Solana Company · NASDAQ:HSDT
Solana — Helius Medical Technologies — Investor Presentation (December 2023)
38 slides from Solana's investor presentation, Dec 4, 2023
Slide 1: Empowering Neuroplasticity: PoNS Therapy for Balance and Gait Deficits
Empowering Neuroplasticity PoNS TherapyTM for Balance and Gait Deficits in Patients with Neurological Disorders December 2023 NASDAQ:HSDT
Slide 2: Legal Disclaimers
Legal Disclaimers This presentation contains forward-looking statements, including statements regarding the Company’s future strategic and operational execution, the success of the Company’s PoNS device and related treatment, the next phase of the Company’s market development activities, clinical an
Slide 3: Executive Team
Dane Andreeff President & CEO Antonella Favit-Van Pelt, MD, PhD Chief Medical Officer ● 20+ years at Maple Leaf Partners as the General Partner and Portfolio manager, a value-based hedge fund which grew to over $2b in assets ● Board member and advisor to Helius for over 6 years, Myocardial Solutions
Slide 4: Board of Directors
Sherrie Perkins Director ● 20 years neuromodulation medical device experience in neurology, psychiatry, and sleep medicine ● Former Marketing and Business Development Executive, Cyberonics, Inc. (Nasdaq: CYBX) and LivaNova PLC (Nasdaq: LIVN) ● Former member Board of Directors, eNeura, Inc. ● Former
Slide 5: About Helius: The PoNS Device
The Portable Neuromodulation Stimulator “PoNS” Device The first and only orally applied therapy combining trigeminal nerve neurostimulation via the tongue with physical therapy to improve functional outcomes Supported by an extensive IP portfolio (47 U.S. patents issued; 53 foreign patents issued) e
Slide 6: The Long-Lasting Impact of Balance Deficit
The Long-Lasting Impact of Balance Deficit1,2 • Balance and gait deficits are commonly experienced by individuals with neurologic disorders • These deficits can be particularly frustrating because they often profoundly impact a person’s quality of life • Balance and gait deficits have a significant
Slide 7: PoNS Therapy
PoNS Therapy™
Slide 8: PoNS Device
PoNS Device Empowering the brain and improvement during PoNS Therapy™ • Mouthpiece electrodes stimulate the tongue surface, sending signals to the brain • The stimulation produced by PoNS is believed to help strengthen the neural connections associated with balance and walking when combined with phy
Slide 9: Inducing Neuromodulation to Create Long Term Neuroplastic Changes
Tongue Stimulator Facial Nerve (CN-VII) Trigeminal Nerve (CN-V) • When PoNS is on, translingual neurostimulation (“TLNS”) is initiated. • TLNS delivers electrical impulses that stimulate the lingual branch of the trigeminal nerve and the chorda tympani branch of the facial nerve. • This stimulation
Slide 10: PoNS Therapy: Safe and Effective
PoNS Therapy 10 14-Week PoNS Therapy Safe and Effective 70%+ ~70+%§ 69% of stroke patients had a significant improvement in gait and 28% were no longer at risk of falling1 74% of patients with traumatic brain injury showed significant improvement in balance2 91% of PoNS sessions are completed at hom
Slide 11: Commercialization and Reimbursement
Commercialization and Reimbursement
Slide 12: Large Potential Addressable Markets
Large Potential Addressable Markets U.S. Market 12 1§ MILLION1 Affected by MS 70% report difficulty walking2 7§ MILLION3 Affected by stroke Impaired walking affects about 80% of survivors4 2.8§ MILLION5 Sustain a TBI annually 80% report balance impairment6 Authorized for gait deficit due to symptoms
Slide 13: Understanding the MS Market Opportunity in U.S.
