Aclarion, Inc.

Company purpose

Aclarion is a healthcare technology company that uses Magnetic Resonance Spectroscopy (MRS) and proprietary biomarkers to optimize clinical treatments for spine-related pain, with a focus on discogenic low back pain (DLBP) and plans to expand to neck pain.

Core products and technology

• NOCISCAN: Software platform that analyzes MRS data to identify chemical biomarkers in intervertebral discs and reports which discs are consistent with pain.
• NOCICALC: MRS spectral processor that converts raw NOCISCAN data into spectra and performs degeneration/pain biomarker calculations; FDA Class I medical device (registered; 510(k)-exempt).
• NOCIGRAM: Post-processed report and NOCISCORE outputs (0–10 scale) derived from NOCICALC data; marketed as Clinical Decision Support Software under the 21st Century Cures Act (not regulated as a medical device by FDA).

Intellectual property

• Exclusive license from the Regents of the University of California (UC) for key NOCISCAN-related inventions.
• Patent portfolio (as of 12/31/2025): 28 issued U.S. patents, 7 pending U.S. patent applications; 24 granted foreign patents, 12 pending foreign applications.
• Patent families cover signal processing for MRS, diagnostic methods using MRS biomarkers, scanner-related improvements, and future pipeline concepts including AI-enhanced MRS.
• U.S. patent expirations generally range from 2026 to 2037 (subject to extensions and maintenance).

Market scope and opportunity

• The U.S. low back and neck pain market is among the largest healthcare spenders; U.S. LBP/neck pain costs were cited at roughly $134.5 billion (2020 JAMA reference).
• Initial near-term focus is the discogenic LBP market. The initial addressable market for NOCISCAN is the roughly $10 billion in U.S. spine fusion procedures, with potential expansion to an approximately $40 billion market when pre-surgical and conservative therapies are included.
• Practical market barriers include limited deployment of spectroscopy software across MRIs and compatibility with only certain MR scanner models.

Customers and commercial footprint

• RadNet: Three fully operational NOCISCAN imaging centers are owned or operated by RadNet (RadNet operates about 430 outpatient imaging centers nationwide).
• Revenue in the U.S. and U.K. has largely come from direct patient payments and a few payer interactions; in the U.K., three insurers reimburse the NOCISCAN scan.
• In Q1 2025, Aclarion engaged its first customer using Philips MRS capabilities on the NOCISCAN platform, expanding beyond Siemens compatibility.
• Alphatec Spine (ATEC) is a strategic partner with a co-marketing and distribution framework to evaluate NOCISCAN with select surgeon networks and potentially extend access via Alphatec’s channels.

People

• As of December 31, 2025: 10 full-time employees, 1 part-time employee, 1 full-time consultant, and 2 part-time consultants.
• As of January 1, 2026: 11 total employees across R&D, strategy/business development, and administration.

Regulatory status

• United States
  • NOCICALC: Class I, 510(k)-exempt device (FDA registered).
  • NOCIGRAM: Positioned as Clinical Decision Support Software under the 21st Century Cures Act (not regulated as a medical device by FDA).
• European Union / United Kingdom
  • NOCISCAN is CE-marked as Class I (self-certified under the previous Medical Devices Directive); transition to MDR classification as Class IIa with Notified Body review planned prior to December 31, 2028.
  • Brexit implications apply; the UK market is transitioning to UKCA/UK regulatory pathways.
• Privacy and data handling: Subject to HIPAA, GDPR, and related privacy/security regulations; data processing and cross-border transfers are a compliance focus.

Reimbursement and codes

• U.S. CPT codes: Four Category III CPT codes were established in 2021 for MRS-based intervertebral disc assessment (0609T, 0610T, 0611T, 0612T). These are temporary codes that the company seeks to convert to Category I via evidence from registries and trials (e.g., CLARITY Trial).
• The company is pursuing payer coverage, CPT code conversion, and potential APG/industry reimbursement pathways; current revenue relies on patient payments and U.K. payer arrangements.

Pipeline, R&D, and clinical evidence

• Gornet Study (published 2019, European Spine Journal) showed high correlation between discs identified as painful by NOCISCAN and improved surgical outcomes when those discs were treated; two-year outcomes (April 2023) showed durable improvements when identified discs were treated.
• CLARITY Trial and additional studies are planned to support reimbursement and potential label expansions.
• R&D priorities include AI/machine learning integration, expansion to cervical discs, integration with regenerative and cell therapies, and broader pain management pathways.

Partnerships and strategic relationships

• Siemens: Longstanding collaboration since 2017 covering joint development and potential commercial integration, with termination rights for either party.
• Philips: Collaboration began in 2025 to extend MRS capability beyond Siemens-compatible scanners.
• RadNet: Operates three NOCISCAN-enabled imaging centers, providing a pathway to scale in the U.S. outpatient imaging market.
• Alphatec Spine (ATEC): Strategic partnership announced January 2024, including potential exclusive distribution rights and integration with Alphatec’s ecosystem.

Financial runway and funding

• Company-stated cash resources are sufficient to fund operating plans into the first quarter of 2028.
• Public financing activity: IPO occurred in April 2022. An indexed milestone payment related to the UC license was paid May 2, 2022 ($123,828).
• Further capital may be needed to support expansion, clinical studies, payer negotiations, and scaling operations.

Operations

• The company operates with a single operating segment.
• Business model combines software products (NOCICALC/NOCIGRAM) with service relationships involving MR scanner owners/operators and imaging centers.
• Management emphasizes ongoing data collection and registry-building (clinical registries and CLARITY) to train models and demonstrate clinical and economic value.

Location and contact

• Headquarters: 8181 Arista Place, Suite 100, Broomfield, Colorado 80021.
• Website: www.aclarion.com