Hospital for Sick Children Leading Child Health Research

The Medical Technology Blog

Sick Kids takes centre stage in robotics, imaging and simulation technology development

At first glance, a first time visitor to the Hospital for Sick Children, or “SickKids” as it’s more commonly known, could be forgiven for thinking that they were in a plush shopping centre rather than a major specialist paediatric hospital. Indeed, it has all the trappings of coffee bars, food outlets and such forth.  The downtown Toronto-based hospital is a sprawling campus of old and new buildings, colourful furniture and equipment, and boasts one of only three medical centres in the city equipped with a helipad.

Centre for Image Guided Innovation & Therapeutic Innovation

Somehow, the combination seems to works because the hospital has grown rapidly to become Canada’s largest centre for child health research. Supporting this strategy has been the Centre for Image Guided Innovation & Therapeutic Innovation (CIGITI), which was set up at SickKids in 2009 and, as part of a public/private partnership is developing three technologies with paediatric and foetal applications:, namely minimally-invasive endoscopic manipulators, a natural orifice anastomotic device and MR-guided high-intensity focused ultrasound.

In the case of the KidsArm technology development, the public contribution comes in the form of research and clinical expertise (SickKids) and government-based funding, whilst the private sector contribution encompasses contributing robotics (MDA Corporation), imaging (Philips Healthcare) and simulation (L-3 Communications MAPPS) technology.

The ambition for KidsArm can hardly be described as modest. The goal is for the technology to effectively to secure a position as a world leader in robotic surgery and imaging. Billed as the first robotic surgical arm for paediatric imaging, the device allows surgeons to navigate to a specific treatment area without impacting upon structures such as blood vessels. It could also be used to perform procedures such as the suturing of vessels and tissues at a rate of at least ten times faster than a surgeon.

The surgical platform is intended for use across all key surgical specialties, including cardiac, foetal, urosurgery/general surgery and neurosurgical areas. The device also has the benefit of producing virtual reality-based models that can be used in planning and teaching.

As with all high-profile technological breakthroughs, CIGITI has not got a clear field in terms of competitors, which include the likes of Intuitive Surgical, which has emerged in recent times as a leader in robotic technology through its DaVinci system. Still, confidence in the KidsArm’s attributes is strong and in a presentation to analysts, CIGITI isn’t afraid of holding back on a direct head on comparison with Intuitive Surgical.

First up, CIGITI says the KidsArm is markedly smaller and lighter than that from Intuitive, and that its device will be much cheaper and adaptable than its rival. As the KidsArm device is specifically targeted for paediatric use, it can also be used for any procedures that require minimal inversion. In contrast, Intuitive’s technology stands accused of being too large for paediatric use and limited to urological applications. Other technology standouts for KidsArm include built-in telesurgery and imaging guidance initially focused on MRI.

Unlike Intuitive, development of CIGITI’s technology is still at the relatively embryonic stage, although a clinical working model is expected to emerge within two years. Backed by C$10 million in funding awarded by the Canadian government in 2010, Phase I of the programme, which started in 2009, has been focused on the development of technological innovations such as in the areas of advanced complex surgical delivery, mulit-modality fusion and real-time image guidance and creation of surgical simulation models.

Whilst this process is still continuing throughout 2012, Phase II of the programme, which started in 2011 and will last two years, involves a critical analysis of the KidsArm technology. This includes a review of minimally-invasive surgery (MIS) vs robotic surgery, a look at fusion and real-time image-guidance and improving the accuracy of the surgical system and simulation modules. Analysis will also be carried out at high-frequency imaging for foetal intervention procedures. All this work, if it continues to impress, is likely to lead to commercial and clinical opportunities for the technology from 2014 onwards.

So why is a hospital taking such an active role in product development and when it’s primary role is providing healthcare provision? Aside from the revenue earning potential of creating IP assets that can be licensed or used for start-up companies, the collaboration stands to general high-end manufacturing jobs, healthcare and research opportunities and substantially improve education available from school students and rising all the way up to medical staff, both in Canada and the province of Ontario.

