Solana Company · NASDAQ:HSDT
Solana — Helius Medical Technologies — Investor Presentation (November 2017)
34 slides from Solana's investor presentation, Nov 9, 2017
Slide 1: A Revolution in Mind
A Revolution in Mind November 9, 2017 www.heliusmedical.com | TSE:HSM | OTCQB:HSDT
Slide 2: Legal Disclaimers
Legal Disclaimers This presentation includes certain statements that may constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements contained in this presentation, other than statements of histo
Slide 3: Traumatic Brain Injury
30,000/year active duty soldiers with TBI 200,000 retired soldiers diagnosed with TBI 20-30% of new cases result in chronic symptoms Traumatic Brain Injury Military Athletic / Civilian Common Types of TBI due to Military Activity: Explosive blast injury Penetrating injury Diffuse axonal injury Large
Slide 4: PoNS Designed to Stimulate the Trigeminal and Facial Nerves Through the Tongue
PoNSTM Designed to Stimulate the Trigeminal and Facial Nerves Through the Tongue www.heliusmedical.com | TSE:HSM | OTCQB:HSDT
Slide 5: Neuroprotective Effects of Trigeminal Nerve Stimulation in Severe TBI
Neuroprotective Effects of Trigeminal Nerve Stimulation in Severe Traumatic Brain Injury Nature Scientific Reports, Chiluwal A, Narayan R, Chung W et al. July 28, 2017 “These data provide strong early evidence that activation of the trigeminal nerve system affords neuroprotection following brain dam
Slide 6: What is the Sensory Organization Test (SOT)
What is the Sensory Organization Test (SOT) The Sensory Organization Test (SOT): Uses computerized posturography to quantify a patient’s use of sensory input: vision, vestibular and somatosensory cues to maintain postural stability The SOT utilizes six “conditions” to interpret a patient’s degree of
Slide 7: Effect of Physical Therapy Alone in Treatment of Balance Disorder in TBI
Effect of Physical Therapy Alone in Treatment of Balance Disorder in TBI Dr. Deborah Backus, PhD Director of MS Research at the Shepherd Center and President of the American Congress of Rehabilitation Medicine has more than 30 years of experience in neurological rehabilitation and research says: “Mo
Slide 8: Neuromodulation, Neuroplasticity and Trigeminal Nerve Stimulation
Neuromodulation, Neuroplasticity and Trigeminal Nerve Stimulation Neuromodulation is the application of external stimuli to provoke changes in brain activity It occurs through two mechanisms: acute changes to how existing synapses work, and chronically by the creation of new synapses The trigeminal
Slide 9: Regulatory Science vs Clinical Science
Regulatory Science vs Clinical Science Regulatory science is done to satisfy the need for regulatory authorities to determine the safety and efficacy of an intervention (Drug or medical device) Regulatory submissions require reliable data from randomized, controlled multicenter studies as standard f
Slide 10: Independent Controlled Clinical Trials to Date
Independent Controlled Clinical Trials to Date Demonstrate 3 independent randomized controlled clinical trials demonstrate statistically significant improvements in SOT scores when PT + High Frequency Pulse PoNS is compared to PT + no stimulation in multiple disease states Montreal Neurological Inst
Slide 11: Results from Multiple Sclerosis Study
Active ArmPlacebo ArmActive ArmPlacebo Arm Active ArmPlacebo Arm ** Results from Multiple Sclerosis Study fMRI Changes in Group A, B vs Healthy Controls **dorsolateral prefrontal cortex (DLPFC) ***rostral anterior cingulate cortex (rACC) 14 subject (7/7) study: All received physiotherapy with Group
Slide 12: Results from Multiple Sclerosis Study: Working Memory fMRI
www.heliusmedical.com | TSE:HSM | OTCQB:HSDT HFP Stim Arm No Perceptible Stim Arm Group A: Post PoNS™ device training fMRI shows significant increase in BOLD signal in the left DLPFC** (t=3.55, p=0.01), rACC*** (t=3.057, p=0.02) and a trend for significance in the right DLPFC (t=2.3, p=0.06). Result
Slide 13: Clearly Defined Regulatory Pathway
Clearly Defined Regulatory Pathway FDA deemed the study of the PoNSTM for mild-moderate TBI a ‘non-significant risk (NSR) device study’ under the IDE regulations Assessed the study as not posing a significant risk to human subjects FDA guidance points to 120-day regulatory review upon submission for
Slide 14: So, what does an SOT of 40 look like?
So, what does an SOT of 40 look like? The mean baseline SOT in our clinical trial was approximately 40 (42.1 and 41.1 in HFP and LFP respectively) This video is of a patient that did not participate in our clinical trial It is shown to demonstrate the clinical presentation of a person with an SOT sc
Slide 15: What does an SOT Score look like?
