Primary Market Opportunities
Current methods of risk assessment for diabetic foot ulcers are
poor and as a result, US hospitals perform over 150,000 lower
extremity amputations each year, with the majority of these being
the result of diabetic foot complications. Using OxyVu
to assess healing potential and predict where ulcers may form
addresses a significant unmet medical need.
Diabetes is one of the most serious, under-treated, and rapidly
growing diseases facing the world today. It affects over 200 million
people worldwide and more than 20 million people in the United
States. Within the US, the number of new cases of diabetes has
jumped 40% in the last decade. US Center for Disease Control data
predicts continued growth to epidemic proportions.
Although medical research experts have not yet discovered a diabetes
cure, they have found that they can minimize the ravages of diabetes
complications by defining specific risks, accurately assessing
evolving pathology and ensuring rapid institution of effective
therapy.
This is particularly true in providing appropriate care for the
diabetic foot. A lower extremity ulcer develops in as many as
25% of patients with diabetes during their lifetime. Foot pathology
associated with vascular disease is a major source of morbidity
among diabetics and a leading cause of hospitalization. Infected
and/or ischemic diabetic foot ulcers account for about 25% of
all hospital days among patients with diabetes. Costs of foot
disorder diagnosis and management are estimated at over $5 billion
annually. Foot ulceration precedes 85% of lower extremity amputations.
Proper prevention, evaluation and treatment of diabetic foot disease
would clearly improve the quality of life for people with diabetes.
The average annual risk for ulceration in a patient with diabetes
is between 6% and 7%, indicating that roughly 1.5 million patients
will develop a foot ulcer each year.
Peripheral arterial disease affects primarily people older than
55. There are currently 59.3 million Americans older than 55,
and over 12 million of them have peripheral vascular disease.
It is estimated that only a third of patients with PAD have been
diagnosed at this time. This represents a dramatically under-diagnosed
market. Although pharmacologic treatments for PAD have traditionally
been poor, 2.1 million nevertheless receive pharmacologic treatment
for the symptoms of PAD. Additionally, ~500,000 patients undergo
vascular procedures such as peripheral arterial bypass surgery
(~100,000) or peripheral angioplasty (~400,000) annually and are
candidates for pre and post surgical testing.
One difficulty in diagnosing PAD is that in the general population,
only about 10% of persons with PAD experience classic symptoms
of intermittent claudication. About 40% of patients do not complain
of leg pain, while the remaining 50% have leg symptoms which differ
from classic claudication.
Relying on a history and exam alone is not recommended. In one
study, 44% of PAD diagnoses were false positive and 19% were false
negative when history and physical exam alone were used. For this
reason, physicians have looked for other means to help them in
their diagnosis.
As in the case of diabetic foot disease, current technologies
have fallen short. Nonetheless, patients are frequently sent to
peripheral vascular laboratories for non-invasive studies. |
