Leigh Salvo - Westwicke Partners John Simpson - Founder & Executive Chairman Jeff Soinski - CEO Matt Ferguson - CFO.

Jason Mills - Canaccord Genuity Josh Jennings - Cowen and Company Chris Cooley - Stephens, Inc..

Welcome to Avinger Incorporated's Fourth Quarter 2015 Earnings Conference Call. [Operator Instructions]. I would now like to introduce your first speak for today Leigh Salvo, you’ve the floor..

Thank you, Andrew, and thank you all for participating in today's call. Joining us today is Avinger's Founder and Executive Chairman, Dr. John Simpson; CEO, Jeff Soinski; and CFO Matt Ferguson. Earlier today, Avinger released financial results for the fourth quarter and full year ended December 31th, 2015.

Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws which were made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Any statements contained in this call that are not statements of historical fact should be deemed to be forward-looking statements. All forward-looking statements, including without limitation are examination of historical operating trends and our future financial expectations are based upon our current estimates and various assumptions.

These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements.

For a list and description of the risks and uncertainties associated with our business, please see our filings with the SEC. Avinger disclaims any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements whether because of new information, future events, or otherwise.

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, March 01, 2016. I'd now like to turn the call over to Dr. John Simpson..

Thank you, Leigh. And following our FDA approval of our Pantheris product this year [ph] I would have to say that we’re exhilarated.

I want to say that exhilaration is maybe an understatement for the way we feel it upon on the approval of the first ever OCT-guided directional atherectomy catheter, and we welcome Pantheris to lumivascular family at Avinger. What a great journey, along the way we met many wonderful patients, physicians, staffs, and helpers.

Early investigative efforts started in [indiscernible].

I feel like it's important to acknowledge all of the individuals who have participated in this because at each stop along the way we made generally very valuable and important observations that have led us to the concept of how we perform directional atherectomies with OCT guidance and how we could make Pantheris better.

Today, we want to start by thanking all those patients and physicians who participated in our early research work and the VISION study in the US. None of this could have happened without them, and the entire Avinger team remains committed to better patient care.

Together, we’re making lumivascular a reality and lumivascular is the term we use to characterize directing interventions using OCT guidance, so each day this becomes an even more amazing journey.

Over and over again, we’re asked what makes Pantheris that different from all the other interventional catheters? We say there are many things of course but perhaps the most important is the camera.

This of course leads to the next question which is how do you make a camera that small? This then of course commits us to -- we have admit that this is not a traditional camera but rather a laser and fiber optic system that creates an image of the vessels what acts like a camera, but it's even better than a camera because it's not only seems from inside of the vessel, but it actually sees through the vessel wall, and this is the information that allows the physician to determine the distribution of plaque in the vessel wall with extraordinary accuracy, and target the treatment only on the disease portion of the vessel leaving the healthy portion of the vessel alone.

So, this information is not available from angiography or fluoroscopy and we have always needed to actually radically change the way vascular disease is treated.

So now that Pantheris joins the lumivascular family as the first commercially viable OCT guided directional atherectomy catheter in the U.S., actually in the world, we're getting closer to reaching our goal of changing forever the way vascular disease is treated and help make the vascular interventionist ever more efficient and more effective.

The commercial version of Pantheris now includes multiple ease-of-use provisions recommended by the VISION investigators, and it maintains the same imaging, cutting, and tissue management capabilities that is used in the original Pantheris.

The one new feature most related to ease of use in the commercial version of Pantheris is that the occlusion balloon used to help clear [indiscernible] from the OCT imaging field has been moved from the tip of a surface sheath to the shaft of the Pantheris.

This eliminates a separate sheath insertion, improves bud flow management while making the Pantheris more practical to use as a single operator. This has been the goal for us for a long time to make this a single operator type intervention. So in Europe, this has proven to be a very effective and welcome simplification.

Some doctors who have been our skeptics have said things like, okay so this is not as complicated as I was told, and it does not take as long as I thought. And then another doctor said, since this could require less tests by hospital, we will be very happy.

