Clemson University

Next-generation bioresorbable vascular scaffolds offer an alternative to metallic drug-eluting stents. By James M. Lindsey III, Zeus Once hailed as the fourth revolution in percutaneous coronary intervention (PCI), bioresorbable vascular scaffolds (BRS) did not live up to the hype. Leveraging the fundamentals of PCI innovations that came before it — balloon angioplasty, bare-metal stents, and drug-eluting stents (DES) — the idea of a magical device that could provide the same era-defining functionalities and then disappear was an exciting proposition. While promising, first-generation polymeric BRS suffered from several fundamental limitations. Due to the relatively lower strength of the Poly-L-lactic acid (PLLA) polymer, the scaffold struts were required to be thicker at ~150 microns versus ~80 microns for DES, creating a more thrombogenic environment due to disturbances in blood flow. Also, due to the limitations in the polymer’s ductility, limited over-expansion ratios were prescribed, providing less room for error during sizing and implantation, thereby increasing the likelihood of strut-malapposition and subsequent intraluminal scaffold dismantling upon scaffold degradation. However, even with these drawbacks, it has been reported that while adverse events were more common with the first-generation scaffold than with a contemporary DES, the period of excess risk ended at three years, corresponding to the time for complete scaffold resorption. Therefore, if comparable safety and efficacy to that of DES can be achieved during the first three years post-implantation, BRS technology may indeed live up to its potential, and not only in the treatment of coronary artery disease (CAD), but also in the treatment of peripheral artery disease (PAD). Stringent requirements: a challenge for effective polymeric BRS A BRS has a dual mandate: Provide safe and effective arterial/radial support to prevent post-revascularization recoil; and resorb in a benign fashion, allowing for the restoration of the natural vessel function. For a polymeric BRS, providing effective radial support is no small task. BRS are required to have a low delivery profile, requiring them to be both crimpable and expandable, resulting in a high degree of localized strain. On top of that, it is often required that a BRS be “over-expanded” to achieve good strut apposition to the vessel wall. After this high-strain-laden implantation process, the BRS must be able to maintain a high yield stress to prevent vessel recoil. Finally, after providing sufficient support for vessel remodeling, the BRS must resorb without complication. How can a BRS possibly meet these stringent requirements? The answer lies in optimized polymer microstructure. Polymer microstructure: the key to new beginnings BRS are most commonly fabricated by laser cutting a polymeric precursor tube. As such, the chemical and mechanical properties of this precursor tube are paramount in achieving a safe and effective BRS. The selection of an appropriate polymer chemistry sets the stage for not only the duration of luminal support, load transfer, and time-to-complete absorption, but most importantly, provides the chemical template for the control of polymer microstructure. Polymer microstructure is defined primarily by the spatial positioning of polymer crystallinity and molecular chain alignment. It is critical that all steps in the manufacturing process of a BRS be designed with an eye toward optimal polymer microstructure, and not only an optimal microstructure at the time of implantation but also throughout the various phases of degradation and resorption. For a BRS to undergo high strain without failure, a highly aligned microstructure, often referred to as high molecular orientation, coupled with small-crystallite crystallinity, is required. This microstructure transforms the polymer from one susceptible to brittle fracture to one with high strength and ductility. In addition, highly uniform spatial positioning of such microstructure allows for predictable and uniform degradation, taking aim at two of the major late outcome drawbacks of first-generation BRS, namely intraluminal scaffold dismantling and thrombosis. Tailored microstructure for tailored BRS designs BRS for the treatment of both CAD and PAD can differ considerably in design, sizing, and functionality. Because of these differences, a polymer tube comprised of a single microstructure is not likely to be an ideal precursor for multiple BRS designs. New advancements in polymer processing techniques enable tailored microstructures for tailored BRS designs. Through the application of multi-dimensional stresses governed by precise control over strain, strain rates, and temperatures, these new techniques allow for precise control over polymer crystallinity, crystallite size, and molecular orientation across multiple axes of the precursor tubing. The application of these stresses in a three-dimensionally uniform fashion provides critical levels of uniformity, including dimensional uniformity, mechanical property uniformity, and uniformity of degradation, all leading to consistent and predictable BRS performance in the acute phase and throughout resorption and vessel restoration. Given that a BRS design laser-cut from a precursor tube will assume the three-dimensional microstructure of the tube by superimposition, the ability to tailor the three-dimensional tubing microstructure for a particular BRS design is paramount in achieving an optimized result. Molecular orientation can be tailored bi-axially to yield circumferential and longitudinal orientation profiles that favor specific BRS designs with respect to functionality and specific stress-strain responses experienced during crimping and deployment. This customization allows for the precursor tubing to be tailored to specific BRS designs, and for unique BRS designs with differentiating features to be realized. Paving the way for the future New polymer processing techniques capable of precisely controlling the polymer microstructure are enabling novel BRS designs for the treatment of both CAD and PAD. Tailored microstructures now allow for thin-strut BRS designs with high radial strength and improved over-expansion capabilities for coronary and BTK BRS as well as high-strength, large-diameter designs for ATK BRS. Advancements in tailored and highly uniform microstructure provide a platform for uniform degradation and improved clinical outcomes, while newly offered polymer chemistries beyond PLLA, such as PLGA (poly-L-lactide-co-glycolide) and PLC (poly-L-lactide-co-caprolactone), are allowing for even greater possibilities with respect to resorption time and BRS functionality, including self-expanding BRS. Armed with these new techniques and capabilities, new BRS therapies that once seemed unimaginable are now within reach. James M. Lindsey III is a senior research engineer at Zeus with Bachelor of Science degrees in Biological Sciences and Mechanical Engineering, and a Master of Science degree in Bioengineering, all from Clemson University. Lindsey played a leading role in the invention of Absorv XSE, Zeus’ flagship bioabsorbable oriented tubing platform designed for next-generation BRS, as well as many other bioabsorbable products. How to submit a contribution to MDO The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.

