Medical Technology Archives

Cypress Steps up Focus on CNS Therapies

The Medical Technology Blog

Welcome back to this weeks second article from the Medical Technology Blog, which centres on the pharma company Cypress Bioscience, please read on…

In an effort to expand its CNS pipeline, Cypress Bioscience has struck a deal with Mountain View, CA-based Alexza Pharmaceuticals to license the latter’s Staccato technology – a novel nicotine inhaler system intended to aid in smoking cessation. Cypress’ Chairman and CEO, Dr Jay D Kranzler, views the licensing deal as consistent with the company’s renewed focus on CNS drug development, and plans to take the technology into Phase I development late next year.

According to a specialist in nicotine addiction, Dr Neal Benowitz of the University of California San Francisco, a pulmonary nicotine device like Staccato nicotine may be useful in addressing a “pressing pharmacological problem” in overcoming nicotine addiction – namely the acute cravings during quit attempts are inadequately treated by current nicotine replacement therapies. Benowitz believes that a device that provides for rapid absorption of nicotine, combined with electronic controls to adjust doses for tapering and cessation, is “what the field has been waiting for.”

This is not the only step that Cypress has made lately to forge ahead in the world of CNS drugs. Late in August, the Californian company acquired patent rights and technology related to a novel, intranasal formulation of carbetocin, a potential breakthrough treatment for the core symptoms of autism. Cypress made an upfront payment of US$750,000 Marina Biotech, the developer of the therapy, which could increase to US$27 million in milestone payments. Cypress has committed to funding all continuing development activities, and will pay single-digit royalties to Marina based on any commercial sales.

Staccato and carbetocin have joined CYP-120 and CB-CAP in Cypress’ existing development portfolio of CNS therapies. CYP-120 is an antipsychotic for the potential breakthrough treatment of schizophrenia, which was licensed from BioLineRx in June and is currently under clinical development; while CB-CAP is a technology platform of cell-bound complement activation products to diagnose and monitor debilitating autoimmune disorders. The latter technology was acquired from Cellotape Corporation in February 2009 and Cypress hopes to see the first services using the therapy to be available in the fourth quarter.

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

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Medtronic Boosts Atrial Fibrilation Presence

The Medical Technology Blog

Medtronic boosts AF market presence with Health Canada approval

Welcome back to the Medical Technology Blog. Once again i have to apologise for the lack of posts recently, but i am currently updating our main website Espicom, with 60+ pages of world pharmaceutical market pages as well as many new reports, which i will list in my next post, thank you for your patience, please read on…

In a move that brings Medtronic one step closer to securing its goal of becoming the physician partner of choice for atrial fibrillation (AF) ablation, the company has welcomed news of Health Canada approval for its Ablation Frontiers Cardiac Ablation System.

Ablation Frontiers’ radiofrequency (RF) ablation technology for the treatment of AF was added to Medtronic’s growing AF Solutions franchise in February 2009 when the company acquired Ablation Frontiers for US$225 million. Operating within Medtronic’s Cardiac Rhythm Disease Management (CRDM) business, Ablation Frontiers, alongside CryoCath Technologies, a leader in cryoablation treatments for AF which was acquired by Medtronic in November 2008, expand the company’s AF Solutions business. The goal of Medtronic’s AF Solutions franchise is to be the physician partner of choice for AF ablation by bringing breakthrough AF therapies to patients and physicians that are simpler, safer, and offer more predictable procedure times than current treatment methods.

With this latest receipt of Health Canada approval, it would seem that Medtronic is now well positioned to address the increasingly significant area of AF with its Ablation Frontiers Cardiac Ablation System tools now approved for use in Canada, which include the GENius multi-channel RF generator and the Pulmonary Vein Ablation Catheter (PVAC), a single anatomically-shaped mapping and ablation catheter designed to efficiently isolate the pulmonary veins to treat AF. The GENius generator and PVAC, with the addition of the Multi-Array Septal Catheter (MASC) and Multi-Array Ablation Catheter (MAAC), are available in Europe and are under investigational use in the US. As a condition of Health Canada’s approval, Medtronic will provide periodic clinical updates on the safety and effectiveness of the PVAC catheter.