What does an SOT Score of 40 look like? www.heliusmedical.com | TSE:HSM | OTCQB:HSDT
Slide 16: The Clinical Study
Th Clinical Study A double-blind, randomized, controlled* study of the safety and effectiveness of the PoNS™ device for translingual noninvasive neuromodulation stimulation (“TLNS”) training in subjects with a chronic balance deficit due to mTBI. Indication Chronic balance deficit due to non-severe
Slide 17: Important Inclusion Criteria For the Study
Important Inclusion Criteria For the Study All subjects were at least one year post injury Further spontaneous recovery unlikely All subjects had to: have participated in a focused physical rehabilitation program for their TBI related balance disorder and have been deemed by the treating clinician t
Slide 18: Statistical Analysis Plan for TBI Study
Statistical Analysis Plan for TBI Study www.heliusmedical.com | TSE:HSM | OTCQB:HSDT Assess Primary Endpoint: responder analysis of HFP vs LFP at 5 weeks If responder analysis is statistically significant If responder analysis is not statistically significant Collapse HFP and LFP into a single group
Slide 19: Statistical Analysis Safety Endpoints
Statistical Analysis Safety Endpoints Primary: Frequency of falls, as determined by daily event recording on the subject data case report form during the in clinic phase. Fall is defined as an episode where a subject lost his or her balance and fell or would have fallen, were it not for another inte
Slide 20: PoNS Responder Analysis – Primary Endpoint
PoNS Responder Analysis – Primary Endpoint P<0.081 HFP PoNS group response showed a trend to significant change vs response of LFP PoNS Group N=61 N=61 Responders = 15 point improvement in SOT above baseline www.heliusmedical.com | TSE:HSM | OTCQB:HSDT
Slide 21: PoNS Study Data Efficacy
PoNS Study Data Efficacy Normal Range SOT Score N=61 N=61 www.heliusmedical.com | TSE:HSM | OTCQB:HSDT SOT Score *HFP: Mean increase over baseline at end of Week 2 = 20.9 with 95% lower confidence limit of 16.6, p< 0.025 **HFP: Mean Increase over baseline at end of Week 5 = 27.3 with 95% lower confi
Slide 22: Is the LFP Device Demonstrating Therapeutic Activity?
Is the LFP Device Demonstrating Therapeutic Activity? It was prospectively contemplated that LFP device might potentially have a therapeutic effect. Thus, in the statistical analysis plan it was proposed that if secondary effectiveness endpoints did not generate p-value of less than 0.05, (data show
Slide 23: Secondary Effectiveness Endpoint Combined Data Analysis at Week 2
Secondary Effectiveness Endpoint Combined Data Analysis at Week 2 When mean of the combined data set is significantly greater than zero, it indicates that results for both devices combined demonstrate statistically significant improvement in SOT scores. Device N Mean SD SE 95% Conf. Interval p-value
Slide 24: Secondary Effectiveness Endpoint Combined Data Analysis at Week 5
Secondary Effectiveness Endpoint Combined Data Analysis at Week 5 When mean of the combined data set is significantly greater than zero, it indicates that results for both devices combined demonstrate statistically significant improvement in SOT scores. Device N Mean SD SE 95% Conf. Interval p-value
Slide 25: US Medical Method Patents Issued
7 US Medical Method Patents Issued Skin Stimulation + Physical Therapy = Therapeutic Outcome Skin Stimulation + Cognitive Therapy = Therapeutic Outcome Oral Cavity Stimulation + Physical Therapy = Therapeutic Outcome Oral Cavity Stimulation + Cognitive Therapy = Therapeutic Outcome Oral Cavity Stimu
Slide 26: Primary Safety Endpoint Met – Decrease in Number of Falls
Primary Safety Endpoint Met – Decrease in Number of Falls www.heliusmedical.com | TSE:HSM | OTCQB:HSDT
Slide 27: Secondary Safety Endpoint Met - Headache Disability Index
Secondary Safety Endpoint Met - Headache Disability Index Showed a General Lowering in Both Groups www.heliusmedical.com | TSE:HSM | OTCQB:HSDT
Slide 28: Long Term Treatment Study
Long Term Treatment Study Study completed May 28th, 2017 Tactile Communication Neurorehabilitation Laboratory at University of Wisconsin-Madison Sponsored by US Army Double blind randomized controlled trial in patients with mild to moderate TBI 22/21 patients High Frequency Pulse stimulation Vs Low
Slide 29: Patients in both Groups were Significantly Clinically Better
Patients in both Groups were Significantly Clinically Better at 2 weeks, 14 weeks and 26 weeks 12 weeks washout – no stimulation On Average Patients improved from an impaired SOT score to normal SOT Score in 14 weeks of treatment with HFP Normal Score was maintained throughout 12 week washout period
Slide 30: Dynamic Gait Index
Dynamic Gait Index Both treatment groups had baseline scores in the 'elevated risk of fall category' (≤ 19; normal=24) By the end of participation, the scores for both groups approached normal levels (Active: 22.82; Control: 22.65) N=22 N=21 www.heliusmedical.com | TSE:HSM | OTCQB:HSDT DGI
Slide 31: Patients in both Groups Demonstrated an overall Reduction in Headaches
Patients in both Groups Demonstrated an overall Reduction in Headaches www.heliusmedical.com | TSE:HSM | OTCQB:HSDT HDI
Slide 32: So, what does a normal SOT score look like?
So, what does a normal SOT score look like? This video is of a patient that did not participate in our TBI clinical trials but had previous experience with the therapy It is shown to demonstrate the clinical presentation of a person with a Normal SOT score Every subject is different and there are ma
Slide 33: Video of Subject with SOT Score in Normal Range
Video of Subject with SOT Score in Normal Range www.heliusmedical.com | TSE:HSM | OTCQB:HSDT
Slide 34: Overall Conclusion
Overall Conclusion In three previously published independent controlled clinical trials: PT + HFP PoNS therapy has been observed to be statistically significantly superior to PT with no stimulation in SOT scores HFP PoNS therapy produced FMRI confirmed statistically significant neuro plastic change
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