Coronary Artery Stents – Investment Sought by Arterius!

The Medical Technology Blog

Photograph of the Taxus drug-eluting stent, fr...
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In today’s post from The Medical Technology Blog, I’m covering a couple of articles from my home country, the UK. The first article concerns the coronary stent market, which has had its fair share of difficulties over the years.

Bare Metal Stents were first developed in the mid 1980s and gained wide clinical use throughout the 1990s, but while they were successful in the treatment of coronary artery disease, they also had problems of their own, and were found to cause the growth of scar tissue within a stent.

By the turn of the new century, manufacturers began to develop stents that also included a polymer from which pharmaceuticals could be released called drug-eluting stents, to reduce the inflammatory response of the body to the stent. Again, safety fears arose when long-term clinical data indicated a small risk of late stent-thrombosis. Questions have also been raised on the cost-effectiveness of drug-eluting stents, with bare metal stents still being advocated for certain cases on cost grounds. Please read on to find out how the stent business is moving on…..

Arterius, a UK-based medical device company, is seeking a £3 million investment to fulfill its plans to bring the first biodegradable coronary stent to the worldwide market. Arterius is one of only a handful of companies developing this technology, which is set to significantly cut the cost of heart disease treatment in the UK and worldwide.

Coronary stent technology has been developed over the years from the bare-metal stent, which has a 30 per cent failure rate, to the most recent invention, the drug-eluting stent. However, this latest technology is claimed by some to be flawed as blood clotting can still occur. A fully biodegradable stent is now being considered to be the answer to these problems and Arterius’ work could have a major impact on patient well-being, as well as the overall cost of treatment.

The development work is being led by Kadem Al-Lamee and Alistair Taylor, with support from three UK universities. Prototypes will be developed by Professor Phil Coates and his team at the University of Bradford, IRC in Polymer Engineering. The company is hopeful that the patented technology will enter Phase I trials by 2014.

Founders of Arterius, Kadem Al-Lamee and Alistair Taylor joined forces in 2009 to combine their experience in the stent industry to design a new product. Taylor was co-founder and chairman of Lombard Medical, which bought Al-Lamee’s company, Polymed, in 2001. Taylor was also the CEO of Schneider, which developed the first ever stent.

Elsewhere…

A new study conducted by researchers at the Wake Forest University Baptist Medical Center indicates that chest pain may no longer have to mean a hospital stay, meaning there could be another option for diagnosing heart-related chest pain that costs less and, in some cases, allows the patient to return home the same day. The study is featured online and is scheduled to appear in a future issue of the Annals of Emergency Medicine.

Dr Chadwick D Miller, an assistant professor of emergency medicine and lead author on the study, explained that nearly half of the approximately six million people in the country each year who visit the emergency department (ED) with possible cardiac-related chest pain are categorised as “non-low risk” upon initial consult, and are therefore admitted to the hospital for further testing and evaluation. This tendency to admit immediately, however, leads to an over triaging of patients as only a small fraction of those admitted patients ultimately experience a serious cardiac event.

Current treatment guidelines provide the infrequently-used option of placing these patients with ‘non-low risk’ chest pain in an observation unit, where symptoms are monitored closely and care is delivered based on predetermined care pathways, while more invasive diagnostic testing is postponed until needed and there is an intense focus on efficiency.

For the current study, researchers randomly assigned 110 ED patients with chest pain to either “usual care,” involving admittance to the hospital, or care in an observation unit. Patients in the “usual care” group received a variety of tests typically used for diagnosing chest pain, including stress echocardiograms, cardiac MRI and cardiac catheterisations. For the patients in the observation unit arm, researchers brought in the use of cardiac MRI to provide diagnostics to an area that typically relies mostly on subjective decision-making by care providers.

I included that last article as a couple of years ago I was rushed by ambulance to A & E for a suspected heart attack, I felt foolish, and that I was wasting the time of all these busy people. I was in for 2 days and they wouldn’t let me leave until all tests proved beyond doubt that I hadn’t had an attack, god knows what it cost the NHS, any study that can eventually cut down on these ‘false alarms’ should be followed up.

That’s all from me for now, come back soon. Paul.

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Eye Imaging-Early Warning for Alzheimers!