Going forward, Medtronic’s previous acquisition of Ablation Frontiers and CryoCath Technologies is set to further expand the company’s presence in the AF market with additional product milestones expected to take place in the near future. These include the anticipated receipt of FDA approval for the Medtronic Arctic Front Cardiac CryoAblation Catheter System, for which a PMA was submitted in March 2010, and gaining FDA approval for Ablation Frontiers’ system of catheters and the RF generator for permanent, or chronic, AF.

Please check back soon for an updated list of new reports at Espicom Business Intelligence, thanks, Paul.

Espicom Business Intelligence

Medtronic Agrees to Buy Osteotech for $123 million

The Medical Technology Blog

Medtronic bags Osteotech as expansion into biologics continues apace

In a move representing a further step in Medtronic’s strategy to build a broader business in regenerative biologics, the Minneapolis, MN-based corporation has agreed to buy Osteotech for US$123 million, or US$6.50 per share, following unanimous approval from the latter’s Board of Directors.

Osteotech is a leader in the growing field of biological products for regenerative healing, and has working on a number of technology platforms. Medtronic’s acquisition of the New Jersey firm is designed to complement Medtronic’s existing bone healing portfolio and expand its current presence in the spine, orthopaedic trauma and dental markets into many additional treatment areas, including joint reconstruction, foot & ankle, and sports medicine.

In recent years, Medtronic has made attempts to enter the regenerative biologics market. In March of 2007, the company signed an agreement with OsteoGenix, an orthobiologic pharma company based in California, enabling OsteoGenix to complete preclinical work on its bone anabolic agent and advance the programme through clinical trials. The agreement gave Medtronic an additional source of bone growth therapies for surgeons whose patients require bone grafting options. As recently as April 2008, Medtronic and Scil Technologies agreed to the development of the latter’s rhGDF-5 (recombinant human growth and differentiating factor-5) dental regenerative technology.

However, Medtronic has been looking for ways to speed up its biologics presence and has moved to take advantage of a spat between directors and shareholders that has dogged Osteotech in recent times, in order to boost that strategy. Osteotech’s Board has faced growing criticism over strategy and direction from a dissident group of shareholders with a stated aim to gain majority control of the boardroom. The acquisition by Medtronic is likely to put paid to this campaign just when it appeared that the shareholder group was gaining momentum. The Osteotech Board itself had appointed Deutsche Bank Securities in 2009 to advise the company on strategic options that could enhance shareholder value after growing frustrated at the inability for its share price to reflect the value of its biologics portfolio.

Despite its corporate difficulties, Osteotech’s extensive portfolio of biologics is used in a broad range of musculoskeletal procedures, and its Grafton range of demineralised bone matrix products holds a large body of evidence that support its “best-in-class” bone-generating capabilities. The company is also currently seeking FDA clearance for the first product based on its HCT (human collagen technology) platform, an engineered human collagen biomaterial.

As regenerative medicine continues to move to the fore as a first-line treatment in orthopaedic and spinal cases, the acquisition agreement seems to be mutually beneficial for both companies. For Medtronic, Osteotech’s products and capabilities will hugely assist the former gain a more prevalent position in today’s competitive musculoskeletal biologics market; and for Osteotech, the protection and safety offered from such a large corporation was too good to pass up.

In related news, RTI Biologics has been forced to calm shareholders that its relationship with Medtronic, involving the supply of BioCleanse sterilised biologic implants to meet Medtronic’s spinal allograft needs, will not change in near-term. RTI says that Medtronic is “supportive” of the agreement, which runs until June 2014.

I hope you found this article of interest, it was written by Sophie Bracken, editor of Orthopaedics Business for Espicom Business Intelligence.

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The Medical Technology Blog

Hello and welcome back once more to The Medical Technology Blog.

The European Union has applied EUR 1.67 million from its Sixth Framework Programme (6th FWP) for research programme to help develop an instrument that more quickly identifies the harmful bacteria or fungus that may be lurking in the wounds of burn victims and causing an infection. Such a device would help to speed up the diagnostic and healing process by days.

At present, doctors have had to rely on microbiological tests that take several days to identify which bacteria are responsible for the infection. In contrast, researchers from Germany, Italy, Lithuania and the UK have been working on a small prototype electronic device, known as the Woundmonitor, which can pinpoint the type of bacteria within a few minutes, by identifying the minute amounts of gas the bacteria are producing. The quicker infections can be diagnosed, the faster patients can be treated, which can in turn lower the cost of lengthy hospital stays.

