15 GHP Q4 2022 Arterius’ added value is defined by its technologies, offering to the biggest and best players in each medical device industry sector to enhance the performance of their products. There are various beneficial aspects which capture a share of a very significant market: • The central problem with the first-generation biodegradable stents was their large strut size (both thickness and width), and rate of failure (due to fracture or heterogeneous strut resorption). Arterius has an opportunity to develop a range of biodegradable stents to address these unmet clinical issues which are capable of overturning the longstanding dominance of metal products. • The competition is unable to replicate the mechanical benefits achieved by Arterius’ manufacturing process without infringing Arterius’ patent, affording Arterius, a significant head-start in the race to commercialise a biodegradable stent. • The cardiovascular and vascular products market, comprise both large, highly mature indications and numerous immature high growth markets, including the China/Asia regional markets, which have lower barriers to entry relative to the potential economic returns. • The Arterius team has significant experience in the development of medical devices. The development team is supported by a consortium of experts comprising of a clinical advisory team, regulatory team, and well-known material scientists and engineers from academia. The company has also formed several collaborative relationships with academic, clinical research centres and commercial partners to explore its patented core technology of solid-phase orientation to enhance the biodegradable polymer stentsmechanical characteristics. As Chief Technical Director with over 40 years of research experience in biomaterial sciences, Kadem Al-Lamee has been involved in and managed a number of these collaborations with major medical devices, biotechnology companies and academics. His role at Arterius is to ensure that innovation is always the highest priority within the various projects, leading to business success. Arterius employs highly skilled staff within the fields of polymer chemistry, biomaterials sciences, biomedical engineering, regulatory and quality assurance. The extensive and varied experience of its staff in different applications of medical devices allows them to apply its technologies to clients’ devices in a very short period of time. Arterius is now very much focused on its future, where it has plans to develop a range of technologies to be applied onto peripheral vascular biodegradable stents and drug-coated balloon products which are very attractive to the largest and well-resourced medical device manufactures. The most recent development in the range of devices being used are drug-coated balloons (DCBs). DCBs were developed to reduce high restenosis rates, particularly in peripheral vessels but also to prevent coronary artery in-stent restenosis. The surface of these balloons carries antiproliferative/anti-thrombotic drugs that is delivered to the vessel wall when inflated. The drugs help prevent restenosis in a diseased vessel wall with significantly less drug passing into the blood stream, potentially reducing unforeseen adverse events, including mortality. Arterius Ltd. is a medical devices company which was established by Kadem Al-Lamee and Alistair Taylor in 2009. The company’s goalsaretoapplyitsadvancedandinnovative technologies of biomaterial science and engineering onto its clients’ products to enhance their device performances, ultimately resulting in greater patient benefit. Arterius has established a strong pre-clinical data package around next-generation fully biodegradable drug-eluting stents. A stent is a small mesh tube which is placed in a diseased artery to keep it open following a minimally invasive procedure to widen the blood vessel (also known as angioplasty). The clinical performance of stents depends on the following parameters: the mechanical and physical properties of the material utilised to produce the device, the device design, and the effectiveness of the drug incorporated into the device to prevent restenosis (re-narrowing). Although metal stent technologies have been evolving for decades with claims based on improved outcome due to the advancement of these parameters, there are fundamental problems with inserting (and leaving) a permanent implant in a blood vessel. These problems manifest months or even years following the procedure in the form of thrombosis, lumen re-narrowing, chronic local inflammatory reactions, mechanical behaviour mismatch between stented and non-stented vessel, and may also reduce options for future (needed) interventions. While these events are relatively rare, the widespread use of metal stents places an unacceptable burden of morbidity and mortality on doctors. Following stent implantation, the need for vessel scaffolding and drug delivery are only temporarily (6-12 months) required until the arterial remodelling, and healing is completed. Therefore, the first-generation biodegradable (polymer based) stents were developed to provide comparable mechanical support for long enough to prevent restenosis of the diseased arteries, before disappearing once their job is done. However, the larger physical dimensions (stent strut thickness higher than 120-micron) of these biodegradable stents, the low tensile strength, and the low radial strength, have resulted in other, unforeseen consequences, in the form of slightly higher rates of thrombosis and difficulty with stent implantation. High tensile strength material helps to achieve a stent with high radial strength and thinner struts to improve trackability, flexibility, and deliverability to smaller vessels. Hence, Arterius has developed a novel low-cost manufacturing process which enables the production of the next-generation high tensile strength polymeric biodegradable stents with the lowest strut thickness (95-micron) comparable to the best-in-class commercially available metal products. Leading Innovators of Vascular/Cardiovascular Scaffold Technology 2022 Sep22346 Company: Arterius Ltd For the technologies contact: Kadem Al-Lamee, PhD, CChem, FRSC – Chief Technical Officer Email: [email protected] Website: www.arterius.co.uk
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