Plus Therapeutics Inc (PSTV) 2009 Q1 法說會逐字稿

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to the Cytori Therapeutics first-quarter financial results conference call. During today's presentation all parties will be in a listen-only mode. Following the presentation the conference will be open for questions. (Operator Instructions). As a reminder, this conference is being recorded today, Monday, May 11, 2009. I would now like to turn the conference over to Christopher Calhoun, Chief Executive Officer. Please go ahead, sir.

Hi, good morning, and welcome to Cytori Therapeutics first-quarter 2009 conference call. This was a great quarter for the Company; let me start with a few of the highlights which include receipt of four new patents and allowances, establishing a distribution partnership with GE in Europe, completion of the APOLLO acute heard attack trial and solid revenue growth.

During today's call I will focus on three topics -- first, our strong revenue growth in Q1 and important financial metrics; second, progress in our three clinical trials; and third, our expanding partnerships. Let's start with financials.

During Q1 this year we sold or placed 19 Celution Systems, 13 were sold and six were placed into trial centers, compared with three Celution System sales shipped and booked in Q1 2008. By the end of March a cumulative total of 73 Celution Systems have been sold or placed of which 57 have been sold to end-user customers or distributors and 16 are at clinical trial centers.

We also realized a year-on-year and quarter-on-quarter increase in consumable orders during the first quarter to 241 units, that compares to 138 during Q1 '08 and 186 during Q4 '08. The total accumulated number of consumables that have been shipped surpassed 1,000 during the quarter. We completed the sale of our second StemSource Cell Bank during the quarter which was the first one installed in Japan. The Cell Bank was purchased by Kyoto Prefecture University Hospital, one of the oldest and most prestigious hospitals in Japan. We believe Kyoto's leadership represents significant customer validation to hopefully accelerate future sales.

Our StemSource Cell Bank sales are very active; despite the long sales process we have several potential sales very late in the sales cycle. We're seeing a strong increase in potential sales for Celution and StemSource related products around the world. Revenues will likely continue to be variable quarter to quarter. With that said, we believe Q1 represents a strong start to the year and that we are on track to achieve our full-year goal of at least $10 million in product revenue.

In Q1 product revenues were up significantly to $1.9 million which represents significant growth both sequentially and year on year. Our operating expense and cash loss are down significantly year over year and quarter over quarter. In Q1 we achieved continued reductions in operating costs, particularly in R&D, as key development objectives to enable broader sales of the Celution and StemSource products were achieved.

In addition, we continued to reduce G&A cost by $2 million compared to Q1 2008. These operating expense reductions were partially offset by an increase in sales and marketing expenses related to our international Celution and StemSource commercialization efforts.

Going forward, we expect to further reduce cash operating expenses by an additional $1 million to $1.5 million per quarter which would represent the full effect of the previously announced reductions made in March. On a pro forma basis, factoring in a full quarter impact of these reductions, we estimate the Q1 cash operating loss would have been between $4.5 million and $5 million, which is approximately a 50% improvement compared with Q1 2008. We're committed to continuing this trend through the achievement of 2009 revenue goals and continuing to contain expenses where possible.

We ended Q1 with $15.5 million in cash and equivalents. Subsequent to the end of the quarter we were pleased to raise an additional $4.2 million in net proceeds from the sale of unregistered common stock and warrants. With this improved cash position and successful cost reduction we believe we're in a much stronger position to achieve our 2009 commercialization clinical and strategic goals.

I would now like to update you on our three company sponsored clinical trials. Our RESTORE II post-marketing trial for breast reconstruction of partial mastectomy patients after breast cancer continues to enroll with 37 patients treated to date. We have six active trial centers and two more coming online during the second quarter. As an increasing number of patients are completing the six-month follow-up period each week, we believe we will have sufficient data to present meaningful interim results from RESTORE II in December at the San Antonio Breast Cancer Symposium.

