Introducing Espicom Interactive

The Medical Technology Blog

Introducing Espicom Interactive – Espicom’s new online delivery platform

Welcome back to Pharmaceutical News. Today we have some exciting news, the launch of our new service Espicom Interactive.

Espicom Interactive is our new feature-rich online delivery interface which provides a range of powerful and useful time-saving functions. Available now, Espicom Interactive lets you maximise the value of your Espicom service, with features such as the ability to save your researched text instantly to MS Word. Tables, graphics and illustrations are instantly opened and saved in MS PowerPoint and MS Excel.

Field staff and agents worldwide will benefit from machine translation into 9 languages, which cover key emerging markets such as Brazil and China. Watch the instructional video below to assess the power and versatility of the Espicom Interactive platform.

Espicom Interactive Instructional Video

 

For many companies the cost of business information represents a significant investment. Its practical use in defining commercial strategy and in understanding market environments is critical to success. However, the value of such investments is only really beneficial if the service empowers staff to greater efficiency in its use. Business information should be a support to effective decision making and not a burdensome administration task.

To download the Espicom Interactive Brochure please click on the thumbnail below

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To access Espicom Interactive and review a sample document which will let you try the service for yourself at no charge, please click on the link to Espicom Interactive




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Patient Sues Wright Medical Technology

The Medical Technology Blog

Patient sues Wright over defective ProFemur total hip system

Dale Purcell, a plaintiff from Phoenix, AZ has filed a lawsuit in the US District Court against Wright Medical Technology after needing emergency surgery following a sudden catastrophic fracture of the titanium modular neck of his Wright ProFemur total hip system in July 2011. Purcell had the device implanted in June 2005.

According to the complaint, the titanium modular neck used in the plaintiff fractured and broke very near the femoral stem, leaving a broken portion of the titanium neck wedged inside the stem. The fracture of the modular neck adapter caused failure of the system, requiring corrective surgery, and made it extremely difficult to extract the fragment. The complaint points out that “Studies have shown that modular neck adapters made from titanium alloy, such as the ProFemur modular neck adapter…are more likely to suffer fretting corrosion and fatigue fracture than those made from cobalt-chromium”.

A 2009 report by the Australian Orthopaedic Association claims to show that the Wright ProFemur Z femoral stem had a high failure rate, requiring approximately 11.2 per cent of all patients receiving the implant to need revision surgery. Wright is alleged to have changed the material in the ProFemur hip system modular necks in 2009 from titanium to cobalt chrome alloy, but took “no corrective action in the form of a recall or even an announcement of warning to the medical community or to the public at large concerning its decision to switch from titanium modular neck adapters to cobalt chrome adapters”.

Article source: Orthopaedic Business News kindly provided by Sophie Bracken, Espicom’s medical newsletters editor.



Espicom Business Intelligence

Canada’s Healthcare Support System – Part 2

The Medical Technology Blog

Medical Industry WeekPrivate and public sectors working to boost Canada’s healthcare system

This model differs from the usual avenues for non-profit organisations looking to develop treatments. Traditionally, these parties have been required to beg for cash from companies on a donation basis with various degrees of success. A prime example of the OCE model in practice is the Ontario Diabetes Association, which is conducting research that will be supported by OCE funding with an industry partner.

At the core of the OCE philosophy is the requirement that any research that it backs has to be a product that the industry partner can use to create jobs. The process helps these non-profit organisations to get research done but also spurs on economic development. SIP’s initial proposals are focused on collaborations in the health improvement sector (first area to attract proposals in 2011), followed by sustainability environment and poverty reduction initiatives.

Healthcare Technology Exchange

Representing a major lynchpin in efforts to continue the turnaround of the Canadian Med-Tech industry is the Healthcare Technology Exchange (HTX), a Federal and Ontario government-funded organisation that aims to support the research and development of advanced healthcare technologies.

Originally set up by the Ontario government, the HTX bids to help companies bridge, what John Soloninka, HTX’ President & CEO, describes as, the “valley of death”. The rather dramatic phrase refers to the pre-commercialisation gap where companies need some financial assistance before showing up on the radar of banks, institutions, public investors or venture capitalists. This important contribution has largely come in the form of government “angel tax-relief”, a process that allows small companies to apply the necessary capital to support R&D, trials, reimbursement and other activities.