LOUISVILLE, Ky.--( BUSINESS WIRE )--XLerateHealth (XLH), a nationally recognized healthcare accelerator headquartered in Louisville, KY, in partnership with the University of Kentucky (UK) through UK Innovate, announced the selection of eight innovators across the Southeast IDeA State region (the XLerator Network), to participate in the National Institutes of Health (NIH) funded IDeA Regional Entrepreneurship Development (I-RED) Program. Participants were selected through a competitive application process for work on technologies that include Medical Devices and Therapeutics. Daniel Bonthius, MD/PhD , Co-founder of Apex Orthopaedic, LLC (Clemson University, SC) is developing a novel surgical system called R-FIX that utilizes rib fixation to correct early onset spinal deformities. Rani Brooks, PhD , Founder of BioPhoundry, LLC (Tulane University, LA) has developed a synthetic biology platform that accelerates drug-discovery for precision antibiotics to combat drug-resistant infections. Brittany Levy, MD , Founder of TalkiTourni, LLC (University of Kentucky, KY), created an automated emergency tourniquet device aimed to improve rates of adequately applied tourniquets outside of the hospital setting. Michelle Martinez, PhD , Founder of Dynamiko Pharmaceutics, LLC (Universidad Central del Caribe, Puerto Rico) is developing affordable and selective anticancer compounds that target a predominant pathway in Triple Negative Breast Cancer. Brad Profitt, DC, DPT, DScPT , Founder of Ortho-HAB, LLC (Marshall University, WV) has developed a medical device, KneeXT, geared towards recovering knee extension post trauma/injury/surgery. Mark Tseytlin, PhD , Co-founder of BioMap5D, LLC (West Virginia University, WV) is developing molecular imaging medical devices that hold promise for diagnosing/treating cancer, as well as detecting and treating implant infections. M’Hamed Turki, MD , a gastroenterology and endoscopic fellow (Marshall University, WV) has invented an oropharyngeal cannula that is attached to a bite guard, and allows the passage of endoscopes and helps prevent hypoxia during upper endoscopies. Ken Webb, PhD , Co-founder of NeuroHope Therapeutics, Inc (Clemson University, SC) is developing a drug-loaded, polymer-based nanotherapeutic to treat central nervous system trauma. Their first indication will be acute spinal cord injury. “ Our team is grateful to the NIH for their continuous support of academic technology commercialization. The resources made available to researchers and clinicians in the IDeA States by this grant are invaluable. The XLerator Network’s External Advisory Committee is excited about the eight innovators selected to participate in the second I-RED cohort, and is delighted to have been part of the selection process,” said Dr. David McLoughlin, Chair, External Advisory Committee, XLerator Network (XLN). The goal of the I-RED program is to help selected participants acquire the fundamental business and entrepreneurial skills needed to successfully commercialize their technologies. As part of this program, XLN will expand the suite of healthcare focused commercialization modules on the ScholarRx platform. The team will also provide wrap-around commercialization services that include healthcare focused programming, talent access through their Executive-On-Roster® (XOR®) platform, and test a newly created Mentor / Startup Founder “Customer Discovery” matching program. “ This second NIH/NIGMS STTR award will allow us to build on prior work to develop, launch, test, and validate entrepreneurship education and training tools that foster the translation of promising biomedical discoveries and technologies from research laboratories into commercial products,” noted Jackie Willmot, CEO and Co-founder of XLerateHealth. About XLerateHealth XLerateHealth’s mission is to cultivate and grow impactful healthcare innovation in the Midwest, Southeast, and other areas of the country where great innovation often goes unrecognized and underfunded. Founded in 2012, XLH supports the development of healthcare innovation through its healthcare accelerator, which helps startup founders commercialize their business and attract funding. XLerateHealth also leads the efforts to build and operate the XLerator Network, an NIH-funded partnership with Academic Lead University of Kentucky along with 24 other academic institutions in the Southeast. The objective of this work is to increase the commercialization of promising life science and healthcare innovations in the NIH-designated Southeast Institutional Development Award (IDeA) states. About UK Innovate UK Innovate at the University of Kentucky is the innovation, entrepreneurship and economic enterprise for University of Kentucky Research. Through technology commercialization, corporate partnerships, social innovation, innovation training and economic development initiatives related to UK’s research innovations, talent and community, UK Innovate works to move ideas into the world faster, where they can make the greatest social and economic impact possible.