The above comments came from physician who attended the recent live telecast of the LINC Conference in Leipzig, Germany. Following the telecast of two live Pantheris cases by Dr. Arne Schwindt, we had a record interest from physicians about bringing live boxes into their hospitals.

Several physicians come in about preferring to purchase Pantheris rather than other planned atherectomy catheters that they were planning to bring into their lab. Those interventionists were impressed by Dr.

Schwindt as he performed these two live Pantheris cases, and he performed them as a single operator which, in each case takes about 20 minutes, and the ones that he used for the demonstration purposes, Dr. Schwindt also explained how the Pantheris provided the potential to reduce radiation exposure.

So safe, effective, not a lot of time, and hopefully less radiation are all favorable features individually, but together they are the foundation of our mission to radically change the PAD treatment forever.

My prediction is, we will look back on the live transmissions from LINC, in a year or two as the turning point in the lumivascular attack on PAD.

We've only just begun our attacks on PAD and developments are already underway for the next two Pantheris devices which include enhanced cutting capabilities and a lower crossing profile to treat distal lesions in smaller vessels. These will be exciting to update you on in the future.

And with that, I'll turn the call over to Jeff to discuss the recent Avinger business results and our plans for the coming year.

Jeff?.

Thanks, John. Good afternoon and thank you all for joining us. Obviously an exciting day for Avinger, and great to be able to share with all of you. Special congratulations and thanks to Dr. Simpson for the vision, and to him and the entire team here at Avinger who've been tireless in their pursuit of this goal.

Needless to say clearance and launch of Pantheris is a huge event for Avinger, and we're incredibly excited about the future. However I'd like to begin with a look back at 2015. 2015 was such an important year for Avinger.

During the year, we became a publicly traded company, made substantial progress on our product development goals, and significantly expanded our operational and commercial infrastructure. We successfully completed our VISION clinical trial, which supported the 510k clearance of Pantheris.

We increased the installed base of our lumivascular platform from 60 to 95 accounts, and we continue to expand programs to drive utilization of our currently available image guided catheters for CTO crossing. We also significantly expanded our sales and marketing infrastructure to support the U.S. commercial launch of Pantheris this year.

Our clinical experience with the first generation Pantheris in 2015 exceeded all VISION safety and efficacy end points leading to 510(k) clearance of the clinical version of the device in October.

All physician investigators were very pleased with the outcome, but most thought that ideally the catheter should be easier to use and the procedure should require less time. Based on this input, we immediately began working to incorporate their feedback into the second version of Pantheris, which was approved today.

This enhanced version of Pantheris which we are also launching commercially today addresses both ease of use and procedure time improvements as well as provides additional features such as lower crossing profile, 360 degree imaging, and improved manufacturability. Turning to the growth of our installed base.

We added 35 lumivascular accounts during 2015 to reach a total of 95 lumivascular accounts at the end of the year. This represents a greater than 50% increase compared to where we ended 2014.

In the third quarter, we continued to pilot and expand the light box placement to purchase option, which along with sales of light boxes led to 26 new lumivascular accounts added over the last two quarters. This was a notable acceleration compared to nine lumivascular accounts added in the first half of 2015.

In the fourth quarter, we added 13 new lumivascular accounts including five light box imaging consoles sold at new accounts and a net increase of eight lumivascular accounts installed under one of our pilot programs. Turning to sales and marketing, we recently added Joe Rafferty as Vice President of Sales.

Joe's a 30 veteran in medical technology, sales and marketing primarily with peripheral vascular and coronary products and procedures and we are delighted to have his leadership in this key role as we launch Pantheris.

During the year we expanded our sales force headcount from 32 to 57 increasing our sales force by 25 sales professionals or approximately 80% compared to the end of 2014. We have added and will continue to add infrastructure to support all of our new and legacy sales professionals.

We made the decision to bring more new hires on board in advance of the Pantheris launch to provide more time and opportunity for training on Pantheris.

We'll continue to build our sales force throughout the year depending on the requirements identified during the apt launch with our current plan calling for a total of 70 sales professionals at year end.

