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…

NTUH joins selective club that have achieved successful robotic-assisted kidney transplant.

An organ transplant team at National Taiwan University Hospital (NTUH) has become the first to carry out a robotic-assisted kidney transplant procedure in Asia.

The procedure involved the use of Intuitive Surgical’s da Vinci robotic surgery system, an FDA cleared system that is approved in the US for use in urological, general laparoscopic, gynaecologic laparoscopic, selected transoral otolaryngology, general thoracoscopic and thoracoscopically-assisted cardiotomy surgical procedures. Whilst robotic surgery has been used in all kinds of operations on human, robotic surgery has not gained widespread use in organ transplantation, due to insufficient manoeuvring space caused by the implant organ, as well as the requirement for a precise vascular suture technique and risk of haemorrhage. So far, only a few cases from European and American countries have been reported in literature.

The traditional open transplant requires a 15 to 20 cm incision, but causes more pain and discomfort for patients, and can trigger wound hernia due to high tension. In order to reduce postsurgery discomfort for patients, the NTUH organ transplant team has been working developing a robotic surgery system for organ transplantation.

In late July, NTUH’s organ transplant team successfully completed the milestone procedure. The surgery requires a few small incisions and efficiently decreases the possibility of complications. The team believes that accomplishment of this robotic assisted kidney transplant is an important milestone for organ transplant development.

The da Vinci system is used to used to mirror the movement of the surgeon’s hands using two controller sticks. The system offers high definition 3D vision and magnified views. Additionally, in comparison to traditional surgical techniques it is regarded as minimally invasive, offering the patients the benefits of rapid recovery and a small incision, whilst lowering the potential for complications.

Article Source: Medical Industry Week (MIW)

Sunquest becomes latest company to meet Roper’s key acquisition criteria

Welcome back to the Medical Technology Blog, we have a great post today provided by Sophie Sanderson. Sophie is the editor for Diagnostics Focus , please read on…

Adding to its vastly expanding medical platform and honing in on its focus on diagnostics, Roper Industries has set its sights on the acquisition of Sunquest Information Systems, a provider of diagnostic and laboratory information systems to healthcare providers worldwide, in an all cash transaction valued at nearly US$1.5 billion.

Roper expects the acquisition of Tucson, AZ-based Sunquest to be immediately cash enhancing and to generate around US$140 million or more of EBITDA in 2013. Sunquest, which has offices in the UK and India, is owned by a group of investors resulting from a 2010 recapitalisation led by Huntsman Gay Global Capital, in partnership with Vista Equity Partners, which has owned the company since 2007. Sunquest is expected to be an ideal fit with Roper’s Medical and Software platforms – which represents just one of the latters four business segments.

Roper is perhaps more commonly known as a designer, manufacturer and distributor of radiofrequency products and services, industrial technology products, energy systems and controls, as well as medical and scientific imaging products and software. Roper’s Medical and Scientific Imaging segment primarily offers products and software in medical applications, high performance digital imaging products and software, and hand-held and vehicle mount computers.

Focusing on the company’s Medical and Scientific Imaging segment, net sales in this area for 2011 were US$611 million, representing 22 per cent of Roper’s total net sales, which reached an impressive US$2.8 billion. Acquisitions alone added US$26 million in sales for the year ended 2011.

With claims that its balance sheet is stronger than ever before, and enjoying the more recurring revenue from its disciplined acquisitions of the last several years, it is unlikely that Sunquest will be the last in a string of revenue-generating acquisitions for the company.

Source material: Diagnostics Focus

MiCardia gets busy with its mitral valve technology

Welcome back to the Medical Technology Blog. In the first instalment of her guest blog, Coral Campbell highlights interesting developments from Irvine, CA-based MiCardia. Please read on…

MiCardia has had its hands full this week with a successful fundraising venture that received the thumbs up from its investors and culminated with the spin-off of its transcatheter technology.

The spin-off company, called ValCare, has backing from an Israeli investor, will be hoping for big things from its transcatheter technology. The venture has US$8.0 million to further advance the technology and holds the intellectual property for the company’s transcatheter mitral valve repair system.

ValCare’s transcatheter mitral valve repair system uses interventional cardiology methods to implant a mitral annuloplasty device – a target market potential that has been touted to be worth upwards of US$3.5 billion. The next job for the company is to complete the development and test the device in pre-clinical studies in the near term.

Back at MiCardia, investors have given the company a vote of confidence by backing a near US$4.5 million funding programme. The cash will help support the business during the rest of 2012 and 2013. MiCardia plans to use the proceeds of this funding to expand the commercialisation of its enCorSQ mitral valve repair system in Europe and selected countries worldwide.