For SickKids, such efforts help to improve patient care and the quality of healthcare provided by the institution by introducing novel image-guided tools into the paediatric setting. So far, in just two years, SickKids/CIGITI has created a number of positions across all levels of academia, filed for three patents covering surgical tools (including one for KidsArm), secured C$25.8 million in research funding, signed a licensing agreement with Medical Modeling relating to patient-specific cranial facial models and templates and forged tentative links with venture capitalists.

Article source: Medical Industry Week – supplied by Lawrence Miller, editor.




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Pathwork tissue of origin test confirms clinical validity

The Medical Technology Blog

Independent study of Pathwork tissue of origin test confirms clinical validity; “cost-effective for increasing cancer patient survival”

Results of a study conducted at Virginia Commonwealth University of the Pathwork Diagnostics’ Pathwork tissue of origin test have been published online in the American Journal of Clinical Pathology, in a paper entitled “Clinical verification of the performance of the Pathwork tissue of origin test: utility and limitations”. The Pathwork tissue of origin test is an FDA-cleared, Medicare-covered molecular diagnostic for identifying tissue of origin. It uses a tumour’s own genomic information to help pathologists and oncologists in the diagnosis of challenging cancer cases such as those that are metastatic or that have a complex clinical history.

In the study, the analytic and clinical performance of the tissue of origin test was examined in 43 poorly differentiated and undifferentiated tumour samples. Results showed 97 per cent (95 per cent confidence interval, 80.4 to 99.8 per cent) agreement between the tissue of origin test result and the reference diagnosis, which was determined on the basis of clinical correlations and immunohistochemical findings and was among the 15 tumour tissue types covered by the tissue of origin test.

The Pathwork tissue of origin test measures gene expression levels of 2,000 genes and uses algorithms to compare the tumour’s gene expression pattern with that of 15 tumour types, representing 58 morphologies and 90 per cent of all solid tumours. The test provides objective genomic information to help the physician diagnose what type of cancer the patient has. An accurate diagnosis allows oncologists to match therapy to the cancer.

In a related development, results from a study involving the Pathwork tissue of origin test have been presented at the American Association for Cancer Research – International Association for the Study of Lung Cancer joint conference on The Molecular Origins of Lung Cancer: Biology, Therapy and Personalised Medicine in San Diego, CA. The study, “Cost-effectiveness of gene-expression profiling for tumour-site origin”, was authored by John Hornberger, Irina Degtiar, Hialy Gutierrez, Ashwini Shewade, W David Henner, Shawn Becker and Stephen Raab.

The retrospective, observational study examined treatment changes made in patients by physicians who received tissue of origin test results. Changes in planned chemotherapy, surgery, radiation therapy, blood tests, imaging and referral to hospice care before and after test results were recorded. Estimates of the effect of changes in chemotherapy on survival were based on National Comprehensive Cancer Network (NCCN) and other treatment guidelines. Costs were estimated based on data from NCCN and Centers for Medicare and Medicaid Services fee schedules. Changes in overall survival, costs and cost per quality-adjusted life year (QALY) gained were estimated. In the study, use of chemotherapy regimens consistent with guidelines for the final tumour-site diagnosis increased from 42 per cent to 65 per cent. Overall survival was projected to increase from 15.9 months to 19.5 months, a mean gain of 3.6 months. The average increase in survival adjusted for quality of life was 2.7 months and the average cost per QALY gained was US$46,858.

Article source; Diagnostics Focus, edited by Sophie Bracken, medical news editor at Espicom Business Intelligence.

 


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Gilead submits sNDA for Truvada for reducing the risk of acquiring HIV

The Medical Technology Blog

Gilead Sciences Truvada

Gilead Sciences has submitted an sNDA application for the approval of once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the US.

If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex, a prevention approach called PrEP. The application is based on the results of two large placebo-controlled trials of Truvada as PrEP, sponsored by the National Institutes of Health (NIH) and the University of Washington.