HTX manages its C$21.4 million budget, provided by the Ontario Ministry of Economic Development Innovation to help SMEs and start-ups to get funding to reach the domestic and global market and to attract multi-nationals to set up R&D in Ontario through incentives. The agency co-invests with other investors in R&D in small medium enterprises (SMEs), but also provides persuasive incentive funding for large organisations.

Over the last 12 months, HTX investments include GE Healthcare digital pathology; as well an October 2010 investment in Xagenic, a company that came out of Ontario universities and is developing rapid POC molecular diagnostics focused on infectious diseases and cancer. Other low key investments include e-health, tissue simulation, radiology applications and embedded micro processors that have led to partnerships with multi-nationals, FDA clearance and licensing. In effect, HTX believes that a small amount of assistance in the right area makes all the difference.

HTX Research Grants

HTX awards research grants of C$350,000 and C$750,000 to come such as Baylis Medical, Tornado Medical Systems, RNA Diagnostics, XLR Imaging and Patient Ordersets.com, Colibri Technologies (catheter-based 3D imaging), Profound Medico. Collectively, they provide an infrastructure – effectively engines of commercialisation – and create assets that benefit the province of Ontario as a whole.

One of the HTX’s leading investments is PICOE, an initiative that is bidding to transform digital pathology, a market that is comparable in development of that for digital radiography ten years ago. HTX invested C$2.25 million in support of GE’s development plan, of which more is featured later in this article.

Centre for Imaging Technology Commercialization

Also being backed by HTX is the Centre for Imaging Technology Commercialization (CImTeC), an organisation that helps small companies to compete in markets and overcome regulatory issues to make a fully viable product. One such example is a joint initiative between Sunnybrook Hospital and the University of Western Ontario that is focused on medical imaging opportunities. This has resulted in a C$28 million incubator-style five-year project for small local and international companies to get the expertise and help needed to commercialise technologies at a faster rate.

The Ontario Brain Institute

The Ontario Brain Institute (OBI), which is focused on neurosurgery/brain health opportunities, is also seen as a potential catalyst for growth for Ontario and Canada as a whole. Although highly competitive, neuroscience is still regarded to be in its infancy despite its potential to become as big as cardiovascular care in the next five to ten years.

Supported by local philanthropist investment. OBI is acting as single umbrella for the provinces’ neuroscience area, encouraging synergy across all institutes, and focusing on marketing innovative devices worldwide. Providing a template for other sectors, a total of 22 companies, spanning diagnostics, imaging, prosthetics and devices, and brain fitness, have benefited from C$20 million in investment that has resulted in the commercialisation of 22 technologies. Operating at the heart of ONE is the MaRS organisation and its most recent incarnation – MaRS Excellence in Clinical Innovation and Technology Evaluation (Excite), an innovation incubator that was publicly revealed for the first time in Toronto in late December 2011. The alliance brings together a health system ((Ontario Health Technology Advisory Committee); Federal Government departments; Academia (Council of Academic Hospitals of Ontario and over ten academic health institutions across Ontario); Industry (MEDEC and HTX) and the MaRS Discovery District in Toronto.

The goal of MaRS Excite is to respond to increasing demand for effective and reliable healthcare technology assessment. Whilst the emphasis has been on finding out that a device is safe and effective, there is also the need to establish its cost effectiveness by comparing the technology against substitutes and competing technologies. Uniquely, MaRS Excite aims to move this process, usually done after the product is approved and on the market, back to the development stage.

The initiative will seek to harmonise health technology evaluation into a single, pre-market evidence-based evaluation process for technologies with disruptive potential and specific relevance to health system priorities. Medical technologies considered for EXCITE pilot studies include devices and equipment used to maintain, restore and promote health. They encompass interventions at any stage of health care, including primary prevention, early detection of disease and risk factors, diagnosis, treatment, rehabilitation and palliative care.

Currently, the evaluation of medical technology is conducted and funded by the provincial government and occurs after regulatory approval and market introduction. However, the post-market approach can be inefficient, fragmenting pre-market risk-based evaluation from post-market evidence-based evaluation.