Enrollment in our APOLLO trial for acute heart attack patients is complete. As reported last month, the lead investigators in the Data Safety Monitoring Board determined that the study has met the primary goals of safety and feasibility. A total of 13 patients have been enrolled in the study and we expect data to be available during the first quarter of 2010. We expect to complete enrollment in our PRECISE trial for chronic cardiac ischemia patients in the second quarter of 2009. Based on recent progress we expect to report the data from this study in early 2010.

I would now like to discuss our three key partnerships. Let's start with strategy. Our vision is for Cytori to be the global leader in regenerative medicine. To achieve that success we need to be able to sell and deliver not only the first-in-class but the best-in-class products.

So how do we measure success in regenerative medicine? Our primary goal is to grow our base of installed solution products into every major hospital and clinic around the world, that's a big goal. Our success can then be tangibly measured by our revenue growth, by the breadth of applications available and by the number of patients who benefit from our products.

We have formed three strategic partnerships to reach that goal. First, in 2004 we formed a joint venture with Olympus, the largest medical device company in Japan and one of the leading medical technology companies in the world. Our partnership with Olympus is centered on design, development and manufacturing of a solution family of products.

To reach the 15,000 plus targeted hospitals and clinics around the world we need the highest quality products, scalable manufacturing and global service infrastructure. Olympus brings all of this plus an established brand of highest quality that is recognized by our target customers worldwide. Our partnership is strong and we're working closely together to bring the next generation system to the market which will be named [Celution I].

As the design is being finalized and Olympus now moves towards production we, in parallel, will be submitting the preparatory files in Europe this summer. We will formally announce the timing of the launch of this product once the final testing is complete, regulatory approvals have been received and our launch plans are establish both internally and with our manufacturing, marketing and distribution partners.

Our second partnership is with a leading pharmaceutical company which we have, for competitive reasons, not yet disclosed. In order to safely and effectively process adipose tissue certain enzymes are required, our Celase enzyme functions as a high-tech chemical scissors that has been optimized to digest and break down tissue to release the clinically relevant stem regenerative cells. Although this enzyme is thoroughly and automatically washed out by the Celution System, it's critical that any and all enzymes used must meet the highest level of safety and quality; they must, in other words, be clinical grade.

Together during the past few years we've invested and worked with our pharmaceutical partner to develop and produce the ideal and highest quality enzymes. This includes manufacturing enzymes that are animal product free including avoiding the BSE or Mad Cow Disease risks associated with other similar enzyme products. Additionally, our product is manufactured under GMP conditions and is both sterile filled and packaged.

There is no similar product available today and this is exclusively marketed by Cytori. We believe this represents a significant barriers to entry for any who may try to follow our lead. Furthermore, this enzyme not only sets a very high bar for quality, but it defines the standard for safe clinical grade enzyme products. It's our intention to focus increasingly more in 2009 on these critical reagent products, our present development partner and their overall importance as a key barrier to entry.

Our third partnership is with General Electric, one of the world's largest and leading innovation and technology companies, who just last week and announced their $6 billion Health Imagination Initiative to enable better healthcare through cost, access and quality. GE Healthcare is a $17 billion unit of General Electric and employs 46,000 people worldwide and is helping patients in more than 100 countries.

To reach every major hospital and clinic around the world it helps if you already know these hospitals and you count them among your customers. It's our hope that in time GE Healthcare will put forward Cytori's products for this Health Imagination certification as we believe that our technology is ideally suited to change the practice of healthcare with attractive economics that benefit hospitals and patients alike.

We formed our first partnership with GE during Q1 this year. This entry-level distribution agreement includes most of Northern and Western Europe for both our StemSource and Celution products and has an initial term of 18 months. We are already seeing the benefit of this partnership not only in the flow of purchase orders but in many important ways, let me share a few of these.

First, GE has already been opening the door to hospitals and clinics where we didn't have access or relationships including the introduction of the first systems in the UK.