We've also been focused on preparing our lumivascular physicians for the launch of Pantheris to-date using Cadaver Lab and observation of actual cases in Europe we've trained over 100 U.S. positions on the use of Pantheris. With that I'll now turn the call over to Matt who will review our Q4 financial results and provide guidance for 2016.

We will then review our key objectives for 2016 and open the call for your questions.

Matt?.

Thank you, Jeff. Total revenue was $2.9 million for the fourth quarter ended December 31, 2015, 7% decrease from the fourth quarter of 2014 and 5% increase from the third quarter of 2015. Lightbox imaging console sales were $1.2 million, a 19% decrease compared to the fourth quarter of 2014 and a 37% increase from the third quarter of 2015.

Revenues from disposable devices were $1.7 million, a 4% increase compared to the fourth quarter of 2014 and an 11% decrease from the third quarter of 2015.

Revenue results in the fourth quarter of 2015 reflect an increased focus on expanding and training our commercial organization and growing the number of lumivascular accounts in anticipation of the U.S. launch of Pantheris. Gross margin for the fourth quarter of 2015 was 37%, down from 49% in the comparable quarter of 2014.

This decrease was primarily attributable to the growth of the our manufacturing infrastructure again in anticipation of the Pantheris commercial launch in the current quarter. Operating expenses for the fourth quarter of 2015 were $13.4 million compared to $8.5 million in the fourth quarter of 2014.

This growth was primarily attributable to Pantheris development expenses, expansion of our commercial organization and increased expenses associated with operating as a publicly-traded company. Loss from operations for the fourth quarter of 2015 was $12.3 million, compared to $7.0 million for the fourth quarter of 2014.

Net loss for the fourth quarter of 2015 was $13.5 million compared to $8.2 million in the fourth quarter of 2014. Adjusted EBITDA, which is a non-GAAP measure, was a loss of $9.8 million for the fourth quarter of 2015, compared to a $6.5 million loss for the fourth quarter of 2014.

Turning to our balance sheet, Cash and cash equivalents totaled $43.1 million as of December 31, 2015, compared to $12.3 million as of December 31, 2014.

In addition to our current cash balance, the debt transaction we completed in September also allows us to drawndown an additional $10 million anytime through the end of the second quarter of 2016 and it also provides for an additional tranche of $10 million based on achieving a minimum of $25 million in trailing 12 month revenue by the end of 2016.

This access to additional capital which is at our option significantly increases our flexibility as to when we return to the equity markets to raise additional capital.

Turning now out to our financial guidance for 2016, 2016 revenue is expected to be in the range of $25 million to $30 million, representing year-over-year growth ranging from 134% to 180%. A revenue forecast assumes expansion of our installed base of lumivascular accounts to approximately 150 by year end.

It also assumes an immediate initiation of Pantheris sales since we’re just 30 days from the end of the quarter we expect Pantheris to contribute modest revenue this quarter and then ramp steadily from there as we move through the year. Gross margin will also reflect a significant continued ramp up of our manufacturing infrastructure.

For the year we expect gross margin to be in the range of 40% to 43% however due to continued ramp up cost in Q1 we expect a significantly lower gross margin in the first quarter at approximately 20%.

Adjusted EBITDA for 2016 is projected to be a loss of $40 million to $43 million as we further invest in the development of our lumivascular platform product and continue to expand our commercial infrastructure. Net loss per share for 2016 is projected to be $4.35 to $4.55 and this assumes a weighted average share count of 12.8 million.

And at this point we will now turn the call back to Jeff for closing remarks..

Well I hope you can take away from our call how excited we all are about the year ahead for Avinger. Our number one priority for 2016 is a successful U.S. launch of Pantheris taking advantage of our growing sales force and our expanding installed base of lumivascular accounts. As Dr.

Simpson mentioned we will continue our design and testing of Pantheris catheters with enhanced cutting capabilities and lower profiles to treat below the knee vessels and to further expand our market opportunity.