Most burn injuries occur at home or at work and are more predominant among vulnerable groups such as the elderly or young children. Early diagnosis and treatment of infection in burn patients is critical. However, despite advances in modern medicine, it still takes up to three days for microbiological tests to identify the bacteria present in the wound. Traditionally, medical students were taught to recognise bacterial infections by their characteristic odour. Clinicians and researchers from Germany, Italy, Lithuania and the UK in the Woundmonitor project used the same approach, but were assisted by the latest information and communication technologies.

The researchers developed an instrument that can identify types of bacteria from the small amount of volatile gases, recognisable by smell, that they emit. The experts first identified the three major types of bacteria: staphylococcus, streptococcus and pseudomonas, which account for about 80 per cent of the bacterial infections found in burns. They then identified the volatile chemicals spread by the bacteria when they multiply. With this information, the team designed an instrument containing eight gas sensors. The pattern of the responses from the sensors represents the characteristics of the chemicals present, by which the bacteria are identified.

This complex , but nimble, instrument has already been tested in a hospital in Manchester, UK, and at a Kaunas regional hospital (Lithuania). Results are said to have been very satisfactory and the researchers have positively assessed the instrument’s risk level. Several commercial companies have also indicated an interest in the instrument and discussions are underway to develop the instrument for commercial use.

The University of Manchester in the UK s co-ordinating the EUR 2.2 million programme, which commenced in January 2006. Other partners in the project include Puslaidininkiu Fizikos Institutas and Kaunas Medical University Hospital (both in Lithuania), CNR-Istituto Nazionale per la Fisica della Materia and Biodiversity (both Italy-based), Umwelt-Systemtechnik (Germany) and the Department of Burns and Plastic Surgery at South Manchester University Hospitals Trust.

Thanks to Lawrence Miller for this post, Lawrence is Espicom‘s medical newsletters team leader, and the managing editor of Medical Industry Week and Diagnostics Focus

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The Medical Technology Blog

The National Institute for Health and Clinical Excellence (NICE) has issued new guidelines that recommend that clinicians consider offering patients endoscopic resection (ER) of high-grade dysplasia and intramucosal cancer, including T1a, as an alternative to removal of the affected part of the oesophagus (oesophagectomy). Additionally, ER should also be considered alone, to treat localised lesions. Oesophagectomy is the current standard NHS treatment for Barrett’s oesophagus, and this latest guidance signals a renewed focus on less invasive techniques such as ER and ablative treatments. T1a is a classification of cancer that shows less than 5 per cent of cancerous cells in the tissue sample.

The guidelines specifically cover the use of ablative therapies such as argon plasma coagulation (APC), laser ablation, multipolar electrocoagulation (MPEC), radiofrequency ablation (RFA), photodynamic therapy (PDT) and endoscopic resection (ER), for treating Barrett’s oesophagus (BO) with high-grade dysplasia or with intramucosal cancer (including T1a) in adults (18 years and older) in secondary care. The recommendations state that an additional ablative therapy (RFA, APC or PDT) could be used after ER to completely remove dysplasia, and RFA or PDT ablation alone could be considered for flat high-grade dysplasia. NICE also advises that APC, laser or MPEC should not be used alone or in combination with each other unless as part of a clinical trial.

It is the first time that NICE has issued guidelines relating to the the use of ablative therapies for the treatment of Barrett’s oesophagus. Ablative therapies destroy the abnormal cells within the oesophagus caused by this condition, without the need to remove an entire section of oesophagus. The condition is a direct consequence of long-term, chronic gastro-oesophageal reflux disease (GORD). The cells that line the affected area of the oesophagus become inflamed and if this happens over many years, these cells may start to change, becoming more like the cells that line the intestine. In some patients, these changes can lead to oesophageal cancer.

In the UK, around 1 per cent of the UK population are currently affected by Barrett’s oesophagus, placing a significant cost burden on the health service and the need to select the most cost-effective and clinically beneficial therapy. The lack of any previous advise on treatment options as led to widespread variation in treatments being offered. These new guidelines subsequently set out as a clinical pathway for the treatment of Barrett’s oesophagus in England and Wales.