Second, we have access to GE Healthcare's economics team and are working together on pan-European as well as regional reimbursement strategies.

Third, GE's equipment finance arm is helping provide working capital by financing Celution equipment sales to not only GE customers in their distribution territory, but more broadly to Cytori's customers across Europe.

And finally, by partnering with GE we are gaining the brand and strength of one of the world's leading and most admired companies.

Just last week we announced the expansion of our relationship with GE into North America. While in Europe GE had distribution rights for both our Celution clinical products and our StemSource research and banking products, the North American agreement is only for our StemSource family of products which includes our system for laboratory use, cryopreservation and research. The US team has already spent a week at Cytori for training and are able to hit the ground running.

We believe there is a significant market opportunity for our StemSource products and with GE we are now able to bring our first products to the US research and banking market while our clinically oriented Celution branded products are working their way through the FDA. We're extremely pleased to have brought these three partners together. We expect to continue to see order of magnitude growth in the number of patients treated and the expansion of an installed base of solution and StemSource products in hospitals and clinics around the world.

Our vision is clear, and our goals are big. Our success will be measurable and achievable or by working with the world's leading and most admired and successful companies. We'll continue to deliver on the promise of regenerative medicine. I would now like to open up the call for questions.

(Operator Instructions). Steve Brozak, WBB Securities.

Good morning, gentlemen, and congratulations on a great quarter. But I'm not going to talk or ask questions about the financials. What I care more about is the presentation that you guys did last week in terms of the clinical presentations on reconstruction was probably one of the more stunning things I've ever seen.

Have you gotten any feedback from clinicians here in the states or abroad just looking at that work? It was something that, candidly, I've never seen before. And have you gotten comments obviously after you -- or queries after you announced the GE collaboration?

Steve, good morning. We're going to have Mark answer that. Mark is actually joining us from Tokyo this morning.

Hi Steve, it's Marc Hedrick. What people may not understand is we've been visible at the US Plastic Surgery meetings for the last two or three years. And the visibility continues to increase such that at the hot topic section of the ASAPS meaning, which is the section of the meeting where the latest up-and-coming technology is presented, we've really dominated that for the last two years.

And so, based on that visibility and the success we're having around the world, we see increasing interest from US doctors for the technology. And so, the challenge for us is to really continue to drive sales, drive notoriety and get those results presented that we're generating in Europe and then get through the FDA process so we can make this available. And Steve, your second question was with respect to what now?

With respect to GE and the visibility there, because you're now talking about a situation where the time that they spent talking about future business and what their future strengths were going to be, obviously then 10 seconds later the announcement is made with you guys. I have to believe that there's no coincidence there. Have you gotten any feedback about that? Because putting two and two together shows that their interested in the potential of your technology.

I can't really talk about what we may or may not be planning in the future with respect to GE. But I think the relationship has been evolving over the last year through the diligence process, then leading to early success for the European market and now an entry into the US market.

And so clearly, as Chris outlined, we fit strategically into some new initiatives coming through General Electric. The visibility that we're seeing in the market from our other partners or distributors and our customers is growing. And so, it's our hope that as we go through the next year or two that we continue to forge a closer and closer partnership with GE.

Great, let me jump back in the queue. And congratulations again, especially on the presentation last week.

Thanks, Steve.

Ted Tenthoff, Piper Jaffray.

Great, thanks very much and my congrats too. Firstly, I'm not sure if I just missed this, but were there any financials disclosed with respect to the GE collaboration, are there any upfronts or payments coming your way?

Hi, Ted, it's Mark Saad. Similar to the agreement that we formed with GE in January, the deal with the US is fairly short term and it's in the form of about 18 months and fairly specific. So products that really are specific to the StemSource product line, not related to Celution. So similar to the fact that they were dedicating resources on the sales side and other resources internally at GE, part of that whole relationship that was not there was upfront money.