The first trial providing data to support the Truvada sNDA is a Phase III, randomised, double-blind, placebo-controlled trial known as the Pre-Exposure Prophylaxis Initiative (iPrEx), which was sponsored by the NIH and conducted among 2,499 high-risk HIV-negative adult homosexuals in the US and countries in Africa, Asia and South America. Results from the trial, published in the New England Journal of Medicine in November 2010, showed that once-daily use of Truvada for PrEP reduced the risk of acquiring HIV overall by 44 per cent compared with placebo and by up to 73 per cent among men who reported taking the drug consistently (defined as at least 90 per cent of days). Among men who took the drug consistently enough to have detectable drug in their body, the risk was reduced by more than 90 per cent.

The Truvada sNDA submission is also supported by data from Partners PrEP, a Phase III, randomised, double-blind, placebo-controlled trial conducted among 4,758 heterosexual couples in Kenya and Uganda, in which one partner was infected with HIV and the other was not. The trial, sponsored by the University of Washington, showed that once-daily use of oral Truvada by the HIV-negative participants reduced their risk of acquiring HIV by 73 per cent compared with placebo.

Additional supportive data come from two studies sponsored by the Centers for Disease Control (CDC). The first trial, known as TDF2, was a Phase III, randomised, double-blind, placebo-controlled trial conducted in Botswana among 1,200 HIV-negative heterosexual men and women. Participants taking once-daily oral Truvada for PrEP had 63 per cent fewer HIV infections compared with those receiving placebo. The second trial, known as CDC 4323, was a Phase II, randomised, placebo-controlled, double-blind study of homosexual men in the US primarily designed to assess the safety, adherence and acceptability of PrEP.

Although full details are not yet available, another separate Phase III study of Truvada for PrEP known as FEM-PrEP was stopped in April 2011 based on a recommendation by the study’s Independent Data Monitoring Committee that the trial would not be able to establish the efficacy of Truvada among HIV-negative women in sub-Saharan Africa. The reason for this outcome is not yet understood and a complete detailed analysis of the data is currently under way.

In all studies, side-effects included nausea, weight loss and serum creatinine elevations. The incidence of side effects was consistent with Truvada’s safety and tolerability profile when used as HIV treatment, which is supported by more than 1.8 million years of patient use. Overall, there have been more than 4.4 million patient years of experience with tenofovir-containing regimens. Three cases of resistance to emtricitabine were reported in the iPrEx trial among participants who tested negative for HIV infection by serology at enrollment, but were later found to have been infected with HIV prior to enrolment using a different assay. Two of these cases occurred in the active drug arm, and one case occurred in the placebo arm.

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Espicom Predicts the Global Telemonitoring Market Could Exceed US$1 Billion by 2015

The Medical Technology Blog

Rising rates of chronic disease are pushing healthcare providers into seeking better and more-cost-effective ways of delivering care. Telemonitoring technology has great promise but has yet to be widely implemented, and the early results reveal significant operational obstacles which must be overcome in the medium term if it is to reach its full commercial potential.

The Global Telemonitoring Market graph

The Global Telemonitoring Market, 2010-2016E (US$ million)

According to a new Espicom report, Telemonitoring: Challenges & Opportunities, the global telemonitoring market could be set for rapid growth, driven by the world’s ageing population and increasingly unhealthy lifestyles, which are leading more and more people to need care for chronic diseases.

Interest in telemonitoring is on the rise due to its potential to improve the health of patients with chronic diseases, enable people to receive care in the comfort of their own home and reduce the number of patients that have to been seen in doctors’ surgeries. With the World Health Organization estimating that chronic diseases now account for twice as many deaths as communicable diseases, including HIV/AIDS, TB and malaria, and predicting that deaths due to chronic disease will increase by 17% over the next 10 years, the need to effectively manage these conditions has never been more pressing. The global economic downturn and reduced healthcare budgets are also leading healthcare managers to look to telemonitoring as a way of “doing more for less”.