The deadline for the initial phase of the MaRS Excite plan passed in December and 2012 promises to be a big year for the programme, which will have to match the ambitions of the MaRs organisation to more effectively capture the commercial potential of Toronto’s science and technology research activities.

Since opening in 2005, MaRS has steadily grown to reach full capacity, paving the way for the plans to commence the second stage of its development, which involves a significant expansion of its facilities – a process that is expected to be completed in 2013.

Excite is just one aspect of the MaRS alliance and is symbolic of the collaborative framework within Ontario. A framework of partners that include:

  • MaRS Innovation, a member-based partnership designed to transform the Toronto-based academic research enterprise into an established cluster;
  • Business Acceleration Programme (BAP), a range of entrepreneur support programmes and services coordinated by MaRS and delivered through the Ontario Network of Excellence;
  •  Social Innovation Generation, which actively develops programmes to support the launch and growth of a social nature;
  • The Investment Accelerator Fund (IAF) and the C$7 million fund for life science companies that provide sustainable economic benefit to Ontario;
  • The Ontario Network of Excellence (ONE); and
  • The Centre for Impact Investing, a national hub focused on increasing the awareness and effectiveness of social finance to catalyse new capital, talent and initiatives dedicated to tackling social and environmental problems in Canada.

This network of organisations all provide the ingredients that has the ultimate aim of ensuring that Ontario and Canada compete effectively in the healthcare industry on both a macro and micro economic level.

Over the next series of articles, Medical Industry Week focuses on how some of these businesses and organisations are using these programmes in practice throughout Canada and with a view to competing globally.



Espicom Business Intelligence
The Medical Technology Blog

Welcome back to the Medical Technology Blog. Today’s article comes from the Cardiovascular Device Business Newsletter from Espicom Business Intelligence.

VentriPoint Diagnostics has met with the FDA to review its plans for the clinical trial and regulatory submission for the first application of the VMS heart analysis system for the congenital heart disease known as Tetralogy of Fallot. The FDA informed the company it had answered all its questions and addressed all of the earlier observations pertaining to the trial, paving the way for the start of the trial in the US.

The Tetralogy of Fallot study has begun in the US and is designed to show substantial equivalency between the gold-standard, MRI method and VentriPoint’s 2D-ultrasound, VMS technique. Based on advice from the FDA, the study has been designed to collect images at multiple sites and to analyse them in core labs. Nationwide Hospital in Columbus, OH is the lead centre for the study and the University of Nebraska has been named as a second site. A number of other clinical sites are expected to join the study. Nationwide Hospital has also been selected as the core lab for the analysis of MRI studies and the Hospital for Sick Children in Toronto, Canada has been selected to carry out all the analyses of the studies.

To date, 20 patients have been enrolled in the study and a total of 75 evaluable cases are required for study completion. VentriPoint anticipates enrolment will accelerate as the other centres become operational. The data collection should be completed this spring and a response from the FDA is anticipated this summer, depending on the rate or recruitment by existing and new centres.

VentriPoint estimates the market for product for Tetralogy of Fallot to be US$200 million and is already marketing the device in Europe and Canada, where it is approved for clinical use. The company has a target of placing 50 VMS devices in 2012 and anticipates that sales will increase rapidly during 2012 should FDA approval for Tetralogy of Fallow is achieved and approval for pulmonary hypertension is received in Europe and Canada.

The pulmonary arterial hypertension application is expected to over lap with the US congenital heart disease programme. A clinical evaluation of the pulmonary arterial hypertension application has already begun at the University of Chicago. This should be complete in a few weeks and, if successful, VentriPonit will use the data to file for CE mark and Canadian approval marketing applications. A number of medical centres have agreed to be part of this pivotal trial. Based on experience with the Tetralogy of Fallot trial, the company has already started the IRB and budget-approval processes with these major cardiovascular centres, as this is the most time-consuming part of the process. The sites will be selected shortly and will become operational as soon as possible.

Much of 2011 has been spent upgrading both hardware and software based on the feedback from the users and developing new applications such as pulmonary hypertension. The latest software, version 1.1, is completed and undergoing final testing. The major hardware feature expansion is the ability to interface with the newer digital ultrasound machines, which the company says is likely to  take over the market in the next five years. A key software enhancement is the ability to export VMS studies to the hospital PACS, enabling third party DICOM viewers to review the VMS results. Existing sites will be updated remotely with the new version as soon as it has been released for general use.