In lieu of upfront money they're dedicating their teams to get going on this, develop a track record. And because we're not seeing that upfront money as well, we're not going with a long-term deal. So it was a way for us to get market traction, hopefully see some growth signs over the future and hopefully turn that into something that potentially could be larger down the road with either them or someone else. And we have the flexibility to do that.

Great. And when we look at the quarter specifically it looked like there was some nice step up in sales to third party, which is good to see. It also looked like there was a step up in cost of product revenue and a decrease in margin. So was that part of the selling cost and how should we think about margin/selling costs through third parties going forward?

Hi, Ted, it's Mark Saad again. I think I mentioned on prior calls that there is going to be margin, just like we're going to have revenue variability quarter to quarter, certainly during the time frames where we're more reliant on system sales, there is a sales cycle process and we believe the growth is showing. But quarter-to-quarter predictability is not something we're expecting in the eminent term. But obviously over time, as more and more consumables are part of the equation, we could start to hopefully get more predictive.

On the margin side, I think I mentioned before that we will see a variability of margin really depending on where we're selling the product. Because where we're selling the product may be direct like in certain countries where we may have higher margins on those sales and other countries where we're going through a distributor, specifically certainly with the system sales we're going to see a lower margin on that.

So as an example, if we're selling a Celution System direct we're probably going to see 50% to 60 plus percent gross margins. If we're selling through a distributor it will probably 40%, maybe slightly more, maybe slightly less depending on the country and the circumstance. And then on StemSource side we're seeing about 50 plus percent gross margins on those StemSource sales.

So when you put it all together, when you look at Q1 I think it would imply that we did more distributor sales than direct sales. We had a StemSource sale which we identified in the quarter, so that gives you a sense of what the margins would be on those $600,000 of revenues. And then the remaining Celution revenues were, for the most part, distributor revenues, so those were at the lower end of the range I talked about. So as we go forward and continue to have that revenue mix of direct versus distributor and StemSource, it's going to vary within that 40% to 60% range. Does that make sense?

Yes, totally. And I apologize if I missed this, but did you give guidance with respect to how long the cash should last following that recent private placement?

Sure. If you bring on the $4 million -- $4.2 million that we brought on since the end of the quarter and we announced we had $15.5 million at the end of the quarter, so that gives you approximately $19.5 million on a pro forma basis.

Chris discussed, as well as in our numbers, what our actual reported results were, and if you just look at the cash loss from operations, cash used in operations, it was about $6.0 million in the quarter. Which if that's all we knew we would know that that's $1.3 million better than what it was in Q4 2008 and about $3 million better than it was at this time last year. So in and of itself it's been a significant improvement in our cash used in operations.

At the end of Q1 in March we did a further reduction, as previously announced and disclosed, as we had really achieved key development objectives and really were able to pare back a lot of the development as well as other G&A cuts we could make. And so we believe on a pro forma basis, if you were to look at Q1 pro forma for those cuts that were taken towards the end of Q1, you can see another $1.5 million or so of incremental cash impacted those changes. So that would give us a reasonable idea that we're in that $4.5 million pro forma Q1 basis on cash used in operations.

So with that, kind of applying that forward with the cash we had at the end of Q1 pro forma for the new equity that was raised, I think it suggests that we should be able to achieve our goals this year, get through the year and achieve what we hope to be pretty meaningful commercial, clinical and other strategic goals.

Great, thanks. And I'll hop back in the queue too.

(Operator Instructions). Ted Tenthoff.

Just going back to the data side, very excited about the progress on enrollment there, congratulations. I know there are quite a few cardiac trials enrolling currently with stem cells, so it's good to see you guys getting the traction there.

Chris, you had said that the DSMB or someone had said that you had met the primary endpoint of safety and feasibility in the 13 patients enrolled in APOLLO. Can you go into a little bit more detail what that means? And the data that we'll get in 1Q then will be -- so that's basically an end of study comment and then what we'll do is get the follow-ups for the primary endpoints? Or just walk us back through what that trial is looking and what this initial read means?

