Thank you. Before we get started, I would like to remark briefly about forward-looking statements. Except for historical information mentioned during the conference call, statements made by the management of Sunshine Heart are forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that are based on management’s beliefs, assumptions, expectations and information currently available to management. Those risks include, but are not limited to risks associated with the possibility that the company’s clinical studies do not meet their enrollment goals, meet their endpoints or otherwise fail that regulatory authorities do not accept the company’s application or approve the marketing of the C-Pulse System, the possibility that the company maybe unable to raise the funds necessary for the development and commercialization of its products that the company may not be able to commercialize its products successfully in the EU and the other risk factors described under the caption Risk Factors and elsewhere in the company’s filings with the Securities and Exchange Commission. By providing this information, the company undertakes no obligation to update or revise any projections or forward-looking statements, whether as a result of new information, new developments or otherwise. You should review the cautionary statements and discussion of risk factors included in the company’s press release issued today, the company’s latest 10-K subsequent reports as well as other filings with the Securities and Exchange Commission under the titles Risk Factors or Cautionary Statements related to forward-looking statements. For additional discussion of risk factors that could cause actual results to differ materially from management’s current expectations and those discussions regarding risk factors as well as the discussion of forward-looking statements in such sections are incorporated by reference in this call and are readily available on the company’s website at www.sunshineheart.com. During this call, management will also discuss non-GAAP financial measures as defined by the SEC Regulation G. Reconciliations of these non-GAAP financial measures to the comparable GAAP financial measures, are included in the company’s earnings press release and supplemental information. In addition, a replay of the call is provided through the link on the Investor Relations section of the company’s website. With that said, I would now like to turn the call over to Dave Rosa, Sunshine Heart’s President and Chief Executive Officer. Sir, you may proceed.

Thanks, operator. Good morning, everyone and thank you for attending Sunshine Heart’s third quarter 2015 results teleconference. With me today are Claudia Drayton, Sunshine Heart’s Chief Financial Officer; Molly Wade, Vice President of Worldwide Patient Recruitment and Marketing; Jim Georgakopoulos, Chief Scientific Officer; and Debra Kridner, Executive VP of Regulatory and Quality Affairs. Additionally, I am also pleased to have Dr. Leslie Miller and Dr. Alan Gass join the call. Dr. Miller of the University of South Florida Heart Institute and Dr. Gass of Westchester Medical Center will address questions relating to the COUNTER HF study, our future protocol regarding patient weaning, the new data regarding potential neuromodulation signals and impact on patient recovery. Those centers were recently activated in the COUNTER HF study. Dr. Miller is very well-known for his work with patient recovery and LVADs and can offer his perspective on our recent data collected with respect to the neurohormonal response. Both Dr. Gass and Dr. Miller are also on Sunshine Heart’s advisory board. The third quarter was an important period for the company on multiple fronts as we advanced the C-Pulse Technology, continued to activate COUNTER HF study sites and make progress with our fully implantable system. I am particularly pleased with having a patient also reach the 5-year mark on the C-Pulse therapy and the progress made during the quarter to maximize the potential of the C-Pulse platform. During the quarter, we collected preclinical animal data for pulmonary hypertension, recorded initial echocardiography and neurohormonal clinical data pointing to neuromodulation as a potential mechanism for myocardial recovery. In addition, we continued the development of the next generation fully implantable system. Before proceeding with an update on our overall progress, I would like to remind everyone that on August 31, we announced that the FDA approved an amendment…

Thanks Dave. Good morning everyone. This morning we released our interim unaudited financial results for the third quarter of 2015. Next, I will walk you through a few of the financial highlights. As we have reported before our revenue to-date has been generated by sales of C-Pulse systems in hospitals and clinics in conjunction with our U.S. clinical study. The company did not record any revenue during the third quarter of 2015 as there were no implants performed during this period that qualified for reimbursement. The company recognized $59,000 in revenue during the third quarter of 2014. Results for the nine months ended September 30, 2015 and 2014 includes revenue of $59,000 and $118,000 respectively. As we have stated before we have obtained reimbursement for some, but not all of our implant procedures because some private insurance companies and certain governmental institutions have a non-coverage policy for experimental or investigational procedures. Since all activities are conducted under clinical studies in both the United States and Europe, we record all costs associated with our devices directly to research and development expense as incurred. We expect to continue to do so until such time as we begin producing devices for commercial sales in either Europe or the U.S. Operating expenses on a GAAP basis in the third quarter of 2015 totaled $6.3 million compared to $6.2 million in the third quarter of 2014. Equity compensation expense included in operating expenses totaled $0.5 million for the third quarter of 2015 and $0.7 million for the comparable period in 2014. Excluding equity compensation expense, non-GAAP operating expenses totaled $5.7 million and $5.5 million for the three months ended September 30, 2015 and 2014 respectively. Operating expenses for the quarter reflect lower spending resulting from the consolidation of certain management positions offset by increased investments…

