£1.1 million project to develop new biodegradable stents

£1.1 million project to develop new biodegradable stents

A £1.1 million project to develop biodegradable stents for patients with severe vascular disease, which affects around one million people in the UK, has started thanks to Innovate UK funding. The unique project, a collaboration between the UK-based medical device company Arterius and the Translational Biomedical Research Centre (TBRC) at the University of Bristol, will develop a new type of bioresorbable stent that prevents the complications associated with metal stents.


Severe peripheral vascular disease (PVD) is caused by the formation of blockages in arteries, which reduces blood supply to the brain, heart, kidneys and limbs causing strokes, heart attacks, kidney failure and limb amputations. The disease is a growing international healthcare problem affecting about 20 per cent of the UK population aged 55–80 years and 200 million people worldwide.

Current treatment for the condition relies on permanent metal stents being inserted through a needle over a wire into the blocked artery to open up the blockage. However, these metal stents are associated with early blood clots and long-term chronic inflammation at the stented site. This triggers recurrence of blockages within one to two years (also known as in-stent restenosis) leading to readmissions, repeated revascularisation and huge hospital costs.

The two-year project is the culmination of a research-industry consortium comprising Leeds-based medical device company Arterius and University of Bristol researchers led by Professor Raimondo Ascione at the Bristol Medical School.

Together, the team will join strengths and expertise to refine existing Arterius’s technology to develop smart peripheral bioresorbable stents with novel mechanical and biocompatible properties able to treat the blockages and then dissolve between 18 to 24 months. The new device aims to prevent the life-long presence in the treated arteries of a metal stent and the associated chronic inflammation/restenosis and complications.

Professor Raimondo Ascione, Chair of Cardiac Surgery and TBRC Director at Bristol, said: “There is a huge need for innovation based on rigorous preclinical development and testing in the area of severe peripheral vascular disease. We are delighted to join forces with Arterius to form a unique UK-based biomedical consortium with potential to be a global player in this field.”

Dr Kadem Al-Lamee, CEO, Arterius Ltd, added: “Development funding supported by the Innovate UK programme will significantly help us to continue our ongoing collaboration with top UK universities, in order to explore this ground-breaking research in the cardiovascular field. Thanks to this project, Innovate UK, our technology, and the partnership with TBRC-Bristol, we could help millions of patients globally.”

They also agreed: “Our primary goal of this consortium is to develop bioresorbable smart stents for pre-clinical assessment in carotid and iliac-femoral arteries as well as a platform technology, which we plan to use to tackle in the future other areas of peripheral vascular disease such as below the knee, given the high level of biomedical innovation.”

The team plan to develop and test the prototype smart stent for safety and efficiacy using state-of-the art clinical and imaging technologies at Bristol’s TBRC preclinical facility. The ultimate goal is to take this new device to the bedside in a first in man trial in three to four years.


Further information

The Biomedical Catalyst is a unique partnership between the Medical Research Council and Innovate UK, providing responsive and effective support to the most innovative life sciences opportunities to accelerate the progress of novel products toward patient benefit.

The aim of the Biomedical Catalyst is to support the development of innovative healthcare products, technologies and processes. These can include (but are not limited to):

  • disease prevention and proactive management of health and chronic conditions;
  • earlier and better detection and diagnosis of disease, leading to better patient outcomes;
  • tailored treatments that either change the underlying disease or offer potential cures;
  • SMEs can apply for a share of up to £8 million to continue a project’s early stage development and technical evaluation, up to readiness for clinical testing.

The Biomedical Catalyst was established in 2012 to achieve 3 key objectives:

  • deliver growth to the UK life sciences sector;
  • deliver innovative life sciences products and services into healthcare more quickly and effectively;
  • provide support to academically and commercially led research and development.

The programme provides funding to help UK SMEs speed up bringing new products to market and secure onward investment.

The programme is run by Innovate UK and the Medical Research Council, both part of UK Research and Innovation.

Arterius Welcomes New Clinical Advisers

Arterius are pleased to welcome Prof. Patrick Serruys and Dr. Yoshi Onuma to our clinical advisory board.

Prof. Serruys (Imperial College, London) will become chair of the clinical advisory board, also now featuring Dr. Onuma (Cardialysis, Netherlands) and Dr. Rasha Al-Lamee (Imperial College, London).