Thanks for the question, this is Chris. As you know, these early trials are really intended for primarily safety and then also looking at feasibility. And so they're always up to some number. So in this case the APOLLO trial was going to be up to 48 patients and the design was four dose cohorts of 12 patients per group and then within each 12 there was a three-to-one randomization so that nine would get a treatment and three would get controlled and of course this is double blinded placebo-controlled.

So the way that this materialized, after the first 12 patients were treated it took about a year to enroll those. We knew immediately -- we already knew from that experience that it was safe and that there were no major adverse coronary events in any of these patients which was the primary safety metric that we were looking at as well as other safety concerns. But essentially the trial met that early safety goal.

And then looking at feasibility, well is it possible in a pretty extreme case, and you have to imagine these are patients that have major heart attacks, these are very, very large heart attacks where their rejection fractions are down in the mid-40s and they're on a lot of blood thinners and anticoagulants. And so, to be able to go in, harvest a little bit of fat tissue through a liposuction, process it at the point of care and then deliver those cells in a safe way right down the coronary artery in these major heart attack patients, this is a nontrivial study.

And so we were able to show not only that we could do that safely, but it's feasible. And then the question is, as the data starts to come out, and again this is blinded, the investigators were excited about the data and they chose on their own to present the first five patients' data, and again it's blinded, but when they showed these patients at the meeting earlier this year, essentially what they said was they could see through the blinding and based on the data they could see significant reductions, I think the average was about 45% reduction in the size of the perfusion defect at six months in five of the patients, that's the average across the first five.

And so they together, and looking with the Data Safety Monitoring Board, looked at that data and believed it was so significant that effectively this isn't something they would normally see in clinical patients with heart attacks of this magnitude. And based on that they think they can see through the blinding. But this is having a major effect on the benefit to these patients.

And so they got together and they said, look, we've established safety and feasibility already; we can do this safely even though the extreme situation of doing liposuction on heavy anticoagulant patients in a major heart attack and it seems to be working. So let's stop enrolling patients, let's get to the six-month endpoint data where it's a full battery -- this is probably one of the best designed studies out there where they're looking at all the possible endpoints with MRI and CT and so forth.

And they're going to have a real good view on not only the injection fraction improvements, which is a functional measurement, but also physiologically looking at perfusion defect changes and so forth so that we can really get a good understanding of the benefit of these cells in these patients which seems to be right now incredibly high.

And so based on that the investigators are already working with our team to design and develop the next study which will be finalized after we get the data put together. But essentially they said that it's met the endpoint so let's get the data and then let's leverage that to go into a pivotal trial.

Okay. Now, so that's all excellent news. I have to ask though, because if we've gotten 12 we've basically gone just to the first dose cohort and have not escalated. So isn't there something that you could learn, A, in terms of additional safety data; B, in terms of dose escalation, to actually continue to enroll patients in this study even while we potentially plan for a pivotal? It just seems to me hasty to stop a study that's this successful if what we're going to get is incremental information, particularly with respect to the design of the pivotal study. So what's the rationale of not continuing that?

Right. This is a very insightful question and I think that it brings about why this whole biologic thing is a new way, it's a new technology, it's a new class of therapeutics and we have to look at it in a different way. And I think you're talking about a traditional drug trial where really you're looking at dose and dose response and if we give more cells are we going to get more dose response? And so that's the way that we originally designed this trial years ago.

But in the interim we've been continuing to do a lot of work in the lab and in animals and what we've learned is that dose response may not be as critical of an issue for cell-based therapy. So why would that be? And I think the answer is you're going to put it a certain level of cells, so there's going to be a certain minimum requirement to get an effect. But what we're learning is that beyond that, if we add another 1 million cells or another 2 million cells per kilo it may not have a significant effect because the corresponding receptors have to be there.