In addition we will evaluate our options for comparative clinical trials as we continue to build the clinical body of evidence in support of our lumivascular approach for the treatment of PAD. And at this point We'd like to open the call for your question..

[Operator Instructions]. Our first question comes from the line of Jason Mills from Canaccord Genuity. Your line is open..

So I'd like to start with sort of a 20,000 feett question, it's been a bit over a year since you executed your initial public offering, and I was wondering if you could give your current perspective on the competitive landscape in peripheral intervention as you get set to launch Pantheris immediately in the market relative to what you saw a year ago when you went public, and just sort of what you see is the opportunity initially for Pantheris in the US, I guess, specifically..

Yes.

Just let me start off and give my, from a talker [ph] perspective, and then Jeff and Matt can certainly add in more of the business perspective, but I think that right now we're seeing reports coming in from all of the different devices that are being used to treat peripheral artery disease, right, and I think we see that drug eluting balloons have -- there's a little bit reality check on drug eluting balloons, you know they definitely make some improvement, but the drug eluting balloons need help to travel across the border, there are several trials that are ongoing to look at atherectomy.

Followed by drug eluting balloons, and of course my position is that atherectomy by itself done correctly with Pantheris will not require the drug eluting balloon to be used nearly as often, perhaps [indiscernible].

There is also some risk of using the drug eluting balloon after aggressive atherectomy if you cut too deep in the artery wall, then you can get aneurisms because the drug that’s on the balloon is there to prevent scarring and healing from occurring and that's really required if you've cut too deep in the artery wall.

So I think overall the landscape is more favorable for us now than it might have been a year ago, because I think at that time the drug eluting balloon was thought to a panacea and that’s well-established now that it is actually just not the case.

It's certainly not a panacea but it could have relevance and I wouldn't exclude it from saying that it cannot be used after our device, but I think it is not going to be required nearly as often and I think also the interest in trying to find some way to avoid stents is increasing because as the stent dwelve time I’d say in the patient increases, fractures increase.

As fractures increase, then restenosis increases and stent failure increases. So I think that it's really favorable for us and I don't think that it's -- I don't think it's just my imagination.

I think if you look at the doctors who never really want to put a stent in, if they can avoid it they would, and the hospitals love that because they definitely have to pay for this task.

Now, the issue that I think that is not as well appreciated as maybe some people make is that the radiation exposure reduction associated with the potential – we haven't really documented that currently, but certainty it will occur in my mind eventually that we can just do this without nearly as much radiation, and that has to be just a huge driver for the interventional group as far as I can see and sort of that’s the way I look at it.

I think the bloom is off the [indiscernible] drug eluting balloons, they do have value but they're not a panacea, nobody wants to put in a lot of stents, and they like to do stuff with less radiation, I think we give that -- that is the option that we actually provide that is really, really, really totally unique..

I think that was very comprehensive answer from Dr.

Simpson, but maybe just add a couple of things to that clinical perspective is, first of all as we look at the market I think we continue to see a high degree of interest and strong growth with directional atherectomy and the significant debulking that directional atherectomy can provide versus more of a vessel prep approach that would be followed by some kind of a adjunctive treatment.

It's also very exciting about the landscape that we enter is that we are a familiar device to the degree that we are a directional atherectomy device, but we provide the additional empowerment of real time visualization which has the direct clinical results that Dr.

Simpson speaks of, but it also empowers the position to make better decisions as to what they want to do next.

And so just as we have this powerful clinical proposition, we think we're extremely well positioned and very much on trend with the focus on safety and quality based metrics in health care institutions, and we’ve talked at previous calls about our economic value proposition with less need for retreatment because of less restenosis, with less need for adjunctive therapy because of the empowerment of visualization enabling you to the physicians to not damage the vessel but also to see how they left the vessel and then less exposure to radiation which I think in the past year has become even more of an issue in the institutional setting as well as the strong desire to reduce exposure to contrast media for patient.

So it all comes together I think both on a clinical proposition basis and in economic value proposition basis, and we're committed to developing data to support both..

