Aclarion, Inc. · NASDAQ:ACON
Aclarion — Investor Presentation (October 2022)
21 slides from Aclarion's investor presentation, Oct 25, 2022
Slide 1: Better Data Better Care
Better Data Better Care October 2022 NASDAQ: ACON
Slide 2: Disclaimer
Aclarion 2022 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 that ar
Slide 3: Problem
Aclarion 2022 3 Problem Patient is in pain but which disc is the cause? Trial & error treatment paradigm Expensive Poor Outcomes Low value
Slide 4: Solution
Aclarion 2022 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 2022 5 Better Surgical Outcomes Gornet study published in European Spine Journal 1 139 cLBP patients with 73 undergoing surgery 97% of patients improved if all Nociscan positive discs treated 54% of patients improved if a Nociscan positive disc was not treated Durable at 2 year follow up 20
Slide 6: Nociscan Product
Aclarion 2022 6 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 integri
Slide 7: Nociscan vs. Provocative Discogram
Aclarion 2022 7 Nociscan Virtual Discogram Provocative Discogram Non - invasive Invasive Objective Subjective No pain Severely painful by design No radiation Lumbar CT = ~10x radiation of chest x - ray Can be added to a standard lumbar MRI Additional exam after MRI 25 - 45 min Half - day procedure w
Slide 8: Intellectual Property
Aclarion 2022 8 Intellectual Property 21 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 9: Product Status
Aclarion 2022 9 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 Pop
Slide 10: Market Opportunity
Aclarion 2022 10 $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 11: Regulatory Approvals Secured
Aclarion 2022 11 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 12: Reimbursement Landscape
Aclarion 2022 12 Reimbursement Landscape CPT Code Description 0609T MRS, determination & localization of discogenic pain (cervical, thoracic, or lumbar); acquisition of single voxel data, per disc , in ≥3 discs – PAID TO IMAGING CENTER 0611T MRS, determination & localization of discogenic pain (cerv
Slide 13: Reimbursement Strategy
Aclarion 2022 13 Reimbursement Strategy Source: Gornet M, Peacock J, et al. Magnetic resonance spectroscopy (MRS) can identify painful lumbar discs and may facilitat e improved clinical outcomes of lumbar surgeries for discogenic pain. European Spine Journal (2019) 28:674 - 687 NOCISCAN demonstrates
Slide 14: Commercial Strategy
Aclarion 2022 14 Commercial Strategy KOL Engagement • Recruit 5 - 10 National KOL Surgeons to formal engagement • Use Nociscan to gain experience • Initiate independent studies • Participate in larger clinical trials • Participate in podium presentations and society advocacy Key Near Term Catalysts
Slide 15: Clinical Strategy
Aclarion 2022 15 Clinical Strategy 1 Gornet M, Peacock J, et al. Magnetic resonance spectroscopy (MRS) can identify painful lumbar discs and may facilitate improved clin ic al of lumbar surgeries for discogenic pain. European Spine Journal. 2019; 28:674 - 687 2 State of Spine Think Tank meeting – Ju
Slide 16: Augmented Intelligence Landscape
Aclarion 2022 16 Augmented Intelligence Landscape • Founded 2016 – heart disease • Cloud - based model • Avoid invasive angiogram • Series C - $223M • Series C Valuation - undisclosed • Founded 2007 – heart disease • Cloud - based model • Avoid invasive angiogram • $240M Series E in 2018 • Series E
Slide 17: Management Team
Aclarion 2022 17 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 50 US & International patents • Public company board experience • Neurosurgeon & spine fellow • U.S. Mi
Slide 18: Independent Board
Aclarion 2022 18 Independent Board Non - independent Independent Steve Deitsch Audit committee chair Bill Wesemann Lead independent director Compensation committee chair Amanda Sequira Nominating committee chair Scott Breidbart, MD Jeff Thramann, MD Executive chairman Brent Ness CEO David Neal
Slide 19: Advisory Board
Aclarion 2022 19 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 20: Balance Sheet Highlights (Unaudited)
Aclarion 2022 20 Balance Sheet Highlights (Unaudited) June 30, 202 2 Cash and Cash Equivalents $ 3.8M Total Debt $ 0 Estimated Quarterly Cash Burn Rate $1.2M - $1.4M Market Data Oct 21, 2022 Price $0.83 52 Week Range $4.05 - $0.77 Average Daily Trading Volume (90 - day) 377,424 Market Capitalization
Slide 21: Key Takeaways
Aclarion 2022 21 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