Good afternoon, ladies and gentlemen. Welcome to the Cytori Therapeutics Third Quarter 2017 Earnings Results Call. [Operator Instructions]. Before we begin, we want to advise you that over the course of the call and question-and-answer session, forward-looking statements will be made regarding events, trends, business prospects and financial performance, which may affect Cytori's future operating results and financial position. All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the Risk Factors section included in Cytori's annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission. Cytori advises you to review these risk factors in considering such statements. Cytori assumes no responsibility to update our advice cannot revise any forward-looking statements to reflect events, trends or circumstances after the date they are made. It is now my pleasure to turn the floor over to Dr. Marc Hedrick, Cytori's President and Chief Executive Officer. Sir, you may begin.

Good afternoon. Thank you, Ian, and welcome, everyone, to our third quarter 2017 earnings call. My name is Marc Hedrick, President and CEO of Cytori and joining me on today's call is our Chief Financial Officer, Mr. Tiago Girao; and our VP and General Manager of Cell Therapy, John Harris, who is calling in from Japan. On the call today, I will provide an overview of the company's key areas of focus and provide a clinical development update. Then John will discuss commercial related activities and performance and finally, Tiago will update on financial performance. Then we will have Q&A after which I will update on forthcoming milestones. In early September, we refocused our strategy and restructured our operations. We did this so we can successfully meet our most important near-term objectives that will drive shareholder value. First of all, with respect to our HABEO scleroderma product, based on the STAR trial data set, we will have a PMA pre-submission meeting with FDA soon to determine the next steps for the program. As shareholders know, while STAR missed the primary endpoint in the combined patient group, in the key prespecified subset of patients with more severe disease, we showed that the treatment was safe and in key end points the therapy approached the statistical significance as defined by p-value of less than 0.05. Also the magnitude of improvement in the treatment over placebo was clinically meaningful in a population of patients that really has no true treatment options. We're also focused on completing STAR's sister trial in France that is the SCLERADEC-II EU investigator initiated trial that we hope will provide some supporting data to our regulatory filings. This is a 40-patient trial. Second, we are allocating resources to our cell therapy assets in Japan, and to BARDA, both of…

Thanks, Mark. Cytori commercial areas of emphasis for the balance of 2017 are, 1, continued double digit consumable utilization growth in Japan; 2, enrollment of patients in our Managed Access Program through our new partner, myTomorrows, in Europe, Middle East and Latin America; and 3, securing a commercial partner for ATI-0918 in Europe by the time we have submitted for EMA approval. I will address each of these in more detail later in my remarks, but first allow me to highlight our results for the third quarter. 2017 Q3 global product revenues were about $470,000. Q3 is typically light and Q4 is typically the strongest quarter of the year. Our global Q3 consumer utilization was flat when compared to 2016 timing and seasonality elements are at play. There are less elective surgeries done in the summer months, but generally that increases in the late fall through the end of the year. As I mentioned, Q4 is typically our best quarter. We have a good funnel with new initiatives to support new system sales and consumable growth. Now let me give you some more details surrounding our commercial activities. First, Cytori, Japan's January through September consumer utilization net a 17% increase, which is in line with our double-digit growth objectives. Driving this year-on-year increase of consumables for self-pay indications is our installed base of 77 solution instruments in Japan. Our customers have over 75 discrete regenerative medicine law approvals in a wide variety of therapeutic areas. We continue to pursue opportunities to extend our installed base in Japan. In response to customer interest to lower the capital equipment entry level, we have identified ways to lower the capital hurdle for clinics to acquire our devices and recently executed a distribution agreement with a well-known company that rents capital equipment to aesthetic…

Thank you, John, and good afternoon, everyone. Our primary focus continues to be the development of our late-stage clinical pipeline and related commercial preparatory activity with the objective of driving shareholder value. In parallel, we are wisely managing our resources to continually improve our operating performance. Despite the additional new investments in our recently acquired assets from Azaya, operating cash burn was reduced to $4 million in Q3 of 2017 from $4.6 million in Q3 2016. The reduction in cash burn was mostly related to reductions in operating expense. Net loss totaled $4.8 million in Q3 2017 or $0.14 per share as compared to $5.4 million or $0.26 a share in Q3 of 2016. For the year-to-date period, net losses, when adjusted for a noncash charge of $1.7 million, were $16.7 million as compared to $17.1 million during the same period in 2016. For research and development expenses, in Q3, our R&D expenses, excluding share-based compensation, were $3 million as compared to $3.9 million in expense for Q3 of 2016. The decrease in R&D spending is due to the completion of enrollment of the STAR trial as well as completion of option 1 under the BARDA contract, offset by our investments into ATI-0918, our nanoparticle doxorubicin, for which manufacturing activities are ramping up in our San Antonio facility. In addition, the decrease is also attributed to the decrease in headcount from the restructuring activities implemented in September of 2017. As a percentage of overall spend, our R&D expense for Q3 was 55% of total operating expenses when excluding share-based compensation. This is in line with our plans and indicative of our focus in late-stage clinical programs. Furthermore, as outlined during our last earnings call, our year-to-date figures include a noncash charge of $1.7 million related to reprocess R&D intangibles acquired…

