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THE PROBLEM: UNDIAGNOSED SLEEP DISORDERS
Sleep is an essential component to human survival, is a central component to memory consolidation and executive function, and is critical to homeostatic and regulatory mechanisms. Sleep disorders are believed to affect 70+ million Americans, and are factors involved in a significant amount of morbidity and mortality, from depression to atrial fibrillation to congestive heart failure.
Sleep Apnea
Sleep apnea, the leading indication for sleep studies, is a high prevalence disorder and is estimated to be as common as adult diabetes, affecting 12-30+ million Americans, but is diagnosed in less than 4 million individuals due to the time, expense, cumbersome testing, and relative scarcity of sleep laboratories to diagnose the condition. Estimates have placed just the cardiovascular costs of undiagnosed sleep apnea at $120B per year, Medicare and insurers are currently reimbursing $3B+ per year for sleep studies. Medicare and insurers are currently paying between $1,500-$3,000 for a single night of sleep study, and recently Medicare has approved reimbursement for at-home sleep evaluations. Sleep laboratories are expected to enjoy double digit revenue growth in the next five years. The number of sleep beds is expected to grow between 15-20% over the next five years. Currently there are about 3,000 sleep centers in the U.S. Approximately 60-80% of a sleep center’s patients are being evaluated for sleep apnea. Waiting times for most patients are approximately 2-6 weeks in the U.S. due to limitations of sleep laboratory and trained technician scoring and physician interpretation capacity.
NeuroVigil intends to change the approach toward servicing this market through two essential innovations that will afford the company the ability to better meet the growing demand for sleep studies and the diagnosis of important sleep pathology. Its technology will provide this through efficiency and automation, increase relative margins of sleep centers and of physicians at sleep centers, allow them to increase the number of analyses performed, and increase the diagnostic accuracy of sleep evaluations leading to more appropriate treatment. The two pronged approach, both of which incorporate the NeuroVigil technology will focus both on improving sleep center performance and at-home device deployment and usage, and will provide a device and associated diagnostic/analytic capability offering substantially better suited than its competitors for the $2B+ home market.
Drugs Affecting Sleep
A myriad of pharmaceutical agents are known clinically to negatively affect sleep, but sleep testing during pharmaceutical clinical trials or post-marketing surveillance of these compounds is rarely performed. Several pharmaceutical companies have demonstrated significant interest in understanding the effects that their drugs may have on sleep, in an effort to advocate for improved or extended indications or labeling by the FDA for marketing claims, or to demonstrate more advantageous adverse effect profiles compared to competitors. The NeuroVigil technology, as described, not only automates EEG reading, the cornerstone of assessing the architecture of sleep, but requires fewer channels and dramatically expands the window of data one receives from current EEG signals.
Safety & Sleep Problems
The transportation safety market exceeds $10B in annualized revenue. More than 100,000 motor vehicle accidents, half of the accidents and a third of the fatalities on the road, are directly attributable to drivers falling asleep at the wheel. Many commercial vehicle accidents are a direct result of an operator falling asleep at the wheel, and are a combination of driver fatigue which is currently unmonitored and a significant (estimate 40%) prevalence of sleep apnea in this population. Sleep apnea is alone thought to account for 1,500 annual deaths on the road.
The FAA and FTA have both enacted sweeping policies over the prior two decades to regulate the activities of pilots and ship operators to limit fatigue and sleeplessness on the job. This regulation helps to prevent but does not provide continuous, unobtrusive monitoring of pilots and operators that can be used dynamically to alert them if drowsiness occurs. Billions of dollars are currently spent in all aspects of the transportation industry to reduce on the job drowsiness, but no active monitoring and alert system has been invented and is currently being used. As an extension of NeuroVigil’s iBrain product offering, the Company intends to develop an iBrainT device which will seamlessly integrate into the workflow of the pilot, operator, or driver, continuously monitor their brain activity for precursors of drowsiness and provide an appropriate alarm to them if such signals are detected. This technology has the promise of rapid, widespread adoption and accident prevention, as was reiterated by Chairman of American Airlines, Jerry Greenwald, upon learning about NeuroVigil’s technology. NeuroVigil is poised to position the iBrainT as a mandatory device for individuals involved in the transportation industry.
Of course, one can imagine other industries where sleep problems affect safety and performance, and NeuroVigil will be there to help individuals, businesses, and government to improve safety and sleep.