Thanks Claudia. This concludes our prepared remarks. Before we turn the call over the Q&A portion, I would ask that the questions for Dr. Gass and Dr. Miller be asked first just with all due respect of their time. And Dr. Miller was at attendance in our October advisory board meeting, unfortunately Dr. Gass at the 11th hour had something come up that prevented him from coming. So some of the questions relating to maybe the advisory board meeting and the data that we presented at that regarding this neuromodulation effect Dr. Gass has not had the luxury to see, but Dr. Miller has. So with that we can open up the questions for the physicians.

Thank you. [Operator Instructions] And our first question comes from Suraj Kalia from Northland Securities. Your line is now open.

Good morning everyone. So Dave let me start out with the obvious, how many patients are there in the funnel right now for COUNTER HF?

So there is a total of 117 Suraj, 62 of them are from activated – currently activated centers and the other 55 are from centers that are looking to come on.

And would I…

So, we are right now at the maximum by the way if all these 13 additional centers are activated, we would be at the maximum number of allowed centers that the FDA has given us which would be 40.

And would I be close enough in saying that between one and three and one and five patients would get enrolled in the COUNTER HF study if I use that metric?

Yes that’s, that would be approximately correct.

And I know you guys don’t give guidance per se in terms of patient enrollment, even if I do lets say one five to use the worse case scenario, you’re talking roughly around 24 patients give or take that will end up. Are we talking about, now that most of the sites are activated is this a one quarter phenomenon or you think this will bleed out into Q2 and the reason I ask is, because last quarter you all talked about optimizing the presentation of therapy, I just want to sort of tie both them together and kind of get some directional color from you guys?

So, good question regarding optimizing the therapy, one of the things that has come up and I’ll say it was really brought to our attention by Dr. Miller, was that would be very helpful in doing that was to produce a patient consent video. So, today what happens is a patient will meet with the doctor, a clinical coordinator, we’ll receive the patient consent form which, I think is probably close to 30 pages, we’ll take that home come back and then make a decision as to whether or not they are going to enroll in the study. And sometimes if the physician is not able to meet with the patient to discuss this, then the patient is left to have and he will go through the documentation speak to the clinical coordinator and we feel and again Dr. Miller brought this up, we feel that there is a more efficient way of doing that. And that’s to have a video that actually has in essence a condense version of the patient consent form and it would highlight obviously the therapy, the clinical data and obviously the risks. So that’s something that we are working on now, I don’t expect that’s going to have that’s going to be introduced this quarter, it’s more likely that will be done really next year. So, is it a one quarter phenomenon I assure hope not? I mean we don’t have. We have all the centers pretty much activated from the study that were initially activated. But we still have 13 more that we have to get through. So there is still with another 13 sites, we get to 40. Now we’ve got a good number of sites and I would expect this to carry forward.

Fair enough, Dave. One for you and one for Claudia, Dave on the fully implantable that expedited access pathway obviously a lot of companies are making hay with this new pathway that the FDA presented, should need to triangulate that you all are looking at, someway weaving this into COUNTER HF? Are we talking about a standalone, should I say program, clinical effort on its own?

Yes. Suraj, I will address that. Right now, I am not going to speculate how this plays into COUNTER HF. I think we need to get at least a better understanding of what the FDA’s thoughts are on this. And when we contacted them earlier and so it looked, we really feel this therapy would apply to it. Their response was, hey we’re excited to sit down and review this, but here is what we need to see from you before we’re able to give you any feedback. So, I would say, yes this could have some pretty big implications, but on a positive way for the company. But I would rather reframe from saying guys this is what we’re going to do, because I would like to at least first hear from the FDA as to what their thoughts are on this.

