Medical Technology Archives

i-Optics starts major sales push

The Medical Technology Blog

i-Optics starts major sales push for its corneal topographer system

Welcome back to the Medical Technology Blog, we have a great post today provided by our medical newsletters team-leader, Lawrence Miller, Lawrence is the editor for Medical Industry Week, please read on…

Investors certainly seem happy enough with the progress of the Netherlands-based ophthalmic diagnosis company, I-Optics, which this week has unveiled a corneal topographer system, called Cassini, that is designed to detect higher order aberrations with far better precision and accuracy than with ring topographers. The release took place at the the annual meeting of the British Contact Lens Association and follows the completion of a series D financing round that resulted in the company’s coffers increasing by EUR .7 million.

Specifically aimed at expanding the market for multifocal, toric, aspheric and ortho-k contact lenses, the system aims to meet the challenges of opticians and optometrists in ensuring accuracy in fitting such devices in patients with premium contact lenses. The unveiling also follows on from another tipped for 2012 growth development, namely the EasyScan non-mydriatic retinal imaging system, which was released in late 2011.

Cassini is based upon colour LED topography (CLT), which has been developed with the Amsterdam VU Medical Centre and replaces the rings used in Placido topographers with 672 colour-coded LEDs set in a pattern, thereby offering superior precision and accuracy, also for dry eyes and irregular corneas. The technology can measure high and low order aberrations precisely and in any direction, in contrast to Placido topographers that are limited to accurate measurements in a radial direction. Further refinements of the technology could potentially include early keratoconus detection and progression monitoring, cataract and refractive surgery and LASIK surgery.

Keratoconus affects approximately three million patients worldwide, and early diagnosis is key to ensuring the best possible treatment. The CLT could potentially detect the condition and other corneal irregularities due to to its ability to measure small aberrations with submicron accuracy and precision. The indication is currently being tested in a patient study being carried out at an undisclosed eye healthcare centre.

Longer term, it could also be possible to measure the power and shape of intraocular lenses (IOL) more precisely by combining Cassini’s CLT technology with further technology that measures the axial length, anterior chamber size and other parameters for IOL fitting. I-Flow says the current devices generate a post-op error of 0.5D, whilst using Cassini could reduce this to 0.2D and result in a smaller number of patients requiring glasses after the procedure.

Article Source: Medical Industry Week




Espicom Business Intelligence

Novartis withdraws application for Exelon/Prometax extended indications

The Medical Technology Blog

Drug Delivery Insight Update

The EMA has been notified by Novartis Europharm of the latter’s decision to withdraw its applications for an extension of the therapeutic indication for  Exelon and Prometax (rivastigmine), 4.6mg/24h and 9.5mg/24h transdermal patches.

In March 2011, Novartis submitted an application to extend the marketing approvals for the two transdermal patches to include a new indication for the symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease. At the time of the withdrawal, the application was under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Exelon was first approved in the EU in May 1998, and its duplicate, Prometax, was approved in December 1998. The transdermal patches are currently intended for the symptomatic treatment of mild-to-moderately severe Alzheimer’s disease.

The company stated that it decided to withdraw the application after the CHMP indicated that in order to conclude a favourable approval additional data was required, which could not be generated within the time-frame allowed in the centralised procedure. Both medicines continue to be approved in the currently approved indications.

Article source: Espicom’s business publication Drug Delivery Insight, edited by Sophie Bracken.

 



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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

espicom-interactive-brochure-screenshot

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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UK healthcare sector investment

The Medical Technology Blog

Investment in nanoscience set to benefit UK healthcare sector

Grant funding totalling over £6.5 million has been awarded for seven business-led projects that will focus on developing therapeutic agents and diagnostics where nanoscale technologies are the focus of innovation. The funding will be provided by the UK Engineering and Physical Sciences Research Council (EPSRC) and the Technology Strategy Board, and the projects will be led by Critical Pharmaceuticals, Johnson Matthey, Mologic, Nanomerics, OJ-Bio, Renishaw Diagnostics and Sharp Laboratories of Europe.

The aim of the investment is to help ensure that the UK can become an early competitive adopter of these technologies and rapidly meet the urgent and difficult challenges posed within the worldwide healthcare sector, by translating early-stage ideas from academia and commercialising them through the building supply chains with businesses. This investment is part of a two-stage initiative under the Nanoscience through Engineering to Application Grand Challenge for Healthcare. The university partners on two of the funded projects had initially received three years of funding from EPSRC and these projects will follow onto scale-up the technologies developed in the first stage.

The proposed R&D projects will seek to develop closer links between the healthcare community and the emerging nanoscale technologies community, in order to rapidly develop and commercialise early-stage nanoscale technologies. Key challenge areas include the earlier and better detection and diagnosis of disease, leading to marked improvements in patient outcomes, and effective treatments that are tailored to patients’ needs, and which either modify the underlying disease or offer potential cures.

£1 million UK government funding

Separately, a group of projects are to receive over £1 million of UK government funding to enable them to develop new and improved “health-economics” tools or products that will assist and improve the design and evaluation of clinical trials for infectious agents. The funding, from the Technology Strategy Board, in partnership with the Department of Health, UK and with additional contributions from EPSRC to fund academic social science components, has been awarded for three development contracts. These will be undertaken by Diagnostics for the Real World (Europe), Integrated Medicines and the Health Protection Agency.

