Everist closes in on market release for mobile ECG system

The Medical Technology Blog

Cardiovascular Device Business Product Launch

Everist Genomics is preparing for the market release in January 2012 for its CardioDefender diagnostic system, an FDA-approved and CE marked mobile phone ECG system that provides physicians and patients with hospital-quality heart rhythm monitoring outside of the hospital setting. The system incorporates capabilities that enable physicians to diagnose and treat potentially life threatening arrhythmias that might otherwise be missed.

According to Everist, CardioDefender is the first system to deliver mobile, real-time, beat-by-beat, and quantitative heart monitoring and automated reporting by combining patented analytical mobile phone software with a Bluetooth device and electrodes. The electrodes, which are attached to the patient’s skin, transmit heart rhythm data to the Bluetooth device, which then transmits the data to the mobile phone. The software in the mobile phone analyses the heart rhythm data, and the data is sent to a cardiac monitoring centre which keeps an encrypted record of the data that can be reviewed by physicians. Physicians are also able to receive arrhythmia alerts via their mobile phone, tablet, laptop or desktop computer. In the event of a significant arrhythmia, the  system will automatically transmit an alert to the patient’s physician while the event is occurring.

Following regulatory clearances in 2010,  CardioDefender has already been deployed at more than 150 medical facilities in the US for postapproval commercial evaluation. Between January and October 2011, the number of patient days of heart rhythm monitoring performed with CardioDefender grew from fewer than 5,000 to more than 18,000 patient days per month.

For up to date information on product launches and much more, please click on the link to the Cardiovascular Device Business.

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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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FDA steps up bid to drive innovation in healthcare

The Medical Technology Blog

The FDA has handed over an award of US$2 million…

…to support two regional ‘Centres of Excellence in Regulatory Science and Innovation’ (CERSI) in the US. The centres, which will be located at the University of Maryland and Georgetown University, will focus on strengthening science and training needed to modernise and improve the ways drugs and medical devices are reviewed and evaluated.

In August 2011, the agency released the strategic plan for “Advancing Regulatory Science at FDA”, the main focus of which was to accelerate delivery of new medical treatments to patients, improve paediatric health, protect against emerging infectious diseases and terrorism, enhance safety and health through informatics, protect the food supply, modernise safety testing and meet the challenges of regulation. More recently, in October, the agency announced a related initiative, “Driving Biomedical Innovation: Initiatives for Improving Products for Patients”. This plan focuses on “continuing dialogue with companies, innovators, patients and other stakeholders to identify barriers to progress and better define what steps need to be taken to overcome any obstacles to innovation”.

Working with FDA scientists, CERSI researchers will assist the FDA in driving innovation in medical product development as well as in advancing laboratory, population, behavioural and manufacturing sciences. The agency chose to pilot the CERSIs in Washington, DC, to allow for the greatest possible face-to-face collaboration and training with FDA staff.

Thanks to Sophie Bracken for this article, Sophie is editor of Espicom’s business publication Drug Delivery Insight.

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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.

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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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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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The Medical Technology Blog

Abbott’s plan to break itself up into two businesses – one for medical products and one for research pharmaceuticals – has suddenly got the analysts’ thinking caps on.

Barely a moment after the surprise news went public, the talk was on the future of both businesses and their chances of survival. Overall, the changes have been welcomed and represent a key moment in the 123 year old company’s history. It’s been there before, on a smaller scale of course, with the formation and successful spin-off of its hospital products business into Hospira in 2007, which has since enjoyed strong growth.

Both of Abbott’s divisions have grown in stature and offer contrasting demands in terms of resources so the split into two businesses is bound to improve clarity amongst the investment community. The medical products business will have 2011 revenues of approximately US$22 billion and the research-based pharma unit will have an estimated US$18 billion sales turnover. However, without the protection of the other, both companies could swiftly find themselves the target of deal makers.

With clarity comes opportunity. Abbott’s upstart research business finds itself just outside of the biggest players of the pharmaceutical market, but with a hot drug on its hands in the form of Humira – an anti-inflammatory drug that posted sales of US$6.5 million in 2010. In a market where the focus is on product pipelines, particularly blockbuster ones, the unnamed Abbott business has a relatively strong pipeline.

Whilst the spin-off is impressively detailed, there’s the nagging doubt that the company, like Johnson & Johnson, continues to find it hard to break up the relationship of medical devices and pharmaceuticals, a model long since ditched by the likes of Bristol-Myers Squibb, Allergan and Pfizer. The medical device business, which is particularly strong in cardiovascular devices and ophthalmic products, sits uneasily amongst the slightly larger divisions of generics, and nutritional products. Whilst Generics enjoys double-digit sales growth, such targets remain elusive in the medical device field for Abbott.

Still, Rome wasn’t built in a day and the spin-off plan is likely to keep investors happy for the moment at least. The company has shown in recent times that it isn’t afraid of ditching certain markets if it feels warranted. The company’s ruthless and swift exit from the spine market when the going got too tough being a classic case in mind.