So if you put in more and more cells you may not be adding any value or marginal value whereas in a drug you would see a very different response. So in the case of these biologics, our experience is that this idea of cell dosing and dose response may be different than it is with the drug. And so what we've found is that we've got a safe dose, that it seems to be feasible, and the magnitude of the benefit seems to be very, very significant.

Now we have to counterbalance that with -- again, you're looking at a pretty extreme population of patients with large heart attacks, heavily anticoagulated, there's a lot going on in there and there is a risk when you take adipose tissue in these heavily anticoagulated patients. So we also wanted to minimize the risk of having to take more and more tissue out and risk bleeding and other complications.

And so factoring all of this in, we didn't really see a benefit of increasing the dose in this set of patients. The effect was really positive, at least based on the -- and again, we're blinded, but at least on what we think we're seeing. And it's safe and feasible at this point.

Well, it seems to me that you actually haven't explored that higher dose so that you really haven't confirmed that. But moving on maybe just to the regulatory side of things, what's the FDA going to think about that as we go towards a pivotal study? And I understand that this is different in that cells can work differently in terms of a biological response, but what is the FDA going -- what is their view on stem cells?

Is it really that different from a drug through [Sieber] and what would they say to not exploring a higher dose? I mean I know -- again, this isn't a standard drug, so obviously we don't need to achieve a maximum tolerated dose or anything along those lines, but it still seems to me that there is benefit in understanding those upper limits.

I fundamentally disagree with the premise that we haven't studied it. I think we have studied it and we've done probably more pigs and more advanced preclinical work than anybody out there with dose escalation. So my comments are really based on an enormous amount of data that we've got internally and/or that we've already put out there.

So I think that this concept of dose escalation that works for a drug really may not apply here. I mean I think you've got every therapeutic dose level to get a benefit. But once you've gotten that it seems to us from all the work that we've done that you may not get significant incremental benefit by adding more and more cells just because the receptors may or may not be there.

Okay, I can appreciate that. But now again (multiple speakers).

So looking forward to the SPA, you're right, this is a whole new class of therapeutics, this is a new area and I think FDA is working to understand this along with everybody else. And I think we're really well-positioned to go to FDA with an enormous amount of data. And now, in the maybe 500 or 600 patients treated worldwide, we've got a big database of patients that have been treated, maybe not directly in cardiovascular applications, but more broadly that we can draw from, that this can be done safely, that these cells are safe, that we're not seeing tumors, we're not seeing other things. So we can really focus on the benefit and putting these cells in and helping patients with significant needs.

Great, excellent. I appreciate it and congrats on all the progress.

Thanks, Ted.

(Operator Instructions). Jon Robohm, Gagnon Securities.

Good morning, gentlemen; it's a group of us here. On the GE signing up with the United States and the StemSource banking arrangement, it's taken you a long time to really gain some momentum in Japan -- that seems to be starting. Why do they/you think that it should be meaningful here in the United States and what kind of timeframe do you think that will take?

Good morning, Neil, this is Chris. This is -- what we're trying to do is bring a brand-new technology that's innovative, potentially disruptive to other things out there and, as you know, there's a lot of blocking and tackling going on. It takes a lot of time to bring this new technology, get over the fears and the uncertainty and the lack of knowledge base that's out there about these new technologies.

And the way that we're doing that is we work with key opinion leading centers and key opinion leading doctors that begin to use the technology and then get out there and report on their experience. And based on their data and their patient experience with our technology word gets out and others start to grow and it's the typical disruptive approach I guess.

And so what we're seeing is especially I think Japan is a great comment because it's probably the most advanced. If we look at the acceptance of the technology and the acceleration of the velocity of the product usage and patients treated, it's clearly the lead place in the world, I'd say the UK is probably second. And it's being driven by these core foundational blocking and tackling efforts that are going on where we get key opinion leaders out there that are using the technology and growing it.

