Medical Technology Archives

Silence pours cash into development projects

The Medical Technology Blog

Last post on the Medical Technology blog before i shoot off on my hols, so no posts till i get back. Today’s article comes from Drug Delivery Insight, please read on…

Leading RNA interference (RNAi) company Silence Therapeutics has been busy lately. The UK-based firm tapped investors for nearly £6 million in funds last month, and has wasted no time in putting it to use. The company believes the funds, which were raised by both new and existing shareholders, will place it on a much improved financial footing.

The first slice of the funding was allocated to plan the closure of Silence’s US operations, which are located in Redwood City, CA. The US closure is expected to take place in the third quarter of this year, but the company’s German operations will remain open. As a result of the closure of the US base, Silence’s CEO, Phil Haworth, will step down once a replacement is found.

The second chunk of funding will be put towards Silence’s ongoing R&D efforts. The first portion will be used to complete the company’s ongoing Phase I trial of Atu027 for the treatment of advanced solid cancer, and is earmarked for completion during the second half of this year. Also, a Phase Ib trial of Atu027 in particular tumour types will be started in mid-2012. IND applications for Atu027 in solid will also be paid for by the funding in the second half of next year, and preclinical development will be stepped up for Silence’s Atu111 programme. The latter provides systematic delivery to the lung for treatment of pulmonary diseases.

Representing Silence’s most advanced drug candidate, Atu027 is a liposomal siRNA formulation targeting PKN3 for the treatment of advanced solid cancer that incorporats the company’s very own AtuPlex delivery technology. The company says it has proven its value by inhibiting the growth of blood vessels, thereby inhibiting blood supply to the tumour. Half-time results from the Phase I solid tumour trial of Atu027 are “encouraging”, as the drug has so far shown to be safe and well-tolerated. Silence hopes to finish the Phase I trial in the second half of this year, and release data before year-end.  The release of updated data from the trial was made at the recently-convened ASCO meeting in Chicago, IL.

Atu111, for the treatment of acute lung injury, is Silence’s most advanced candidate outside of the oncology field. It combines the company’s DACC drug-delivery system with AtuRNAi. The product’s target is being kept under wraps by Silence at the moment, but preclinical models using the DACC delivery system have shown sustained knockdown of up to three weeks in the lung endothelium.

As far as collaborative partners go, Silence is getting ready to start a Phase IIb trial for PF-‘655 in the second half of 2011, which is licensed to Quark Pharmaceuticals and Pfizer for the treatment of diabetic macular oedema.  Silence hopes Quark and Pfizer will report data from the trial later this year. Quark is also developing QPI-1002 for the treatment of delayed graft function and acute kidney injury in partnership with Novartis. In September 2010, quark kicked off a Phase II trial of QPI-1002 for the treatment of delayed graft function and plans to begin a second Phase II trial of the product in acute kidney injury during the course of this year.

Thanks to Sophie Bracken for this article, Sophie is editor of Drug Delivery Insight at Espicom Business Intelligence.

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Scientists use tumour’s ‘fingerprint’ to test for rare cancer

The Medical Technology Blog

Today’s article in the Medical Technology Blog is provided by Sophie Sanderson editor of Diagnostics Focus, please read on…

A team of researchers from the UK look to have come up with a ‘cheap and reliable’ diagnostic test for a rare form of cancer – hereditary leiomyomatosis and renal cell cancer (HLRCC) – which involves screening tumour samples for a particular molecular fingerprint unique to this cancer.

HLRCC is a disorder that causes the development of benign, but often painful tumours in the skin and, in females, in the uterus. Between one in six and one in ten people affected by the disorder will go on to develop an aggressive form of kidney cancer called papillary renal cell cancer. The disorder is caused by mutations, which may be inherited, in a gene responsible for the production of an enzyme known as fumarate hydratase (FH). This leads to an accumulation within cells of fumarate, which promotes the development of cancer cells. Normally, every cell has two copies of each gene: one inherited from the mother and one inherited from the father. HLRCC is said to follow an autosomal dominant inheritance pattern, in which a mutation happens in only one copy of the gene – meaning that a parent with a gene mutation may pass along a copy of their normal gene or a copy of the gene with the mutation.