Just two follow ups and then I'll get back in queue. The first, your guidance for how the installed base will grow over the year? It seems pretty obvious that you've taken sort of the last couple of quarters run rate at 13 and annualized that to get to right around 50 or little above 50.

Should we be thinking about the new customers in that linear fashion is the first question or will be more front or back end loaded for whatever reason, and then secondly you mentioned also some of the development work you're doing both below the knee Pantheris lower profile and also you've talked in the past about a calcium cutting device as well as a longer term in coronary.

Can you give us any more granular detail on the commencement of trials or registries or things that would move you towards an approval in any of those areas over the next couple of years as well. Thanks a lot. Congrats on the approval..

Why don't I start with the build install base and then let Dr. Simpson speak to the pipeline products. But you know as we developed our forecast and our program for 2016 you know I think we took a very thoughtful and grounds up approach.

When we look at building our installed base we do believe that we will continue that as you pointed out that accelerated pace of adoption based on now Pantheris being available as well as the larger sales force but also the fact that we've introduced or added more flexibility into the Lightbox acquisition model.

Both are placement of purchase option which we've talked about on past calls as well as now the introduction of a rental model with the approval of Pantheris. So that will enable us to continue to accelerate, I think the expansion of the installed base throughout the year. We don't see that as a hockey stick kind of build.

We are focused on our sales force I think is doing an excellent job on prioritizing targeting the right hospitals and outpatient labs where physicians who are committed to the benefits of the lumivascular approach, physicians who want to build their practice working with us and who we think can really even add to our knowledge and share data and experience as we refine our products and programs.

So our long term goal is to be the leader in this space and ultimately to change the standard of care for PAD and we think an important part of that is targeting the right physician and prioritizing getting on board with folks who really want to be part of this lumivascular revolution.

So I guess the simple answer is we don't see this as a hockey stick, we see it as an accelerating pace of expansion but throughout the year..

I would maybe just briefly address the issues associated with the calcium cutter. I think I’ve helped develop calcium cutters for many years so I feel pretty comfortable with that.

But I don't think that our device that we're talking about more efficient cutting, definitely would be calcium would be a part of more efficient cutting but will not be restricted to just calcium.

I think we have there are other things that we would like to explore which we’re actually exploring in and probably some of that will be OUS, we'll explore issues within stent stenosis, with this restenosis period. Calcium, smaller vessels, below the knee all those things I think are up for grabs.

I feel confident that we have the best device you can ever imagine to do execute on the promise of been able to treat [indiscernible] and also small vessels where it'll be very careful with the vessel while you treating, all the below the knee vessels fall in that category and then once those devices are more formally evaluated and we have more confidence in them and particularly the small device will be very similar to what we would expect to be is in the coronary arteries and as per timelines and that would be great if I could really give you timelines and I would like to do that, but I don't think I could do that really rationally at this point but tell you that for sure.

We're fully capable of doing this, we’re actually working on it as we speak..

Our next question comes from the line of Josh Jennings from Cowen and Company..

I wanted to first ask just about the launch.

You had some time to train a 100 doctors and get some more accounts to adopt the Lightbox, just wanted to -- I was curious within those 100 doctors any kind of directional relay on how many accounts have been trained, any guidance around we should expect to train by the end of '16 and just any more color on the training process and is there anything within the label from a training perspective that needs to be completed for a physician before they start moving forward with full scale adoption?.

Let me start off by talking about their physician trainings. As you may recall our generation one device, our first device had a balloon on a separate sheet that we use to include the blood flow so we can really get good OCT images and it was one of the frustrating parts of the procedure and we've eliminated that completely.

So that blend now has been moved away from the sheet, the tip of that sheet, now it actually sits on the Pantheris catheter itself and it's a much more efficient, and a much more effective to for managing blood and providing -- images are better. The cases are easier and now than the training of the physician is a lot easier.

