Aclarion and ATEC Execute Strategic Partnership Agreement to Advance Commercialization of Nociscan

January 08, 2024 at 08:00 AM EST

Partnership aims to include Aclarion’s surgical decision support technology within ATEC’s AlphaInformatiX platform to better inform spine surgery

Aclarion’s Nociscan is the first augmented intelligence platform to measure pain biomarkers in the lumbar spine to help physicians identify the location of chronic low back pain

BROOMFIELD, CO - (NewMediaWire) - January 08, 2024 - Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence algorithms to help physicians identify the location of chronic low back pain, announced today that it has executed a strategic partnership agreement solidifying the previously signed non-binding Letter of Intent (“LOI”) with Alphatec Spine, Inc., the wholly owned operating subsidiary of Alphatec Holdings, Inc. (Nasdaq: ATEC).

Uniting the unique structural information powered by ATEC’s AlphaInformatiX platform with the innovative biomarker data that enables Aclarion’s Nociscan solution to help identify potentially painful discs will provide surgeons with unprecedented data on one platform. That platform will be designed to improve clinical outcomes, while reducing overall procedural costs for patients with chronic low back pain (cLBP).

The agreement memorializes a multi-step strategic partnership in which ATEC and Aclarion have committed to work together to identify key opinion leader (KOL) surgeons to evaluate the Nociscan technology. Feedback from the surgeons will inform clinical evaluations designed to assess the utility of Nociscan in conjunction with EOS imaging, the foundation of ATEC’s AlphaInformatiX platform. As positive synergies emerge, ATEC and Aclarion intend to co-market Nociscan in targeted markets. In exchange for select access to ATEC’s surgeon network for the evaluation and advancement of Nociscan, Aclarion has agreed to provide ATEC with certain exclusive distribution rights to include Nociscan as part of an integrated procedural solution.

Pat Miles, Chairman and CEO of ATEC, commented, “Moving from our previously signed LOI to this agreement in just a matter of weeks demonstrates our shared vision for the solution we can create together. We share an intent to move through the phases of the agreement efficiently and have already identified internal leaders and resources to accomplish the first phase in the weeks to come. We believe in the importance of biochemical markers within the treatment paradigm and by partnering with Aclarion, we can progress toward a mutual objective to integrate and advance technologies that improve the predictability and reproducibility of spine patient care.”

Aclarion’s proprietary decision-support tool, Nociscan, is the first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Nociscan objectively quantifies chemical biomarkers demonstrated to be associated with disc pain. Biomarker data is entered into proprietary algorithms to highlight if a disc may be a source of pain. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving physicians clarity to optimize treatment strategies.

Aclarion’s published trials confirm the comparative advantage of Nociscan in achieving differentiated surgical outcomes. In April 2023, a peer-reviewed publication demonstrated that the success rate at two years for discogenic low back pain surgeries was 85% for patients whose treatment strategy was consistent with Nociscan-identified discs; a 22 percentage point improvement over patients whose treatment strategy was inconsistent with Nociscan-identified discs (85% vs. 63%; p=0.07).^{^[1]}

“With ATEC, our Nociscan solution can accelerate progress through our stated standard of care strategy,” said Brent Ness, CEO of Aclarion. “KOL advocacy, evidence accumulation, and increasing scan volume mirrors what we have agreed to in the first three phases of this agreement. The expertise, reach, and resources of our partner give us tremendous confidence that we will succeed. We believe that bundling Nociscan, which helps to identify the source of pain in an evaluation process, with the critical clinical data provided by ATEC’s AlphaInformatiX platform will lead to better outcomes - a thesis we intend to prove in the upcoming months.”

Chronic low back pain is a global healthcare problem that impacts approximately 266 million people worldwide. Conventional imaging and diagnostics provide valuable structural information but are limited in identifying the source of the pathogenic pain.

About Aclarion, Inc.

Aclarion is a healthcare technology company that leverages magnetic resonance spectroscopy (MRS), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms to optimize clinical treatments. The Company is first addressing the chronic low back pain market with Nociscan, the first, evidence-supported, SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Through a cloud connection, Nociscan receives magnetic resonance spectroscopy (MRS) data from an MRI machine for each lumbar disc being evaluated. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers demonstrated to be associated with disc pain. Biomarker data is entered into proprietary algorithms to indicate if a disc may be a source of pain. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving physicians clarity to optimize treatment strategies. For more information, please visit www.aclarion.com.

About ATEC

Alphatec Holdings, Inc., through its wholly owned subsidiaries, Alphatec Spine, Inc., EOS imaging S.A.S. and SafeOp Surgical, Inc., is a medical device company dedicated to revolutionizing the approach to spine surgery through clinical distinction. ATEC’s Organic Innovation Machine^TM is focused on developing new approaches that integrate seamlessly with the Company’s expanding AlphaInformatiX Platform to better inform surgery and more safely and reproducibly achieve the goals of spine surgery. ATEC’s vision is to be the Standard Bearer in Spine. For more information, visit us at www.atecspine.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about the Company's current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes" and "expects" or similar expressions, are forward-looking statements. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the Company's current plans and expectations, as well as future results of operations and financial condition. These and other risks and uncertainties are discussed more fully in our filings with the Securities and Exchange Commission. Readers are encouraged to review the section titled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2022, as well as other disclosures contained in the Prospectus and subsequent filings made with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Disclosure

The information stated above was prepared by Aclarion and reflects solely the opinion of Aclarion. Nothing in this statement shall be construed to imply any support or endorsement of Aclarion or any of its products by ATEC.

Investor Contacts:

Kirin M. Smith

PCG Advisory, Inc.

646.823.8656

ksmith@pcgadvisory.com

Media Contacts:

Jodi Lamberti

SPRIG Consulting

612.812.7477

jodi@sprigconsulting.com

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Aclarion and ATEC Execute Strategic Partnership Agreement to Advance Commercialization of Nociscan

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