Thank you, Tiago. So quick update on anticipated milestones that are on the near-term horizon. As I mentioned multiple times, we expect to hear back from the FDA regarding our meeting and the outcome of our discussions with respect to the approval path on next steps for HABEO. #2, we intend to complete enrollment in the Japanese ADRESU SUI pivotal trial and the European SCLERADEC-II trial and report data out in 2018. First patient in for BARDA for the RELIEF trial should be forthcoming soon and we're also working diligently to complete the manufacturing and related activities for our nanoparticle doxorubicin 0918 product for EMA filing in 2018 and seeking potential partners. So now I'll turn the call over to you, Ian, for Q&A.

[Operator Instructions]. Our first question comes from the line of Jason Kolbert from Maxim.

I just wanted to get into a little bit of detail on HABEO and this upcoming catalyst with the FDA. Marc, can you just review with us what's some of the dynamics were of the trial? And what's some of the possible outcomes might be at the FDA? For example, one of the things that I know, you and I previously discussed, was the effective placebo and why the placebo group may have been better than expected. How rational do you think the discussions are going to be with the FDA? And then how do you look at the possibilities in terms of the outcomes, that would be very helpful?

Jason, first of all, just the broader dynamics with respect to this product that I think they are important. They sort of fit nicely with what's going on and with regulatory laws in the U.S. and elsewhere. First of all, scleroderma on the hand unmet medical need, nothing approved in the U.S. The diffuse subgroup of which seems to show the strongest effect was a prespecified group and it's 1 of the most severe, in fact the most lethal of all the rheumatic diseases. So there's a real patient need here. We've got strong support from the physicians and from the advocacy groups. So I think that's point #1. #2, is that, I think the regulatory environment might be moving a little bit in our direction with the 21st Century Cures Act and the [indiscernible] guidance as well as the expedited access program for devices [Technical Difficulty] wasn't something that you extrapolated separately without discussing it with FDA that was actually the group that they wanted to have data on, correct? And what does it mean in your opinion that you got so close to showing statistically significance?

Well, I think we had this discussion previously. And when you sit across the table from FDA, they know oftentimes know more about your disease than you do because they have access to data that you don't have access to in terms of multiple trials and these indications. So I think they feel like it was important to look at the difference between scleroderma that was the diffuse versus limited. But that was prespecified, as you mentioned, that's a big reason why we included it. We were just -- we were underpowered to show an effect in that group. But the effect was clinically meaningful and as Jason mentioned, it was actually less placebo effect in those patients because they tend to have more severe fixed disease and it make sense that they'd be less likely to respond with the placebo effect.

Okay. And just last question, the whole DOD being able to essentially run the FDA in some capacity at least not have to utilize them astringently to get things out to help the general military population. Do you feel like that could help your endeavors with what's going on with BARDA right now? Or do you believe that you could potentially be excluded from that?

Well, I think, it actually, you're right. I think we do have pretty long-standing relationship with the FDA in bringing this technology to them for clinical utilization. And I think, they are highly aware that what we're doing with BARDA as well as this orphan disease in scleroderma, but I think, at the end of the day -- they want to approve technologies that are first of all, safe but likely effective, but I think, to look at the big picture at the end of the day it's really on us to show in a scientifically convincing way that our technology is both safe and effective and to the most rigorous standards set by the FDA.

[Operator Instructions]. And at this time, I'm showing that we have no further questions. Dr. Hedrick, I would like to turn it back to you for any further remarks.

Ian, thanks, everyone, for dialing in for the call. Thank you to the questions. And just on behalf of the board and management, we appreciate your interest in the company and the company is very appreciative to, as we always say, the patients that have trusted us with this therapy and our advisors and analysts that follows us, and of course, our hard-working and dedicated employees. Thank you, and please have a good evening.

Thank you. This does conclude today's conference call. Please disconnect your lines at this time, and have a wonderful day.