Aclarion Announces Signing of Strategic Partnership Letter of Intent with ATEC to Advance Commercialization of Nociscan

ATEC is a medical device company committed to revolutionizing the approach to spine surgery through clinical differentiation

Aclarion’s Nociscan is the first augmented intelligence platform to measure biomarkers of intervertebral disc health in the lumbar spine, helping doctors identify the location of chronic low back pain

BROOMFIELD, CO, October 23, 2023 (GLOBE NEWSWIRE) – via NewMediaWire —Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that uses biomarkers and proprietary enhanced intelligence algorithms to help physicians identify the location of chronic low back pain, today announced that the company has executed a non-binding Letter of Intent (“LOI”) to to form a strategic partnership with ATEC Spine, Inc., the wholly owned operating subsidiary of Alphatec Holdings, Inc. (Nasdaq: ATEC).

By combining the unique structural data powered by ATEC’s AlphaInformatiX with the innovative biomarker data that allows Aclarion’s Nociscan solution to identify each intervertebral disc as painful or not, surgeons will have unprecedented data on one platform. The platform is designed to improve clinical outcomes while reducing overall procedural costs for patients with chronic back pain.

Pat Miles, CEO of ATEC, commented: “Developing spinal technologies through innovation requires discipline, time, knowledge and resources. This collaboration with Aclarion reflects our belief in the importance of biochemical markers within the treatment paradigm. Nociscan is exactly the kind of innovation that can advance our shared goal of integrating and advancing technologies that improve the predictability and reproducibility of spine care.”

Aclarion’s proprietary decision support tool, Nociscan, is the first evidence-based SaaS platform that helps physicians non-invasively distinguish between painful and non-painful discs in the lumbar spine. Nociscan objectively quantifies chemical biomarkers shown to be associated with disc pain. Biomarker data is fed into proprietary algorithms to indicate whether a disc may be a source of pain. When combined with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving clinicians clarity to optimize treatment strategies.

Aclarion’s published studies confirm the comparative advantage of Nociscan in achieving differentiated surgical outcomes. In April 2023, Aclarion announced a published, peer-reviewed 85% 2-year success rate for discogenic low back pain surgery in patients whose treatment strategy was consistent with Nociscan-identified discs. This result was a 22 percentage point improvement over patients whose treatment strategy was inconsistent with Nociscan-identified discs (85% vs. 63%; p=0.07).¹

^{1 https://pubmed.ncbi.nlm.nih.gov/37014434/}

“We share a common vision with ATEC on the value of advanced decision support information to improve patient care. This strategic partnership is an important milestone for Aclarion. Pat and the ATEC team are revolutionizing spine surgery, and we appreciate their support,” said Brent Ness, CEO of Aclarion.

The LOI is considering a multi-step strategic partnership. Under the LOI, ATEC and Aclarion will work together to identify Key Opinion Leader (KOL) surgeons who can evaluate the Nociscan technology. Feedback from these surgeons will form the basis for clinical evaluations designed to assess the utility of Nociscan in combination with EOS imaging, the foundation of ATEC’s AlphaInformatiX platform. Based on positive synergies, ATEC and Aclarion will jointly commercialize Nociscan in specific markets. In exchange for selected access to ATEC’s surgeon network for the evaluation and development of Nociscan, Aclarion will grant ATEC certain exclusive distribution rights to include Nociscan as part of an integrated procedural solution.

Chronic low back pain (cLBP) is a global healthcare problem with approximately 266 million people worldwide suffering from degenerative spine disorders and low back pain. 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 uses magnetic resonance spectroscopy (“MRS”), proprietary signal processing techniques, biomarkers and enhanced intelligence algorithms to optimize clinical treatments. The company is entering the chronic low back pain market for the first time with Nociscan, the first evidence-based SaaS platform that helps physicians non-invasively distinguish between painful and non-painful 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 shown to be associated with disc pain. Biomarker data is fed into proprietary algorithms to indicate whether a disc may be a source of pain. When combined with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving clinicians clarity to optimize treatment strategies. For more information please visit www.aclarion.com.

About ATEC

Alphatec Holdings, Inc. is, through its wholly owned subsidiaries, Alphatec Spine, Inc., EOS imaging SA and SafeOp Surgical, Inc., a medical device company committed to revolutionizing the approach to spine surgery through clinical differentiation. ATEC’s organic innovation machine^T.M is focused on developing new approaches that integrate seamlessly with the company’s growing AlphaInformatiX Platform to better inform surgery and achieve the goals of spine surgery more safely and reproducibly. ATEC’s vision is to be the standard bearer in the spine field. 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 management’s current plans and expectations and are subject to a number of uncertainties and risks that could materially affect the company’s current plans and expectations, as well as its future results of operations and financial condition. These and other risks and uncertainties are discussed in more detail in our filings with the Securities and Exchange Commission. Readers are encouraged to read the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, as well as other disclosures in the prospectus and subsequent filings with the Securities and Exchange Commission. . Forward-looking statements 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.

Revelation

The information above has been prepared by Aclarion and reflects the opinion of Aclarion only. Nothing in this statement should be construed as any endorsement or approval of Aclarion or any of its products by ATEC.

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