Aurora Spine Receives FDA 510 (K) Approval for its proprietary APOLLO Anterior Cervical Plate – OrthoSpineNews

CARLSBAD, Calif., March 25, 2021 (GLOBE NEWSWIRE) – Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), designer and manufacturer of innovative medical devices to improve spine surgery outcomes announced today that the company has approved the Food and Drug Administration (FDA) 510 (k) for its proprietary APOLLO Anterior Cervical Plate (ACP) system with a slim 1.9mm design and hyper-angulation ™ -Variability in the Cephalad has been obtained -Caudal screw angulation of 32 ° – Freedom to Angulate ™.

The new ACP system challenges the status quo of cervical spine technology. It is designed to reduce common post-operative complications such as dysphagia, malalignment, and ossification on an adjacent level by allowing surgeons to tailor treatment to the patient’s needs.

  • Freedom to angulateincluding Hyper-Angulation ™ screw variability to optimize performance for each surgical level and to aid construct stability.
  • A wide range of implant length options Fit a variety of patient anatomies and make it easy to maximize the distance from adjacent planes; and
  • A range of advanced screw offerings with fixed and variable angles for better screw placement and better locking accuracy.
  • APOLLO ™ is part of the DEXA ™ product family: positioned to reshape the market through patent-oriented innovations and tackle the next advance in spine surgery – DEXA interbody technology.

“An estimated 180,000 cervical fusion procedures are performed in the United States each year to relieve compression of the spinal cord or nerve roots. The receipt of FDA 510 (k) clearance for the APOLLO ™ (ACP) system reflects Aurora Spine’s commitment to providing innovative, advanced technology for the anterior cervical spine and supporting positive clinical outcomes, ”said Trent Northcutt, President and Aurora Spine CEO. “The introduction of APOLLO ™ (ACP) is key to our long-term cervical implant strategy and represents a significant growth opportunity as cervical spine procedures represent a segment of the global spine market of approximately $ 2.6 billion.”

Mr. Northcutt added, “This approval is an important piece of the puzzle to advance Aurora Spine’s key initiative to bring more proprietary products to market and reduce our reliance on third-party products. Sales of cervical plates in fiscal year 2019 represented approximately 10% of Aurora’s sales. With the APOLLO plate, Aurora can turn another portion of the company’s revenue base into a proprietary product and generate higher margins. This new product will also support the sales of our TiNANO ™ cervical cages and allow us to develop additional products around our DEXA ™ patent that adjusts implants to a patient’s bone density. This approval is a big step for Aurora in fiscal 2021 and we hope to deliver several new key products over the course of the year. “

About Aurora Spine

Aurora Spine is focused on providing new solutions to the spinal implant and pain management market through a range of innovative, minimally invasive, regenerative spinal implant technologies. Further information is available at www.aurora-spine.com or www.aurorapaincare.com.

Neither the 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 press release.

Forward-Looking Statements

This press release contains forward-looking information that involves material known and unknown risks and uncertainties, most of which are beyond Aurora Spine’s control, including, without limitation, those set out under “Risk Factors” and “Forward-Looking Information Caution” in the final prospectus by Aurora Spine (collectively, “Forward-Looking Information”). Forward-looking information in this press release includes information regarding the suggested uses and success of the company’s products in surgical procedures. Aurora Spine cautions investors about Aurora Spine securities of important factors that could cause actual Aurora Spine results to differ materially from those projected in forward-looking statements in this press release. All statements that express expectations, beliefs, plans, goals, assumptions or future events or performance, or involve discussions about them, are not historical facts and may be forward-looking and involve estimates, assumptions and uncertainties that may lead to actual results or results deviate unilaterally from those expressed in such forward-looking statements. There can be no assurance that the expectations set forth 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 assumes no 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), designer and manufacturer of innovative medical devices to improve spine surgery results announced today that the company has approved the Food and Drug Administration (FDA) 510 (k) for its proprietary APOLLO Anterior Cervical Plate (ACP) system with a slim 1.9mm design and hyper-angulation ™ -Variability in the Cephalad has been obtained -Caudal screw angulation of 32 ° – Freedom to Angulate ™.

The new ACP system challenges the status quo of cervical spine technology. It is designed to reduce common post-operative complications such as dysphagia, malalignment, and ossification on an adjacent level by allowing surgeons to tailor treatment to the patient’s needs.

  • Freedom to angulateincluding Hyper-Angulation ™ screw variability to optimize performance for each surgical level and to aid construct stability.
  • A wide range of implant length options Fit a variety of patient anatomies and make it easy to maximize the distance from adjacent planes; and
  • A range of advanced screw offerings with fixed and variable angles for better screw placement and better locking accuracy.
  • APOLLO ™ is part of the DEXA ™ product family: positioned to reshape the market through patent-oriented innovations and tackle the next advance in spine surgery – DEXA interbody technology.

“An estimated 180,000 cervical fusion procedures are performed in the United States each year to relieve compression of the spinal cord or nerve roots. The receipt of FDA 510 (k) clearance for the APOLLO ™ (ACP) system reflects Aurora Spine’s commitment to providing innovative, advanced technology for the anterior cervical spine and supporting positive clinical outcomes, ”said Trent Northcutt, President and Aurora Spine CEO. “The introduction of APOLLO ™ (ACP) is key to our long-term cervical implant strategy and represents a significant growth opportunity as cervical spine procedures represent a segment of the global spine market of approximately $ 2.6 billion.”

Mr. Northcutt added, “This approval is an important piece of the puzzle to advance Aurora Spine’s key initiative to bring more proprietary products to market and reduce our reliance on third-party products. Sales of cervical plates in fiscal 2019 represented approximately 10% of Aurora’s sales. With the APOLLO plate, Aurora can turn another portion of the company’s revenue base into a proprietary product and generate higher margins. This new product will also support the sales of our TiNANO ™ cervical cages and allow us to develop additional products around our DEXA ™ patent that adjusts implants to a patient’s bone density. This approval is a big step for Aurora in fiscal 2021 and we hope to deliver several new key products over the course of the year. “

About Aurora Spine

Aurora Spine is focused on bringing new solutions to the spinal implant and pain management market through a range of innovative, minimally invasive, regenerative spinal implant technologies. Further information is available at www.aurora-spine.com or www.aurorapaincare.com.

Neither the 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 press release.

Forward-Looking Statements

This press release contains forward-looking information that involves material known and unknown risks and uncertainties, most of which are beyond Aurora Spine’s control, including, without limitation, those set out under “Risk Factors” and “Forward-Looking Information Caution” in the final prospectus by Aurora Spine (collectively, “Forward-Looking Information”). Forward-looking information in this press release includes information regarding the proposed use and success of the company’s products in surgical procedures. Aurora Spine cautions investors about Aurora Spine securities of important factors that could cause actual Aurora Spine results to differ materially from those projected in forward-looking statements in this press release. All statements that express expectations, beliefs, plans, goals, assumptions or future events or performance, or involve discussions about them, are not historical facts and may be forward-looking and involve estimates, assumptions and uncertainties that may lead to actual results or results deviate unilaterally from those expressed in such forward-looking statements. There can be no assurance that the expectations set forth 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 assumes no 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
CFO
(760) 424-2004
www.aurora-spine.com
www.aurorapaincare.com

Adam Lowensteiner
LYTHAM PARTNERS, LLC
Phoenix | new York
Phone: 646-829-9700
[email protected]

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