Research & Development
Peripheral Arterial Disease (PAD)
Nearly 24 million people currently suffer from diabetes mellitus, and the prevalence of the disease has been steadily increasing for several years. Patients with diabetes are at a greater risk of developing peripheral artery disease (PAD), a chronic disorder associated with reduced blood flow to the extremities. PAD causes severe pain in the extremities, limits mobility, and in some cases may lead to death. In the US alone, PAD affects some 12-14 million people, and if left untreated will lead to critical limb ischemia with at annual cost of care estimated at $10 billion. The primary cause of the disease is the build up of fatty acids in the blood vessels, or atherosclerosis, that leads to the formation of plaques in the vessels, which in turn block or weaken the vessel walls, ultimately resulting in reduced blood flow to the extremities. Blood clots, diabetes, inflammation, infection and injury can also lead to PAD. The best predictor of the disease is aging; as the population continues to age, the incidence of PAD will continue to increase. Among other risk factors, diabetes may help to explain the recent increase in incidence among younger people.
TV1001SR is a twice-daily orally-dosed slow-release formulation of the FDA-approved therapeutic sodium nitrite. Results from Phase IIa clinical trials support the use of sodium nitrite for the treatment and prevention of peripheral artery disease, and as a non-addictive and cost-effective treatment for diabetic neuropathy.
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