Fair enough. And final one Claudia and I’ll hop back in queue, what is the expected R&D burn on the implantable and the PH program that’s over the next three, six months? Thank you for taking my questions.

Suraj, we don’t comment on those programs in particular at this point, so sorry.

Thank you. [Operator Instructions] And our next question comes from Tom Gunderson from Piper Jaffray. Your line is now open.

Hi, good morning everybody. Dave, I’m going to ask the doctors, you said in the interest of time, I’m going to ask the doctors some questions and then I’ll back in queue. Gentlemen just as a general question, your both I believe in the clinical trial and the COUNTER HF and on the Wall Street side we’ve watching this impatiently probably the same as the company has, and I’m just curious as on your side, you’ve both done clinical trials before. Do you see anything unusual speed bumps in this trial or anything about the product or the patient selection that would keep it from accelerating? Now that some of the pauses and other things have been gotten out of the way?

This is Les Miller. I guess I will take the first response. We are a new setter and I think that this trial was brought here, because I think it shows an important niche that we see in the whole spectrum of advanced heart failure patients, it has many advantages that we think patients at least the few we’ve already contacted have seen as a preference over are they really ready to consider full ventricular assist device in. The advantage is that, that I think patients have responded too quickly is particularly the ability to electively stop this, your certainly well appraised in the field that, if that held that stops you – you have a couple of minutes until you are in really crisis. And so I think that ability not the intravascular, no anti-coagulation. And this encouraging information about potentially improving and recovering ventricular function, we have had a really very encouraging response thus far the first person is ready to go and we have got two more this week. So, I would that as centers see this and begin to be all the clinical trials had an individual site starts and a little bit of a bend in the curve and then I think it will accelerate. So, I am anticipating certainly from our side as, perhaps representative of what new information is come forward that will really begin to bolster the recruitment.

Yes, this is Dr. Gass, I fully agree. I think the space is completely unmet, the functional Class III, ambulatory IV and I think the problem, especially talking about Bridge to Recovery. The VADs are being put in INTERMACS I and II patients are way too late to appreciably reverse remodel or recover. And I think this is the perfect device to achieve that goal and I think that, that will be communicated to the patient from the current physician. The other important thing is quality of life. I mean, if you look at all the quality of life data from implantable VADs, there is only a 20% chance of not having complication in the first year. This is much, much better. So as complication, the patient could come off the device, I mean, ambulatory quality of life and now that the company is putting the science behind the Bridge to Recovery. I think that is really going to try this study, because there really is no LVAD that has achieved the kind of even the science of reversal remodeling. And Bridge to Recovery and an LVAD worldwide is about 5%. So, I think this device needs a lot of our unmet needs.

Thank you. And then again for both of you on the neurohormonal side, Dr. Miller you mentioned sort of the gap and treatment that the Sunshine product could fill possibly here and that’s a good thing. I know it’s early, I know not all the information is out there, but on this neurohormonal reverse remodeling hypothesis, do you think that maybe it open the market a little bit more that you would go earlier upstream that it could have a metabolic effect more emphasized before some of the heart is destroyed or on the other hand you think it get a better impact later stage. Just curious where you see the remodeling that maybe adding to or taken away from the overall market?

Tom, it’s a great question and we always are trying to understand where to position new devices. But I think that the LVAD community tried to rollback into less thick. And I think the complexity and complications of that technology have clearly stopped that movement. So, I think again if you look at people that are symptomatic so-called IIIBs and ambulatory IV that’s a huge population. We have done several projections of the 150,000 to 200,000 people. So, even if we stay within that target range, there is an enormous population, but if you just go back to mechanism, one of the most astounding pieces of data that I have seen is the neurohormonal change and the N-terminal-pro-BNP. You guys have been around and seeing a lot of trial data. And in statistics, if you have the fall of 50 to 100 milligrams, you may reach statistical significance. This was almost 3,000 milligrams from over 5,000 to around 2,000 and there is nothing out there. I don’t think, including the big LVADs that have shown that kind of power in turning off neurohormonal stimulation. So, that and I think the other piece that I look at mechanistically is this change in heart rate variability, which is a really profound look at chronic overstimulation of sympathetic nervous system and loss of that variability and the restoration with this kind of stimulation and it’s proximity in the ascending aorta, I think really lends it anatomically and mechanistically to really taking advantage of stimulating the baroreceptors and having this very positive effect on myorcardial function. So, long answer perhaps, but I think it’s – there is a bigger population. And as we get more experience, we may well bend it back in both directions to define its optimal location.