Sleep is an essential component to human survival, is a central component to memory consolidation and executive function, and is critical to homeostatic and regulatory mechanisms. Sleep disorders are believed to affect 70+ million Americans, and are factors involved in a significant amount of morbidity and mortality, from depression to atrial fibrillation to congestive heart failure.
Sleep Apnea
Sleep apnea, the leading indication for sleep studies, is a high prevalence disorder and is estimated to be as common as adult diabetes, affecting 12-30+ million Americans, but is diagnosed in less than 4 million individuals due to the time, expense, cumbersome testing, and relative scarcity of sleep laboratories to diagnose the condition. Estimates have placed just the cardiovascular costs of undiagnosed sleep apnea at $120B per year, Medicare and insurers are currently reimbursing $3B+ per year for sleep studies. Medicare and insurers are currently paying between $1,500-$3,000 for a single night of sleep study, and recently Medicare has approved reimbursement for at-home sleep evaluations. Sleep laboratories are expected to enjoy double digit revenue growth in the next five years. The number of sleep beds is expected to grow between 15-20% over the next five years. Currently there are about 3,000 sleep centers in the U.S. Approximately 60-80% of a sleep center’s patients are being evaluated for sleep apnea. Waiting times for most patients are approximately 2-6 weeks in the U.S. due to limitations of sleep laboratory and trained technician scoring and physician interpretation capacity.
NeuroVigil intends to change the approach toward servicing this market through two essential innovations that will afford the company the ability to better meet the growing demand for sleep studies and the diagnosis of important sleep pathology. Its technology will provide this through efficiency and automation, increase relative margins of sleep centers and of physicians at sleep centers, allow them to increase the number of analyses performed, and increase the diagnostic accuracy of sleep evaluations leading to more appropriate treatment. The two pronged approach, both of which incorporate the NeuroVigil technology will focus both on improving sleep center performance and at-home device deployment and usage, and will provide a device and associated diagnostic/analytic capability offering substantially better suited than its competitors for the $2B+ home market.
Drugs Affecting Sleep
A myriad of pharmaceutical agents are known clinically to negatively affect sleep, but sleep testing during pharmaceutical clinical trials or post-marketing surveillance of these compounds is rarely performed. Several pharmaceutical companies have demonstrated significant interest in understanding the effects that their drugs may have on sleep, in an effort to advocate for improved or extended indications or labeling by the FDA for marketing claims, or to demonstrate more advantageous adverse effect profiles compared to competitors. The NeuroVigil technology, as described, not only automates EEG reading, the cornerstone of assessing the architecture of sleep, but requires fewer channels and dramatically expands the window of data one receives from current EEG signals.
Safety & Sleep Problems
The transportation safety market exceeds $10B in annualized revenue. More than 100,000 motor vehicle accidents, half of the accidents and a third of the fatalities on the road, are directly attributable to drivers falling asleep at the wheel. Many commercial vehicle accidents are a direct result of an operator falling asleep at the wheel, and are a combination of driver fatigue which is currently unmonitored and a significant (estimate 40%) prevalence of sleep apnea in this population. Sleep apnea is alone thought to account for 1,500 annual deaths on the road.
The FAA and FTA have both enacted sweeping policies over the prior two decades to regulate the activities of pilots and ship operators to limit fatigue and sleeplessness on the job. This regulation helps to prevent but does not provide continuous, unobtrusive monitoring of pilots and operators that can be used dynamically to alert them if drowsiness occurs. Billions of dollars are currently spent in all aspects of the transportation industry to reduce on the job drowsiness, but no active monitoring and alert system has been invented and is currently being used. As an extension of NeuroVigil’s iBrain product offering, the Company intends to develop an iBrainT device which will seamlessly integrate into the workflow of the pilot, operator, or driver, continuously monitor their brain activity for precursors of drowsiness and provide an appropriate alarm to them if such signals are detected. This technology has the promise of rapid, widespread adoption and accident prevention, as was reiterated by Chairman of American Airlines, Jerry Greenwald, upon learning about NeuroVigil’s technology. NeuroVigil is poised to position the iBrainT as a mandatory device for individuals involved in the transportation industry.
Of course, one can imagine other industries where sleep problems affect safety and performance, and NeuroVigil will be there to help individuals, businesses, and government to improve safety and sleep.