Prof. Patrick W. Serruys is is a professor of Interventional Cardiology at the Interuniversity Cardiological Institute of the Netherlands (1988-1998), and Erasmus MC. Since 1980 he was a Director of the Clinical Research Program of the Catheterization Laboratory, Thorax Center at Erasmus University, and till April 1st 2014 (retirement date) the Head of the Interventional Department, Thorax Center, Erasmus MC (University Medical Center Rotterdam), Rotterdam, The Netherlands. Since April 2013 he holds the position of Professor of Cardiology in the Cardiovascular Science Division of the National Heart and Lung Institute (NHLI) at the Faculty of Medicine, within the Imperial College of Science, Technology and Medicine, London. He is a Fellow of the American College of Cardiology and a Fellow of the European Society of Cardiology and scientific council of the International College of Angiology.

TCT 2017 Poster Shows Impact of Strut Thickness on Thrombogenicity in BRS

ArterioSorb™ has been shown to show decreased acute thrombus formation compared to thicker strut bioresorbable scaffolds (BRS) in an in-vitro model.

Shengjie Lu PhD, of the National Heart Research Institute and National Heart Centre Singapore, presented a moderated poster at TCT 2017 in Denver, showing the impact of BRS strut thickness on the formation of thrombus.

Shengjui, from Nicolas Foin’s group, compared thick strut BRS (157μm, Absorb BVS, Abbott Vascular) to thin strut BRS (95μm, ArterioSorb™, Arterius) and a thin strut DES (81μm, Xience, Abbott Vascular). Scaffolds were expanded in in-vitro coronary perfusion models which were perfused with porcine blood. Thrombus formation was then evaluated.

Thin strut ArterioSorb™ showed significantly smaller thrombus area compared to Absorb BVS (p<0.01).

No difference was found between thin strut ArterioSorb™ and Xience (p=0.99).

Summary: Compared to larger strut BRS, the thin strut ArterioSorb™ BRS and metallic DES show decreased acute platelet adherence and thrombus formation. The in-vitro model suggests that clot formation on scaffolds may be modulated by strut profile.

This further corroborates the previously published endothelial shear stress data showing less disruption to the arterial blood flow for ArterioSorb™ compared to Absorb BVS.

The full poster may be viewed here:TCT 2017 Strut Thickness Impact on Thrombogenicity in BRS

 

Arterius Featured in Regen Magazine

Regen Magazine 2017, published by the Medical Technologies IKC and Regener8, reports on activities and achievements of the regenerative devices community.

In Issue 8 (2017) they featured an article on Arterius entitled “Taking on the Giants“.

Find the article, and interview with Dr Kadem Al-Lamee (CEO) below:

 

ArterioSorb™ Blood Flow Shear Stress Data Published in European Heart Journal

A new article, published in the European Heart Journal, provides a comparison between endothelial shear stress (ESS) computations for ArterioSorb™ 3.0 x 14mm scaffolds and Absorb BVS 3.0 x 18mm (Abbott Vascular, US), calculated from in-vivo data.

The article, titled “Non-Newtonian pulsatile shear stress assessment: a method to differentiate bioresorbable scaffold platforms”, by Erhan Tenekecioglu, Prof Patrick Serruys and colleagues, shows that the thinner strut thickness of ArterioSorb™ was measured as strut protrusion by OCT, which showed ArterioSorb™ (89 ± 7 µm), mean protrusion distance was less than in Absorb BVS (150 ± 9 µm).

This resulted in less disruption of the arterial blood flow – higher ESS values than Absorb BVS during all coronary flow periods.

This should, in turn, lead to less risk of scaffold thrombosis in the scaffold caused by slow and turbulent blood flow.

See the full article here.

 

Biomedical Catalyst Grant Award to Arterius Limited

Biomedical Catalyst Grant Award to Arterius Limited

Following the successful completion of the R&D project in 30th September 2016 (supported by a Smart award from the Innovate UK (TSB), Arterius has recently been awarded further funding from the Biomedical Catalyst-Early Stage programme to conduct the In-vitro and In-vivo GLP Evaluation of the Novel Bioresorbable Coronary Scaffolds; ArterioSorb™.