Thanks to Lawrence Miller for this post, Lawrence is Espicom‘s medical newsletters team leader, and the editor of Medical Industry Week.

Please keep reading for more articles later this week, Paul.

Espicom Business Intelligence

FDA -More Research Into Heart Valve Replacement Procedures Needed!

The Medical Technology Blog

GIF-animation showing a moving echocardiogram;...
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Welcome back to The Medical Technology blog. My apologies for the lack of posts last week, but I  was extremely busy updating Espicom’s main website. Please read on….

Interesting news has come this week from a study funded by the FDA’s Agency for Healthcare Research and Quality (AHRQ) which gives qualified backing to the adoption of percutaneous heart valve replacement (PVR) procedures in preference to open heart surgery

The report, produced by the Duke Evidence-based Practice Center for AHRQ and published online in the Annals of Internal Medicine, found that PVR, a minimally-invasive procedure in which a replacement valve is implanted through a catheter rather than by open heart surgery, is a realistic option for some patients with heart valve disease, especially older or sicker patients.

The report concluded that this form of heart valve replacement may be a safe and effective alternative to open heart surgery, especially in the short term, for this patient group. However, the FDA body maintains that information is lacking on the potential long-term benefits and risks of this procedure, particularly compared with open heart valve replacement surgery.

In this study, approximately 92 per cent of patients who received a percutaneous valve survived the procedure, of which 86 per cent survived for at least 30 days. The authors looked at 62 published studies representing a total of 856 patients, as well as additional studies that have not yet been published. However, researchers were unable to make direct comparisons between percutaneous valves and traditional surgical replacement due to differences between patient groups receiving the treatments.

In total, seven percutaneous valves were featured in the study, namely the Sapien transcatheter heart valve (Edwards), CoreValve ReValving system, Melody heart valve (Medtronic), Paniagu heart valve (Endoluminal Technology Research), Lotus valve (Sadra Medical) and Ventor Embracer (Ventor Technologies). This particular study didn’t look at the comparative performance of the devices, leaving that to be revealed through other studies currently in progress in the US. The AHRQ argues that there are plenty of comparative “mine’s better than yours” studies but little in the way of  observational studies and decision modelling that could help inform clinical and health policy in the absence of randomised control trials.

It’s an important question since, as with most of the developed world, the US population  proportion of older adults continues to increase, bring with it higher incidences of degenerative heart valve disease. Calcific aortic stenosis (narrowing) and ischaemic and degenerative mitral regurgitation (leakage) are the most common valvular disorders in adults aged 70 years and older.

Mechanical and, more latterly, bioprosthetic heart valves, have radically transformed the way in which we treat patients with heart disease. The urgent need now is to make sure that includes policymakers, decision makers for third-party payers, clinicians, patients and investigators, get the right form of information.

Thanks for reading, and come back soon, Paul.

Espicom Business Intelligence

Early ACL Repair Could Save Millions And Cut Number Of Secondary Injuries!

The Medical Technology Blog

Arthroscopic reconstruction of the anterior cr...
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Hello and welcome back to The Medical Technology Blog, brought to you by Espicom Business Intelligence. In today’s tough economic climate, everybody is looking to save money, one hospital in America has submitted this study, please read on….

Nearly US$30 million a year would be saved in hospital charges if early, rather than delayed, ACL (anterior cruciate ligament) reconstruction surgery was performed on paediatric patients, according to a study conducted at the Children’s Hospital of Philadelphia (CHP) and presented at the American Orthopaedic Society for Sports Medicine‘s (AOSSM) annual meeting in Providence, RI. Additionally, more than 7,300 tears to the meniscus and 7,800 cartilage tears in children could be avoided each year in the US by early ACL surgery, the study authors say. The study revealed that more than US$29.4 million would be saved in hospital charges for pediatric patients each year in the US by reconstructing ACL tears early rather than delaying treatment.

The timing of paediatric and adolescent ACL surgery has historically been controversial, explained Dr Theodore J Ganley, Director of Sports Medicine and Associate Professor at CHP, as the theoretical risks of growth disturbance in younger patients are balanced against the risk of further knee damage related to delaying treatment until closer to skeletal maturity. The goal of ACL knee surgery is to stabilise the knee allowing patients get back to a healthy, active lifestyle. Long-term, the surgery aims to prevent instability and additional damage to the knee.

