Aurora Spine Receives FDA 510(K) Clearance for Its Proprietary APOLLO Anterior Cervical Plate
CARLSBAD, Calif., March 25, 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, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its proprietary APOLLO Anterior Cervical Plate (ACP) system, featuring a sleek 1.9mm design, with Hyper-Angulation™ variability in the Cephalad-Caudal screw angulation of 32° – Freedom to Angulate™.
The new ACP system challenges the status quo of cervical spine technology. It is designed to help reduce common postoperative complications, such as dysphagia, malalignment, and adjacent level ossification, by enabling surgeons to customize treatment to patient needs versus a traditional one-size-fits-all approach, and consists of:
- Freedom to Angulate, including Hyper-Angulation™ screw variability, to optimized performance for each surgical level to support construct stability.
- A wide array of implant length options to match a variety of patient anatomies and to facilitate maximizing the distance from the adjacent levels; and
- A range of advanced screw offerings with fixed and variable angles to enable better screw placement and locking accuracy.
- APOLLO™ is part the DEXA™ family of products: positioned to reshape the market through patent focused innovation and address the next advancement in spine surgery – DEXA Interbody Technology.
“There are an estimated 180,000 cervical fusion procedures performed in the United States each year to relieve compression on the spinal cord or nerve roots. Receiving FDA 510(k) clearance for the APOLLO™ (ACP) system reflects Aurora Spine’s commitment to deliver innovative, modern technology for the anterior cervical spine and to support positive clinical outcomes,” said Trent Northcutt, President and CEO, at Aurora Spine. “The launch of APOLLO™ (ACP) is key to our long-term cervical implant strategy and represents a significant opportunity for growth, as cervical spine procedures comprise an approximately $2.6 billion segment of the global spine market.”
Mr. Northcutt added, “This approval is an important piece to the puzzle for advancing Aurora Spine’s key initiative of bringing more proprietary-based products to the marketplace and decreasing our reliance on third-party products. Sales of cervical plates in fiscal 2019 represented approximately 10% of revenues for Aurora and the APOLLO plate will enable Aurora to convert another portion of the company’s revenue base into a proprietary product and allow us to capture higher margins. This new product will also support sales of our TiNANO™ cervical cages and enable us to develop additional products around our DEXA™ patent, which matches implants to a patient’s bone density. This approval is a great step for Aurora in fiscal 2021 and we are hopeful to deliver several new key products throughout the year.”
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.
CARLSBAD, Calif., March 25, 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, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its proprietary APOLLO Anterior Cervical Plate (ACP) system, featuring a sleek 1.9mm design, with Hyper-Angulation™ variability in the Cephalad-Caudal screw angulation of 32° – Freedom to Angulate™.
The new ACP system challenges the status quo of cervical spine technology. It is designed to help reduce common postoperative complications, such as dysphagia, malalignment, and adjacent level ossification, by enabling surgeons to customize treatment to patient needs versus a traditional one-size-fits-all approach, and consists of:
- Freedom to Angulate, including Hyper-Angulation™ screw variability, to optimized performance for each surgical level to support construct stability.
- A wide array of implant length options to match a variety of patient anatomies and to facilitate maximizing the distance from the adjacent levels; and
- A range of advanced screw offerings with fixed and variable angles to enable better screw placement and locking accuracy.
- APOLLO™ is part the DEXA™ family of products: positioned to reshape the market through patent focused innovation and address the next advancement in spine surgery – DEXA Interbody Technology.
“There are an estimated 180,000 cervical fusion procedures performed in the United States each year to relieve compression on the spinal cord or nerve roots. Receiving FDA 510(k) clearance for the APOLLO™ (ACP) system reflects Aurora Spine’s commitment to deliver innovative, modern technology for the anterior cervical spine and to support positive clinical outcomes,” said Trent Northcutt, President and CEO, at Aurora Spine. “The launch of APOLLO™ (ACP) is key to our long-term cervical implant strategy and represents a significant opportunity for growth, as cervical spine procedures comprise an approximately $2.6 billion segment of the global spine market.”
Mr. Northcutt added, “This approval is an important piece to the puzzle for advancing Aurora Spine’s key initiative of bringing more proprietary-based products to the marketplace and decreasing our reliance on third-party products. Sales of cervical plates in fiscal 2019 represented approximately 10% of revenues for Aurora and the APOLLO plate will enable Aurora to convert another portion of the company’s revenue base into a proprietary product and allow us to capture higher margins. This new product will also support sales of our TiNANO™ cervical cages and enable us to develop additional products around our DEXA™ patent, which matches implants to a patient’s bone density. This approval is a great step for Aurora in fiscal 2021 and we are hopeful to deliver several new key products throughout the year.”
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.
Source: Aurora Spine Corporation
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
arosf@lythampartners.com