So as it relates to the question I think that we’ve seen this already in training the docs and the cat labs also watching the cases in Europe, that there really are surprised, generally surprised that that this is simpler than they could have imagined it to be based on their early experience and the separate sheet with a separate balloon for inclusion that just added some complexity to the procedure that everybody went give it a try and are thrilled with the way that has been dealt with.

So I think that translates into easier to train physicians and I'm excited -- I can't tell you exhilaration is really such a not an adequate term to say how excited we’re to get the cases starting, our goal is to start the cases tomorrow and so we will hopefully -- and these will be docs that had been looking at finding cases for us and it's interesting too because mainly the doctors have cases that they've wanted to actually wait for Pantheris only because it's safer and it's safer and it's more effective than anything that they could provide right now and I think the training is going to be really good, it's going to be exciting and I think the world is ready for it.

It's a little bit of a shockwave, I think for some of the people but I couldn’t be more excited and confident that the training is going to go well..

And speaking Josh, to kind of some of the number questions you asked. When you look at the number of physician we've trained compared to our current install base, our install base at the end of the year. We've trained physicians representing more than 90% of our current lumivascular accounts. And so we took full advantage and Dr.

Simpson challenged the organization to take advantage of that early clinical approval of Pantheris so that we can move this process forward. The training session that we executed with a couple of hours, the didactic training session followed by hands on Cadaver Lab.

We did these in regional centers around the country so that we could make it easy for travel for the physicians and but there was a large degree of commitment for these individuals to join us for this training session. And the feedback was extraordinarily positive coming out of every session.

So we think we've done a good job preparing at least kind of the lead position user in these accounts prior to the launch of Pantheris. As we grow our install base throughout the year of course there will be the opportunity to train physicians within each of those accounts, we put out a target of approximately 150 accounts by year end.

But we also will look to continue to expand the usage within hospitals by training additional physicians.

So we're not guiding to a specific number of trained physicians by the end of the year but it is something that we are focused on in addition to providing opportunities for advanced training and continued training of our current lumivascular physicians.

One other thing that we did in the fourth quarter that I think was extremely useful and will help us through this launch period of Pantheris is we took several of our physician investigators, 12 of our physicians over to Europe where they could observe live cases with the commercial version of Pantheris and they were well prepared and have been very involved in these training sessions to service physician proctors for new lumivascular or those positions who aren't as familiar with atherectomy or image guided atherectomy which is brand new.

So we will continue to make that investment, we have invested at the same time in training and continued training and improved training of our sales force and we’ve talked about that on past calls but everything we've been doing really over the last quarter has not only been about continuing to build the install base, driving experience with [indiscernible] but preparing for this day today, the launch of Pantheris..

And I just wanted to follow-up on prepared comments and prepared remarks just about or maybe it was an answer to Jason's question about the clinical evidence development strategy and -- are there any further thoughts in terms of moving forward with any further clinical trials and/or on the clinical effectiveness or cost effectiveness?.

So we do have clinical trials that are underway that we’re restructuring, I can't say that we started the trial but yet we have a trial.

The first one will be at radiation reduction trial, so we will be looking at the reduction in time required and I'm sorry radiation exposure required to do Pantheris procedures versus ocelot and that will be kind of first trial that I think you'll see we certainly have trials that we’ve talked about it a lot with everyone I think having a randomized comparison between our device versus the other atherectomy catheters and/or doing a Pantheris procedure and then at the end of that procedure randomized patient then drug related balloon more Pantheris, more atherectomy would be another thought.

But these are all -- they're discussed aggressively on a daily basis but I think it would be inappropriate right now to actually put any timelines on that -- I except that to say maybe that the radiation reduction study is imminent..

And I think the one additional study that you're referring to, Josh is we have talked about and we are well along in our plans to initiate a clinical trial focused on these quality based metrics and the economic benefits of Pantheris in partnership with a large capitated system.

So as we get further along and closer to enrollment in that study we will share more news and certainly announce when we begin enrollment..

And last question just on guidance, I know you don't want to give specifics on your assumptions between capital and revenue but any incremental directional help would be appreciated and maybe just if you could let it -- one of your instructions that the capital revenues or capital sales are going to grow year-over-year in ‘16? Thanks a lot and congrats again..