A 14-year review of ACL reconstructions presented by the authors at the 2009 AOSSM annual meeting revealed a four- to 11-fold increase in meniscal and cartilage injuries with a greater than 12-week delay in ACL treatment. In the current study, a model for paediatric ACL reconstruction was developed based on probabilities derived from the ACL review. Identical groups of 100,000 patients, representative of the US population, were simulated to undergo either early or delayed ACL reconstruction, with the secondary meniscal and cartilage damage and hospital charges compared between the two groups.

The decision tree and statistical modelling approach for the study, created by the study’s co-author Suneel Bhat, is claimed to be “unique” in that it incorporates variability, thereby generating a model simulation of a large scale prospective study, which provides a way to generalise implications, said Ganley. The simulation found that in females in the US, delaying ACL reconstruction beyond 12 weeks resulted in 1,560 medial meniscal tears and 2,100 cartilage tears relative to early surgery each year. In males, delayed surgery resulted in 3,300 medial meniscal tears and 5,720 cartilage tears relative to early surgery.

Apart from the financial benefits to this approach, surely there has to be less discomfort for the patient, that must be factored in as well? I’d certainly like to hear the thoughts of any clinicians reading this post.

In my next post…

…….Cook Medical’s biopsy forceps outperform rival in providing effective cancer diagnosis…..

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UC Davis Study Identifies Early Alzheimer’s Risk Method!

The Medical Technology Blog

Hello once again to The Medical Technology Blog. A couple of weeks ago I posted an article concerning the Early Detection of Alzheimer’s Disease (AD) using Eye-Imaging, and today I have another post that also concerns the early identification of Alzheimer’s, using a different method. I apologise if I appear to be concentrating on Alzheimer’s, but as I said before, I think it a horrendous disease. An uncle of mine suffered from AD and by the time he was admitted to a specialist home for Alzheimers sufferers, he could neither recognize his wife, nor my mother, it was heartbreaking for them both. I welcome any study into this disease, please read on….

A study by researchers at the University of California Davis has found that abnormal brain images combined with examination of the composition of the fluid that surrounds the spine may offer the earliest signs identifying healthy older adults at risk of developing Alzheimer’s disease (AD), well before cognitive problems emerge. Published in the journal Neurobiology of Aging, the study analysis identified a subgroup of healthy adults who would later experience a decline in memory performance typical of early AD long before other study participants.

For the study, the scientists used data from the Alzheimer’s Disease Neuro-imaging Initiative, which provides researchers with access to brain scans, clinical data and other laboratory results from spinal fluid and blood tests from more than 800 older adults. Some study participants began with a clean slate of cognitive health, some with mild cognitive impairment, and others with mild or moderate AD.

The researchers analysed data from 220 normal older adults who had undergone structural MRI and clinical examinations, and approximately half also provided spinal fluid samples. Among the 96 participants, cluster analysis identified three distinct subgroups of individuals based solely on their baseline imaging and laboratory measures. Over the next three years, few of these healthy individuals showed any cognitive change. However, cognitive tests for people in one of the subgroups – approximately 10 per cent of the sample – declined at nearly five times the rate as healthy older adults. The researchers believe this group, which had the most extreme MRI and spinal fluid measurements, may represent the earliest stages of subclinical cognitive decline and AD.

The finding is said to be an important step towards discovering the constellation of imaging and fluid biomarkers that foreshadow cognitive decline, as well as a means of determining whether new treatments are effective. It is believed that this method could improve clinical trials for prevention and reduce the numbers of study participants necessary to speed drug discovery – and eventually change how the pharmaceutical industry and National Institutes of Health conduct AD clinical trials.

According to Laurel Beckett, a professor of public health sciences at UC Davis and the lead study author, these findings indicate that a distinctive pattern of imaging and biomarker deviations from typical adults may be an early warning sign of neurobiological pathology and an early sign of AD. By the time people are diagnosed with AD using cognitive tests, there is already a lot of brain damage. It is therefore hoped that future methods combining brain imaging and biomarker assessments can enable earlier diagnosis, while learning more about the mechanisms causing AD so that better treatments can be developed.

Thank you for reading, please check back soon, and feel free to  leave a comment and your name, with a link back to your own site or blog.

Regards, Paul

Espicom Business Intelligence

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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