Markets for HVA
Market Potential
NHSi delivers HVA via a proprietary internet-based software platform – the HVA Platform.
Vascular disease is a leading cause of death and disability. Vascular disease occurs
in every region of the body, including the heart (cardiovascular disease), the brain
(cerebrovascular disease), and the arms and legs (peripheral vascular disease) and
results in a range of conditions that lead to functional impairment or death. In
addition to heart attack and stroke these conditions include dementia, sleep apnea,
hypertension, kidney failure, and diabetes-related vasculopathy.
In the US alone, the market size for HVA has been estimated by The Monitor Group
to exceed $3 billion, including both clinical applications and demand from drug
and medical device development. In the numerous clinical areas where HVA is applicable,
Monitor estimates a potential for more than thirty million tests in the US. In the
commercial research market, there are currently more than 400 drugs in pre-clinical
development and more than 250 drugs in Phase I and II clinical trials in HVA-relevant
conditions. One major pharmaceutical company has already used HVA in connection
with a drug trial.
“As a clinician, researcher and instructor in the uses of TCD, I believe that that
HVA represents the most significant advance for the use of ultrasound in neurological
and cerebrovascular disorders since the launch of TCD some 25 years ago. It provides
clinicians and researchers with unrivalled insight into the physiological and hemodynamic
characteristics of neurovascular disorders, as well as the effect of systemic diseases
on the cerebrovascular system. It also informs regarding regional and global hemodynamic
effects, with rapid recognition of hemodynamic patterns, which are difficult if
not impossible to identify and objectively quantify with traditional TCD. This affords
clinicians improved ability to identify, diagnose, and treat patients with a wide
array of conditions caused by or resulting in vascular compromise.”
Charles Tegler, M.D.
(McKinney-Avant Professor of Neurology, Wake Forest University)
Advantages of HVA Over Traditional Imaging Tests
Traditional imaging tests, including CAT, PET, MRI, and SPECT, are costly and time-consuming,
expose patients to high levels of imaging agents, and are available only at fixed
site locations that may be inaccessible to certain patients. Most importantly, vascular
disease detection with these tests depends on images of anatomical change that show
blockages or damage and this is not apparent until significant, often irreversible
damage has occurred.
HVA offers clinicians the ability to measure and to monitor vascular states at a
single point in time, or over a period of time. This highlights changes caused by
disease progression or therapeutic intervention.
HVA offers a distinct advantage over stand-alone TCD in clinical trials and clinical
practice; its measurements are comprehensive, objective and reproducible across
users and instrument systems.
NHSi will initiate commercialization by targeting five conditions: sleep apnea,
cognitive impairment, carotid artery disease, stroke, and traumatic brain injury.
Each is widely prevalent in the general population and ineffectively addressed with
current technologies and standards of care.
Advantages of HVA Over Traditional TCD
Traditional TCD ultrasound provides clinicians only with metrics on mean flow velocity
and pulsatility. It depicts images of blood flow velocity in a waveform image showing
only a single vessel and cannot facilitate either integration of metrics and vessels,
nor provide comparisons to either healthy or disease reference data.
HVA offers comprehensive data on all vessel segments. It generates a characterization
of regional and global vascular states that is both holistic and granular. This
refinement allows clinicians to assess vessel performance with much more precision
than they could with simple TCD and place them in the proper context of the entire
neurovascular system.
Target Applications
Sleep Apnea
Sleep apnea is a common, extensively undiagnosed condition in which breathing is
disrupted during sleep. An increasing body of evidence has shown that the presence
of sleep apnea is a significant risk factor for such conditions as heart disease,
stroke, hypertension and dementia.
Current diagnosis requires at least one overnight sleep study in a sleep laboratory
that can cost in excess of $1,000 per night. Often poorly tolerated, the sleep study
frequently needs to be repeated to obtain a valid result. Following a confirmed
diagnosis, a further sleep study is required to “titrate” the most common therapy,
Continuous Positive Airway Pressure CPAP).
The current methods for selection of patients for sleep studies frequently err both
in including those who test negative, and excluding others who would test positive.
Both errors result in significant wasted healthcare costs and poor patient management.
HVA for Sleep Apnea
HVA provides a means of performing a physiological assessment for those at high
risk of having the condition, thus improving the diagnostic yield of the sleep study,
and cutting costs for payors. HVA also provides a means for monitoring patients’
physiological response to CPAP therapy.
“I have made HVA an integral component of my approach to the diagnosis and management
of this extensively under diagnosed condition (Sleep Apnea), and believe it will
be widely adopted and applied by pulmonologists here in the US and overseas.”