The funding award follows the organisations’ participation in the “Assessing the Impact of Near-Patient Testing” competition for development contracts managed by the Technology Strategy Board and developed in discussion with the National Institute for Health and Clinical Excellence (NICE) and the British In Vitro Diagnostics Association. The competition was run under the Technology Strategy Board’s infectious disease programme that aims to reduce the economic burden, death and illness of such diseases.

Two of the projects, to be undertaken by Diagnostics for the Real World and the Health Protection Agency, will focus on sexually transmitted infections, while the remaining Integrated Medicines project will focus on sepsis.

Article source: Kindly provided by Sophie Bracken, editor of Espicom’s business publication Diagnostics Focus




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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
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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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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Alexza Pharmaceuticals Issue Job Warning

The Medical Technology Blog

Alexza employees face the chop in company bid to prop up Adasuve development

Drug Delivery Insight

In an effort to save cash in the current economic downturn, Alexza Pharmaceuticals has made the difficult decision to appoint a financial advisor to assist in exploring strategic options for the company. These options could include a possible sale or disposition of one or more corporate assets, a strategic business combination, partnership or other transactions. In order to conserve cash needed to support operations, Alexza has provided to all of its employees a 60-day notice of layoffs under the California WARN Act. The company expects to significantly reduce its workforce as it continues the actions necessary to pursue FDA approval of Adasuve (Staccato loxapine) and continues its MAA work with the EMA.

Recently, the Psychopharmacologic Drugs Advisory Committee (PDAC) of the FDA voted to recommend that Adasuve be approved for use as a single dose in 24 hours in conjunction with the FDA recommended REMS, for the treatment of agitation in patients with schizophrenia or bipolar mania. The vote on this question was 9/8/1 (yes/no/abstain). The PDAC also concluded that the product had been shown to be effective (vote of 17/1/0; yes/no/abstain), and that the product would be acceptably safe for use as a single dose in 24 hours, when used in conjunction with the REMS proposed by the FDA (vote of 11/5/2; yes/no/abstain). The Adasuve NDA has a PDUFA goal date of 4th February 2012.

Adasuve is an anti-agitation product candidate that combines Alexza’s Staccato system with loxapine, an antipsychotic currently available in the US as an oral formulation for the management of schizophrenia. The Staccato system is a hand-held, single-dose inhaler that delivers a medication comparable with intravenous administration. In clinical studies, Adasuve has shown an onset of effect in ten minutes of dosing, which is the first time point measured in Phase III studies.

Article source; Kindly provided by Sophie Bracken, editor of Espicom’s business publication Drug Delivery Insight




Espicom Business Intelligence

French Breast Implants Scare

The Medical Technology Blog

Breast implants safety thrown into question as France makes precautionary move to remove controversial PIP implants from patients

Just when the breast implant industry was getting some kind of good safety record, the death of a woman in France who had been implanted with an implant made by the French company, Poly Implants Protheses (PIP) has re-ignited the debate about the safety of the devices.

There’s no doubt the breast implant industry has worked hard to restore its image and relevance since the dark days of the 1980s when the embryonic industry was dogged by safety concerns and mass litigation. However, the spectre of safety has never really gone away completely. Last year, PIP had its breast implants banned after they were found to include a non-medical grade silicone filler. The issue has rumbled on quietly all year in Europe, but has been reignited following the death of a woman implanted in France with a PIP breast implant has been now been associated with an anaplastic large cell lymphoma (ALCL), a rare form of cancer which affects cells of the immune system.

The UK MHRA, in a bid to calm nerves, has pointed out that there is currently no evidence of any increase in incidents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates other than in France. Information obtained from the Australian Regulatory Authority is also consistent with consultations it has made with experts in the Netherlands, Portugal, Italy, Ireland, Hungary, Austria, Denmark and Malta, in terms of rupture events. There has also been no reported cases of lymphoma.

Despite that, authorities in France have recommended that 30,000 women in the country have their faulty breast implants removed as a precautionary measure. The French government, which still says there is no evidence of a cancer link, plans to cover the financial cost. Media reports suggest around 40,000 women in the UK have the implants and the conflicting signals arising from the two countries makes it a very uncertain time for those who have undergone breast implants, let alone those who have directly used PIP implants.
The UK viewpoint basically seems to urge woman to sit tight and discuss the issue with their doctors. Data wise, the agency has a point. The MHRA points out that approximately 1 per cent of women in the UK with PIP breast implants have suffered implant failure, including rupture. This contrasts with information from the French medical device regulatory authority, AFSSAPS, which suggests a failure rate, including rupture, of around 5 per cent in France. It doesn’t go far as trying to explain the reasons behind this anomaly, which doesn’t provide too much consolation.

From an industry perspective, it means the industry is back in the doghouse in terms of respectability. In the US, the FDA hasn’t been spent most of this year formulating plans to tighten up the implant regulatory process even more, with the result that companies are likely to face even more scrutiny than ever. Of course, the social cost makes these responses entirely natural, and agencies cannot fail to acknowledge the issues out there, but it looks like the start of difficult times for the breast implant industry in 2012 unless they can meet these challenges and prove, once and for all, that these implants are effective and safe options for women.

Article source: Article kindly provided by Lawrence Miller, editor of Espicom’s business publication Medical Industry Week, and editor-in-chief of the medical newsletters team.




Espicom Business Intelligence

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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