In terms of our capital sales versus disposable, we really are I think moving more and more now that Pantheris approved to be in a company that is driven by disposable sales and less so by capital sales which is maybe more where we've been over the last couple of years and I would say inherent in our guidance when you look at going from 95 accounts at the end of 2015 up to a total of 150 by the end point of 2016.

We would assume probably somewhere in the quarter to a third of those would be sold Lightboxes or capital sales and others would take advantage of one of our placement to purchase programs or rental program or something along that line.

So the result I would expect that without giving a specific number for capital sales I wouldn't expect an increase there necessarily that most of the increase would be driven increase in our overall sales would be driven by disposable sales primarily Pantheris..

Our next question comes from the line of Chris Cooley from Stephens, Inc. Your line is open. .

Let me just maybe go back I want to clarify a prior question and maybe look into 2016 a little bit more and has your position changed regarding the potential timing for let's call a gen-3 Pantheris from around the calendar year-end this or is that just maybe just semantics and your responses, they are premature I think is how you phrased it to kind of outline a timeline for that next gen lower profile and potentially more efficiency calcium cutting devices, I just want to make sure I'm clear on the expected timing for that gen-3?.

So we have active programs that are ongoing and we're excited about that. I think we would expect that those -- that the innovation in that space is going to be tested OUS which is we've almost always done and as some of the stats that we outlined earlier mostly in Munster [ph] is my guess.

And I think that we like to be able to give you timelines but I think it's a little bit premature until we have a little bit more visibility on -- we know that these devices are the designs have been pretty much completed and that they are manufacturable and that and they're testable as soon as we get all the forms fill out it if you, so it's more of that than it is any significant iterative risk I would think and the designs but -- you'll see some good information but I think it's a little bit early to offer -- for me personally I don’t feel comfortable giving any timeless but I don't think we have very good visibility on that but we do have some assumptions and that has a sheet in front of him now that he must be reflecting on that.

As he is looking at something with numbers..

Well surely I'm not going to share everything but I guess I would say Chris that we -- and the guidance that we gave as far revenue we’re assuming any specific contributions from new devices beyond this version of Pantheris that was just approved today.

So no additional expansion of our addressable market based on having a device for cutting calcium or below the knee treatment during 2016, that’s our assumption..

Can I drawn an analogy here, this is probably totally inappropriate in a call like this but the question that has just been posed seems to me like a little bit like asking the guy that team that just won the NFC Championship, what are their thoughts on the Super Bowl and they want to just celebrate winning the NFC Championship for a night and so I'm a little bit in the mode of I'm so thrilled and/or exhilarated, I don’t know what the right term is about getting this milestone because you know we've been pursuing this for more than years and years and years.

So that doesn't mean that I'm not cognizant of the challenges in front of us with calcium cutting and stent resources, just resources period. We need to take those chances on but sort of -- we’re celebrating the NFC Championship..

I guess just my follow-up then as it pertains to the 2016 guidance.

Matt, could you maybe give us a little bit of better feel for the disposables between what we're seeing from Pantheris versus what we would see on the CTO side? And then maybe similarly now you have a new Head of Sales fully in place, added reps, kind of talk to us about maybe some of the metrics that you're holding them to as they go through the year in terms of productivity with an existing accounts as well as account expansion, just kind of maybe walk us through some of that with broad strokes.

Thanks so much..

Well in terms of catheter sales and how we think about it, we really do think about it as a total lumivascular opportunity within each account and specifically given that every account that have acquired a Lightbox through any of our various programs has already expressed and they've already shown interest in us a lot by using it and getting success with it so far.

We would expect that that would continue to be an important part of our overall portfolio. And we think a lot and talk a lot about ways that we can provide motivation and incentives for when there is a CTO for both ocelot and Pantheris to be used in the procedure.

All of that said the opportunity is clearly much larger in the atherectomy space and we see it as probably four to five times larger just in terms of the overall market opportunity.

