Company Overview Summary

Company Name

• Aclarion, Inc. (formerly Nocimed, Inc.)

Business Focus

• Healthcare technology company specializing in non-invasive diagnostics for low back and neck pain, using Magnetic Resonance Spectroscopy (MRS) and proprietary biomarkers.
• Aims to improve diagnosis of painful intervertebral discs, particularly discogenic low back pain (DLBP), and support surgical decision-making.
• Utilizes AI and machine learning to analyze spectroscopy data to identify chemical biomarkers associated with pain and structural degeneration.
• Developing software platforms such as NOCISCAN®, NOCIGRAM®, NOCICALC®, and other diagnostic tools.

Products and Technologies

• NOCISCAN: Non-invasive software that enhances MRI by analyzing MRS data to identify chemical biomarkers indicative of pain in spinal discs.
• Proprietary biomarkers licensed from UCSF that correlate with degenerative pain.
• Software post-processes MRS data to produce reports called Nocigrams, which help clinicians determine if specific discs are pain generators.
• Focus on improving surgical outcomes by accurately identifying painful discs non-invasively, reducing reliance on invasive provocation discograms (PD tests).

Industry and Market

• Addresses the $134.5 billion U.S. low back and neck pain market.
• First commercial application targets the $10 billion spine fusion procedures market in the U.S.
• Seeks to expand across conservative, regenerative, and surgical treatment pathways for low back pain.
• Market limitations include compatibility with certain MRI scanners (primarily SIEMENS and Philips); software cost ranges from $25,000 to $50,000 per scanner.

Regulatory and Reimbursement

• The company’s products have received Category III CPT codes for MRS on intervertebral discs (codes 0609T-0612T).
• The NOCICALC® product is classified as a Class I medical device (regulated by the FDA), primarily used for data processing.
• The NOCIGRAM® product is considered clinical decision support software under the 21st Century Cures Act and is not regulated by the FDA.
• CE marking obtained via self-certification; working toward compliance with EU Medical Device Regulation (MDR), which may reclassify the product as Class II.
• The company plans to pursue reimbursement coverage and has initiated efforts for converting Category III CPT codes into permanent Category I codes.

Employees and Customers

• As of April 2025:
  • Employees: 6 total
    • 2 in full-time R&D
    • 1 in strategy/business development
    • 3 in general administration
• Customers: Limited sales to date; initial engagements include a customer using Philips MRI MRS capabilities.
• The first clinical study involved 139 patients with a total of 623 lumbar discs evaluated; 73 patients underwent surgery.

Revenue and Financials

• To date, most revenue is derived from patient out-of-pocket payments.
• The company has only recently obtained reimbursement codes and is transitioning to commercial operations using proceeds from IPO.
• As of December 31, 2024:
  • Cash: approximately $0.46 million
• Losses:
  • 2024 net loss: $6,992,927
  • 2023 net loss: $4,911,374
• Total accumulated deficit: $51,262,311

Growth Strategy

• Expand payer coverage for CPT codes.
• Focus on markets such as NYC, San Francisco, Chicago, Phoenix, Miami, Denver, Detroit, and Indianapolis.
• Collaborate with key opinion leaders (KOLs) and medical societies.
• Expand compatibility to additional MRI scanner vendors.
• Support label expansion and international market entry.
• Continue clinical research and peer-reviewed publications.

Key Partnerships

• Siemens:-developed compatible MRI software protocols; collaboration since 2011, with a strategic agreement from 2017.
• Philips: engaged in early discussions for compatibility with their MRI scanners (Q1 2025 engagement).
• RadNet: owns 5 imaging centers performing NOCISCAN exams.
• Alphatec Spine: partnership agreement announced January 2024 to evaluate and potentially co-market NOCISCAN with spine surgent networks.

Core Technology

• Magnetic Resonance Spectroscopy (MRS) to analyze chemical composition of intervertebral discs.
• Proprietary biomarkers and software licensed from UCSF.
• Developed custom MRS protocols and advanced signal processing approaches.
• Multiple patents issued and pending (total of 24 US patents, 17 foreign patents), with expiration dates mainly between 2025-2037.

Summary

• Aclarion develops non-invasive diagnostic software that leverages MRS and AI to identify painful spinal discs, aiming to improve low back pain treatment outcomes.
• The company is in early commercialization stages, with limited revenue and ongoing development to expand market acceptance, scanner compatibility, and reimbursement coverage.
• As of 2025, has 6 employees and a focus on expanding clinical evidence, partnerships, and regulatory approvals to grow revenue.