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More than two billion people worldwide suffer from some brain-related disease causing an annual economic burden in excess of $2 trillion USD. Novel therapeutic approaches to the treatment of nervous system disorders represents one of the most unmet needs in modern medicine (Whitney, 2007).
In the United States alone, approximately 76 million patients may receive therapeutic benefit from neuromodulation devices (Rice, 2006).
Broad Market Statistics & Unmet Medical Needs
INDICATIONSdepression, acute mania, bipolar disorders, hallucinations, obsessions, schizophrenia, catatonia, post-traumatic stress disorder, drug addition, Parkinson’s disease, Alzheimer’s disease, epilepsy, dystonia, tics, stuttering, tinnitus, spasticity, recovery of cognitive and motor function following stroke, and pain syndromes - migraine, neuropathies, back pain, internal visceral diseases (Wagner, 2007).
Current Neuromodulation Approaches
Therapeutic, but invasive
Noninvasive Paradigm Shiftultrasound offers better
focusing capabilities and deeper brain penetration
compared to rTMS
We have discovered noninvasive methods for controlling brain activity using pulsed ultrasound. The ultrasound power levels effective for stimulating brain activity are less than FDA approved limits established for the use of diagnostic ultrasound.
AzTE
Transcranial ultrasound can be used for the remote control of brain activity in a safe, reliable, and focused manner.
INDICATIONSMapping prior to surgical removal of diseasedbrain tissue for patients with brain tumors,epilepsy, and movement disorders. Brain mapping through DCES is used for numerous other neurosurgical/neurological applications.
Electrocotricography and Direct Cortical Electrical Stimulation
Necessary brain mapping procedure, but invasive
ManagementIP/
Technology
Neural Circuit
PhysiologyCore
TransducerEngineering
Core
Animal ModelCore
ObjectivesI. Expand our IP portfolio containing advanced technologies designed for the remote control of brain activityusing pulsed ultrasound.
II. Develop and market noninvasive ultrasonic neuromodulation devices designed for the diagnosis, management, treatment, and prevention of neurological and neuropsychiatric disorders.
Company Core
Provide leadership, develop strategy, oversee IP, evaluate productivity, and align core strategies for optimal progress
ManagementIP/Technology
Management Objective
Founding President - William J. Tyler, Ph.D.COO - Hemant Agawral, M.B.A
CTO - Sumon K. Pal, Ph.D.others officers under recruitment
SABRobert Spetzler, M.D.
Karl Deisseroth, M.D., Ph.D.
Implement modern biophysical approaches to investigate the effects of pulsed ultrasound on brain circuit function.Neural Circuit
PhysiologyCore
Neural Circuit Physiology Core Objective
Sumon K. Pal, Ph.D.William J. Tyler, Ph.D.
Design, develop, and refine transducers/methods for optimally delivering pulsed ultrasound to the brain.
Alternative
Neuro-stimulatio
n Approach
es
TransducerEngineering
Core
Transducer Engineering Core Objective
Ultrasound Engineer, Ph.D.Biomedical Engineer, Ph.D.
Electrical Engineer
Continued investigation of the neurostimulation potential of pulsed ultrasound in intact brain circuits.Animal
ModelCore
Animal Model Core Objective
William J. Tyler, Ph.D.Sumon K. Pal, Ph.D.
Investments Sought$5.5M/48-mo ($3.5M/1st 24-mo + $2.0M/2nd 24-mo)
Offering & Proposed Equity DistributionVCs - 35% equityFounders - 27% equity (stock reserve)Boards - 20% equityEmployees – 9.5% equityUniversities – 8.5% equity
Financial Highlights
Initiate SynSonix R&D Activities+ 6-month –Facilities Established Cambridge, MA or Phoenix, AZ+ 12-month – R&D/Patent Filing
Gen I Ultrasonic Neuromodulation Device+ 18-month – Prototype First Devices+ 24-month – Market Evaluation/Licensing
+ 36-month – Test, evaluate, seek FDA clearance through a de novo 510K process Focused Ultrasonic Neuromodulation Device+ 40-month – Prototype FUND+ 48-month – Market/Licensing
SYNSONIX
UltrasonicNeuromodulation
Technology
Projected Milestones Timeline
$3.5M/1
st 24-mo
$2.0M/2
nd 24-mo
Data Blitz
+ Therapeutic Neurostimulation (replace DBS/VNS/rTMS) neuropsychiatric treatment; neurological treatment; trauma management
+ Rapid Response Medical Devices
+ Military Defense Applications
+ Brain-computer Interfaces
+ Entertainment Industry
+ Neurodiagnostics
The SynSonix Vision for Ultrasonic Neuromodulation Technology
A Revolution in Deep Brain Stimulation