Whilst this blog is not saying that Abbott’s commitment to medical devices is likely to wane in the short-term – the current spin-off alone will take at least a year to complete at least, but one wonders how long it will take before investors start questioning to rationale of keeping a medical device/pharma mix over the long term. Would an opportunistic offer from Medtronic or an attractive offer from a private equity group change things? One suspects that all the time the company keeps posting sales growth and delivers the financial numbers, Abbott’s investors won’t mind a bit either way.

Thanks to Lawrence Miller for providing this article, Lawrence is Espicom’s medical newsletter team leader and editor of Medical Industry Week

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Medical Futures & Cipher Pharmaceuticals in Tramadol Deal

The Medical Technology Blog

Medical Futures to gain a slice of Canadian tramadol market through deal with Cipher

Medical Futures, a Canada-based pharma company, has signed a pact for Cipher Pharmaceuticals to distribute Durela in Canada. Patent-protected Durela is a once-a-day formulation of tramadol for the treatment of moderate- to moderately-severe chronic pain in adults. It was approved by Health Canada in August and has immediate- and extended-release properties.

As for the particulars of the distribution deal, Cipher will receive an upfront payment from Medical Futures of C$300,000, and could also be eligible for future payments, dependant on net sales milestones. Also, Cipher will get its hands on a double-digit royalty on new sales. Cipher has further responsibily for product supply and manufacturing, which will be taken care of by its supplier, Galephar Pharmaceutical Research.

Medical Futures’ CEO, Colin Campbell, says he is excited to offer Durela in Canada, believing that the product “strengthens and demonstrates [Cipher’s] commitment to providing top tier solutions to the Canadian market”. It appears Cipher is equally delighted with the deal, as it provides valuable royalty revenue to the company. Cipher also recently shook hands on a US$5.5 million US distribution deal for Durela with Vertical Pharmaceuticals, with the former set to receive a payment of US$1 million on the first commercial sale of the product.

With sales of over US$60 million in 2010, the seemingly robust Canadian tramadol market looks like a sure thing for both parties. Medical Futures plans to launch Durela in the first quarter of 2012.

Thanks to Sophie Bracken for this article, Sophie edits Espicom’s business publication Drug Delivery Insight.

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Flutiform Presents Good Safety Profile in Asthma Patients

The Medical Technology Blog

Drug Delivery Insight

Good efficacy and safety profile of flutiform in asthma patients seen in ERS-presented studies

Data presented at the European Respiratory Society (ERS) congress shows that a combination of fluticasone propionate (fluticasone), an inhaled corticosteroid (ICS) and formoterol fumarate (formoterol), a long-acting beta2-agonist (LABA) within a single aerosol inhaler (flutiform, manufactured by Napp Pharmaceuticals) was more effective than each of the compounds administered alone on measures of lung function. It was also found to be effective in treating asthma as fluticasone and formoterol administered concurrently via separate inhalers, and had comparable efficacy in improving the lung function and a similar safety profile with budesonide/formoterol, a licensed combination asthma therapy.

Three Phase III studies for the fluticasone/formoterol combination were presented at ERS…

…the first of which measured the change in FEV1, a common measurement of the lung function, from morning pre-dose at baseline to pre-dose at week 12 seen with low-dose of the fluticasone/formoterol combination compared with formoterol. The change in FEV1 from morning pre-dose at baseline to two hours post-dose at week 12 was also compared with fluticasone in 357 adult and adolescent patients with mild to moderate asthma. This double-blind, parallel group, multicentre study, conducted in patients aged 12 and above, showed superior efficacy of the fluticasone/formoterol combination when analysed against each individual component separately on these endpoints.

The second study was an open-label, parallel group…

…European multicentre study of 210 adolescent and adult patients with mild-to-moderate-severe persistent, reversible asthma. The study demonstrated non-inferiority of the fluticasone/formoterol combination compared with the individual compounds administered concurrently based on post-dose FEV1 at week 12.

A final, double-blind, parallel group trial…

…compared the efficacy and safety of the fluticasone/formoterol combination with the budesonide/formoterol combination in 279 adolescents and adults with moderate-to-severe, persistent reversible asthma. This trial showed that the fluticasone/formoterol combination resulted in comparable improvements with the budesonide/formoterol combination in change in morning pre-dose FEV1 from baseline to week 12. The fluticasone/formoterol combination and the budesonide/formoterol combination were also shown to have similar safety profiles.

The data support previous studies, which have shown the efficacy and safety of the fluticasone/formoterol combination in adults and adolescents (aged 12 years and above). An MAA for the fluticasone/formoterol combination has been submitted to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for approval and a decision is expected later this year.

To purchase the latest report on new drug delivery technologies please click on the link below

Emerging Drug Delivery Technologies & Strategies

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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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