Elliot Stokar, M.D., Pulmonologist
(Medical Specialists – Munster, IN)
Current beta site user of HVA
Market Potential
An estimated 18-20 million people in the US alone are believed to have sleep apnea.
Of these up to 60% remain undiagnosed. Approximately 2 million sleep studies are
conducted annually. NHSi estimates the addressable market for HVA for sleep apnea
to exceed $430 million annually in diagnosis, CPAP titration and ongoing disease
management.
Cognitive Impairment
Approximately 7.5 million people in the US alone are believed to be afflicted with
dementia. Of these, approximately 70% (5.2 million) suffer from Alzheimer’s disease,
while 5% to 10% are thought to have Normal Pressure Hydrocephalus (NPH), an extensively
under-diagnosed, treatable form of dementia caused by a buildup of fluid in the
cranial cavity. NPH, unlike all other forms of dementia, is reversible if diagnosed
and treated promptly.
In addition to the 7.5 million people with dementia, there are millions who suffer
from Mild Cognitive Impairment (MCI). Numerous research studies estimate that an
additional 5% to 16% of the population over age 50 suffer from MCI (this is 5 to
15 million people – a range which illustrates the inconsistency and inadequacy of
existing diagnostic methods). MCI is characterized by impairment of memory, language
or other essential cognitive functions that is noticeable to others and detectible
in cognitive test scores, but not severe enough to interfere grossly with daily
life. Approximately 50% of those afflicted with MCI go on to develop dementia. In
others, MCI symptoms persist but do not worsen; others still regain normal cognitive
function. Research has further shown that diagnosis and treatment of MCI may delay
the onset of dementia.
As populations age in the US and developed countries, the prevalence of all forms
of cognitive impairment is expected to increase significantly. By 2050, the prevalence
of Alzheimer’s disease in the US alone is projected to be 20 million.
NHSi initially intends to promote HVA in two respects: first, as an aid in the diagnosis
and management of NPH, and subsequently as an aid in the assessment and management
of MCI and more advanced cognitive disorders, including Alzheimer’s and vascular
dementia.
Current diagnostic tests and treatment for adult NPH require invasive and costly
surgical procedures. For diagnosis, a lumbar puncture is required to test cerebrospinal
fluid. Approximately 50% of patients who undergo a lumbar puncture are shown not
to have NPH. For those diagnosed with NPH, the most common therapy involves insertion
of a permanent shunt device to modulate cerebrospinal fluid levels.
HVA for NPH:
NHSi’s research has demonstrated that HVA reveals a selective pattern in the cerebrovascular
system that may be used to determine which patients likely have NPH, thereby improving
the diagnostic yield of the lumbar puncture procedure. The Company believes HVA
can be employed cost-effectively to act as a screen for all patients with significant
dementia symptoms, to identify the 10% who have this reversible condition. In addition,
HVA can provide clinicians with an important tool for assessing how their NPH patients
are responding to therapy following insertion of permanent shunt devices and discharge
from the hospital.
“NHSi’s HVA technology offers those involved in the diagnosis and management of
NPH a unique ability to add and integrate physiological insights derived from a
comprehensive neurovascular assessment to and with our assessments of patient gait
and cognitive characteristics. In our pilot trial HVA showed a significant difference
between responders and non-responders to CSF drainage at presentation and after
CSF removal, HVA showed a unique pattern of specific vessel sites that was significantly
different between responders in combination and individually.”
Mark Luciano, M.D., Ph.D.
(Chairman, Section of Pediatric and Congenital Neurosurgery, Cleveland Clinic)
HVA for MCI:
NHSi will deploy HVA to aid in the assessment and management of patients at medical
practices and institutions that specialize in cognitive conditions in the aging
and elderly population such as the Cleveland Clinic’s Aging Brain Clinic.
Market Potential:
The market opportunity for tools to refine the diagnosis/differentiation and management
of cognitive impairment is enormous and will continue to grow rapidly as the population
ages. NHSi estimates the market in the US alone to be $75 million for NPH and $250
million for MCI per year.
The development of dementia-related therapies is an urgent research priority for
the pharmaceutical industry. NHSi estimates that currently there are more than 300
HVA-relevant dementia trials ongoing, representing a market of $75 million per year.
HVA has enormous potential in animal and human trials to measure vascular response
to dementia drugs. HVA can effectively screen trial populations, potentially providing
early identification of drugs likely to fail, thus increasing approval rates, increasing
uses for existing products, and reducing overall development costs and time-to-market.