The Medical Technology Blog

PET scan of a human brain with Alzheimer's disease
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Hi and thanks for visiting The Medical Technology blog. Today’s post concerns the news that non-invasive optical imaging of the eyes could lead to earlier diagnosis, intervention and monitoring of Alzheimer’s disease (AD) That is according to new research published online in the journal NeuroImage, showing that the nerve cell-damaging plaque that builds up in the brain with AD also builds up in the retinas of the eyes and shows up there earlier.

Scientists at Cedars-Sinai Medical Center, in collaboration with colleagues from the Weizmann Institute of Science in Israel and the University of Southern California, discovered characteristic amyloid plaques in retinas from deceased AD patients and used a non-invasive optical imaging technique to detect retinal plaques in live laboratory mice genetically modified to model the human disease. The combined results suggest the possibility that non-invasive retinal imaging may be helpful in early diagnosis of the disease.

The researchers considered the retina a better target for non-invasive imaging of AD since it is readily accessible and, unlike other components of the eye, is part of the central nervous system, having a direct connection and therefore many similarities with the brain. Previous studies have documented non-specific visual disturbances, eye disorders and certain types of retinal abnormalities occurring with AD and other neurodegenerative conditions, but this is the first to identify human retinal plaque deposits that could provide a specific diagnostic marker of the condition.

In lab tests, plaques in the retinas of mice genetically modified to model AD could be detected at a very early, pre-symptomatic stage – before the plaque appeared in the brain. A high-resolution, non-invasive optical imaging approach was developed to monitor individual beta-amyloid plaques in the retinas of live mice. The system is based on a specific marker and the adaptation of an existing optical system used to examine rodent eyes.

The research team used a fluorescent compound, called curcumin, to label and detect retinal plaques. This is believed to be the first use of curcumin as an imaging agent to detect AD-related plaques in the retinas of live animals. Curcumin binds to beta-amyloid plaques and makes them visible when viewed microscopically. In the Cedars-Sinai research, curcumin injected into the bloodstream of live mice crossed the blood-retinal barrier and specifically bound to the retinal plaques, allowing them to be viewed in high resolution with a non-invasive procedure.

Curcumin is more commonly known as the main base for the indian spice, turmeric, often used as a colourant is responsible for the yellow colour and was once described as Indian saffron, but of course, being significantly cheaper. Curcumin has been clinically trialled for uses within many diseases including multiple myeloma, pancreatic cancer, myelodysplastic syndromes, colon cancer,  and psoriasis.

Observations from multiple genetically-engineered mouse models of AD demonstrated a correlation between retinal plaques and brain plaques as disease progressed. In the laboratory mice, an immune system-based therapy that reduces the amount of plaques in the brain also reduced plaque load in the retina to the same extent, suggesting that the retina could represent the brain in assessing response to therapy. Beta-amyloid plaques were identified in retinal samples from human patients who had died from AD, and their features correlated with the diagnosed stage of the disease. Importantly, plaques were detected not only in patients who definitely had the disease, but also in the retinas of some people who were suspected of having early-stage AD based on clinical diagnosis and microscopic examination of brain tissue after death.

Collectively, the results are said to offer the first evidence for the existence of Alzheimer’s-specific plaques in the retina of human patients and the ability to detect individual plaques in live mouse models, creating a strong basis for future research building on these findings. According to the authors, these studies establish the potential of direct retinal beta-amyloid plaque imaging in live subjects as a tool for early AD diagnosis and prognosis, as well as assessment of therapies.

Alzheimer’s is a horrendous disease that steals away the people you love and have known perhaps all your life; it recently had strong coverage in the national press in the UK, when John Suchet, well-known journalist, news reader, presenter and author, wrote the moving book ‘My Bonnie’, after his wife was consumed by Alzheimer’s . I welcome this news, and would like to see more money and research spent on AD, though this is unlikely in this present economic climate.

That’s all for now, please drop back soon, or if you would like more information on the medical technology industry visit our main site at Espicom Business Intelligence.

Thanks, Paul.

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EyeTechCare News!

The Medical Technology Blog

In the first post of our medical technology blog, we take a look at EyeTechCare. The original idea for the company came from Fabrice Romano in 2006, and the company was eventually formed in 2008, when Romano brought two other team members on board, Laurent Farcy and Philippe Chapuis, to become the co-founders of EyeTechCare.