Led by researchers at the Henry Wellcome Building for Molecular Physiology, University of Oxford, an international team of scientists claim to have identified a particular protein modification that is induced by FH deficiency (and hence an over-abundance of fumarate). This alteration is unique to this type of tumour and can be used as a biomarker – a biological ‘fingerprint’ to identify tumours caused by this mechanism.

For the first time, scientists are now in a position to screen for tumours caused by this rare, but often very serious condition using a test that is simple, cheap and reliable. The test for this protein modification offers great potential as it can be carried out in under two hours and will identify tumours with FH mutations. This approach is also said to be more cost-effective than genetic testing of all possible cases using DNA sequencing. When screening cases of papillary renal cell cancer using this new test, the researchers identified undiagnosed cases of HLRCC for genetic testing.

In the future, by applying this test in all cases of papillary renal cell cancer to identify people with FH mutations, families could receive advice on their own relative risks of developing the disorder and associated kidney cancer. Dr Lesley Walker, Director of cancer information at Cancer Research UK, reinforces the importance of this notion, stating that “…being able to identify other family members who are at risk so they can be monitored more closely is crucial to improving survival rates from this rare aggressive form of kidney cancer.” Tests like this could also help identify other patients with the same mutation, paving the way for the development of targeted treatments for specific groups of patients that could revolutionalise cancer treatment in the future.

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Todays article in the Medical Technology Blog is provided by Sophie Sanderson who is the editor of Diagnostics Focus, please read on…

A move to tackle the rates of lung cancer detection and survival by researchers in Germany seems to have led to an interesting new test that could potentially help save the lives of smokers in the future. The blood test, which is the result of work carried out by colleagues from the University of Cologne and University of Bonn, would make it easier to detect a lung tumour and improve the chances of survival.

The aim of the research was to develop a subsequent test that was not only able to differentiate lung cancer patients from healthy subjects, but also from persons with chronic lung diseases. The blood of over 200 smokers was studied, half of whom had lung cancer. Examining the research subjects’ blood using biochips for certain nucleic acids led to the finding of typical patters. Interestingly, over 480 molecules were recognised whose concentration in the blood changes when a person develops lung cancer. These nucleic acid molecules can be seen in the blood cells either in increased or decreased quantities and form in the body when certain genes are transcribed. In patients with lung cancer, a typical pattern emerges that can be detected with a measuring programme.

The stakes are huge and the development of a test for lung cancer offers huge potential. Lung cancer is already the second most common cancer in the UK, and in many cases the cause can often be linked back to smoking. Although people who have never smoked can also get lung cancer, nine out of ten cases are related to smoking. There are four different stages to lung cancer, going from stage I where the cancer is small and only in one area of the lung, to stage IV where the cancer has spread to another part of the body. Dr Joachim Schultze comments that “The prognosis for patients in stage III and IV is still very poor even today; even with the most modern therapies, the point of death can only be postponed.” When considering stage I lung cancer, it can be treated surgically and in most cases it can be cured, however, a tumour is detected in only about 15 per cent of all such cases.

It is anticipated that if a boost to the detection rates could be achieved with the use of a screening blood test, it could lead to an increase in survival rates. In the future, there is the potential for a lung cancer screening test to become part of routine practice. Whether this can be achieved remains to be seen, but for researchers the positive results will serve as an encouraging development.

Check out more articles like this by signing up to Espicom’s fortnightly publication Diagnostics Focus, thanks for reading.



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The Medical Technology Blog

Synthes has bowed to intensive media speculation and confirmed that it is in talks with Johnson & Johnson over a possible takeover by the US healthcare giant.

Any deal to acquire Switzerland-based Synthes would represent one of the largest attempted by J&J since it lost out to Boston Scientific in the battle for control of Guidant. J&J is rumoured to be offering around US$20 billion to acquire Synthes, a major player in the spine and trauma markets. If J&J were to secure its target it would return the company’s DePuy business to the top spot in the worldwide orthopaedic market and ending Zimmer’s dominant position. A combined DePuy-Synthes unit could potentially be worth US$46 billion and boast strong positions in orthopaedic, spine, sports medicine and biologic products. Ironically, Zimmer itself went to the number one position by securing another Swiss company, Centerpulse, in 2003.