Looking ahead, VentriPoint is actively seeking partnerships with large manufacturers of ultrasound equipment for combination products and distribution. The company says there is considerable interest in developing a stand-alone system for pulmonary hypertension, as this would be a completely new application for ultrasound.

Article source: Lawrence Miller, editor Cardiovascular Device Business, and medical newsletters team leader 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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The Medical Technology Blog

Welcome back to the Medical Technology Blog. Today’s post is taken for Espicom’s business publication Drug Delivery Insight, which is edited by Sophie Braacken, please read on…

Prosonix has presented new research showing that a combination of two inhaled respiratory drug molecules in a pre-determined ratio within Multi-component Particles (MCP) significantly improved co-localisation of the active drug components in the lung. The presentation was made by Prosonix’ Dipesh Parikh at the Drug Delivery to the Lungs 2011 (DDL2011) conference in Edinburgh, UK.

In the presentation, Prosonix describes how its Umax technology has enabled the development of one such example of MCP, which combines budesonide (BDS) and formoterol fumarate dihydrate (FFD) in a single particle, in a pre-determined ratio with “exquisite” control and consistency. The combination of BDS and FFD forms the basis of AstraZeneca’s multi-billion dollar respiratory drug product Symbicort. Combining multiple active drug components into a single particle using Umax® technology is shown, using Raman chemical imaging, to result in optimal co-association and co-localisation of the drug molecules at the correct sites in the lung and respiratory tract.

The concurrent delivery of inhaled corticosteroids (ICS) and long-acting B2-adrenergic bronchodilators (LABA) is a key treatment for asthma and chronic obstructive pulmonary disease (COPD) with mutual synergy of action cited as important for clinical performance. Previous analysis by Prosonix of currently marketed suspension-based MDI and DPI combination product formulations, which consist of individual drug components in a simple mixture, has shown limited co-localisation. Compared with these combination products, the improved co-localisation of MCPs to targeted parts of the lung is expected to achieve more pronounced synergy and additive efficacy on the key target cells directly from the solid state, improving outcomes and leading in turn to lower doses and improved safety and compliance.

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European Commission Investigates Synthes Takeover

The Medical Technology Blog

European regulatory authority casts an eye over Johnson & Johnson’s Synthes takeover

The European Commission (EC) has opened an in-depth investigation into the planned acquisition of Synthes by fellow orthopaedic company, Johnson & Johnson. The EC now has until 19th March 2012 to take a final decision on whether the transaction would reduce effective competition in the EEA.

The investigation has been prompted by concerns in Europe that the proposed acquisition would remove a competitor from some markets that are already concentrated. An initial investigation showed that the proposed transaction would combine two of the leading suppliers of spine devices and would strengthen the position of Synthes as the current market leader in trauma and CMF devices and of J&J in shoulder devices in a substantial number of EEA member states. The EC also has concerns that the remaining competitors in many of the markets may not be able to exert sufficiently strong competitiveness with the merged entity. The removal of Synthes may also have a negative impact on the level of innovation, leading to a reduction of choice for patients and potentially an increase in prices for the orthopaedic medical devices concerned. Consequently, at this stage, the acquisition raises “serious doubts” as to its impact on competition.

Synthes accepted a US$21.3 billion takeover offer from J&J in April 2011. The deal, which has a target completion date of mid-2012, would make J&J’s DePuy arm the largest orthopaedic device manufacturer in the world.




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New Medical Market Country Profiles

The Medical Technology Blog

Hi and welcome back to The Medical Technology Blog.

A short announcement today just to say that we now have a new addition to the blog, which are the Medical Market Focus pages.

The Medical Market Focus tab provides a short introduction to the global medical market reports provided by Espicom Business Inteligence, and if you hover your cursor over the tab, a drop-down menu shows you the current medical device market country profiles featured this month.

This months feature profiles;

Please let me know if you have a specific country you would like to see featured.

