Aclarion, Inc. · NASDAQ:ACON
Aclarion — Investor Presentation (September 2023)
26 slides from Aclarion's investor presentation, Sep 28, 2023
Slide 1: Better Data Better Care
Better Data Better Care OCTOBER 2023 NASDAQ: ACON
Slide 2: Disclaimer
Aclarion 2023 2 Disclaimer The information in this material is provided for general information purposes only and does not take into account the investment objectives, financial situation and particular needs of any individual or entity . This presentation contains forward - looking statements withi
Slide 3: Problem
Aclarion 2023 3 Problem Patient is in pain but which disc is the cause? High surgical decision variability Expensive Poor Outcomes Low value
Slide 4: Solution
Aclarion 2023 4 Solution Technology labels each disc as painful or pain free Personalized treatment path is optimized Lower cost Better outcomes Higher value care
Slide 5: Better Surgical Outcomes
Aclarion 2023 5 Published in the European Spine Journal in 2019 & 2023 Better Surgical Outcomes Gornet et al Gornet study published in European Spine Journal 1 139 cLBP patients with 73 undergoing surgery 85 % of patients improved if all Nociscan positive discs treated 2 63 % of patients improved if
Slide 6: EVALEA: Economic Value Analysis of Low back pain
Aclarion 2023 6 EVAL E conomic V alue A nalysis of L ow back pain Objective: Determine if non - invasive diagnostic (Nociscan®) is cost - effective compared to provocative discography • Economic modeling based on the Gornet trial and spine industry economic cost factors • Statistical modeling and an
Slide 7: CLARITY Trial
Aclarion 2023 7 CLARITY C hronic L ow b A ck pain R andomized I ndependent T rial stud Y Prospective, randomized, controlled trial evaluating the outcomes of surgical patients when the surgeon has access to Nociscan data compared to when the surgeon does not have access to Nociscan data Principal In
Slide 8: NIH-BACPAC Back Pain Consortium
Aclarion 2023 8 NIH - BACPAC Back Pain Consortium (BACPAC) Two NIH studies aimed at finding the best diagnostic tools for chronic low back pain and evaluating their effectness via clinical outcomes in four different patient sub - groups. • Sponsored by the National Institutes of Health (NIH) • comeB
Slide 9: ACTIVE Study
Aclarion 2023 9 ACTIVE A utologous mesynchymal stem/stromal C ells for T reatment of workers affected by chronic low back pain due to multilevel I nter VE rtebral disc degeneration • Sponsored by Campus Bio - medico University • Up to 204 scans: T0, T3, T6, and T12 months • Began Q4 2020 • Complete
Slide 10: Nociscan Product
Aclarion 2023 10 Nociscan Product Spectroscopy analyzes the chemical composition of tissue Proprietary signal processing software transforms raw spectral data into clear biomarkers Acidic pain markers 1 • Alanine (LAAL = lactic acid + alanine) • Lactic Acid (LAC) • Propionate (PRO) Structural integr
Slide 11: Clear Delineation Between Pain & No Pain
Aclarion 2023 11 Clear Delineation Between Pain & No Pain 1 Freemont AJ, Rheumatology (2009) 48:5 – 10 2 Immke and McCleskey, Nat Neurosci. (2001) Sep;4(9):869 - 70 Six ratios for each disc • Pain markers in the numerator (3) • Structural integrity markers in the denominator (2) • Differentially wei
Slide 12: Provocative Discogram vs. Nociscan Virtual Discogram
Aclarion 2023 12 Provocative Discogram Nociscan Virtual Discogram Invasive Non - invasive Subjective Objective Severely painful by design No pain Lumbar CT = ~10x radiation of chest x - ray No radiation Additional exam after MRI Can be added to a standard lumbar MRI Half - day procedure with days ou
Slide 13: Intellectual Property
Aclarion 2023 13 Intellectual Property 22 issued U.S. Patents 17 issued International Patents Post processing technologies to more reliably & accurately measure biomarkers from MRS spectra Exclusive worldwide license from UCSF for intervertebral disc biomarkers & ratios Use of proprietary biomarkers
Slide 14: Product Status
