29 March 2010
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TFT announces today that it has been awarded FDA approval to market its Spiral Laminar Flow TM AV Access Graft.
AV Access Grafts are used for end stage renal dialysis (ESRD) patients as part of their lifeline to haemodialysis treatment. The two most common causes of ESRD are diabetes and hypertension, the rates of which are rapidly increasing due to growing obesity rates in the United States. Diabetes is also a growing feature in many countries outside the US.
AV Access Grafts are commonly used because the natural vein cannot withstand repeated cannulation (puncturing) and because they become usable relatively quickly. The main alternative to an AV Access Graft is to create an AV Fistula using native vessels; these take longer to mature than AV Access Grafts, however. Both AV Access Grafts and AV Fistulas have to be cleaned and replaced due to clotting, non-maturation and graft failure.
TFT's Spiral Laminar Flow TM Graft includes its proprietary Spiral Laminar FlowTM (SLF™) technology. SLF™ restores the natural blood flow pattern where other grafts create turbulence and disturbance at the point where the implant rejoins the natural blood vessel. Clinical data for the SLF™Bypass Graft shows that by restoring natural blood flow the performance of implants can be enhanced and that there are likely downstream benefits of improved blood flow.
The global market for AV Access Grafts is currently estimated to be between $75m and $100m with the US market estimated to be growing by at least 5.5% per annum.
TFT will present papers at two conferences in the next few months at The 32nd Charing Cross Vascular Congress in London in April and at the Vascular Access Society of the Americas (VASA) meeting in May. TFT will also publish its two-year clinical data for its already commercially available SLF™ bypass graft during 2010.
Commenting, David Lawrence, CEO, said "This is another step forward for the business. We also await the outcome of our CE Mark application. We have been making progress with our SLF™Bypass Graft over the past year and this provides us with the range of products that we need to fully penetrate the worldwide Vascular Graft market. Feedback from customers indicates that this may well be a bigger product than the Bypass Graft and that there is a clear clinical need. We are also continuing to develop our business in new markets and hope to launch in Russia, Argentina and Brazil during 2010. We're looking forward to getting more support from Scottish Enterprise and Scottish Development International to support the ongoing business development. I am extremely proud of what we have been able to achieve in the past two years with a team of less than 10 people."
Peter W. J. Hinchliffe, Chairman, comments, "Another significant step forward for the SLF™ platform technology and the Next Generation of physiologically correct vascular implants, well done team."
For further information please contact David Lawrence 01382 598532 or 07836374740, david.Lawrence@tayflow.com
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