Although telemonitoring holds much promise, there are several issues that are hindering its adoption. The technology has not been shown conclusively to improve care or reduce costs and it doesn’t yet have broad reimbursement coverage. More importantly, it requires healthcare providers to change working practices and realign healthcare budgets, while patients have to want to be actively involved in their healthcare for it to work.

Telemonitoring lets doctors monitor a patient’s health while the patient is at home, collecting vital signs data and information on current symptoms, medication, diet and exercise. It alerts healthcare providers if a patient’s health is deteriorating so that action can be taken. The technology can be used for any disease where doctors need to keep a regular check on patients, including heart failure, hypertension, diabetes and respiratory diseases, as well as patients with a combination of diseases.

Joanne Maddox, senior health analyst at Espicom and the report’s author comments “…for the industry to capitalise on the growing interest in telemonitoring, there needs to be a focus on gathering clinical data that show the technology is both clinically and cost-effective. This will help to convince healthcare providers of its usefulness and pave the way for reimbursement”.

For further information on the report please visit Telemonitoring: Challenges & Opportunities



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Biologic Therapies bursts onto orthobiologics scene

The Medical Technology Blog

Welcome back to the Medical Technology Blog. We start off the week with an article from the orthopaedics business, please read on…

A new company has been propelled into the orthobiologics industry as the result of a joint venture between device firms Scorpion Medical and Monet Medical. Dubbed Biologic Therapies, the new company will focus on the design, development and manufacture of components for the biologics sector of the medical device industry.

Orthobiology is the inclusion of biology and biochemistry in the development of bone and soft tissue replacement materials for skeletal and tissue healing. Biologic Therapies  will  attempt to take this process to a new level by creating ‘Autologous Orthobiologic Therapy’. The company believes it can use the body’s own stem cells to increase the healing potential and provide quicker restoration of function within muscle, tendon, ligament, bone and cartilage, said Dr R Wade McKenna, owner and operator of Monet Medical and  by an orthopaedic surgeon. Biologic Therapies will be led by President Steve Bales, a former employee of DePuy and Encore Medical.

McKenna’s autologous biologic therapy (bone marrow aspirate stem cells) treatments are designed to augment overall healing and improve surgical and non-surgical results. The treatments are for ligamentous injuries involving the knee, ankle and elbow. Treatments in the knee include ACL, MCL and LCL injuries. In the elbow, stem cells are used successfully to treat acute and chronic medial and lateral epicondylitis. Ligamentous injuries around the ankle are referred to as sprains but can often represent significant tears to the stabilising structures of the ankle. Autologous biologic therapy is used around the ankle in chronic and acute sprains to shorten the recovery time and improve the quality of healing tissue.

As its first product offering, Biologic Therapies is actively working to bring to market a new, patented device for accessing a patient’s own stem cells through the safe and painless harvest of bone marrow. This device is scheduled for market release during the first quarter of 2012. The company believes this device is unlike anything currently available and expects it could become the “gold-standard” for use in stem cell harvesting procedures.

Closely following the stem cell harvesting device will be a range of implant systems for fracture fixation, which will include the ability to introduce stem cells precisely at the fracture site. In addition, Biologic Therapies intends to create a strategic initiative to broaden the training and product support by offering an educational element to surgeons and healthcare professionals. The educational programme will aim to enhance the awareness and efficacy of this emerging technology as well as share Biologic Therapies’ surgical protocols designed to increase the success rate of autologous orthobiologic therapies.

Thanks to Sophie Bracken for providing this article, Sophie edits Espicom’s business publication Orthopaedics Business News.




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US researchers uncover protein associated with heart attacks

The Medical Technology Blog

Today’s post on the Medical Technology Blog come from Medical Industry Week, Espicom’s current business publication on the medical industry, please read on…

Researchers from Loyola University Chicago Stritch School of Medicine have discovered a possible new blood test to help diagnose heart attacks.

Featured within the Journal of Molecular and Cellular Cardiology, the investigators provided details of a large protein known as cardiac myosin binding protein-C (cMyBP-C), which is released to the blood following a heart attack. Senior author, Dr Sakthivel Sadayappan, believes this could potentially become the basis for a new test, used in conjunction with other blood tests, to help diagnose heart attacks, however, additional studies will be necessary to establish cMyBP-C as a true biomarker for heart attacks.