Since the beginning of the new year, it seems J&J has been looking for a big deal and was strongly linked with a US$11 billion approach for UK-based Smith & Nephew. The pharmaceutical/medical device giant can afford it as well, with around US$28 billion in cash lying in its balance sheet. Whilst it can clearly afford it, the company doesn’t tend to overpay with its purchases – a fact that appears to have been illustrated following the non-appearance of an offer for S&N – and will be hoping that rumours of a rival offer from Medtronic do not materialise.

So what makes Synthes such an attractive proposition to J&J? Although headquartered in Switzerland, the majority of Synthes’ 2010 sales (58 per cent) originate in North America and followed by Europe (23 per cent) and Asia-Pacific (12 per cent). The company increased its sales by 8 per cent to US$3.7 billion in 2010 and net earnings jumped 10 per cent to US$908 million. It has strong trauma and spine products, whilst DePuy’s expertise is particularly focused in hip and knee implant – which means the case for synergies and antitrust approval could also be strong.

Despite its size, J&J is under pressure to react to competition in its medical device fields, particularly within the cardiovascular market. The company’s once dominant position in drug-eluting stents has long been usurped by Boston Scientific, and competition from the likes of Abbott and Medtronic have bitten hard. Within orthopaedics, DePuy has been dogged by a series of recalls that are understood to have cost J&J nearly US$1 billion so far. The unit has also been hit with several lawsuits regarding its recalled ASR hip implant, with complaints rolling in on a weekly basis. Despite these woes, DePuy still upped its net sales during 2010 by 4 per cent to US$5.6 billion, highlighting the potential of orthopaedic products to achieve strong revenues and profit margins.

News that Synthes is even discussing a deal represents a rare opportunity to buy a company that has never really been touted as a bid target. The reason for this is that the company is majority-owned by its Chairman and guiding light, Hansjorg Wyss, and various Wyss-family controlled trusts so any bid will have to meet his approval to stand a chance of success. Switzerland also has complex minority shareholder rights – just ask Novartis after its protracted battle for Alcon – so although the talks are significant, a deal is not entirely certain.

J&J’s approach for Synthes could kickstart a further period of consolidation in the orthopaedic market or alternatively represent an albeit mighty dent. Below the big players, Wright Medical Group is in a bit of a bother having kicked out some its management team recently, whilst the question remains – will anybody make a move for S&N? The rather quiet cosy world of orthopaedics looks like waking from its slumber at last!

Thank you to Lawrence Miller for a great post, Lawrence is Epicom’s medical newsletters team leader, and also editor of the excellent publications Orthopaedic Business News and Medical Industry Week.

Thanks for reading, back in two weeks time, Paul.

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Viagra’s New Competitior?

The Medical Technology Blog

GHV hopes to grab a slice of Viagra’s success with sublingual ED product offering

Global Health Ventures, a specialty pharma company focused on drug-delivery and formulation, is attempting to gain a piece of the lucrative erectile dysfunction (ED) market by testing out its ED treatment – X-Excite (sublingual sildenafil citrate) in Europe. GHV will take on global market-leader Pfizer in a European treatment comparison study that will pitch X-Excite against Pfizer’s well-established Viagra treatment. The EMA has given the comparison study the go-ahead, and GHV hopes to begin in the next few weeks.

ED affects around 10 per cent of men worldwide, and is currently treated by drugs that prevent the enzyme 5-phosphodiesterase – drugs like sildenafil, tadalafil and vardenafil that collectively generate over US$3 billion a year. They all, however, carry side-effects related to gastric and colonic absorption. Step forward GHV, with its sublingual sildenafil citrate formulation, aimed at bypassing gastro-intestinal side-effects and making ED treatment more patient-friendly.