ArterioSorb™ is an innovative medical implant product currently being developed by Arterius, a UK medical device micro/SME, to treat coronary artery disease (CAD). CAD is the leading cause of death both in the UK and worldwide, responsible for more than 73,000 deaths in the UK each year. ArterioSorb™ is a next-generation bioresorbable cardiovascular scaffold (BRS, stent), to be implanted within the coronary arteries in order to open blocked vessels, and to biodegrade within two years when healing is complete and it is no longer needed. In this 24-month project, Arterius will perform the in-vitro and in-vivo studies necessary to demonstrate the safety and efficacy of ArterioSorb™. After completion of this study, the company will enter the First-in-Man trials and commercialisation, which will enhance the growth and global profile of the company, create new skilled jobs and enhance our global competitiveness in the field of stent technologies. There is currently no UK company offering a BRS for the global market. Following this project, ArterioSorb™ will launch to compete with the global BRS products. The goal of Arterius is to develop as a major UK SME with global competitiveness in the polymer based BRS market to treat cardiovascular disease.

Dr Kadem Al-Lamee, CEO, said “Development funding supported by the Innovate UK (TSB) programme will significantly help the company to stay ahead of the competition and to continue their ongoing collaboration with the UK academics and clinicians, in order to continue this ground-breaking research and to commence clinical trials by 2019”.

END

The Innovate UK (TSB) is the UK’s innovation agency.  Its goal is to accelerate economic growth by stimulating and supporting business-led innovation.  Sponsored by the Department for Business, Innovation and Skills (BIS), the Technology Strategy Board brings together business, research and the public sector, supporting and accelerating the development of innovative products and services to meet market needs, tackle major societal challenges and help build the future economy. For more information please visit www.innovateuk.org.

The Biomedical Catalyst programme is managed by the Innovate UK (TSB), It offers funding to small and medium-sized enterprises (SMEs) with potential and ambition for growth, to engage in game changing, cutting edge innovation R&D projects in the strategically important areas of science, engineering and technology, from which successful new products, processes and services could emerge.

http://www.innovateuk.org/deliveringinnovation/smart.ashx

Arterius team up with Prof Patrick Serruys at EuroPCR 2016 (Paris)

Arterius team up with Prof Patrick Serruys at EuroPCR 2016 (Paris)

Arterius are delighted to be working with Professor Patrick Serruys of Erasmus Medical Centre (Netherlands) and Cardialysis.

Professor Serruys presented a talk entitled “Bench testing evaluation of a novel fully drug-eluting BRS” at EuroPCR on 19th May 2016.

The talk was part of the “BRS: Evolving Technologies and Applications” session, also featuring presentations about Elixir’s DESolve scaffold, Abbott’s ABSORB clinical data, Biotronik’s BIOSOLVE-II trial data, and REVA Medical’s Fantom scaffold.

Prof Serruys presented the latest bench testing development results of the ArterioSorb™ bioresorbable vascular scaffold.

Arterius wins FP7 European grant

Arterius wins FP7 European grant

Arterius Limited has been awarded a research grant from the European Union (Seven Frame work Programme, FP7) for a collaborative project to develop the next generation of biodegradable coronary stent for the treatment of coronary artery disease. The project started in January 2014 with fourteen members collaborating on the project and total costs of €5.8 million.

The incidence of coronary artery disease is increasing worldwide given the growing ageing population and increased risk factors such as diabetes, obesity and hypertension. Effective therapies are needed to ensure quality long-term results for patients. New stent technologies such as biodegradable stents, that provide the temporary support to the vessel and disappear overtime, are a viable alternative to the current permanent metallic drug-eluting stents and bare metal stents.

Dr Kadem Al-Lamee, CEO at Arterius Limited will lead the commercial exploitation of the product and dissemination of the project technical results.

