Incorporated in 2009 by Dr Kadem Al –Lamee and Mr Alastair Taylor, the Company commenced activities in November 2010 in the development of a novel next-generation polymer-based Bio-resorbable Coronary Scaffold (BRS), more commonly known as a ‘stent’. The bio-resorbable attribute allows the stent to dissolve over time, typically 12–24 months, before being absorbed by the body. Therefore, there is no requirement to physically remove the stent. The Company’s solution offers a huge opportunity to minimise the frequency of surgery or medical interventions and could give patients a better post-operative quality of life.
The focus for the Company’s products will initially be on coronary stents, however the Company is also looking to develop products to support peripheral (relating to your circulation and organs), biliary (bile duct) and urological (urinary tract) applications.The Company has developed a prototype under the trade-marked name ArterioSorb™. The product is currently undergoing pre-clinical evaluation, with the Company targeting a First in Man (FIM) clinical trial by the end of 2018, followed by CE marking activities in 2019.
The stent is made from polylactic acid (‘PLA’). With the stent walls at just 95 microns (95 millionths of a metre) thick, compared with the 157 microns thickness of the market leading product. The stent itself is made using an adaptation of a die drawing technique originally developed at the University of Bradford and has since been patented. The die drawing process is where the semi-crystalline polymer (similar to plastic in look and feel) is heated and is mechanically pulled/stretched continuously over a very narrow heated pipe that allows the polymer fibres to form the tubular mesh. Once each stent is at the required length it is cut with a laser. The patented die drawing technique has been independently proven to increases the polymer material strength and flexibility.
The unique ‘open cell’ design allows the stent to be crimped very tightly to the catheter in a spiral system to make insertion into finer arteries much easier for surgeons. The stent, once in place, and expanded importantly has the equivalent strength and flexibility of a metal stent, to support the cell walls.
The Company aims to address the gap in the market for a polymer-based bio-resorbable coronary stent (‘BRS’) that would match the delivery, mechanical and clinical performance of the best-in-class market dominant Drug-Eluting Stents (DES). Drug-Eluting Stents are coated with a drug that is slowly and continuously released into the artery. The coating helps prevent the artery from becoming blocked again.
The mainstream use of stents in surgery started in the early 1990’s during which time they have saved countless lives. Made of either metal or plastic, a stent is a small mesh tube that is inserted into narrow or weakened arteries, to support artery walls whilst keeping the blood vessels open. Stents can also be used to maintain ducts, canals or blood vessels to ensure continuous uninterrupted blood flow. Stents are most commonly used when a person is considered at risk of heart attack, or is suffering from heart disease. Stents are inserted into the body, normally in the groin area and are attached onto small balloons, which when they reach their target site are opened inside the artery to reinstate blood flow. The stent will support the vessel wall thereby ensuring that blood flow to the heart or affected organ is normalised.
The main disadvantages of traditional metal/plastic stents is that the surrounding blood vessels start to narrow again after just a few months, resulting in a condition called restenosis (this is when the vessels or arteries become blocked again shortly after stent implantation due to cells growing around the new stent structure, or shortly after a stent has been removed, either way it causes a further narrowing of the blood vessel and will most likely require further surgical intervention).
Doctors have tried to combat restenosis by introducing stents that emit drugs to slow down cell proliferation (increases in the number of cells surrounding, and attaching to the stent), and these have been successful in reducing short-term restenosis. However, due to the inherent problems associated with the longer-term use of stents (beyond 12 months on average), restenosis rates remain an ongoing concern for doctors and surgeons. Stents that are in place for sustained periods of time become susceptible to an increased risk of life threatening blood clots occurring.
The Company aims to launch its ArterioSorb™ product as the thinnest BRS available on the market today that is completely absorbable by the body. Patients will immediately benefit from the new technology due to the reduced risk of restenosis and stent thrombosis (complete closure of the blood vessel) without any adverse health problems. The newly available bio-resorbable materials used to make products such as Arterisorb™ are now viewed by medical Key Opinion Leader’s as credible and cost effective, giving the Company significant future market potential.
To date, the Company has been based at the Bio-incubator at Bradford University and is working with a number of the UK Universities of Southampton, Nottingham and Bradford and the two research institutions AccelLab (Canada), and Cardialysis at Erasmus University (The Netherlands).