Article Source: Cardiovascular Device Business

FDA unveils plans for device ID system for medical devices

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…

FDA proposal

In response to requirements in legislation that passed US Congress, the FDA has proposed that most medical devices distributed in the US carry a unique device identifier (UDI) in a move aimed at improving the quality of information in medical device adverse events reports.

The plans, which are now the subject of a 120 day comment period, aim to help the FDA identify product problems more quickly, better target recalls and improve patient safety. So far, the agency has conducted four pilot studies in the development of this proposed rule. With certain exceptions, under the proposed rule, a UDI would include a device identifier, which is a unique numeric or alphanumeric code specific to a device model; and a production identifier, which includes the current production information for a device.

Risk-based, phased-in

The FDA is proposing a “risk-based, phased-in” approach to implementation, focusing on the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements. The agency is proposing to exempt OTC devices sold at the retail level as these devices generally have UPC codes in place.

A UDI acts as a key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device, such as its expiration date and batch or lot number. This information will be contained in a publicly available UDI database called Global Unique Device Identification Database (GUDID), which will not contain any identifiable patient information.

The plans target the more accurate reporting, reviewing and analysing of adverse event reports so that problem devices can be identified and corrected more quickly. Other benefits include a reduction in medical errors and better management of medical device recalls.

Article Source: Medical Industry Week (MIW)

German researchers look at materials to keep stents secure

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 Cardiovascular Device Business, please read on…

Researchers from the Fraunhofer Institute in Germany are working on the development of a special surface coating that keeps the stent in place.

When coronary blood vessels are constricted, cardiologists try to prevent a heart attack by widening them with stent implants that stabilise the veins and arteries, improve the flow of blood and prevent vascular obliteration. These stents can be used to treat pathological constriction of the windpipe. This kind of respiratory stenosis, which may be caused by tumours, chronic infections or congenital deformities, can be life-threatening. In such cases, the metal or plastic stents are designed to enlarge the trachea and prevent it from closing up altogether. However, the stent implant can slip out of position, closing off the windpipe altogether. Bacteria can also colonise the stents and trigger pneumonia. The reason for this is that the stents have no barrier-forming cells of the kind usually present in the respiratory system, whose task is to fend off bacteria and inhaled substances such as particulate.

Dr Martina Hampel, a scientist at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB in Stuttgart, working with Professor Thorsten Walles, head of the department of thoracic surgery at the University Hospital of Würzburg and a visiting scientist at the IGB, participated  in the “REGiNA” project, the goal of which was to develop surface coatings that enable the stents to be incorporated in the surrounding tissue, thereby reducing the risk that they will move. REGiNA, a German acronym for Regenerative Medicine in the Neckar-Alb and Stuttgart Region, is funded by the German Federal Ministry of Education and Research (BMBF).

The scientists used stents lined with a polyurethane (PU) film, which were produced by Aachen-based Leufen Medical. In the subsequent tests, a wide variety of different coatings were applied to the PU film. In addition to synthetic polymers composed of organic acids, the researchers also tried out biological proteins such as fibronectin and type-I collagen. The coating was modified again using plasma technology, with vacuum-ionised gas being used to treat the surface. The experts used an untreated PU film for control purposes.

In order to find out which of the surface coatings was the most suitable, the researchers brought both lab-cultivated cell lines and human primary tracheal epithelial cells into contact with the films in cell culture vessels. The primary goal was for the primary respiratory cells from human tissue to attach themselves to the film. The researchers achieved their best results with the protein-coated film, on which the primary tracheal epithelial cells grew particularly well and multiplied. The team found that whilst respiratory cells proved to be more vital on bioactive films rather than on ones treated with plasma, polymer-coated film turned out to be “completely useless.”

The laboratory tests have since been completed, and animal tests are currently being prepared. If the lab results are confirmed in these tests, the next step will be to conduct clinical trials of the modified stents at the Schillerhöhe specialist lung clinic, a part of the Robert Bosch Hospital. The hope is that, within a few years, well-tolerated, cell-compatible surface coatings will be available for use in other biomedical prostheses, such as pacemaker leads, tooth implants and replacement joints.

Article Source: Cardiovascular Device Business

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

DSM agrees to pay US$360 million for Kensey Nash

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

Kensey Nash’s Board of Directors has accepted a US$360 million (EUR 275 million), US$38.50 per share offer, from Royal DSM, a Netherlands-based company active in health, nutrition and materials. The offer is subject to customary conditions, including antitrust clearance, and is expected to be completed by the end of the second quarter of 2012.

