Aclarion, Inc. announced that the Company has executed a non-binding Letter of Intent to form a strategic partnership with ATEC Spine, Inc., the wholly owned operating subsidiary of Alphatec Holdings, Inc. Uniting the unique structural data powered by ATEC?s AlphaInformatiX, with the innovative biomarker data that enables Aclarion?s Nociscan solution to identify each disc as painful or not, will provide surgeons with unprecedented data across one platform. The platform is designed to improve clinical outcomes while reducing overall procedural costs for patients with chronic back pain. 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, Aclarion announced a published, peer-reviewed, 85% success rate at 2 years for discogenic low back pain surgeries for patients whose treatment strategy was consistent with Nociscan-identified discs. This result was a 22%point improvement over patients whose treatment strategy was inconsistent with Nociscan-identified discs (85% vs.

63%; p=0.07). The LOI contemplates a multi-step strategic partnership. Under the LOI, ATEC and Aclarion will work together to identify Key Opinion Leader (KOL) surgeons to evaluate Nociscan technology.

Feedback from these surgeons will inform clinical evaluations designed to assess the utility of Nociscan in conjunction with EOS imaging, the foundation of ATEC?s AlphaInformatiX platform. Assuming positive synergies, ATEC and Aclarion will co-market Nociscan in targeted markets. In exchange for select access to ATEC?s surgeon network for the evaluation and advancement of Nociscan, Aclarion will provide ATEC with 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 disease and low back pain. Conventional imaging and diagnostics provide valuable structural information but are limited in identifying the source of the pathogenic pain.