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Commercialisation of Advanced Extrusion Technologies Delivering Disruptive Innovation for the Next Generation of Catheter Based Medical Devices.

Periodic Reporting for period 1 - ExtruLub (Commercialisation of Advanced Extrusion Technologies Delivering Disruptive Innovation for the Next Generation of Catheter Based Medical Devices.)

Reporting period: 2015-07-01 to 2015-11-30

DiaNia Technologies vision is to harness our core technology as a key enabler in providing better medicine for patients undergoing non-invasive, catheter based surgeries. ExtruLub Technology has the potential to transform the outcome for patients by facilitating greater device performance through lower profiles whilst increasing the safety of the final catheter. In parallel, engineering improvements enable lean manufacturing processes leading to cost containment.
The main objectives of phase 1 involved testing the feasibility of a number of technical and business topics in order to develop a convincing commercial proposition. From a technical perspective, an implementable strategy to upscale the technology to a full production setting, whilst maintaining control of our know-how and the end quality of our product, has been developed. In parallel, a goal based commercial plan detailing client numbers and deal structure to enable the company to grow has been generated.
The results of the work performed indicate that this innovation is in high demand and has a high probability of commercial success executed appropriated. Such success is highly dependent on a suitable market entry strategy, in a global catheter market expected to be worth $43 bn in 2019[1]. Therefore, our identification of market sectors with a compelling need for lower device profile and safer products during the course of this Phase 1, was reinforced by a safety communication posted by the US Food & Drug Administration (FDA) on November 23rd 2015[2], as shown in Figure 1. A number of work packages detailing the various resources required to achieve this success, including human, material, services and financial have been developed. The process to identify potential partners for Phase 2 of the H2020 SME Instrument is 50 % completed with discussions commenced with a second partner.

1. BCC Research (2014) “Global Markets for Catheters” March Code: HLCO19F.
On commercialisation of this technology, its application in devices by market leaders in certain sectors of the global catheter market, our target clients, will improve the outcome and increase the safety of patients undergoing non-invasive surgeries. Additionally, reduction in device profile has the potential to reduce hospital stay times, which coupled with transformation of the manufacturing process, could led to societal benefits including the potential to lower overall health care costs in general.
Fig 1 FDA safety communication of 23rd Nov 2015 highlighting the issues with lubricious coatings.