Sunshine Heart: Elaine Stead. 'Offering a brighter future for heart failure patients'




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Video title: Sunshine Heart: Elaine Stead. 'Offering a brighter future for heart failure patients'
Released on: January 25, 2012. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, Fintan Walton talks to Elaine Stead, Vice President Corporate Development of Sunshine Heart.
Sunshine Heart's technology and specialisation
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at AusBiotech's convention in Adelaide. On this show I have Elaine Stead, who is Vice President of Corporate Development at a company called Sunshine Heart , welcome.
Elaine Stead:
Thank you. Thanks for having me.
Fintan Walton:
Pleasure and Elaine, first of all could you just tell us a little bit about the history of Sunshine Heart ? Where the technology comes from and where you are specialized?
Elaine Stead:
Sure, so Sunshine Heart was originally incorporated in Australia, but it was based around a technology originally devised by William Peters, who is a cardiac surgeon who is based in New Zealand, and in 2004 the company was listed on the ASX and we did some initial clinical trials in Australia with some Australian patients which were quite promising and as the technology developed the company has slowly transitioned to Minneapolis where it's now based, because that is the centre of the cardiovascular medical device universe.
C-Pulse heart assist system: Advantages and applications
Fintan Walton:
Okay, so what is the technology and what differentiates it against other approaches to that particular disease?
Elaine Stead:
So Sunshine Heart 's technology is called the C-Pulse Heart Assist System and it's actually a cuff that wraps around the ascending aorta of the heart and it has a balloon an inflatable balloon attached to that cuff that inflates and deflates in synchrony with the heart, so as the heart fills up with blood the cuff inflates and that causes a bit of down pressure on the heart the heart gets more coronary perfusion or more blood flow to the heart which is what it needs to function properly and then when the heart contracts the balloon deflates and that causes a vacuum which allows blood to be essentially sucked out of the heart and then pumped around the body and those two things mean that it actually unloads the heart or reduces the workload of the heart so that the heart has time to recover.
Fintan Walton:
So in what condition will that be normally applied in?
Elaine Stead:
So it's applied to patients who have heart failure , and heart failure is a huge issue six million patients in the US have heart failure, 10% of patients 10% people over 65 have heart failure and it's the leading course of hospitalization in developed markets like the US and Australia. So it's a huge issue the economic burden is about $56 billion per year in the US alone so it's huge and heart failure can range from quite mild heart failure where patients have no symptoms to quite severe where there symptomatic they are very, very ill they need heroic measures to be relieved of their symptoms and when I say heroic measures I mean heart transplantation or implantation with artificial hearts such as LVADs which are called left ventricular assist devices. So there is quite a range and the range of heart failure that we believe the C-Pulse system addresses is class III heart failure which is moderate to severe heart failure these patients have symptoms with minimal exertion they can't walk to their letter box without being shorter breadth and having difficulty breathing and they are also the largest proportion of heart failure patients about 30% of heart failure patients are in class III.
Fintan Walton:
Right, so obviously it requires surgical intervention to put it in and then presumably it's in there forever or is it in just for a short period of time?
Elaine Stead:
Well we don't know how that will work just yet, so it's important to note that yes it is implanted wireless surgical procedure but it's done minimally invasively so it's a small incision about the size of the pacemaker incision that's just done between two ribs and so what that means is that it's less recovery time for the patients in hospital, you don't have to crack the chest open to put the device in and it has a drive line that runs through the chest and into the abdomen and comes out and attaches to a driver which is what pumps the air into inflate the balloon and a battery pack and what we've seen with the patients that we have implanted we have implanted 20 patients in the recent pilot study that we've just announced early results for.
Fintan Walton:
And that's in the US?
Elaine Stead:
That is in the US yes and what we've seen with those patients I think the longest patient has had the device implanted for two-years and what we've seen with those patients is 19 out of 20 patients either halted or improved their heart failure classification which is just amazing. If you do nothing with the heart failure patient their heart failure would get worst they will go from class I to eventually class IV and be very, very ill, so the fact that we've been able to halt that heart failure progression or actually improve their heart failure is really promising and what we've actually seen in the two patients is they've gone from class IV and class III, so these are the very sickest patients in heart failure to completely a symptomatic and what we've been able to do with those patients is turn the device off.
Clinical trials and development programs
Fintan Walton:
Right, so as you said it's still in clinical trials, so what is the next series of stages that are required to make sure that this is actually enriched as a product?
