The more you know, the better you can treat PAD.

TV1001SR is a twice-daily orally-dosed slow-release formulation of the FDA-approved compound, therapeutic sodium nitrite. Results from Phase 2a clinical trials support the use of sodium nitrite for the treatment and prevention of peripheral artery disease. An unexpected outcome of the studies was that some patients reported a significant reduction in PAD-associated pain. This led to our developing clinical protocols for PAD and PAD-associated pain for Phase 2b trials, expected to begin in second half of 2020.

Peripheral artery disease, or PAD, is a chronic disorder that reduces blood flow to the extremities, resulting in severe pain, limited mobility, and in some cases, death.

The primary cause is the buildup 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. Blood clots, diabetes, inflammation, infection and injury can also lead to PAD.

If left untreated, PAD, will lead to critical limb ischemia (CLI), or a blockage of arteries in the lower extremities. This may lead to amputation of the affected limb.

In the United States, estimates are that PAD affects nearly 9 million people with an annual cost of care at $10+billion annually.

TV1001SR promotes recovery in tissues damaged as a result of PAD by restoring blood flow. When given in an extended-release formulation versus the single dose methodologies currently in use for other indications, TV1001SR was shown to restore blood flow, leading to the development of new blood cells (angiogenesis), and new collateral blood vessels (arteriogenesis).

In initial research studies the drug effectively restored ischemic tissue blood flow (blood supply to the tissues), and was effective in a wide range of pathologies involving alterations of angiogenesis including diabetes, wound healing and tissue necrosis or death of tissues that cannot be restored.

In clinical trials, TV1001SR was shown to not only restore blood flow to affected tissues, patients in the study reported a reduction in pain as a result of the improved circulation.

With further testing, TV1001SR may be shown to be a non-addictive alternative to chronic opioid therapy for patients with PAD-related pain.

The next step for TV1001SR is a Phase 2b clinical trial to confirm clinical efficacy and therapeutic dose range. Clinical protocol development is underway for this next phase.

In addition, the company intends to apply for the secondary indication of PAD-associated pain as part of its Phase 2b trials.

JanOne, a NASDAQ-listed company, is intensely focused on bringing new ideas to market to combat the opioid abuse epidemic in the United States. Acquiring the rights to continue testing and developing TV1001SR for PAD and PAD-associated pain is just one step in finding ways to kill pain, not people.

JanOne is dedicated to finding innovative, actionable solutions to opioid abuse, and working with the team on TV1001SR is an important first step in fighting that abuse one disease at a time.

At the helm of JanOne is Chairman and President Eric Bolling, who is motivated by the tragic overdose death of his only son, Eric Chase. Bolling believes that the only good to come from his loss is the opportunity to use it as a lesson and a rallying cry for all Americans to battle the opioid abuse crisis.

Our innovative approach is to find disease indications that cause significant pain for which opioids are often prescribed. We seek to find potential medications that can treat the underlying cause of that disease while also potentially relieving any associated pain. We hope to find potential medications to safely and directly treat pain without addictive qualities.

Estimates are that PAD affects up to 200 million people worldwide and nearly 9 million in the US alone. Along with causing significant limits in mobility, PAD often leads to significant pain. In initial clinical research, TV1001SR was found to not only improve PAD, but it also reduced patients’ pain. If we can find a way to keep PAD sufferers from needing prescriptions for opioid-based pain medications, we’ve already started to make inroads into fighting the opioid abuse crisis where it often starts – the prescription pad.

No, JanOne is focused on ending the opioid abuse crisis by finding and bringing to market non-addictive alternatives to opioids, and by promoting other ways to fight the use and abuse of both prescription and non-prescription opioids. This is more important than any political party or policy belief. Solving the opioid abuse crisis crosses party lines and is something we can all work together to solve.

The company’s name, JanOne, expresses the start of a new day and new beginnings. January One is the first day of a New Year – a day of optimism, resolution, and hope. JanOne affirms the company’s strategic commitment to fresh thinking and innovative means to assist in ending the worst drug crisis in our nation’s history: Opioid addiction. We think we can do this one disease at at time and, in the process, find potential solutions to directly treat pain without addictive qualities.

Formerly Appliance Recycling Centers of America, Inc., the company recently re-positioned to enter multiple lines of business that can have a positive impact on humanity. Just like ARCA has successfully done its part to impact the environment, our next line of business is to fight addiction and more specifically opioid addiction. Like many successful businesses, we see a problem that needs to be solved. Thus, we have broadened our business to combat the opioid abuse crisis. By entering into the pharma sector, we bring together world-class scientists, medical leaders, and private-sector resources to tackle an urgent public health crisis.

The company continues to operate its legacy businesses – ARCA Recycling and GeoTraq – under their current brand names.

JanOne’s subsidiary, ARCA Recycling, recycles household appliances by providing turnkey recycling and replacement services for utilities and other sponsors of energy efficiency programs. JanOne’s subsidiary GeoTraq engages in the development, design and, ultimately, expected sale of Mobile IoT modules.

JanOne’s subsidiary, ARCA Recycling, recycles household appliances by providing turnkey recycling and replacement services for utilities and other sponsors of energy efficiency programs. JanOne’s subsidiary GeoTraq engages in the development, design and, ultimately, expected sale of Mobile IoT modules.

We’ll continue to search for innovative ways to reduce dependence on opioids – whether they be prescription- or medication-based, or illicit. Our goal is to end our national opioid abuse crisis.