Sunshine Heart : John Erb. Introducing C-Pulse® Heart assist system, a new treatment for heart failure

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Video title: Sunshine Heart : John Erb. Introducing C-Pulse® Heart assist system, a new treatment for heart failure
Released on: January 25, 2013. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, filmed at AusBio 2012 in Melbourne, Australia, Fintan Walton talks to John Erb, Chairman at Sunshine Heart
Summary about Sunshine Heart
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at AusBiotech in Melbourne, in 2012. On this show I have John Erb, who is Chairman of company called Sunshine Heart, welcome.
John Erb:
Thank you. Good to be here.
Fintan Walton:
Pleasure to have you. John, Sunshine Heart just give our audience a brief resume of what Sunshine Heart is all about?
John Erb:
An exciting technology to really help a large patient population that doesn't have much hope today. Class III heart failure is a large group of folks that, probably a million and a half in the US and probably another million and a half in Europe, Australia and you can probably go again with Asia, so a large group, and they are primarily today treated with diuretics, diuretics cause a neural hormonal response that basically helps the downward spiral of heart failure escalate, what Sunshine Heart's has is basically the C-pulse, a counter-pulsation device, that is not put in the blood pathway, but it basically around the order and it actually helps the heart pump blood that improves the patient's ability, their ejection fraction or their ability to pump blood throughout the rest of the body.
C-pulse heart assist system and its clinical development
Fintan Walton:
So the key thing here it is obviously a medical device?
John Erb:
Fintan Walton:
Medical device. So now the other thing of course it's been going through clinical trials and could you give us, I mean last year we had an interview with Elaine Stead ( who described the technology, what's happened in the last year?
John Erb:
Well we completed the feasibility trial very positively, 20 patients that actually improved their heart failure class, improved their quality of life and that's a significant outcome from those early feasibility. From that we went to the FDA for IDE and have received IDE approval, Investigational Device Exemption, to be able to identify 40 sites in the US where we actually will be and enroll patients in a much larger trial, randomized against standard medical care and really look forward to a great result in that. We also have CE mark, so we have several sites, primarily focused on Germany initially, where we will start using it on patients in Germany.
Fintan Walton:
Right, now in terms of length of time for these particular clinical trials when do we expect to get some results from the clinical trials you are conducting out there?
John Erb:
The actual trial itself there is a 12 month follow-up so we will follow these patients for a 12 months after the initial implant and that's really the key as how do they progress particularly as we measure against standard medical care.
Recent public offering in Sunshine Heart
Fintan Walton:
Sure, now obviously taking a company like Sunshine Heart forward you need money, you need liquidity for your shareholders, you've had that liquidity here in Australia, but you've also recently done an IPO in the US, do you want to tell us a bit about that?
John Erb:
Yes a very successful IPO for an early, particularly for an early stage company. I think that the investors see the size of the market, the real clinical need and see this as an up and coming opportunity for them to invest in, so I think that's really key there, but we've raised a little over $20 million, which will take us through most of our IDE clinical trial, and you know once you have, it's a building block process, once you demonstrate initial success then add more patients, be able to report on additional patients enrollment under the CE mark in Germany, it all begins to add up. So I think we have a very bright future here as we roll out the milestones that company is going to be working on.
Overall business model and marketing strategy
Fintan Walton:
In terms of the overall business model for Sunshine Heart going forward, obviously you've got this important device, the focus is on that at the moment, do you see Sunshine Heart being the ultimate sales and marketing corporation for this product or do you see this being ultimately sold or licensed to another larger organization?
John Erb:
Well I think the role of management and the board is to build value in the company, and if you build value, hit your milestones the company will grow, value will increase and that may be additional funding to expand the commercialization process in Australia, Europe, the US or it may entice a potential acquirer, because it is a big market and because there are is not a good medical therapy out there for these patients, there is a lot of companies that will be watching very closely what Sunshine Heart does, but again our strategy is not to lets quick get some patients enrolled and try to sell the company, we really want to build value, and you build value good things happen.