The 24-patient clinical trial will compare sublingually-delivered X-Excite with Viagra and will take about three to four months to complete. The study aims to look at the speed at which each drug appears in the bloodstream and its effect on liver enzymes that might address some of the side-effects that are often seen with the current administration route. X-Excite delivers sildenafil citrate – the active ingredient in Viagra – sublingually. Sublingual delivery is widely believed to be the fastest way to get a drug into the blood, bypassing the liver. A lot of side-effects from drugs are due to liver metabolism and the use of the liver as the first passage to the body. In theory, GHV’s sublingual delivery should have fewer side-effects because it bypasses the liver.

GHV’s sublingual technology aims to enhance drugs to be delivered to the body without the use of injection, enabling the majority of pharmaceuticals to be rapidly absorbed through the mucosal membrane (the tissues of the mouth). The technology is a good match for drugs that need fast results and have major side-effects. It has so far been tested against 40 major drugs, and is used in GHV’s other product candidates – Nico-Z (sublingual nicotine for smoking cessation) and T-Stim (an anti-obesity drug).

Thanks to Sophie Bracken for this article, sophie is the editor of Espicom’s Drug Delivery Insight news service.

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Reva – Bioreabsorbable Drug-Eluting Stents News

The Medical Technology Blog

Reva raises A$77.5 million as investors take a bet on the next big thing in stent technology – bioreabsorbable drug-eluting stents

Welcome back to the Medical Technology Blog. This is the last post of the year as I finish today for the Christmas holidays, please read on…

Reva Medical, a start-up company focused on the development and eventual commercialisation of its bioreabsorbable stent products, has successfully raised A$77.5 million (net) from an initial public offering (IPO) through an issue of CHESS depositary interests (CDIs) on the Australian Securities Exchange.

Based in San Diego, CA, the company has received approximately US$100 million in funding to date and attracted the attention of both Boston Scientific and Medtronic, both of which have previously made sizeable investments in the company. Boston Scientific’s participation included an option to acquire Reva at a later date. However, as a result of the share issue, these merger plans have now been terminated – at least for the time being – with Boston Scientific holding onto an option to distribute Reva’s products should they reach the market. Medtronic is also maintaining its support and has invested a further A$10.5 million in the Reva share placement. Reva plans to use A$38.9 million of the proceeds to support development work, with A$31.4 million invested in ReZolve and A$7.5 million other programmes. A further A$10.3 million will be spent on funding the pilot and pivotal CE mark trials, A$24.2 million on working capital and the remaining A$4.2 million on manufacturing. Overall, the proceeds are expected to support Reva’s development over the next three years.

Billed as the “next major advance in coronary stent technology”, Reva’s core technology, known as ReZolve, is a non-permanent implant that combines a “slide and lock” stent design with a polymer. In development for over ten years, the device claims a number of significant advantages as it is designed to provide the same benefits as traditional metal stents, with the additional benefit of being dissolved by the body over time after treatment of the artery. The reabsorption of the stent minimises clotting risk and reduces the need for long-term drug therapy. In addition to cardiovascular disease, this technology could also be applied for the treatment of other conditions, including peripheral artery disease and spinal trauma surgery. With regards to the latter, Reva is currently seeking a partner interested in licensing its side-chain crystallisable  polymer for use as a flowable cement.

Reva has held an exclusive licence since 2004 for its polymer material from Rutgers University in New Jersey for use in stents, stent coating and embolics. In July 2010, Reva entered into a new licence agreement with Rutgers which broadened the company’s exclusive rights to the original polymer group and all new polymer compositions developed to cover all vascular applications. The company also intends to use sirolimus, an anti-restenotic drug used in other DESs. A target dose of 80µg of sirolimus is coated onto the outside surface of the ReZolve stent using a polymer solution containing the drug.

Reva is targeting a competitive coronary stent market that was valued at over US$5.3 billion in 2009, with drug-eluting stents (DESs) taking up US$4.4 million of this total. The company finds itself in potential competition with the likes of Johnson & Johnson (Cordis), Abbott Laboratories, Boston Scientific and Medtronic, which collectively accounted for 95 per cent of all DES sales in 2009.

Primary competition for Reva’s products is expected from both traditional DESs and other bioreabsorbable stents. Whilst a number of companies are working to develop bioreabsorbable or polymer stents, so far only two have reached the clinical trial stage. Abbott Laboratories is developing its Bioresorbable Vascular Scaffold (BVS), which is forecasted to reach the European market before Reva’s Resolve stent, and Biotronik, which is developing its second generation Dreams magnesium-based reabsorbable stent. Biotronik began clinical trials of its device in July 2010.