Now we might have to discount that a little bit because we can't address the entire market at this point, we kind of think about being able to address about half the market for atherectomy cases to start out with but you know as a result we do think of the Pantheris opportunity and the Pantheris sales in 2016 as being a multiple of what we've been able to do with ocelot so far and what we'd expected it to be going forward..

It's also fair to share that -- so we will leave tonight to start the cases tomorrow and the number of patients that have been signed up by the doctors is that same multiple that Matt is just talking about.

So they can find a couple of ocelot cases that was great for their first experience and you know we're talking about eight or nine Pantheris first cases in a lot of hospitals because the prevalence of the disease that is treatable with the Pantheris is much more common than the CTO prevalence and the treatment of the CTO.

So I did expect that based on all the equation that we have and the doctors that, we have three doctors that are claiming to do the first cases tomorrow.

And I think we can probably do if we did all the cases we can do 15 cases tomorrow if we did -- there is no chance that we are going to be able to do that but this never occurred with the ocelot or with the balloon angioplasty of ACS or DVI device back in early the atherectomy days either..

Chris, I know you’re aware of the powerful data of course small numbers but very strong results, positive results we got in CTOs or legions as far as the CTOs in our vision trial.

Not only in terms of delivering a TLR rate by legion equivalent to the legion set overall, at only 6.5% but also only having one stent placed in 33 CTOs and so we think it may excellent sense to have a total lumivascular approach and as Matt talked about we’re exploring promotional opportunities such as procedural pricing etcetera to stimulate that but it just makes sense across the CTO to say inside the true lumen and set it up perfectly for a treatment with Pantheris.

And I think with those expanding in small base with lumivascular being used in more procedures because of atherectomy that we will get an uptick on our ocelot because it's about 20% of legions start out as the CTO.

The primary driver of growth on the proposal side of the business and the business that we’re all is Pantheris but I believe ocelot will benefit as well. That is a terrific device..

[Operator Instructions]. Your next question comes from the line of Steve Lichtman from Oppenheimer. Your line is open..

This is Dennis Keller [ph] filling in for Steve.

Just two questions, just to confirm and understand there are trials underway, will there be any data presentations or posters at the cardiovascular conference this year?.

So as we look at -- first of all we will have a strong presence at the different conferences this year.

We’re going to be at OIS, we will be NCVH, SVS, PVC, SCAI, VIVA and PCT, although I'm not sure if we will have a booth at TCT, we will have a presence there and as well as regional shows and so you know we will continue to develop data even at LINC I'm not sure if you saw any of that, Steve.

Some of our physician investigators and partners in Europe who have been using Pantheris did present their own single site data. We think there will be more opportunity for either our U.S. based or European based Former VISION investigators or early lumivascular adopters to develop and present some of their own data.

And then as we move into the second half of the year hopefully we'll have some additional data to present from some of our ongoing studies but we will put more precise timelines out as we move forward throughout the year..

Secondly for Matt, just what kind of accelerate in ocelot are you assuming in your '16 guidance? Or is that would that be largely be upside?.

We have assumed only modest changes in ocelot from year-to-year just given the trend that we've been over the course of 2015 but I do think there is a lot of opportunity that probably does represent some upside potential to the numbers that we gave but I think there's a lot of focus on Pantheris right now.

There are a lot of good results and potential with ocelot as well and I think we'll just have to see as we have products in the market and how the mix plays out..

You should expect to see some a lot of single center presentations because everybody want to talk about their Pantheris experience in the early going and it will be -- I think a lot more interesting to the academic and scientific community than the ocelot..

Thank you. That's all the questions that we have in the queue at this time. So I would like to turn the call back over to management for closing remarks..

Well thank you very much for joining our call this afternoon. It's not only an exciting time, it's an exciting day for Avinger as we commence commercial launch of Pantheris. We appreciate your interest in our company and your continued interest in our progress. Thank you very much. .

Thank you..

Ladies and gentlemen, thank you again for your participation in today's conference. This now concludes the program and you may all disconnect your telephone lines at this time. Everyone have a great day..