Thanks, Dr. Miller. Dr. Gass?

Yes. I just want to – there is really nothing that needs that need in the ambulatory IIIb or IV. And if you look at the medical therapy that exists, all the cornerstone therapies do not really achieve this long-term. And once the patient gets to this point, clearly, the medical therapy is not achieving the goal of reverse modeling. So, I think the traditional trajectory is that on mathematical therapy, these patients are going to progress. And this is really going to kind of stop that progression. And I think there is really again an unmet need to reverse remodel. There is nothing out there, certainly nothing. Medically, the LVADs are firm with not only big surgery, lot of complications like certain complications, this will meet that need.

Thanks. That’s it for me, Dave. I will let somebody ask the doctors some questions.

Okay.

Thank you. Our next question comes from Jan Wald from the Benchmark Company. Your line is open.

Good morning, everybody. And doctors, I guess just in terms of maybe carrying on with what Tom just asked, on the neurohormonal modulation, it sounds like there is a pretty strong signal that has been seen to-date. How do you translate that into a clinical study? What do you see having to be done to prove the point in order to make it hazardable for other folks?

This is Dr. Miller again. I think that, that’s a little bit challenging to really look at biochemical markers other than as we said you have got two things that physiologically we can look at heart rate durability most of these people have devices in that we can track that and show that restoration. And secondly, BNP, I mean, I think that’s become the surrogate of all neurohormonal stimulation in the heart and I think that’s in the protocol as an endpoint. So, I think we will have a good look at it getting more defined into tracking baroreceptor activity and so forth, I think is really extrapolating from the animal experience into what we see in the clinic. But I think if you look at the data, one of the most compelling parts to me is the concordance of the data in terms of all of the changes are going in a really consistent manner in terms of wedge, cardiac output, ejection fraction and not a small point in this is the left ventricular and systolic volume. I think that maybe you have seen the data from the large meta-analysis that looks at what a 30 milliliter reduction and systolic volume in the meta-analysis suggests that you have an 80% chance of achieving a mortality benefit. So, all of these things and reducing while stress, are measured and consistent with the mechanisms that have been suggested. And all of those are again really critical in the concept of recovery. And I think that all this really sets the stage to move as I think Dave suggested into really trying to study recovery in this technology, because the data and the signal so far are so encouraging and the mechanism underlying why it’s different than a distal intra-aortic balloon pump or other technologies is really pretty astounding and I think very encouraging.

And at this point, I wanted that – the issue, the latest issue about reducing pulmonary advanced resistance of pulmonary hypertension, I think one of the biggest unmet needs is heart rate failure. And I think speaking to moving upstream, if you can put this device in out of the right time to prevent pulmonary hypertension in the heart rate failure, I think that’s unmet need. And the other thing about biomarkers, they seem to be coming out everyday we used to go less than three our institutions. I think going forward, there will be more of that’s available to kind of confirm the benefit of this device for reverse remodeling.

And I guess this is an impression I have and I maybe wrong, but if I looked at pulmonary hypertension and things like that, baroreceptors are certainly involved in it and very hard to prove that there is a benefit from a particular therapy. And I am thinking in particular of renal denervation. And I don’t know if there is an analogy here or not, but do you think the signal is strong enough and it will be maintained well enough that it will be demonstratable in the clinic?

With right-sided support or left-sided support?

Both I guess.

I think both would seem to be as suggestive, it’s a little earlier and the experience with the pulmonary vascular support, but I think that the left-sided support really looks as we said. If you look at the whole aggregated data, it all suggests that this is all moving in the right direction and likely in response at least in part to not just coronary perfusion and reduced resistance that we have kind of thought about in this technology, but not really getting into a much more fundamental understanding of why this could be different and why that mechanism will be so important in achieving a goal of recovery and removing devices.

Okay, thank you very much. I appreciate the answers.

Thank you. And I am showing no further questions from our phone lines. I would now like to turn the conference back over to Dave Rosa for any closing remarks.

I want to thank both Dr. Gass and Dr. Miller for being present and for all of you guys as well for participating on the call. Thanks and have a good rest of the day.