Reva is now in the process of finalising the design of the ReZolve stent, with a 50-patient pilot human, non-randomised trial scheduled to commence in Brazil and Germany during the second quarter of 2011, with patients followed at one, six and 12 month intervals after implant of the device, and annually thereafter, for a period of up to five years. Positive findings could then led to enrolment in a 350-patient trial at centres in the EU, Brazil, Australia and New Zealand, in the first and second quarters of 2012, with a full to securing marketing approval in Europe by the end of 2013. If successful in generating such sales, Reva anticipates using the revenue to fund the US human clinical trials, as well as other development activities. Highlighting the tough regulatory climate for DES technology in the US and the associated costs incurred, Reva’s proposed US trial programme, in contrast to Europe, would involve at least 2,000 patients.

Thank you to Lawrence Miller for that article, Lawrence is Espicom’s medical newsletters team leader, and editor-in-chief of Medical Industry Week

A big thank you to all my readers, Happy Christmas and a prosperous New Year to one and all.


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Clinical Study Seeks Cure for Parkinsons Disease

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MJFF launches biomarker initiative study aimed at finding a cure for Parkinsons Disease

In its latest quest to find a cure for Parkinson’s disease (PD), the Michael J Fox Foundation for Parkinson’s Research (MJFF) has unveiled further details of its Parkinson’s Progression Markers Initiative (PPMI), the first-ever large-scale clinical study exclusively focused on identifying and validating PD biomarkers. The study forms a major part of MJFF’s goal to develop a cure for PD within the coming decade. Since it began in 2000, the foundation has spent over US$205 million in specialised research in the field, either directly or through partnerships, which has helped the foundation learn more about the disease; develop better treatments for patients; and, ultimately, move a step closer to ending PD.

The latest five-year study, expected to cost US$40 million over five years, will be funded by the foundation with a lead gift from Lily Safra, a Board member of MJFF, and through the support of industry partners that include Pfizer and GE Healthcare. The PPMI study will be led by principal investigator, Dr Kenneth L Marek, President and Senior Scientist, Institute for Neurodegenerative Disorders, New Haven, CT.

The study will be carried out at 18 sites in the US and Europe, and will track 400 people newly-diagnosed with PD and 200 who do not have the disease. The study is testing the most promising biomarker candidates at present through neuroimaging, the collection of blood, urine, and spinal fluid, and clinical and behavioural tests. Valid measures could allow scientists to predict, objectively diagnose and monitor diseases, as well as definitively determine which medications work and which will not. The goal of the collaboration is to help increase the pace of biomarker validation and clinical testing, as well as accelerate the pace of discovery.

Recruitment of study volunteers is now under way at six sites, with all sites expected to be recruiting by year-end. Sites participating in the PPMI include the University of Alabama; Arizona Parkinson’s Disease Consortium; Baylor College of Medicine; Institute for Neurodegenerative Disorders; Northwestern University; the Parkinson’s Institute and Clinical Center; Boston University; Oregon Health & Science University; and the University of Pennsylvania. Additional sites will also join the study in Atlanta, GA; Tampa, FL; Baltimore, MD; Rochester, NY; Seattle, WA; Innsbruck, Austria; Kassel/Marburg, Germany; Tuebingen, Germany; and Naples, Italy.

Described as an observational study as opposed to an interventional trial, the PPMI will not test any experimental drug. Participants will be contributing to a large body of data and biological specimens whose aim is to further biomarker research. The PPMI will make biological samples and collect clinical data from a single, large and well-characterised cohort available to qualified researchers around the world, to help spark further innovation and collaboration, in order to develop new, more effective treatments more quickly.

When considering the implications of this research for the industry, a biomarker could dramatically reduce both the cost and time of development – since to bring a new central nervous therapy to market requires an investment of over US$1 billion and takes over nine years. Current US annual sales of PD therapies are estimated at US$800 million – however, this could increase to US$2 to US$3 billion with the advent of a disease-modifying therapy.

