January, 2010
TissuePatch Instructions for Use “clarified”:After a period of consultation with its notified body Tissuemed has confirmed several changes to the wording used to describe the indications for use of its TissuePatch products. David Mandley, Tissuemed’s director responsible for Regulatory Affairs, who has driven the changes stated that; “These changes are subtle but meaningful and while they do not extend the number of procedures for which the product can be used, they do make it clear that the products can be used on most soft tissues and in the case of TissuePatchDural that the product functions to reinforce Dura and in so doing prevent CSF and/or blood leakage”
The indications statements for the two products now read as follows:
TissuePatch3 is indicated for use to seal and reinforce against air leakage in thoracic surgery and against leakage of low pressure or oozing bleeding or fluid leakage following surgical procedures on soft tissue. TissuePatch3 is intended for use as an adjunct and is not intended to replace sutures or staples, as appropriate, in tissue approximation.
TissuePatchDural is indicated for use to seal and reinforce against fluid (including cerebrospinal fluid (CSF)) and/or blood leakage where repair of the dura mater is required. TissuePatchDural is intended for use as an adjunct. It is not intended to replace sutures, staples or clips, as appropriate, in tissue approximation. Furthermore it is not intended to be used as a dura mater substitute.
Tissuemed announces record sales month in December ‘09To cap off a seventh consecutive quarter of sustained growth Tissuemed recorded its highest ever sales month in December. This included a steadily increasing number of customers in the UK, Tissuemed’s home territory in which the company operates a direct sales team. What is most encouraging for the technology is that the orders are coming from both specialist product areas of Thoracic Surgery and Neuro/Spinal surgery and are a blend of new customer orders and repeat orders from satisfied customers. Tissuemed’s strategy remains to optimise penetration into its existing markets while exploring the potential application for these surgical films in other surgical specialities.
The case for TissuePatch: New Clinical Reports onlineAs TissuePatch finds its way into daily use, so the clinical world reports on its performance. Tissuemed has added two new case studies to its website. Click here to find all 9 clinical case reports including a Craniectomy case from London’s Charing Cross Hospital and a follow up study including radiology from University Hospital, Bonn.
Tissuemed’s clinical programme extends through three formal clinical sites in Europe and will see peer reviewed papers published in early 2010.
Patents granted
Tissuemed has announced that two patents for a key component of its underlying technology have been accepted for grant in Eu and USA. The patents, relating to TissuePatch2 cover fundamental elements of the company’s adhesive Terpolymer technology. A more recent filing relating to TissuePatch3 has now been granted in South Africa. For the company Nick Woods, CEO states; “Tissuemed has always had a policy of robustly protecting its technology and it is always gratifying to receive these notifications as they confirm the claim that what we have is a novel and unique proposition.”
Experience summaries
Tissuemed performs routine diligence work to survey surgical experience relating to use of its products. The company has supplemented this by conducting a review of numerous cases from existing customers. The results provide validation for the company’s claims that use of TissuePatch in its various forms is helping surgeons to do their job, while at the same time offering the potential to provide healthcare economic benefits, in some cases demonstrably reducing patient stay. For the company David Mandley comments; “It has to be a desirable outcome that our product can actually improve the patient experience to the point where their stay in hospital is minimised. The patient benefit is obvious and the cost saving most welcome. Consequently our clinical work is orientated towards demonstrating not just clinical but associated economic benefit too. These reports are based on short term experience, but the suggestion is there that we can favourably influence many surgical procedures”
Revolutionising surgery worldwide: Surgical adhesive polymer company partners with world leading research centre
Surgical sealant film manufacturer Tissuemed Ltd (Leeds, UK) is investing in ‘research expertise’ by sponsoring a PhD student from the University of Sheffield’s world leading Polymer Centre.
Over the next three years Annika Clifton will carry out a research project – sponsored by Tissuemed – to investigate optimising their proprietary adhesive polymer technology for different tissue applications.
Annika will have the goal of adapting Tissuemed’s technology to develop a biodegradable membrane, which is modified to promote skin cell adhesion to wound beds and promote angiogenesis, the growth of new blood vessels.
Tissuemed has already brought to market a range of very fine absorbable films branded TissuePatch, which adhere to the body’s internal tissues, preventing the leakage of air, blood or other fluids encountered in surgery.
Currently the technology used in TissuePatch is more adhesive than competitor surgical glues, is easy to apply, requires no preparation and is effective within 30 seconds of contact. It works like a surgical ‘cling-film’ and has been optimised to address the very specific demands of different surgical environments and tissue types.
This project has been designed to combine the expertise and experience of the University of Sheffield’s Polymer Centre with Tissuemed’s team of polymer scientists, the combination representing years of experience in developing polymer technologies for different medical applications. Although in its current guise the product works well as an adjunct to wound closure, it does not actively stimulate new tissue growth within the body and this is what the research project will focus on.
Tissuemed’s R&D Manager Dr Ian Thompson states: “We are delighted to be working with this prestigious unit and highly expectant that the output will contribute significantly to our understanding of the applications for our technology beyond its current scope. We have a history of developing new products and technologies and this programme will help take us to the next level and potentially revolutionise key aspects of surgery across the world.”
For Sheffield’s polymer centre Dr Steve Rimmer comments: “We are all very excited about this new partnership, which combines around ten years of our own academic work with Tissuemed’s reputation and experience in getting products to market. I am sure we can make a real difference in clinical practice in a relatively short timeframe.”
Since the launch of TissuePatch3 surgeons have started to recognise its merits and specific applications. Lung Volume Reduction surgery is one specialised procedure in which air leaks are more than an occupational hazard and can cause post surgical problems in addition to delaying patient discharge from hospital. Read here how a prestigious centre in UK is using the product with promising results.
Use of TissuePatch3 to enhance Aerostasis in Lung Volume Reduction Surgery
Tissuemed introduces neurosurgical sales team in UK; Sian Storey and Anne Kavanagh have joined Tissuemed in the UK and are already having great success introducing surgeons and nurses to the benefits TissuePatch3 can bring them.
See TissuePatch at Medica, Dusseldorf, 19-22nd November on stand number 16F10-8 in Hall 16
TissuePatch Dural receives CE mark
Tissuemed has been granted the CE mark for its proprietary dural sealant film. Like other members of the TissuePatch family TissuePatch Dural takes the form of a thin, synthetic , self-adhesive film which is easy to apply, requires no preparation and is effective within 30 seconds of tissue contact. The product comes with 3 year shelf life and is available with immediate effect.
New CEO for Tissuemed
Nick Woods has been appointed CEO of Tissuemed following David Fortune’s stepping down from the post after ten years. Additionally David Mandley has been appointed to the board of directors. For more information see Investor relations.
Single Packing
All Tissuemed products are now packaged as single items. The new box design includes foil-packed product as well as multi language instructions for use and for convenience carries triplicate patient notes stickers on the outside.
New company logo
Tissuemed’s company logo has been in use for well over a decade and no longer described the company’s core activity as well as feeling a little “long in the tooth”.
Tissuemed is pleased to publish the findings of a recent study into the Performance of TissuePatch™3 compared with other commercially available Products in the resolution of Air Leaks during Lung Surgery.
click here to read the paper in PDF format...
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