EyeTechCare has completed a EUR 7.5 million funding round, with funds provided by Lyon, France-based insurance company SHAM, a first time investor, and Crédit Agricole Private Equity (CAPE), one of EyeTechCare’s existing shareholders. SHAM has subscribed EUR 3 million to the financing, whilst Crédit Agricole Private Equity provided the balance of EUR 4.5 million.

In its first funding round in July 2008, EyeTechCare raised EUR 1.2 million from CAPE and CEA-Investissement, which enabled it to complete preclinical studies of its device for the treatment of glaucoma. The funds raised in this second financing will be used to complete the first clinical trial in man, as well as establish the manufacturing facilities and the sales and marketing force required for this first product, whose market launch is scheduled for early 2011. The company aims to break even in 2013.

Based in Rillieux-la-Pape, near Lyon,EyeTechCare is developing non-invasive therapeutic medical devices for the ophthalmology market based on high-intensity focused ultrasound (HIFU), which allows ambulatory and rapid treatment to be performed, thereby limiting the cost and the risk for the patient. The company’s first device, EyeOP1, is for the treatment of glaucoma, a disease that affects about 2 per cent of the world population and can lead to blindness. The device uses the UC3 (ultrasound circular cyclo-coagulation) procedure, which makes it possible to reduce intraocular pressure by partially and accurately destroying the ciliary bodies that produce aqueous humour.

Interesting and exciting times ahead for ETC I think, and we wish them well with their product launch next year. A treatment that both reduces cost and limits risk to a patient can only be a good thing, we’ll be watching them closely in the coming months.

Looking towards Europe, Switzerland is opening up more to European trade and is radically changing its hospital financing system within the next few years. The country has, as of March 2010, officially aligned its medical device regulations with European law. Medical technology products such as CT scans, medical implant diagnostic tests, pacemakers and artificial joints are now subject to free trade within the EU. In Switzerland the medical technology sector is seen as having strong potential for growth.

With hospital costs continuing to grow, Switzerland has decided to move towards a DRG-system of hospital finance, which is due to be implemented throughout the country in 2012. In June 2010, the government approved an agreement to standardise costs for compulsory healthcare insurance. The tariff system, once prices are agreed, will allocate a set amount per treatment or hospital stay for each Diagnosis Related Group (DRG).

Good news for the medical device industry I guess, and eventually the Swiss population. Well I hope you enjoyed the first of many, regular posts on The Medical Technology blog, if you have any views on the above please don’t hesitate to comment, and I’ll get back to you as soon as possible.

Drop back soon, cheers, Paul.



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Canada’s Healthcare Support System – Medical Industy Week Special Report

The Medical Technology Blog

Welcome back to the Medical Technology Blog. After a bit of a hiatus, we have a special report compiled by Lawrence Miller (editor of Medical Industry Week) after a recent trip to Ontario, highlighting Canada’s healthcare system. The report features the agencies that are supporting business, and the companies that are benefiting from it. The first is a long piece so I have split it into two articles, please read on…

How private and public sectors are working together to boost Canada’s healthcare system

The Canadian med-tech sector has evolved rapidly to become a priority for Ontario as part of an overall goal to build innovation capacity in the province and establish the region as an “outstanding place” to develop advanced medical technology. It’s an ambitious goal but, over the four busy days, Medical Industry Week was shown how these initiatives are being put in place and position the country and province for significant growth potential. So why the need for change? To do answer that one has to look at Canada’s position as a relatively small local market that lies right on the doorstep of the world’s largest market for medical devices – the US.  Historically, the pattern of implementing healthcare procurement decisions in Canada, where, as Dr Tom Corr, President and CEO of the Ontario Centres of Excellence (OCE) acknowledged, were overtly focused on  small deals with the result of haemorrhaging investment in Med-Tech innovation – that is converting R&D into products and technology – over the past five to ten years.

Given the recent global economic meltdown, the Ontario Province’s Med-Tech cluster is comparatively healthy.  It’s one of the reasons why Ontario as a province is so keen on the Med-Tech. The sector has high value and boasts recession proof nature, and stats from 1997 to 2006 have shown that the medical devices market performed favourably compared with the likes of pharmaceuticals and other higher-profile industries such as IT. Med-Tech companies also have “very good returns” because of the shorter innovation cycles (third less than pharmaceuticals), lower investment requirements, high margin products, high M&A activity as companies are sold in bite size chunks.