Dr Kadem Al-Lamee said: “Biodegradable stent technology is still in the early stages however this technology has the potential to revolutionise the stent industry and improve treatment outcomes for patients with coronary and peripheral vascular disease. In conjunction with a consortium consisting of European universities and industry, Arterius’ business strategy will to build a market leading portfolio of products, required for use in the next generation of drug eluting fully biodegradable stents”.
Arterius’ team will play a major role in collaborating with the following consortium members to achieve the technical and commercial objectives of this exciting project:

Arterius Limited, United Kingdom
The University of Westminster LBG, United Kingdom, (Scientific Coordinator is Dr. Ipsita Roy)
Ceram Limited, United Kingdom, ( Project Coordinator is Dr. Xiang Zhang)
Vornia Limited, Ireland
Spintec Engineering GmbH, Germany
Politecnico di Torino, Italy
University of Southampton, United Kingdom
Friedrich-Alexander-Universität Erlangen-Nümberg, Germany
Fundación TEKNIKER, Spain
Fraunhofer Institute for Production Technology IPA, Germany
University of Cambridge (The Chancellor, Masters and Scholars of the University), United Kingdom
University Clinic Bergmannsheil – Hospital of the Ruhr-University Bochum, Germany
Life and Device SRL, Italy
EURESCOM-European Institute for Research and Strategic Studies in Telecommunications GmbH, Germany

For further information, please contact: Dr Kadem Al-Lamee, CEO

Email: info@arterius.co.uk

Telephone: +44 (0) 1274 23687

Pilot Study for Acute Device Performance Evaluation of a PLLA Bioresorbable Scaffold in a Swine Model

Pilot Study for Acute Device Performance Evaluation of a PLLA Bioresorbable Scaffold in a Swine Model

Arterius Ltd, the bioabsorbable coronary scaffold company have announced positive findings from the acute device performance pilot study for the Arteriosorb™ Absorbable Drug-Eluting Scaffold (ADES).

uCT PR1

Micro CT image of implanted Arteriosorb™ ADES

A study performed in conjunction with a very well known lab to evaluate the scaffold for acute performance: introduction and deliverability, visibility by angiography, deployment and expansion performance, and device sizing.

A total of 6 scaffolds were implanted, and the function and performance were rated as generally excellent, with all devices being easy to position and deploy, with no complications encountered during delivery, deployment or withdrawal. Scaffolds were visible by angiographic evaluation due to the radiopaque markers, and showed no abnormality following implantation, with complete perfusion of the blood flow. Optical coherence tomography (OCT) showed good apposition of the struts to the vessel wall.

Micro CT PR2

Micro CT (above) and OCT images (at top) of implanted Arteriosorb™ ADES

In conclusion, the Arteriosorb™ ADES Bioresorbable PLLA Scaffold showed excellent overall implantation behaviour in an acute hybrid farm pig coronary artery model.

Arterius Ltd are now undertaking 30 and 90 day safety and efficacy preclinical studies, which are expected to be completed in Q1 2015.

For further information, please contact: Dr Kadem Al-Lamee, CEO

Email: info@arterius.co.uk

Telephone: +44 (0) 1274 23687

R&D SMART Award from the Innovate UK to Arterius

R&D SMART Award from the Innovate UK to Arterius

Following the successful completion of two projects (supported by a Smart award from the Innovate UK), Arterius has very recently been awarded further funding from the Smart programme to conduct the design, development and validation of a pre-production prototype rig for clinical evaluation of biodegradable stents.

Increasing evidence is demonstrating that next generation biodegradable coronary stents are outperforming traditional permanently implanted drug eluting stents. Only two biodegradable stents are approved for sale within the EU, with several more in development.
Manufacturing of polymer stents introduces significant challenges. Biodegradable polymeric stents do not have the necessary material properties to facilitate crimping onto a balloon catheter, expansion, and to provide radial support to the target vessel. Different approaches have been developed to improve the material properties, including blow moulding, annealing and micro braiding.
Arterius and University of Bradford have developed the proprietary technique of Die-Drawing to improve the mechanical properties. Excellent results have been obtained with financial support from Innovate UK-SMART Awards for proof of concept research and development, including preclinical assessment.
To date, a small-scale R&D die drawing system has been used. Whilst this proved sufficient for preclinical trials, there is now the need for a dedicated novel pre-production prototype die drawing system capable of producing high quality product in a reproducible manner for the manufacture of clinically approved coronary, peripheral, urology and biliary stents.

Dr Kadem Al-Lamee, CEO, said “Development funding supported by the Innovate UK through the Smart programme will significantly help the company to stay ahead of the competition and to continue their ongoing collaboration with three universities in the UK (Universities of Bradford, Southampton and Nottingham) in order to complete this ground-breaking research and to commence clinical trials by 2017”.

For more information please visit
www.innovateuk.org
http://www.innovateuk.org/deliveringinnovation/smart.ashx