In the past, PD biomarkers have represented a key area of R&D for MJFF, with approximately US$25 million invested to date over several years. As the foundation embarks on PPMI, it believes more strongly than ever that the discovery of PD biomarkers is a high-impact use of its resources, and that this study will pay dividends towards better treatments and a cure.

This article was taken from an issue of our Espicom’s excellent publication Diagnostics Focus which is edited by Sophie Sanderson

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Medical Technology Development Costs Cause Concern In US

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Biosensors highlights concerns over the time and costs of approving devices in the US

Jeffrey Jump, the recently appointed CEO of Biosensors is a frustrated man. His company – a Singapore-based stent manufacturer – has grown increasingly exasperated with the regulatory climate that exists in the US and he wants everybody to know just how difficult it is getting a device approved by the FDA.

Concerns over the lengthy and demanding regulatory process in the US are not new. For years, many of the groundbreaking devices to emerge in the healthcare market – not just in cardiovascular devices – have made their debut in markets outside of the US first. Indeed, many US companies have found themselves marketing their technology in Europe long before the clearance process in the US has been negotiated. Europe’s gain has been the US’s loss but there are fears the gap is widening. In its defence, the FDA’s supporters will argue that its processes are there to protect the American people and if that means a more strenuous approval process then so be it. However, as Mr Jump suggests, it seems as if this regulatory gap is getting worse and the issue has to be addressed.

Worldwide, the approval process continues to take less time and, more importantly, costs less to fund. It takes a device manufacturer three to five years to get a medical device approved in Japan and China, at cost of US$3 million or less in each market. In Europe, the time can range from six months to two years and cost just US$2 million. In contrast, getting approval in the US for a medical device can take between two and seven years and cost between US$50 to US$100 million.

This discrepancy in time and costs is raising a few questions that Mr Jump and other CEOs increasingly feel need to be answered as a business. Most importantly, is it really worth spending that much time, effort and money on securing FDA clearance? It’s an issue that doesn’t just trouble the smaller companies, even the bigger ones are weighing up the options. According to Mr Jump, major medical device companies could be facing bills in the region of US$200 million just to get approval for their next-generation stent technology in the US and, as a direct result, may seriously consider abandoning the US market for this important technology.

With the global economic downturn very much in the memory of CEOs, the stringent and lengthy requirements needed to accommodate the FDA have also seen innovative companies bite the dust as they get bogged down in the regulatory steps imposed by the FDA. For Biosensors this brings opportunities to acquire technology at much lower prices because these companies simply run out of cash and time.

Already, Mr Jump has snapped up CardioMind, a US company which has developed a drug-eluting stent (DES) for the treatment of small vessel lesions, and plans to complete the acquisition of another undisclosed device company shortly. Paying for such high quality assets at knockdown prices is possible for Biosensors because it looks to gain its market share from markets outside of the US, which ultimately place considerably less strain on its cashflow. How long will it be before other companies choose a similar path?

Whilst Abbott will probably find the prospect of not marketing its bioreabsorbable vascular scaffold (BVS) platform in its home country ultimately unpalatable, and you could say it’s big enough to handle the costs, the debate is unlikely to go away. China is set to become the largest market for medical device by 2016, so why go through the trials and tribulations of the US when there are richer pickings to be had elsewhere? Biosensors has already closed its R&D operations in the US and transferred its activities back to Singapore and its R&D centre in Morges, Switzerland – also a centre for R&D for Medtronic and Edwards Lifesciences – because the costs of manufacturing and marketing medical devices in the US do not justify the potential returns.

The FDA is unlikely to be too concerned at the comments made by Biosensors, even if they are shared by the CEOs of some of the largest US medical device companies.  But that could change in the future as there is a real possibility that advanced technology – and US-developed technology in particular – could find itself not available in the US, or at least be available several years behind the global market. This has potential ramifications not only for the US healthcare system but also for the skills base in the US. Will the US be able to keep hold of its expertise if companies are increasingly outsourcing such facilities internationally?