Expectations and future business prospects
Fintan Walton:
Sure, and what can we expect then in the next, what's your anticipated results for the next year, twelve months?
John Erb:
Well I think the primary company focus is on enrollment and getting patients enrolled, beginning to follow, beginning to report on that, that's really key right now. From a development standpoint they have made some real strides in the last six to twelve months to improve the device, so we will actually even have a better device than was used in the feasibility study in those first 20 patients, so that's obviously very, very important.
Fintan Walton:
It's making it smaller is that the concept or is it adding more to it, more technology to it?
John Erb:
It's reducing the weight of the driver. So when the patient utilizes this they basically have a strap and they carry it around with them, and you reduce the weight you'll reduce the burden to the patients, you'll improve the compliance, the patients uses it more often. Another very unique and very positive aspect of this device is that the patient doesn't have to be on it 24/7 and they can actually unplug it, set it aside, take a shower for cleanliness, hygiene and what not and that's a real advantage, the other devices they are pretty much tethered into that driver and that they got to keep it with them this gives them a little bit of latitude.
Fintan Walton:
John Erb, thank you very much indeed for coming on the show.
John Erb:
Thank you, I enjoyed it.
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).
John Erb
At the time of this PTV interview John Erb serves as Chairman at Sunshine Heart. John Erb has over 35 years of experience in the medical device industry. Mr. Erb has been Chairman and Chief Executive Officer of Cardia Access, Inc, a medical device company focused on novel technologies for pacing the heart since 2007. From 2001 through 2006, Mr. Erbwas Chief Executive Officer of CHF Solutions, Inc, a medical device company focused on the treatment of congestive heart failure. CHF Solutions, Inc was acquired by Gambro. From 1997 through 2001, Mr. Erb was President and Chief Executive Officer of IntraTherapeutics, Inc, a medical device company involved in the development, manufacturing and distribution of peripheral vascular stents. IntraTherapeutics, Inc was acquired by Sulzer Medica. Previously, Mr. Erb was Vice President of Operations for Schneider Worldwide, a division of Pfizer, Inc. Mr. Erb spent 10 years with Johnson & Johnson's Iolab Division and started his career with American Hospital Supply Corporation. Mr. Erb serves as Chairman of the Board of Directors for Vascular Solution, Inc, a public NASDAQ company and Chairman of the Board of Directors for Osprey Medical, a public ASX company. Mr. Erb previously served on the Board of Directors of CryoCath Technologies, acquired by Medtronic in 2008 and SenoRx, Inc, acquired by C. R. Bard in 2010. Mr. Erbhas a bachelor's degree in business administration from California State University, Fullerton.
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 commercialization.
Sunshine Heart, Inc.
Sunshine Heart, Inc.(NASDAQ: SSH / ASX: SHC) is an early-stage global medical device company committed to the commercialization of the C-Pulse System, an implantable, non-blood contacting, heart assist therapy for the treatment of moderate to severe heart failure. The C-Pulse System can be implanted using a minimally invasive procedure and is designed to relieve the symptoms of heart failure through the use of counter-pulsation technology, which enables an increase in cardiac output, an increase in coronary blood flow and a reduction in the heart's pumping load. Sunshine Heart has completed an approved U.S. Food and Drug Administration (FDA) feasibility clinical trial of the C-Pulse System and presented the results in November 2011. In March, 2012, the FDA notified the Company that it could move forward with an investigational device exemption (IDE) application. Sunshine Heart received conditional approval from the FDA in September 2012 to initiate its pivotal trial. In July 2012 Sunshine Heart received CE Mark approval for its C-Pulse System in Europe. Sunshine Heart is a Delaware corporation headquartered in Minneapolis with a subsidiary presence in Australia. The Company has been listed on the Australian Securities Exchange (ASX) since September 2004 and on the NASDAQ Capital Market since February 2012.