There are 1,100 companies in the Canadian Med-Tech field, of which 700 are manufacturers. Clusters of expertise have evolved around universities and teaching hospitals such as Waterloo, London,  Ottawa, as well as Thunder Bay and Windsor. Southern Ontario is the third largest medical R&D cluster in North America when taking into account the universities, health science centres etc, whilst volumes of trials and treatments range third largest in North America.

Ontario has 13 million inhabitants, C$46 billion public healthcare system and C$20 billion private system. Historically, however, the healthcare system itself hasn’t had a dedicated R&D arm.  So whilst lots of R&D has been made in the products, but not directly by the payer for the payer. Current moves are aimed at changing this process/environment, with a particularly eye on healthcare IT, diagnostics, home healthcare and medical imaging.

Med-Tech is still a challenge, especially in view of a major decline in funding and participation in recent times of venture capital investors. Angel life science investment has also dropped. This has prompted the policy makers  in the province of Ontario to start a C$400 million government backed venture capital funding initiative, and recently unveiled plans for a C$400 million tax credit initiative.

Most seed capital comes from Angel investors, whilst a fraction comes from government agencies and venture capitalists. At this stage of development, most  Med-Tech companies need it to support clinical trials, approvals, reimbursement studies and outcome trials (healthcare assessment). The Ontario government says that although money is provided by countries worldwide in support of R&D it is not always applied in the most effective areas. It’s a viewpoint that not only looks outwards but is also highly critical of its own perceived failings.

Ontario, and Canada as a whole, has kept on churning out new companies but recognises that it may not have helped them financially in comparison to countries such as the US.  Overall R&D spending has mainly been dished out in the form of tax credits. These help going concern companies, but start-up companies are less keen because they have to earn the money to get the money. The push for Ontario going forward is to refocus from pure R&D funding to translation and commercialisation and direct investment.

Government Funding

Funded by the Government of Ontario, the OCE’s mission statement is to create jobs in the province. Employing around 30 business development people, split in three regions – South West Ontario, Greater Toronto and North East Ontario – the OCE has a clear a focus on tapping into ideas that emerge from both universities and companies.

OCE has a clear criteria in awarding its grants. For every C$1 of funding it provides, the applicant must also at least match this funding. The goal is to support research at the very early stage and then pass it on to other organisations such as like HTX and Mars Excite. This “synergistic” approach with HTX aims to ensure the organisation work alongside each other rather than overlapping.

In total, 95 per cent of OCE funding is targeted within four industrial sectors, of which healthcare comprises 25 per cent. All decisions are externally verified and money is given based on milestones over a time period.

In 2011, OCE secured C$30 million from provincial government and C$5 million from the Federal government, along with industry matching contributions of approximately C$40 million. The initiative claims to have secured over 2,000 jobs were created by OCE initiatives in 2010. Encouraging spin-offs from university graduates/students

In practice, industry often approaches government and OCE employees also work with universities, but ensure that the university works with the company on the project. In fact, the commitment of the OCE is a key attribute to its activities. In some cases, the OCE may even help subsidise some of the salary of medical students as they gain a foothold in the industry for the first year or so, which has resulted in around 75 per cent of these students being offered permanent positions with their employers.

OCE also funds colleges and institution’s with Technology transfer grants. Dialogue with professors helps to identify IP and research that may offer significant opportunities within industry either in terms of a potential start-up or for licensing to larger established businesses.  OCE provides funding and as the technology matures within university helps to look at the issues involved in transferring them to additional programmes.

The OCE’s Social Innovation Programme (SIP) provides a valuable link between industry and not-for-profit organisations and helping the two conflicting parties work to together. In these cases, the non-profit company would hold the IP, and the OCE will provide cash in partnership with companies to make the programme a reality….

This article, and the rest of the articles to follow next week in this series, have been kindly provided by Lawrence Miller, editor of Espicom Business Intelligence’s excellent publication Medical Industry Week and medical newsletters teamleader.

Please come back to read the rest of this article tomorrow, and more in this Canada Healthcare System series this week.

Paul.


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