Carotid Artery Disease
Carotid Artery Disease is caused by the buildup of plaque in the carotid artery
that impedes the free flow of blood to the brain and may result in stroke or other
adverse events.
Current treatments for the condition include insertion of a stent to increase blood
flow through regions blocked by plaque and a carotid endarterectomy, a surgical
procedure in which plaque is removed from inside the vessel to improve blood flow.
HVA for Carotid Artery Disease:
NHSi is studying subjects who undergo these procedures to identify the correlations
between baseline HVA-defined vascular states and the probability of adverse procedure-related
complications including stroke or cognitive impairment caused by embolic debris.
We believe HVA can be used to predict endpoints and improve the risk-benefit ratio
of these procedures. The Company is awaiting completion of data analysis from a
comparative trial conducted at Columbia Presbyterian examining both endovascular
and surgical repair of the carotid artery.
Market Potential:
Based upon an estimated 250,000 carotid artery procedures per year, NHSi projects
a $180 million potential market for the various uses of HVA in connection with initial
diagnosis of carotid artery disease, pre- and post-operative assessments, and ongoing
disease management.
Stroke
TCD is currently used extensively in the acute treatment and post-treatment follow-up
for stroke patients.
HVA for Stroke:
HVA will be utilized for more accurate measurement of stroke patients’ cerebrovascular
condition and response to therapy in neurointensive care, and after discharge to
monitor recovery in the out-patient environment.
“In my opinion, HVA is a promising and novel method to aid in the diagnosis and
treatment of several major stroke risk factors such as carotid artery atherosclerosis,
and in interventional treatment of symptomatic carotid disease. In addition, HVA
is a promising technology for monitoring response to therapy in acute stroke patients
in the ER and NICU and for follow up in the outpatient setting.
The HVA platform may have an important role in selecting patients for acute stroke
treatments, secondary stroke prevention therapies and stroke rehabilitation and
thus to enhance stroke outcomes with substantial benefits for patients at a lower
cost than conventional imaging tools used in clinical stroke care.”
Tatjana Rundek, M.D., Ph.D.
(Assistant Professor of Neurology at the University of Miami)
Market Potential:
There are approximately 500,000 new stroke victims in the US each year. In addition,
there are an estimated 3 million stroke survivors. In the acute care context, there
are approximately 2,000 hospitals in the US with neurointensive care units, of which
half average 10 beds and half average 5 beds.
Based upon a subscription pricing model (described below), NHSi estimates the acute
care stroke market for HVA to be approximately $150 million. In addition, there
is a $300 million outpatient market for ongoing management of stroke victims.
Carotid artery disease and stroke are high priorities in pharmaceutical and medical
device research and development. As with dementia, NHSi estimates that currently
there are more than 300 HVA-relevant trials ongoing in the areas of carotid artery
disease and stroke, representing a potential annual market of $75 million.
Traumatic Brain Injury
Traumatic brain injury (TBI), whether caused by a sports injury, accidental trauma
or combat, can often lead to vasospasm, a condition in which blood vessels spasmodically
contract, severely restricting blood flow and inducing ischemic stroke. Vasospasm
can have a significant impact on patient outcomes, but the ability to anticipate
the severity and longevity of the vasospasm has been poor. Vasospasm can begin 3
to 14 days from the time of injury, and last beyond 30 days.
HVA for TBI:
Preliminary observations in clinical studies of wounded soldiers returning from
Iraq and Afghanistan indicate a potentially important use for HVA. HVA may be able
to identify a pre-spasm state of increased blood flow not previously quantifiable
using standard methods of analysis that will correlate with the subsequent development
of severe vasospasm.
Similarly, a pilot study conducted at Wake Forest University showed that athletes
suffering from sports-related concussions exhibited altered hemodynamics following
injury and that the restoration of normal hemodynamics required significantly longer
time than is generally regarded as sufficient to enable safe return to play.
HVA has a potential role in predicting trauma-induced vasospasm, assessing the effects
of TBI therapies, and in serving as an objective physiological measure to guide
the decision on when an injured person may safely resume activities involving risk
of re-injury.
Market Potential:
There are approximately 300,000 annual emergency room visits by patients with TBI,
representing a $15 million market potential for HVA. There is an additional $50
million HVA market for monitoring the estimated 1.0 million patients living with
TBI who would benefit from annual HVA assessments. This market estimate does not
include the significant multi-million dollar annual military revenue opportunity
in this area.