Between 60 and 70 per cent of all patients who complain of chest pain do not have heart attacks. Many of these patients are admitted to the hospital, at considerable time and expense, until a heart attack is definitively ruled out. An electrocardiogram can diagnose major heart attacks, but not minor ones. There are also blood tests for various proteins associated with heart attacks, but most of these proteins are not specific to the heart. Elevated levels could indicate a problem other than a heart attack, such as a muscle injury. Only one protein now used in blood tests, called cardiac troponin-I, is specific to the heart, however, it takes at least four to six hours for this protein to show up in the blood following a heart attack.

 The Loyola study is the first to find that cMyBP-C is associated with heart attacks. The researchers evaluated blood samples from heart attack patients, and also evaluated rats that had experienced heart attacks. They found that in both humans and rats, cMyBP-C was significantly elevated following heart attacks. cMyBP-C is a large assembly protein that stabilises heart muscle structure and regulates cardiac function. During a heart attack, a coronary artery is blocked, and heart muscle cells begin to die due to lack of blood flow and oxygen. As heart cells die, cMyPB-C breaks into fragments and is released into the blood. Future studies would determine the time course of release, peak concentrations and half life in the circulatory system. Sadayappan holds a provisional patent to determine the risk factors associated with cMyBP-C degradation and release into human body fluid.




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Researchers create human heart cells that can be paced with light

The Medical Technology Blog

This weeks artice on the Medical Technology Blog is taken fromEspicom’s business publication, Cardiovascular Device Business, please read on…

In a paper published in the September issue of the Biophysical Journal, lead author Dr Oscar Abilez, a postdoctoral scholar and PhD candidate in bioengineering, and a multidisciplinary team from Stanford University, describe how they have, for the first time, engineered human heart cells that can be paced with light using a technology called optogenetics. In the near term, the researchers say the advance will provide new insight into heart function. In the long term, however, the development could lead to an era of light-based pacemakers and genetically matched tissue patches that replace muscle damaged by a heart attack.

To create the light-responsive heart cells, the researchers first inserted DNA encoding a light-sensitive protein called channelrhodopsin-2 (ChR2), into human embryonic stem cells. ChR2 controls the flow of electrically charged ions into the cell. For heart cells, the primary ion is sodium, which initiates an electrochemical cascade that causes the cell to contract. They then transformed the optogenetically engineered stem cells into cardiomyocytes those that respond to light.

The key protein for the experiment is ChR2, which is sensitive to a very specific wavelength of blue light and regulates tiny channels in the cell surface. When ChR2 is illuminated by the right wavelength of blue light, the channels open to allow an influx of electrically-charged sodium into the cell, producing a contraction. After creating the cells in a laboratory dish, the researchers tested their new cells in a computer simulation of the human heart, injecting the light-sensitive cells in various locations in the heart and shining a virtual blue light on them to observe how the injections affected contraction as it moved across the heart.

In a real heart, the pacemaking cells are on the top of the heart and the contraction radiates down and around the heart. With these models, the researchers say they can demonstrate not only that pacing cells with light will work, but also where to best inject cells to produce the optimal contraction pattern.

The long-term goal is the development of a new class of pacemakers. At present, surgically-implanted electrical pacemakers and defibrillators are commonplace, regulating the pulses of millions of faulty hearts around the world. However, Abilez adds that neither is without problems – pacemakers fail mechanically and the electrodes can cause tissue damage. Defibrillators, on the other hand, can produce tissue damage due to the large electrical impulses that are sometimes needed to restore the heart’s normal rhythm. In the future, the researchers envision that bioengineers will use induced pluripotent stem cells fashioned from the recipient’s own body, or similar cell types that can give rise to genetically matched replacement heart cells paced with light, circumventing the drawbacks of electrical pacemakers.