Elaine Stead:
Absolutely good question, so the goal of the pilot study is really just to show that the device is safe, we also would like to say that it actually gives some patients benefit but the key thing is to make sure that the device is safe and we think that we now have enough support to move to a pivotal trial and that is a trial that we want to take in the US for FDA approval so that we can eventually market the device have the results, the safety results and the efficacy results confirmed and then seek FDA approval.
Partnership and commercialisation strategy
Fintan Walton:
Right, and the business model for Sunshine Heart going forward is to be its own company, are you looking for partners for this or how you going to commercialize this going into the future?
Elaine Stead:
So right now it is Sunshine Heart 's intention to take the device to market itself, and so we have we've we are all geared up to start the trial next year, there will be a capital raising that we have to undertake in order to fund that, but that's all in train we are in the process of seeking CE mark for the device in Europe so that we can actually implant it in patients in Europe and also generate some revenue. So we do have a strategy to take this to market ourselves, but having said that there is certainly is interest from corporate partners and we've been talking with the number of them for the last year and now that we've released the pilot study results there is absolutely more interest and so we are in decisions with them. So I think it is quite possible to bring on strategic partner at some point, but right now the goal is to take it to market ourselves.
Fintan Walton:
Right, and what length of time do you think it will require to get to market?
Elaine Stead:
So at the moment we have planned that the pivotal study will take about 2-years to complete and we are due to start that in Q2, 2012 and then we would allow six months thereafter a follow-up may be 12 months of follow-up and then we would hope to seek FDA approval.
Future activities
Fintan Walton:
Okay, and the purpose of Sunshine Heart is to just have this one device, it's gonna be one product?
Elaine Stead:
At the moment yes it is, but we are also innovating on that technology and that product, so right now we've developed a number and this was one of the benefits of the pilot studies that we are able to make some key improvements to the technology including tools for example to enable the minimally invasive surgical procedure, we've developed some consumables we've improved the product a little bit we now have the single driver for that for the device, but the next goal is to try and make that device fully implantable, so not to have a transcutaneous drive line because obviously that has potentially incidence of infection at the site, so if we can make it fully implantable then that would be the holy grail and so we've completed some animal studies this year to safe that is indeed possible and it is, so the next 18 months while we are undertaking the pivotal trial we'll also be developing the fully implantable system proof of concept for our first human study.
Fintan Walton:
And you can, obviously getting the power to the pack inside can be done without the wires going through the body?
Elaine Stead:
Yes it can, yes so they got technology now to transmit the power transcutaneously and so the goal would be to have a device that looks no bigger than a phone that you just keep near the driver and allows the device to be fully implantable.
Fintan Walton:
Amazing. Elaine Stead, thank you very much indeed for coming on the show.
Elaine Stead:
Thank you very much for having me.
Fintan Walton
Dr Fintan Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).
Elaine Stead
Vice President
At the time of recording this PTV interview Elaine Stead serves as Vice President Corporate Development of Sunshine Heart Inc. Her previous positions include Investment Manager at CM Capital Investments, Deputy Director at ARI Pty Ltd, Commercial Development Manager at ARI Pty Ltd and CEO at Reproductive Health Science Pty Ltd. Elaine has worked closely with several early stage companies and technologies predominantly in technology identification & packaging, intellectual property protection, and transaction negotiation. Elaine has also played key roles in the formation, fund raising, and management of several start-up companies and has led the negotiations on numerous licensing and research collaboration deals. Elaine has a first class honours degree in biochemistry and a PhD in stem cell biology from the University of Adelaide. She is also a member of AusBiotech.
PharmaVentures
PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialisation.
Sunshine Heart Inc
Sunshine Heart Inc an early stage medical device company, focuses on developing, manufacturing, and commercializing C-Pulse Heart Assist System, for treatment of Class III and ambulatory Class IV heart failure . Product The C-Pulse Heart Assist System utilizes the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. The company has developed tools to allow the C-Pulse to be implanted via a small pacemaker-like incision between the patient's ribs and sternum rather than a full sternotomy, and completed its first implant using this less invasive procedure in 2010. Once implanted, the C-Pulse cuff is positioned on the outside of the patient's ascending aorta above the aortic valve. This device does not directly contact the patient's blood and it may be turned on or off at any time allowing the patient intervals of freedom to perform certain activities. The company seeks CE Mark for the C-Pulse. Competition The company's medical device competitors are Thoratec Corporation, HeartWare International Inc, CircuLite, Inc, AbioMed, Inc, Jarvik Heart, Inc, MicroMed Technology, Inc, SynCardia Systems, Inc, Terumo Heart, Inc and World Heart Corporation in the U.S. and Europe; and Berlin Heart GmbH in Europe. History Sunshine Heart Inc was founded in 1999.