Outstanding Innovation in Medical Device:
Vinod Labhasetwar, PhD

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Vinod Labhasetwar, PhD, Endowed Chair in Nanomedicine at Cleveland Clinic’s Research Institute and recipient of the Outstanding Innovation in Medical Device award for 2020, has dedicated his career to researching drug delivery methods through the use of nanoparticles. Earning his PhD from Nagpur University in India, Dr. Labhasetwar entered the research playing field through a post-doc position and eventual faculty role at the University of Michigan. Here, his research was centered on cardiovascular applications, though his ensuing roles would diversify his experience. At the Nebraska Medical Center, Dr. Labhasetwar worked with cancer therapies and taught at the undergraduate and graduate levels. Dr. Labhasetwar came to Cleveland Clinic in 2007 as a professor of biomedical engineering in the Lerner College of Medicine and began work translating his nanoparticle research into the unmet clinical needs of the central nervous system – such as spinal cord injury.  Leveraging his platform’s versatility, Dr. Labhasetwar proposed the commercialization of his research as a drug delivery platform using a coated angioplasty balloon.  In 2017, Drug-Coated Balloon (DCB) market became well-established for treating Peripheral Artery Disease (PAD). In collaboration with the Cleveland Clinic Innovations, a commercialization strategy was drawn out, and subsequently, a license agreement was stricken with Advanced NanoTherapies, Inc.

Dr. Labhasetwar’s primary technology, further outlined in our 2019 Annual Report, is a drug delivery platform via biodegradable nanoparticles. Such technology offers control over drug availability into tissue with both a short-term and long-term impact. Similar to a medicated stent, the elution profile of these nanoparticles mimics a stent’s therapeutic delivery, without the need for a permanent presence in the vessel. To achieve such performance, the technology platform proposed the same product, both a short-term availability of a therapeutic agent while designing some particles to elute their content over a longer time.  Current technological applications are through a drug-coated balloon (DCB), which is used to open the “atherosclerosed” artery and concomitantly deliver anti-restenotic drugs.

Dubbed NanoDCB, the product’s nanoparticle delivery system remedies several issues seen with market-available drug-eluting or drug-coated balloons, namely rapid washout, coating fall off, and limited flexibility in the treatment plan. With its unique grouping technique to load nanoparticles onto the balloon, NanoDCB limits the washout effect through a nano-engineered delivery system, enabling drugs to cross barriers in the body. NanoDCB’s coating is also highly flexible, eliminating the frequent case of balloon coating falling off pre-procedure.. The nanoparticles’ ability to encapsulate different kinds and doses of drugs allows for increased treatment options not seen with today’s gold standard. Dr. Labhasetwar is currently using the NanoDCB technology in conditions where localized drug delivery to vessel walls is crucial – like in Peripheral Artery Disease (PAD).

“In PAD, stents often don’t work due to the biomechanics of the lower limbs, so the idea of delivering drugs with balloons fits very well,” said Dr. Labhasetwar. In 2019, NanoDCB was licensed to Advanced NanoTherapies to treat atherosclerosis and vessel blockage. In late 2020, Advanced NanoTherapies raised $5.3M in their final tranche of seed funding, with a goal of first-in-man testing in the US by 2022. 

Beyond cardiovascular diseases, Dr. Labhasetwar is hopeful that there are other use-cases for the technology. He continues to innovate in his laboratory, hoping to make breakthroughs in stroke – like expanding the treatment window for tPA, a thrombolytic agent, with reduced hemorrhage risk.  Dr. Labhasetwar also actively pursues research in spinal cord injuries repair, which could be disruptive for quadriplegic patients. “You have to understand the unmet need…,” said Dr. Labhasetwar, “…will it make a difference in the lives of your patients?”

Dr. Labhasetwar credits Cleveland Clinic Innovations for protecting his intellectual property and negotiating the license to Advanced NanoTherapies. “As an inventor, I don’t know everything,” he said with a laugh. “They helped to negotiate the license and bring this idea to life.”  

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