Tailored Medical Devices, (TMD) develops products for the treatment of blocked arteries in the legs, a disease commonly known as peripheral artery disease. Currently, the team is looking to capitalize on advances made in the peripheral artery disease field by developing its patented drug-coated balloon (TMD-DCB) technology to final product and approval stages. Our long-term mission is to research, develop, and license drug-delivery medical devices in the cardiovascular field as well as other broad ranges of medicine.
Our product highlights
Our technology
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
Patent
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.
About TMD
What we do
At Tailored Medical Devices, (TMD), we perform research and development of drug-delivery medical devices to aid in the treatment of diseases. We have an excellent team of research scientists and entrepreneurs with several years of experience in research and commercialization of technologies. We collaborate with healthcare and academia in the region to use the best personnel and resources available in the region to perform extensive research and development of drug-delivery technologies. Currently, we are working on the development and testing of our innovative drug-coated balloon (DCB), a drug-delivery device for the safe and effective treatment of peripheral artery disease (PAD). This technology was originally developed in collaboration with the University of South Dakota (USD) and Sanford Research. The inventors of this technology formed TMD to accelerate the research and commercialization of this device. With individual expertise of the team members along with our experience in working as a research team for the past four years, the long term goal of TMD is to research, develop, and license drug-delivery medical devices in the cardiovascular field as well as other broad ranges of medical areas.
Dr. Daniel Engebretson is the founder and president of Tailored Medical Devices, Inc. He is also the Chair of the University of South Dakota’s Department of Biomedical Engineering. Dr. Engebretson has over 20 years of experience in working and managing small business companies. After graduating with a PhD in Physical Chemistry in 1998 from Michigan State University, he served as a Senior Research Scientist at Dakota Technologies Inc....
Dr. Sujan Lamichhane is a co-founder and Senior Scientist at Tailored Medical Devices, Inc. After earning a doctorate degree in Biomedical Engineering from University of South Dakota (USD) in 2015, he has been working as a post-doctoral research associate in USD’s Department of Biomedical Engineering for more than two years. Dr. Lamichhane has over 6 years of experience in research and development of cardiovascular implants and medical devices......
Dr. Jordan Anderson is a co-founder and Senior Scientist at Tailored Medical Devices, Inc. He earned his doctorate in Biomedical Engineering from USD in 2017. He has over 4 years of experience in research and development of drug-releasing medical devices. His doctorate research was focused on developing formulation and coatings for applications in drug infusion drug-coated balloons. Dr. Anderson has broad research skills and experience in performing and leading.....
Dr. Patrick Kelly, a board-certified surgeon at Sanford Health, is the innovator and founder of Sanford Vascular Innovations. After graduating with a civil engineering degree, he worked as a structural engineer before attending medical school at the University of South Dakota. Dr. Kelly is the Medical Director of the Sanford Advanced Aortic Program, Sanford Vascular Services and the Sanford Wound Clinic. He has pioneered.....
Dr. Tyler Remund is the Director of Commercialization at Sanford Health. He focuses on product development and commercialization of medical technologies. He has years of experience in commercializing technologies in the areas of complex aneurysm repair, vascular drug delivery, and Doppler ultrasound diagnostics. Prior to leading commercialization at Sanford, he worked for a seed stage venture capital firm to support their commercialization efforts in the areas of biofuels, solar energy, drug delivery.....
Kathryn is the Director of Sanford Vascular Innovations, which is a part of Sanford Health that works in advancing the state of vascular care through innovation, expertise and research to reduce the cost of care while improving outcomes and quality of life for patients. She has more than 10 years of experience in introducing medical devices to market. A regulatory master, her many areas of expertise include bringing a novel drug-device.....
News
SBIR Funding
Tailored Medical Devices received phase 1 SBIR award from NIH
Patent and collaboration
Collaboration between USD and Sanford for DCB
South Dakota Giant Vision
TMD selected among 8 business in South Dakota for Governor’s Giant Vision Competition 2018
Careers
TMD currently has no open positions. We will have some open positions this summer for undergraduate/graduate interns and research technicians. Please contact us via email for more details.