Aclarion 2023 14 Product Status Current product Spine surgery decisioning tool to replace discography & improve surgical outcomes • Early commercialization in progress • AI process improvements for reproducibility & scalability in progress • MRI integrations to support scalability Next Generation Po
Slide 15: Regulatory Approvals Secured
Aclarion 2023 15 Regulatory Approvals Secured Current product approvals Next generation AI product • NOCICALC – marketed through FDA registration as a Class 1 exempt device & CE Mark • NOCIGRAM – marketing indication established through the 21 st Century Cures Act as clinical decision support softwa
Slide 16: Market Opportunity
Aclarion 2023 16 $10B 1 U.S. lumbar fusion & disc replacement market – actionable now $40B 2 U.S. lumbar spine market (fusion & non - fusion surgery plus presurgical care) – expansion $135B 3 U.S. low back & neck pain market – ultimate market Market Opportunity 1 Martin BI, Spine (2019) Mar 1;44(5):
Slide 17: Augmented Intelligence Landscape
Aclarion 2023 17 Augmented Intelligence Landscape • Founded 2016 - stroke • Cloud - based model • Earlier stroke detection • $100M Series D in 2022 • Series D Valuation - $1.3B post • Founded 2016 – heart disease • Cloud - based model • Avoid invasive angiogram • $223M Series C in 2022 • Series C Va
Slide 18: Reimbursement Landscape
Aclarion 2023 18 Reimbursement Landscape Description CPT Code MRS, determination & localization of discogenic pain (cervical, thoracic, or lumbar); acquisition of single voxel data, per disc , in ≥3 discs – PAID TO IMAGING CENTER 0609T MRS, determination & localization of discogenic pain (cervical,
Slide 19: Process to Standard of Care
Aclarion 2023 19 Process to Standard of Care = not yet accomplished = initial steps accomplished = accomplished KOL Development & Advocacy Opportunity Assessment Product Development Broad Physician Adoption Standard of Care Patient Driven Adoption Coverage & Reimbursement Product Refinement Capacity
Slide 20: Local Payer Coverage Decisions – Key Catalyst
Aclarion 2023 20 Local Payer Coverage Decisions – Key Catalyst Key Near Term Catalysts • MRI activations for KOLs • Increased scan volumes • Coverage decision from local payers KOL Rx • Nociscan utilization Evidence • KOL evidence • Pre - existing evidence LCD • Health insurers • Employers • Workers
Slide 21: Key Opinion Leader Development & Advocacy
Aclarion 2023 21 Key Opinion Leader Development & Advocacy John Keller MD Juan Uribe MD Sig Berven MD Christopher Ames MD George Frey MD Grand Rapids, MI Phoenix, AZ San Francisco, CA San Francisco, CA Denver, CO Region Dean Karahalios MD Apesh Patel MD Greg Basil MD Roger Hartl MD Eric Potts MD Chi
Slide 22: Management Team
Aclarion 2023 22 Management Team Executive Chairman Jeff Thramann, MD CEO & Director Brent Ness CFO John Lorbiecki Chief Strategy Officer Ryan Bond • Serial entrepreneur with multiple exits • Over 100 US & International patents • Public company board experience • Neurosurgeon & spine fellow • U.S. M
Slide 23: Independent Board
Aclarion 2023 23 Independent Board Non - independent Independent Steve Deitsch Audit committee chair Bill Wesemann Lead independent director Compensation committee chair Amanda Williams Nominating committee chair Scott Breidbart, MD Jeff Thramann, MD Executive chairman Brent Ness CEO David Neal
Slide 24: Advisory Board
Aclarion 2023 24 Advisory Board Scientific Medical Larry Tanenbaum, MD Radiology Section Chair VP, CTO, Director at RadNet Mount Sinai Associate Professor University of Pennsylvania, BA, Biochemistry UCSD, MD USC, residency Bob Eastlack, MD Surgical Section Chair Head of Spine Surgery, Scripps Clini
Slide 25: Key Takeaways
Aclarion 2023 25 Key Takeaways Address a leading cause of healthcare expenditures in the U.S. – up to $134.5B market Industry 1st noninvasive diagnostic with strong clinical evidence of value CPT codes issued & regulatory path secured in US, EU & UK – gateway to commercialization Established path to
Slide 26: Investor Relations
www.aclarion.com Investor Relations Kirin Smith, President ksmith@pcgadvisory.com Ph: 646.823.8656