System
- System can be used both as standalone and complementary procedure
- Clinical study planned to validate outcomes
- Early surgeon feedback reported as overwhelmingly positive
Negative
- Commercial revenue from AERO system won't start until late Q3 2025
- Long-term clinical benefits yet to be validated through studies
News Market Reaction – ASAPF
On the day this news was published, ASAPF gained 11.93%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
CARLSBAD, Calif., March 25, 2025 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a leader in innovative spine and interventional pain management solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Company’s newest product, the AERO™ Facet Fusion System.
The AERO MIS Facet Fusion System is a novel, patent-pending device designed to provide a minimally invasive solution for patients suffering from facet joint-related pain or instability. Cleared for use from spinal levels C2 to S1 (inclusive), the system can be used as a stand-alone facet fusion procedure or as an adjunct to larger spinal fusion surgeries.
Engineered for earlier use in the continuum of care, AERO is ideal for patients experiencing mechanical back pain, minor instability, or degenerative joint disease who have not responded to conservative therapies. The system incorporates intuitive instrumentation and implant technology designed to promote bone fusion while minimizing soft tissue disruption—aligning with Aurora Spine’s commitment to advancing patient-first, surgeon-friendly innovations.
Initial surgeries utilizing the AERO system are expected to begin in late Q3 2025, with several leading spine surgeons already selected to participate in an initial clinical study aimed at validating the device’s clinical outcomes and long-term benefits.
“We are thrilled to receive FDA clearance for the AERO system, which represents the next evolution of our innovation pipeline,” said Trent Northcutt, President and CEO of Aurora Spine. “This system was purpose-built for physicians treating facet joint issues and offers a streamlined, user-friendly solution. Like all Aurora products, AERO balances clinical efficacy with procedural simplicity. Early feedback from surgeon testing has been overwhelmingly positive, and we believe AERO has the potential to become a significant growth driver for Aurora.”
Laszlo Garamszegi, Chief Technology Officer of Aurora Spine, added: “The AERO Facet Fusion System represents a significant step forward in our efforts to provide physicians with intuitive and effective tools. We’re proud of the thoughtful engineering behind this system, which reflects our commitment to improving patient care through innovation. It’s a privilege to see this technology reach this milestone and prepare to make a positive impact in the field of spinal surgery.”
About Aurora Spine
Aurora Spine is focused on bringing new solutions to the spinal implant market through a series of proprietary, minimally invasive, and regenerative technologies. The company is committed to improving surgical outcomes through innovation, efficiency, and patient-centered design.
For more information, visit: www.aurora-spine.com
Forward-Looking Statements
This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, many of which are beyond Aurora Spine’s control. Forward-looking statements include, but are not limited to, statements regarding the expected use and success of the Company’s products, including the AERO Facet Fusion System. Actual results may differ materially. Please refer to Aurora Spine’s final prospectus and public filings for additional information on risks and uncertainties.
These forward-looking statements speak only as of the date of this release. Aurora Spine undertakes no obligation to revise or update them to reflect future events or circumstances.
Contacts:
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
Investor Contact:
Adam Lowensteiner
Lytham Partners
(646) 829-9702
Email: asapf@lythampartners.com
FAQ
When will Aurora Spine (ASAPF) begin initial surgeries with the AERO Facet Fusion System?
What spinal levels is the AERO Facet Fusion System cleared for by the FDA?
What conditions can be treated with Aurora Spine's AERO Facet Fusion System?
How can the AERO Facet Fusion System be implemented in spinal procedures?