Kensey Nash operates across five major segment areas, namely spine (15 per cent of first quarter 2012 revenue), sports medicine (30 per cent), CMF and trauma (16 per cent), cardiovascular (17 per cent) and general surgery (9 per cent). The company produces biomaterials for tissue repair and regeneration, as well as devices and equipment for the delivery of biomaterials and cardiovascular procedures. The strategy involves developing core materials and then working with established medical device companies in selected markets. Key products include the AngioSeal reabsorbable closure device, polylactic acid screws and anchors, bone cement and collagen minerals and collagen patches for general surgery.

Kensey’s collagen/ECM platform is supported by partnerships with St Jude Medical (cardiovascular), Arthrex (orthopaedics/sports medicine), Stryker (spine) and Synthes (CMF and trauma/general surgery). The reabsorbable polymers partnerships include orthopaedic/sports medicine (Arthrex, Orteq and Stryker), spine (Medtronic) and CMF and trauma (Athrex). Kensey’s Bone composites are supported by alliances in spine (Stryker, Synthes, Medtronic and Zimmer) and CMF and trauma (Synthes).

In 2012, Kensey expects to record revenues of US88.5 million, and EBITDA of US$30 million. This is set to rise in 2013 to US$100 million and EBITDA of US$36 million. The growth is expected to come from existing products, entry into new markets and the resulting impact of Kensey’s recent settlement with St Jude Medical over the AngioSeal product line. For DSM, the deal represents an opportunity to expand into two new growth platforms of life sciences and material sciences with a portfolio of products spanning the Bio-Passive (medical coatings and polymers), Bio-Active (reabsorbable polymers and drug- delivery) and Bio-Interactive (therapeutic materials and regenerative medicine).

The much changed DSM has spent the last five years developing a coatings and material drug-delivery business focused on cardiovascular and ophthalmic applications, and has subsequently strengthened these areas and also moved into developing spinal applications. The company, which relocated its HQ to Berkeley, CA, in 2010, is pinning its growth hopes on the cardiovascular, orthopaedic and ophthalmic markets for expansion. The process will involve expanding and developing its range of biomaterials further, whilst at the same time growing an emerging drug-delivery business. DSM will also look at opportunities for regenerative medicine and tissue engineering.

Article Source: Medical Industry Week

Sony eyes growth in medical fields as company swings the axe in its higher profile electronics businesses

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

Sony’s newly-installed management team have unveiled plans to cut a further 10,000 jobs in a bid to revitalise and grow the struggling electronics business to generate new value.
The plans, which will see the Japanese company focus on core areas of digital imaging, games consoles and mobile devices, aim to increase sales to ¥8.5 trillion, and provide a return on equity of 10 per cent, by the year ended 31st March 2015 (FY 2014). Sony’s 2011 sales were ¥7.2 trillion and have already been lowered for 2012 to ¥6.4 trillion.

Sony to grow medical equipment field - ¥50 billion sales by 2014?

Somewhat surprisingly, the turmoil in its high-profile electronics business, particularly with regards to televisions, is set to open doors for the company’s comparatively less profile medical peripherals division. In keeping with many of Japan’s electronic giants, Sony has been taken gradual steps into the medical field, particularly within the areas of medical-use printers, monitors, cameras and recorders. By the end of FY 2014, Sony is targeting sales of ¥50 billion (approximately US$630 million).

In a clear sign of its intention to grow the business, Sony also plans to enter the market for medical equipment components, where it believes its strength in various core digital imaging technologies offer significant competitive advantages in applications such as endoscopes. The latter has inevitably led to talk that the company may ultimately be interested in a tie-up with the scandal-ridden Olympus group, which is struggling to deal with a massive accounting fraud. Olympus’s diagnostic endoscopes dominate the worldwide market in this area. However, with Sony’s eye on other parts of its empire, and Sony’s less than impressive financial performance itself, a tie-up with Olympus seems a bit of a hefty deal to take on.
Such a takeover, however, cannot be entirely ruled out as Sony has also restated its determination to “aggressively pursue” other merger and acquisition deals that can expand its medical business, with the aim of developing the business into a key pillar of Sony’s overall business portfolio. The company recently entered the life science industry, where the company can apply technologies such as semiconductor lasers, image sensors and microfabrication, by purchasing iCyt, a manufacturer of cellular analysis equipment, and Micronics, a company that makes medical and diagnostics equipment.

It remains to be seen if three years from now the name Sony is regarded with more recognition than at the present time. However, given the current commentary coming out of the Japanese company, it seems at least one group of employees in the struggling company will be significantly more relaxed as the cost cutting programme swings into action.

Article Source: Medical Industry Week

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.

To receive regualr articles on drug delivery, please click on the link to Drug Delivery Insight

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;

• Brazil medical device market

• China medical device market

• Egypt medical device marlet

• Greece medical device market

• Italy medical device market

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

Thanks, Paul