But what I can say is that we're absolutely seeing a groundswell here. When we're out talking to physicians, we're out working with not only our key opinion leaders but now the people around them regionally and, for example, even at this meeting in Las Vegas, this technology is getting a lot of visibility and it's getting -- there are people that are now starting to believe that this is real, that the data is supportive of long-term effects, of natural outcomes that are great for the patients and for the physicians and it's really a new option and I think that that groundswell is happening.

So ahead of the US approval for the Celution System in the US, we think it's important to begin that work here where we get our technology into research centers, into the guys that are doing the work maybe not on patients yet but in the lab, and then design in our core Celution System and products so that future applications get built around access to stem cells using our Celution and StemSource products.

So you're thinking that these will get into the centers in some way similar to Japan where you have it in university centers and work in a variety of areas is going on? (multiple speakers)

Yes, I believe that's right. So they're going to be doing things like -- start with banking here in the US which is already a big market for core blood, but now we're bringing banking to the rest of us who didn't bank it when we were kids, so we can now bank our own cells. I think that's why to be a growth market.

In addition, there's a very robust research market. So there are a lot of key centers around the United States that are working with cells or want to be working with human cells, they're restricted for whatever the cost or access to cells and we enable that. So by using our system it can give them access to clinical grade sales at the point of care or in their research center where they can actually use these cells to study in their research work and begin to get out and talk about it.

And as they're designing and developing their own technology, whether it's delivery or harvest or measuring or analytical or therapeutic, they're adding enzymes or other things or growth factors to make cells more specifically targeted, the idea is that they use our fundamental system and access to cells to build on and design around as they consider all of these different components that they're working on in the laboratory so that ultimately our cell source becomes the standard.

I guess I can think of this in software terms of they'll be the applications writer and you're providing the operating system.

Yes. Look, if you want a parallel, I think the age of regenerative medicine, which has already begun, is just like the computer age that began back in the late '70s and the early '80s. And when the first PCs came out and they had this early primitive operating system on there for Microsoft, there wasn't a lot of applications.

There were a lot of pioneers out there who began to write things like games and spreadsheets and word processing and the early tools to make that computer platform useful. And over time -- we can't imagine today not having access to those computers and those tools, we use them in just about every way in our lives. They've changed really the way that we interact and we interact with the world.

This is the same thing. This change, this shift to the age of regenerative medicine has begun and the cell-based part of these therapies, the access to cells is the key ingredient. And we're getting our cell access out there to these pioneers, these early programmers, if you will. And they're developing the applications -- whether it's liver cirrhosis or acute kidney injury or cardiovascular disease or breast reconstruction or breast augmentation and so forth, they're developing these applications that are going to be the driver for this shift to cell-based regenerative medicine.

That's a good description. Thank you, Chris.

Thank you. And we have no further audio questions. I'd like to turn the conference back over to management for any closing statements.

Good. Thank you very much. As we were just discussing, I think cell-based regenerative medicine is here and Cytori stands alone in its capacity to serve this emerging market by providing affordable and practical products that enable clinical grade cells at the point of care for a wide variety of applications.

So far in this year we've already seen many patients treated for breast augmentation and breast reconstruction, but also patients have been treated for incontinence, facial rejuvenation, wound healing, implant salvage procedures, acute and chronic heart disease, and recently the first patient was treated for cirrhosis of the liver. In the coming weeks and months burn patients, kidney injury and kidney failure, peripheral vascular disease and many other important and devastating diseases will be added to this list.

At Cytori we're leading the way in cell-based regenerative medicine and today patients around the world are benefiting. Together with our strategic partners and our core Celution and StemSource products we strongly believe we are rapidly setting the standard for the point of care cell therapy. Thank you for your time today and your interest in Cytori Therapeutics.

Ladies and gentlemen, this concludes the Cytori Therapeutics first-quarter financial results conference call. If you'd like to listen to a replay of today's conference, please dial 800-406-7325 or 303-590-3030 with the pass code 405-9504. ACT would like to thank you for your participation and you may now disconnect.