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IMPEDIMED LIMITED — AGM Information 2017
Nov 14, 2017
65135_rns_2017-11-14_aca3b02f-fcd6-4008-942b-9be2c2ffd53b.pdf
AGM Information
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ImpediMed Limited – 2017 Annual General Meeting Chairman’s Address
Good Morning – I am Cherrell Hirst, Chairman of ImpediMed Limited. I am very pleased to welcome you to our Annual General Meeting for 2017. Thank you for making the effort to be here. I hope you find the meeting useful and please take the opportunity to speak directly with those directors and executives who are present. Also if you are a shareholder, please feel comfortable in asking questions during the open session following the CEO’s address and also as we discuss each of the items on our formal agenda.
Despite having faced a number of challenges during 2017, IPD has made significant progress towards our long term milestones. We continue to steadily grow our US lymphoedema market in key centres; we have brought SOZO to market and achieved regulatory clearance in Europe and Australia for fluid monitoring for Congestive Heart Failure and other indications and for unilateral lymphoedema in the USA; and we have begun our clinical studies in heart failure.
However there is no escaping the fact that the length of time it is taking for the interim analysis of our post marketing lymphoedema trial (PREVENT) to be released is frustrating. This delay has occurred because as a result of the trial’s design, no Interim analysis can be done until a statistically significant number of women in each arm actually develop lymphoedema (a positive tape measure reading) or a positive L- dex and are followed for 12 months. As we all know all too well, we cannot predict, from the 1070 women enrolled in the trial to date, who will develop lymphoedema or when they will develop it, hence we wait.
And of course, the US private payors are maintaining their position of not providing reimbursement until they believe they have sufficient clinical evidence. This despite the fact that a series of positive data being published from other clinical settings. Those studies are not randomised controlled trials but their results are extremely encouraging not only for us but for women with breast cancer around the world.
It may seem that we have lost a whole year because of the delay in trial results but I can assure you we have not lost that time. Once it became apparent that the trial results would be delayed, and private payors would not cover L-Dex, thus making sales difficult and utilisation low even when sales were made, we determined to progress the crucial early work in Congestive Heart Failure which absolutely required a SOZO type device rather than the U-400 and so we set about to make that happen and this has been accomplished.
Which means that when the trial results are available and, assuming they are positive, we will be well placed to further progress our lymphoedema journey and at
the same time we will be appropriately positioned to more rapidly develop the Congestive Heart Failure opportunity.
On another note, your board is fully aware of the quantum of cash invested in FY 2017 which allowed us to progress the business including the development of SOZO, as referred to above, so as to achieve our regulatory clearances and add key oncology centres to our customer base which are fundamental to advancing the launch and our future revenue streams. And as you would expect as a key board responsibility our cash position is continuously monitored.
Rick will cover the detail of these and our other operational activities undertaken during the year in his presentation and there will be the opportunity for questions.
We have, I know, been talking about building strong foundations to unlock the potential of our technology, now for a number of years. Our journey commenced in lymphoedema with the U-400 but just 18 months ago we revised our company strategy to encompass the cardiac opportunity. Critical to delivering on that strategy was the development of a second generation device with the capability of SOZO. Our management team led by Rick are successfully executing on that plan and we are on track to deliver. Transitioning from our old device, the U-400, to SOZO has long been recognized as a challenging period but real progress is now being made and as Rick will attest, we are almost there. Without any doubt, SOZO enhances the potential of our technology by a factor of many times. Now is the time for us to deliver on the promise using those foundations which have been so carefully and thoroughly constructed over the last few years.
This is my last AGM and the last time I will represent ImpediMed as I retire from the board after 12 years as a Director and six as Chair at the close of this meeting. It has been an honour to serve this company for that period of time. I commend to you the three new directors who have joined the board this year and who are standing for election today, two filling unexpected casual vacancies and one an additional director as we increased the number of non-executive directors from 5 to 6. They each bring significant skills recognised as being of value to the board through our skills matrix and they complement the skills of previously existing non-executive directors Scott Ward and Gary Goetze. Together all five make a very strong capable and relevant board. I have indeed been fortunate to serve alongside these and other very capable directors during my 12 years on the board and I thank each and every one for their support.
As announced on 16[th] October, Dr Robert Graham an eminent Australian cardiologist researcher and clinician will join the board following this AGM. Dr Graham is the Chief Executive of the Victor Chang Institute and he brings not only scientific and
clinical knowledge and expertise but also management and governance experience and his global network in the cardiac field will be of immense value to us as we progress towards our cardiac aspirations.
I want to thank and commend Rick and all our people on their commitment and dedication to IPD. I know they always work incredibly hard to ensure the next milestone is achieved. I know they solve problems by working together and I know they are very capably led by Rick and his Executive team. Thank you to each and every one of our people and thank you Rick, for your leadership, your commitment and your passion for ImpediMed - its technology and its future.
To you our shareholders, thank you for your support, your engagement and particularly your patience this year as we have worked through challenges and transitions and on top of that have been shorted in the market. We look forward to your continuing support as together we continue our journey. Thank you for your attendance here today.
Cherrell Hirst Chairman