For Biosensors, the die has been cast. The company is committed to marketing its BioMatrix Flex abluminal biodegradable polymer DES in markets outside of the US, and it doesn’t market or manufacture any interventional cardiology products in the US. That’s not say the Biosensors is totally excluded from the US market – it also sells bare metal stents and balloon dilation catheters, as well as a sizeable business that includes critical care catheter systems, haemodynamic monitoring and related devices used during heart surgery procedures and intensive care treatment. It is also handily placed should Abbott market its BVS device in the US as it also incorporates royalty earning Biosensors technology. But, despite all of these points, you can’t help share Mr Jump’s disappointment that the US market is rapidly becoming out of bounds to innovation.

This post was brought to you by Lawrence Miller, Espicom Business Intelligence’s medical news team leader.

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A warm welcome back to The Medical Technology Blog.

Newcastle University’s bioengineering team has made a bid for some of the credit in helping to persuade Johnson & Johnson‘s DePuy Orthopaedics unit to recall its Articulating Surface Replacement (ASR) hip prosthesis from the market.

The researchers,  led by Dr Tom Joyce, began investigating the ASR hip prosthesis as far back as February 2008, and discovered a number of failings in the design of the implant and offered an explanation into how and why the metal joint was being worn away, releasing high levels of toxic metals into the patient’s bloodstream. The subsequent recall means that thousands of patients – estimated at 93,000 worldwide, are being recalled in an effort to determine the extent of the problem and offer support to those who have been left with the crippling side-effects. According to DePuy, “very few” of the ASR devices remain on the worldwide market, following the company decision in 2009 that it would be discontinuing the ASR system as a result of “declining demand and the intention to focus on the development of next generation hip replacement and resurfacing technologies that best meet the needs of surgeons and patients.”

Joyce explained: “The thinking was that a metal-on-metal ball and socket joint should be far more effective and hard-wearing for patients than the older style metal-on-polymer system where the softer polymer tended to wear away quite quickly, releasing particles and eventually causing the artificial joint to fail. What our research showed was that if the ball and socket were not perfectly aligned then the metal wore away quite vigorously – the initially ultra-smooth surfaces roughening and then grinding away against each other – to release nano-sized particles into the body that were then absorbed into the bloodstream and tissues, causing far greater damage.” According to Joyce, only in a minority of cases were the joints actually functioning correctly.

Concerns first began to arise when a number of patients reported groin pain, some not long after their arthritic hips had been replaced with ASR prostheses. Working with orthopaedic surgeon David Langton, based at North Tees University Hospital and now working towards a PhD in Bioengineering under the supervision of Joyce, the NU team studied over 100 explanted hip joints sent to them from across Europe. Blood tests revealed high levels of cobalt and chrome ions in the blood stream of ASR patients. The ASR is made from cobalt-chrome alloy so this implicated the artificial hip. Using a “state-of-the-art” machine, the team studied the surface of the artificial hip joints and found that instead of being highly polished with a mirror-like surface, the failed devices had become roughened. This caused the lubrication of the joint to fail so that, with each step, the patient was producing relatively high volumes of metallic wear debris.

The ASR device formed part of a class of large diameter, monoblock hip resurfacing and replacement devices often selected by surgeons for younger patients who may benefit from a more stable device that can reduce the chances of dislocation after surgery. The DePuy ASR hip resurfacing system was introduced in 2003 and is only approved for use outside of the US, whilst the ASR XL acetabular system was first launched in 2004 and has been available worldwide.

DePuy, like its peers in the industry, will look back on this chapter in the history of hip replacement and hope to learn its lessons. For one thing, sometimes a development that appears to be successful and the answer to a major problem may not necessarily work out all so wonderful in reality over time. The industry has also had to trade off the benefits of technology with its failings, but recalls such as those from DePuy and Zimmer are inevitably going to make it much more difficult to convince surgeons and and potential patients that future technologies won’t suffer the same fate in the future. It is also likely to lead to much more stringent and expensive clinical trial programmes, and further regulatory scrutiny.

Thanks to Lawrence Miller for this post, Lawrence is the medical newsletters team leader and managing editor of Medical Industry Week and Orthopaedics Business

More to come this week, drop back soon, thanks, Paul.

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