Understanding the MS Market Opportunity in U.S. MS is a well-characterized chronic disease with a fast-growing diagnosed population3 MS patients are vocal and connected on social media MS patients are cared for by neurologists, a relatively discrete group (approx. 16,000 in USA) Gait dysfunction is
Slide 14: U.S. Commercialization Launch Initiatives: Driving Awareness
U.S. Commercialization Launch Initiatives Driving Awareness 14 Education & Outreach • Engage with general and MS neurologists about the benefits of PoNS and how to prescribe • Identify and onboard neuro rehab clinics currently treating MS patients; emphasize that PoNS provides a significant value ad
Slide 15: U.S. Commercialization Launch Initiatives: Building Experience
U.S. Commercialization Launch Initiatives Building Experience 15 Therapeutic Experience Program (“PoNSTEP”) • Helius sponsored open-label, interventional, observational, outcome study evaluating PoNS on-label therapy in target population (MS) aiming to investigate adherence to PoNS Therapy regimen •
Slide 16: U.S. Commercialization Launch Initiatives: Expanding Access
U.S. Commercialization Launch Initiatives Expanding Access / Increasing Ease of Use 16 Telehealth/E-Commerce/Online Pharmacy • Partnered with UpScript Health on direct-to-consumer platform to streamline access to PoNS Therapy, aligning with current trends of self-care, home health care, get-it-now •
Slide 17: Reimbursement
Reimbursement 17 • Pursuing commercial and government reimbursement programs with initial cash pay option • Dual path for reimbursement • DME • Proposed Transitional Coverage of Emerging Technologies (“TCET”) for Medicare coverage • Applied for HCPCs codes • NDC/UPC/HRI • Codes established for both
Slide 18: Potential Addressable U.S. Opportunity in Stroke
Potential Addressable U.S. Opportunity in Stroke 18 7 MILLION1 Americans estimated to be living with complications from stroke 80% have a gait impairment2 Compelling Clinical Evidence3 31 Stroke patients treated with PoNS in Canada 69.2% Improved more than 5 points on functional gait assessment meas
Slide 19: US Path for Stroke Authorization
US Path for Stroke Authorization 19 • Granted second FDA Breakthrough Designation with the proposed indication for dynamic gait and balance deficits due to symptoms from stroke • Engaged with the FDA on Data Development Plan for stroke • Plan includes expansion of Medical University of South Carolin
Slide 20: Potential Addressable Canadian Opportunity
Potential Addressable Canadian Opportunity 20 878§ thousand Affected by stroke1 350§ thousand Living with chronic balance disorder after mmTBI2-5 100§ thousand Affected by MS6 Canadian Reimbursement Efforts • PBC study to evaluate return-to-work data for long-term disability patients (TBI) • Quebec
Slide 21: Pacific Blue Cross Study: Return to Work Outcomes
Pacific Blue Cross Study1 Return to Work Outcomes 21 Balance/Gait Improvement (SOT) Balance/Gait No Longer Barrier to Work Headache Frequency/Severity Reduction Returned to Work PBC estimated that the five individuals who returned to work saved the provider approximately $1.6 million in long-term di
Slide 22: Recent Milestones and Anticipated Value Creation Events
Recent Milestones and Anticipated Value Creation Events 22 • Initial reimbursement in US • HCPCs codes finalized • Renew TBI authorization efforts in US • Data from MUSC stroke study Y 22 Y 24 • Authorized in the US for MS • FDA Breakthrough Designation granted for stroke • Authorized in Australia t
Slide 23: Financial Update, Capitalization & Ownership
Financial Update, Capitalization & Ownership
Slide 24: Financial Update Summary
Financial Update 24 Summary Operations and Cash Flows Q3 2023 Q3 2022 YTD (9/30/23) YTD (9/30/22) Total Revenue $143 $196 $510 $505 Operating Loss $(3,153) $(4,853) $(10,182) $(12,847) Net Loss $(3,663) $(1,030) $(7,805) $(9,186) Cash Used in Operations $(2,452) $(3,821) $(8,382) $(12,167) ($ in tho
Slide 25: Capitalization & Cash Position