Co-author, Dr Christopher Zarins, professor emeritus of surgery and director of the lab, speculates the the work could result in a pacemaker that is not in physical contact with the heart. Instead of surgically implanting a device that has electrodes poking into the heart, engineered light-sensitive cells would be injected into the faulty heart and used to pace the heart remotely with light, possibly even from outside of the heart. The leads for such a light-based pacemaker might be placed outside the heart, but inside the pericardium, the protective sack surrounding the heart. Another concept to be explored is a pacemaker placed inside the heart chambers, as with traditional pacemakers, whose light can travel through the intervening blood to pace light-sensitive heart cells implanted inside. Since the new heart cells are created from the host’s own stem cells, they would be a perfect genetic match.

The authors conclude that optogenetics could also lead to advances beyond the heart. It might lead to new insights for various neuronal, musculoskeletal, pancreatic and cardiac disorders, including depression, schizophrenia, cerebral palsy, paralysis, diabetes, pain syndromes and cardiac arrhythmias.




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Cardiovascular Device Business News

The Medical Technology Blog

Photograph of the Taxus drug-eluting stent, fr...

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Last post of the week in The Medical Technology Blog comes from the Cardiovascular Device Business, Espicom’s business publication. Please read on…

Swedish researchers compare risk of stent thrombosis and restenosis in new vs old DESs

Findings from the complete Swedish Coronary Angiography and Angioplasty Registry (SCAAR) have demonstrated that percutaneous coronary intervention (PCI) with ‘new generation’ drug-eluting stents (DESs) was associated with a 38 per cent lower risk of clinically meaningful restenosis and a 50 per cent lower risk of stent thrombosis compared with ‘old generation’ DESs.

Although many trials and studies support the overall early- and mid-term safety and efficacy of first-generation DESs, there has been concern regarding their long-term safety, especially regarding the potential risk of late stent thrombosis as well as late restenosis. New drug-eluting stents (n-DESs) have been developed with the purpose of overcoming the current limitations of the older generation drug-eluting stents (o-DESs).

The purpose of this study was to evaluate the long-term outcome in all patients who underwent stent implantation with bare-metal stents (BMS), o-DESs and n-DESs in Sweden, using SCAAR, a national registry with complete consecutive enrolment. The latter holds data on consecutive patients from 29 centres that perform coronary angiography and PCI in Sweden. The registry is sponsored by the Swedish Health Authorities and is independent of commercial funding. The technology is developed and administered by the Uppsala University Clinical Research Center. All consecutive patients undergoing coronary angiography or PCI are included. Information with respect to restenosis and stent thrombosis has been registered for patients undergoing any subsequent coronary angiography for a clinical reason since the beginning of 2004.

The current study included 94,384 stent implantations in Sweden (BMS, n=64631; o-DES, n=19202; n-DES, n=10551), from November 2006 to October 2010. Follow-up was performed up to two years post-intervention. The performance up to two years of different types n-DES was evaluated in an unselected, large, real-world population – including patients with myocardial infarction, three-vessel and/or left main disease, bifurcation lesions, graft disease, restenotic lesions and chronic total occlusions. The main findings from this study are that PCI with n-DESs was associated with a 38 per cent lower risk of clinically meaningful restenosis and a 50 per cent lower risk of stent thrombosis compared with o-DESs. These findings can be useful for the management of patients with a high-risk profile that could benefit more from these new devices.

Further studies are said to be needed in order to attempt to discriminate whether one of the three components of the n-DES – the polymer, the stent alloy, the eluting-drug – is mainly involved in decreasing the incidence of stent thrombosis and restenosis. Improved stent designs with thinner struts and more biocompatible polymers may have an important impact on drug elution profiles, endothelial coverage and functional recovery.



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Non-Surgical Treatment for Varicose Veins

The Medical Technology Blog

As the NHS cuts start to bite, could a treatment for varicose veins provide one of the answers?

Maybe not! But Medical Industry Week this week highlighted the rather grand suggestion that a non-surgical treatment for varicose veins could save the UK’s National Health Service over £17 million annually in healthcare costs, and help 7,000 patients avoid further treatment due to unsuccessful alternative treatments. It’s not going to solve all our problems, but if it’s true then it’s a good start!