Willow Industries joins the Cannabis Research Coalition in their efforts to further scientific research in the cannabis industry DENVER, June 4, 2024 /PRNewswire/ -- Willow Industries, the leader in cannabis decontamination technology and microbial control services, announced its strategic partnership with the Cannabis Research Coalition (CRC). The collaboration is aimed to support the CRC's initiatives to further advance the exploration of the cannabis plant and create a sustainable, efficient, and successful industry. Collaborating with academia and industry stakeholders through a cooperative research model, the CRC works in partnership with the Flowering Physiology Laboratory at Clemson University, developing science-based research to address cultivation and post-harvest issues that challenge today's cannabis industry. With a shared commitment to push the boundaries of cannabis research and development, Willow Industries has donated WillowAir units to the coalition, ensuring the highest standards throughout the research process. Engineered to capture and remove airborne contaminants, the air filtration system not only protects employees from respiratory hazards in cultivation facilities but also maintains a clean grow environment, ensuring product safety for patients and consumers. "This partnership underscores how important industry collaboration and research initiatives are to the future of cannabis," said Jill Ellsworth, Founder and CEO of Willow Industries. "With our shared values and commitment to advancing the industry, we are thrilled to join the Cannabis Research Coalition in their pursuit of scientific advancements and industry-wide standards." Through synergistic efforts and a shared passion for innovation and science, the coalition, composed of members from all facets of the cannabis industry, continues to be a catalyst for change. "Today, we unite as pioneers in an emerging industry. Merely a month ago, the Federal government acknowledged the therapeutic potential of cannabis. The call for research, across all departments, resonates louder than ever and is only achieved through industry collaboration," said Allison Justice, PhD, Founder and CEO of the Cannabis Research Coalition and The Hemp Mine. Bolstered by the addition of Willow Industries, the coalition represents a pivotal step towards a more informed and scientifically robust cannabis industry and highlights the collective commitment of industry leaders to advancing cannabis research. For more information about Willow Industries and their innovative decontamination technology, visit . To learn more about the Cannabis Research Coalition and their ongoing research initiatives, visit . About Willow Industries: Willow Industries is the industry leader in cannabis microbial control and post-harvest decontamination technology. Founded in 2015, the company is built on one simple principle: cultivators should be equipped with resources to provide patients and consumers with consistently safe cannabis. Their patented WillowPure systems use organic, ozone-based technology that is scientifically proven to reduce or eliminate contaminants such as yeast, mold, and bacteria from cannabis, while protecting the medicinal properties of the plant. Their team of microbiology experts, Willow Scientific, ensures cultivators employ best practices and quality control alongside modern technology such as WillowAir, which captures and removes airborne contaminants like Aspergillus to ensure a safer workplace and healthier plants. Willow has been named one of Inc. 5000's Fastest-Growing Private Companies in America three years in a row, and is a 2x honoree on the Forbes 42.0 Cannabis list. Based in Denver, CO, Willow's services are available to all licensed cultivators in the United States and across the globe via an innovative and accessible model that employs a holistic, turnkey approach. About The Cannabis Research Coalition: Founded in 2022 by Dr. Allison Justice & Ashley Manning. The Cannabis Research Coalition (CRC) partners with academia and cannabis industry stakeholders to advance the exploration of the cannabis plant. Their mission is to implement science-based research to develop sustainable, efficient, and profitable cultivation techniques. The CRC combines the resources of cannabis industry stakeholders—including individuals and businesses—to fund academic research that provides practical answers to industry challenges. Our cooperative research model, inspired by successful horticulture and greenhouse research collaborations, allows members to benefit from pooled resources, gaining access to cutting-edge, science-based research at a fraction of the cost. By partnering with colleagues, collaborators, and sometimes competitors, our members stay at the forefront of production know-how. For more information, visit . Media Contact: Mike Mejer [email protected] SOURCE Willow Industries