PAD and treatment
Over 200 million adults suffer from peripheral artery disease (PAD) globally, with over 25 million residing in the US and Europe. PAD is caused by fatty plaque buildup on the inner walls of the arteries, leading to blockages that require a procedure to re-open the artery. PAD occurs in arteries supplying blood to the head, arms, organs, and most commonly legs leading to peripheral neuropathy, heart attack, and often amputation of limbs. Patients who have had an amputation due to PAD have a lower 5-year survival rate than patients with stage-4 colon cancer.
In 2014, the U.S. Food and Drug Administration (FDA) approved the use of drug-coated balloons (DCBs) for PAD treatment of lesions located above the knee. DCBs act to open the blocked artery and deliver a drug locally into the tissue to maintain arterial blood flow. In order to prevent arterial re-occlusion, DCBs deliver anti-proliferative drugs such as paclitaxel (PAT) by inflating DCBs at the treatment site.
TMD’s innovative DCB technology
TMD’s technology is an improved treatment method for PAD, which will increase the safety as well as reduce the cost, time, and complications of currently used methods. Our patented drug-coated balloon (DCB) technology is currently being tested and we have obtained some exciting results. Benchtop and pilot-scale animal studies have revealed that TMD’s technology provides a safer and more effective treatment than other DCBs for common forms of PAD.
We intend to apply our innovative technology to solve the critical issues that exist with the current DCBs by using two approaches:
1) Develop a novel drug formulation that produces negligible particles and provides safer treatment than the existing technologies for the treatment of lesions below-the-knee (BTK)
2) Develop a novel drug coating strategy that allows multiple inflations to provide multiple episodes of drug delivery from a single DCB for safer and effective treatment of multiple or long and diffuse lesions
Patent and Publications
Mani G, Lamichhane S, Anderson J, Remund T, Kelly P. “Formulations for Tailored Drug Release”. US10004831B2. Patent granted on June 26, 2018.
Relevant Publications by our team
1. Pre-clinical testing of our multiple-release drug-coated balloons
Anderson J, Lamichhane S, Fuglsby K, Remund T, Pohlson K, Evans R, Engebretson D, Kelly P. “Development of drug-coated balloon for the treatment of multiple peripheral artery segments”. Journal of Vascular Surgery 2019.
2. Pre-clinical testing of our single-release drug-coated balloons
Anderson J, Lamichhane S, Vierhout T, Sherman A, Engebretson D, Pohlson K, Remund T, Kelly P. “In vitro particulate and in vivo drug retention study of a novel polyethylene oxide formulation for drug-coated balloons”. Journal of Vascular Surgery 2017.
3. Early development and bench-top studies of our proprietary formulation
Anderson J, Lamichhane S, Remund T, Kelly P, Mani G. “Preparation, characterization, in vitro drug release, and cellular interactions of tailored paclitaxel releasing polyethylene oxide films for drug-coated balloons”. Acta Biomaterialia 2016; 29(1): 333-351.