Capitalization & Cash Position 25 Capitalization (in thousands) As Reported 9/30/23 Common Stock 688 Warrants** 639 Options 246 RSUs 4 Total Fully Diluted 1,577 **Includes 627K warrants @ $6.9135 strike price Nasdaq Symbol HSDT Market Cap* $4.5M Price Per Share* $6.36 Shares Outstanding* 708K 50 Day
Slide 26: Testimonials – Kerrie Walters, PoNS Patient Ambassador
Testimonials 26 – Kerrie Walters, PoNS Patient Ambassador “I have been living with MS for 35 years and have just completed my 14 week of PoNS Therapy. I am impressed with the results. The difference is apparent on before- and after- videos of me on the treadmill, and I feel steadier and more self-as
Slide 27: References
References 27 Slide 4 1. Peterson M, Greenwald BD. Balance problems after traumatic brain injury. Available at http://uwmsktc.washington.edu/sites/uwmsktc/files/files/TBI_balance.pdf. Accessed September 17, 2018. 2. Centers for Disease Control and Prevention. Report to Congress on Traumatic Brain In
Slide 28: Thank you
)) Helius MEDICAL TECHNOLOGIES Thank you NASDAQ:HSDT
Slide 29: Appendix
Appendix
Slide 30: MS Scientific Advisory Board
MS Scientific Advisory Board 30 • Dr. Deborah Backus, PT, PhD, FACRM, Director, MS Research, Shepherd Center, immediate past president and current Board Member, ACRM • Dr. Francois Bethoux, MD, Director of Rehabilitation Services at the Cleveland Clinic Mellen Center • Dr. Michelle Cameron, MD, PT,
Slide 31: Stroke Scientific Advisory Board
Stroke Scientific Advisory Board 31 • Carl J. Hauser, MD, Beth Israel Deaconess Medical Center, Acute Care, Trauma & Critical Care, Lecturer, Surgery, Harvard Medical School • Steven C. Cramer, MD, MMSc, FAAN, FAHA, Susan and David Wilstein Endowed Chair in Rehabilitation Medicine Professor, Departm
Slide 32: PoNS Therapy Mechanism of Action
Neuromodulation: modification of the nervous system by targeted stimuli PoNS Therapy™ Mechanism of Action 32 Blood oxygen level-dependent (BOLD) signal PoNS device designed to induce Translingual Neurostimulation: trigeminal and facial nerve-mediated neuromodulation via the tongue induces increased
Slide 33: Clinical Evidence: Multiple Sclerosis Study – Gait Deficit
Two groups (10 each): 1. Active Group: PoNS + PT 2. Control Group: Placebo PoNS + PT DGI = Dynamic Gait Index, a measure of the ability to walk Change In DGI Score Versus Time Within The Study Period 0 4.4 6.15 7.7 7.95 3 3.68 4.8 3.45 0 2 4 6 8 10 0 2 6 10 14 DGI Mean Improvement Relative to Week 0
Slide 34: Clinical Evidence: Stroke Pilot Randomized Controlled Trial
Clinical Evidence1 Stroke – Results from a Pilot Randomized Controlled Trial IQR = 9.5 • Post-intervention assessment demonstrated significant and clinically meaningful improvement with PoNS Therapy vs. high-intensity physiotherapy alone • A cutoff score of 17.5 on the Mini-BEST has been shown to di
Slide 35: Clinical Evidence: Multiple Sclerosis Study – SOT Composite Scores
Change over time for Sensory Organization Test (SOT) composite scores Statistical analysis of SOT week 14 scores vs pre-training reveals that improvement in the active group is significant (p<0.001) whereas sham group difference did not reach statistical significance (p<0.06) Gait imagery revealed t
Slide 36: Patients with MS Treated with PoNS in Canada
42 Patients with MS treated with PoNS in Canada 58.3% Patients had achieved at least a 4-point improvement in their functional gait assessment (FGA) PoNS™ Device1 Authorized in Canada for gait deficit due to symptoms of MS since March 2020 36 Promising results from initial real-world evidence gather
Slide 37: Real-World Evidence Poster Presentation
Real-World Evidence Poster Presentation 37 Visit ponstherapy.com to view the poster online
Slide 38: References
References 38 Slide 33 1. Tyler, Mitchell E et al. “Non-invasive neuromodulation to improve gait in chronic multiple sclerosis: a randomized double blind controlled pilot trial.” Journal of neuroengineering and rehabilitation vol. 11 79. 1 May. 2014, doi:10.1186/1743-0003-11-79 Slide 34 1.Galea MP e
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