Thanks, Paul




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Libyan Medical Market Report

The Medical Technology Blog

In the light of recent world developments, Espicom Business Intelligence has just released a new report entitled The Libyan Medical Market: Status & Post-Conflict Opportunities. This report has been compiled from novel forecasts and original materials to give a complete overview of the Libyan health market. Together with the fall of the Gaddafi regime as well as the expected introduction of a more open-handed democratic government, it is time to scrutinize Libya’s medical market economy in the region, examine the way it may develop, and assess the impacts for medical technology companies.

Libya is a small but oil-rich country in North Africa. Under the personal rule of Muammar Gaddafi from 1969 to 2011, it developed an eccentric mixture of socialism and Islam. The country was largely isolated from the international community due to its terrorist links, although Gaddafi made concerted and largely successful moves to re-engage with the West in the 2001-10 period.

2011 saw a bloody but ultimately successful rebellion against Gaddafi’s rule, caused by declining living standards over the past two years, and inspired by the Arab Spring uprisings in neighbouring countries such as Egypt and Tunisia. Aided by NATO airpower, anti-Gaddafi forces based in Libya’s second city, Benghazi, were able to take Tripoli in August 2011, and the whole country by October.

Libya’s oil wealth has enabled it to create a reasonably comprehensive healthcare system, but spending remains low in comparison with other oil-rich countries of comparable income such as Saudi Arabia. There is therefore considerable scope for expansion and modernisation in the future. There is no private insurance as such, so local people are largely reliant on the public hospital system. There is a well-equipped private sector, which caters for wealthier locals and workers in the oil industry.

The 2011 fighting has caused serious dislocation in the health sector, at the same time as placing great strains upon it. Some facilities have been directly damaged, while others have faced shortages of power, equipment, supplies and personnel. Most services have remained open, however, and the transitional council in Benghazi established a health ministry early on, in order to restore some normality. Shortages have become far less acute in the latter part of 2011, helped by short term overseas aid and the unlocking of public funds for use by the transitional government.

Libya makes some drugs locally, but has no significant domestic production of medical equipment, so all its requirements have to be met by imports. These were boosted by the thawing of relations with the EU and USA in 2003-04, since when direct trade became far easier. Imports peaked at just under US$200 million in 2009, but fell back in 2010 to US$146 million or US$22 per capita. Around three quarters is sourced from the EU, principally Germany and Italy. Despite the fall in 2010, Libya remains by some margin the leading African importer of medical equipment in per capita terms, ahead of larger economies such as South Africa or Egypt.

Understandably, the fighting in 2011 had a severe effect on the Libyan medical market. Imports shrank to almost nothing in the March to July period when trade became difficult, not least due to the freezing of government finance. With the fall of Tripoli in August and the death of Gaddafi in October, some much-needed stability has returned and a rapid rebound to pre-2011 levels of spending can be expected as the new government – and the private sector – restock and re-equip. Looking further forward, Libya has the opportunity to use its oil wealth to create a sophisticated and advanced health sector in the style of the Gulf states, assuming a degree of political will and ongoing political stability. The latter is far from a certainty, but the prospects appear far brighter post-Gaddafi than under his rule.

To purchase, or read more on this new report please click on the link to The Libyan Medical Market: Status & Post-Conflict Opportunities.


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Medica 2011

The Medical Technology Blog

Visit Espicom Stand 16F-24-2 in the UK Pavillion for your chance to win an iPad 2!

Is medical market and business intelligence critical to your company? Then let us invite you to visit and review the latest class-leading products from Espicom – the choice of leading executives in 50 countries worldwide.

What’s in store for you on UK Pavilion Stand 16F-24-2…

  • Our brand-new, unique state-of-the-art statistical analysis service Medistat Interactive Market Evaluator which combines a powerful and easy-to-use tool with Espicom’s respected market and trade data – ideal for easily comparing and contrasting trends in order to identify opportunity avoiding risk.
  • Management reports – critical competitive/market analysis for leading sectors such as advanced wound care and point-of-care diagnostics
  • Extensive and comprehensive daily-updated news feeds in key technology areas such as medical diagnostics, orthopaedics and cardiovascular devices

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Also…we would really like your feedback – We are demonstrating our new feature rich delivery platform – come and see its facilities and tell us your opinion, the things you like and what you would like to see more of.

Finally…that iPad2 – We will be holding a draw to win an iPad 2 at the show. To enter, all you have to do is leave your business card with us. Could there be a better way to view Espicom’s excellent content?


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