All medical device companies like to big up their respective device and technologies from time to time, particularly when one considers that regulatory authorities from across the country are tightening the budgets.  So it remains to be seen whether VNUS’ claims are just marketing puff, but it’s interesting to see how companies are increasingly using costing as a sale push, in addition to all the stated benefits of improving healthcare.

Developed by US-based VNUS Medical Technologies, the VNUS Closure Procedure involves a hospital stay of a couple of hours, treatment under local, rather than general anaesthetic, and claims a much faster recovery time with most patients able to walk out of the treatment room unaided. The procedure is also much less resource-intensive than surgery to the NHS, particularly compared to conventional varicose vein stripping, which takes up a great deal of operating theatre time.

For the same costs, the company said this week that a further 25,000 patients could be treated earlier and avoid pain, or discomfort. Further savings are on offer as the procedure can be carried-out in a treatment room so it has the potential to free-up theatre-time, enabling the NHS to treat other serious conditions more quickly and to reduce those all-important waiting-times.

On its own, the VNUS procedure may not represent a significant dent in the £20 billion of spending cuts that the NHS is faced with securing over the next four years, but getting on top of some of these, arguably less glamorous treatments could collectively make a positive impact on meeting this ambitious target. Medical Industry Week argues that it is time to take a closer look at these sort of treatments in a bid to meet a target that even the NHS Confederation says is unlikely to be achieved with the timescale.

This article was provided by Lawrence Miller, editor of Medical Industry Week, and the medical newsletters teamleader.



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Will Axis-Shield give into rising pressure of takeover offer from Alere?

The Medical Technology Blog

Alere, a key player in the rapid point-of-care and laboratory diagnostics market with products that focus on infectious disease, cardiology, oncology, drug abuse and women’s health, has brushed aside negative feedback from Axis-Shield and pushed ahead with a cash offer for the UK-based company.

As part of the offer, Axis-Shield’s shareholders will be offered £4.60 (or approximately US$7.51) for each Axis-Shield share held by them, valuing the transaction at approximately £230 million (or approximately US$375 million). The offer will be conditional upon Alere receiving valid acceptances in respect of not less than 90 per cent of Axis-Shield shares to which the offer relates and not less than 90 per cent of the voting rights carried by those shares.

In June, Alere had made an indicative non-binding proposal to acquire Axis-Shield, however, the latter rejected the proposal and also turned down an offer to conduct further discussions with Alere. At the time, Alere revealed that it was keen to work towards a recommended takeover offer for Axis-Shield and that it would welcome the opportunity to discuss a possible transaction in a constructive manner. The company said its proposal was “a means to facilitate discussions” with Axis-Shield and its shareholders. Now, in a move that adds further pressure on its target, Alere has made an additional open market purchase of approximately 6.4 per cent of Axis-Shield’s share capital.

Axis-Shield is an international in vitro diagnostics company, headquartered in Dundee, UK, with R&D and manufacturing bases in Dundee and Oslo. The group specialises in the supply of instruments and tests for the rapidly growing physician’s office testing market and the development, manufacture and marketing of diagnostic kits in areas of clinical need, including cardiovascular and neurological diseases, rheumatoid arthritis, and diabetes. During 2010, the company made significant advances with the continued growth of its international in vitro diagnostics business and revenues exceeded £100 million for the first time.

Alere believes it’s all cash offer is highly attractive for Axis-Shield shareholders, representing a ‘compelling value proposition’ with a high degree of certainty at a substantial premium to the undisturbed share price. In addition, the company expects Axis-Shield will be complementary to its existing businesses and that it can help develop and grow the Axis-Shield product portfolio to be a clear leader worldwide in its core markets.

Over the forthcoming weeks, the question remains as to whether Axis-Shield will succumb to the pressure to reach an agreement Alere, and whether the latter, with revenues of over US$2.1 billion behind it for 2010, has done enough to win over the UK-based company.



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