19 Jun 2018 09:30
19 June 2018
AorTech International plc
("AorTech" or the "Company")
Development Agreement signed with Vascular Flow Technologies Limited ("VFT")
AorTech (AIM: AOR), the biomaterials and medical device IP company, is pleased to announce that it has signed a Development Agreement with VFT (the "Agreement") for the development of its synthetic heart valve project. The execution of the Agreement, details of which were contained in the Company's announcement of 21 May 2018, follows a period of Technology Transfer where a detailed review of AorTech's historic data, testing and designs was undertaken by the team at VFT.
The project to be undertaken involves detailed computational modelling and analysis of AorTech's heart valve leading to further design optimisation, manufacturing and testing with the objective of preparing a detailed data pack to justify first "in man" testing of this highly disruptive technology.
Bill Brown, Chairman of AorTech, said: "In partnering with the team at VFT, AorTech now has access to Europe's leading experts in the combined field of medical imaging, guided Finite Element Analysis and Computational Fluid Dynamics. Combining the design history with this ground breaking imaging analysis should much improve the quality of the product design, reliability and performance."
Craig Dunlop, General Manager and Director of VFT, said: "The team at VFT has been very impressed with the quantity and quality of data that AorTech has been able to demonstrate to us. We are very excited to be a key partner in the development of the next generation of prosthetic heart valves which should represent not only a step change in performance, but dramatically reduce the cost to manufacture these life enhancing devices."
For further information contact:
AorTech International plc Tel: +44 (0)7730 718296
Bill Brown, Chairman
Stockdale Securities Limited Tel: +44 20 7601 6100
Tom Griffiths/David Coaten
About AorTech:
AorTech has developed biostable, implantable polymers, including Elast-Eon™ and ECSil™ the world's leading long-term implantable co-polymers, now manufactured on their behalf by Biomerics LLC in Utah, USA. With several million implants and seven years of successful clinical use, AorTech polymers are being developed and used in cardiology and urological applications, including pacing leads, cardiac cannulae, stents and neuro stimulation devices. Devices manufactured from AorTech polymers have numerous US FDA PMA approvals, 510ks, CE Marks, Australian TGA and Japanese Ministry of Health approvals.
Elast-Eon™ and ECSil™'s biostability is comparable to silicone while exhibiting excellent mechanical, blood contacting and flex-fatigue properties. These polymers can be processed using conventional thermoplastic extrusion and moulding techniques. A range of materials in a variety of application-specific formulations for use in medical devices and components are available.
In addition to the licensing of biostable polymers, AorTech is now developing medical devices utilizing the key properties of its world class polymers.
About VFT
Vascular Flow Technologies (VFT) has been established since 1998 as an ISO 13485 Medical Device Development & Testing company with unique insight and capabilities in pre-clinical development and testing.
VFT, in conjunction with the Institute of Medical Science and Technology, has developed specific capabilities to investigate the outcomes of surgical procedures and device performance in the pre-clinical stage.
VFT has the means to analyse the morphology and physiology of the cardio vascular system from medical images in a quantitative way. Accurate anatomical segmentations and flow measurements are used to produce realistic computer simulations.
Anatomical geometries and flow conditions can be modified to produce design variations, whose performance can be analysed and compared prior to any animal or clinical trial. These findings can be physically validated using the Thiel-embalmed cadaveric models developed at IMSAT. This embalming technique preserves a pliable vascular tree, which can be perfused with blood-mimic fluid at body temperature, while it is scanned by either CT, MRI or US. Therefore, anatomically realistic experiments are teamed up with anatomically realistic simulations by means of quantitative analysis of medical scans to produce the state of the art method for pre-clinical development of cardiovascular devices.
Medical Imaging Capabilities:
· Cardiovascular segmentation method that presents higher accuracy than the most-commonly used segmentation methods.
· Quantification of geometrical features throughout the cardiovascular system.
· Implant deformation can be assessed by comparing the scans of either a patient or a cadaveric model at different positions. This can be used to enhance analysis of valve performance.
· Segmentations can be used to generate the geometry for a CFD study. The flow features can be correlated with the geometrical features to compare the haemodynamic outcomes of surgeries and medical devices.
CFD Capabilities:
· Cardiovascular flow parameters obtained from medical scans.
· Modification of patient-specific geometries to simulate the outcomes of surgical procedures or device implantation.
· Dynamic boundary conditions for pulsatile pressure and flow coupling: resistive, Windkessel, or inductive.
· Haemorheological models to simulate blood damage, thrombus growth, non-linear viscosity or flow enhanced diffusivity.
· Parametric studies, which consists of comparing the physical outcomes of many variations of both geometry and boundary condition.