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Executives

David Drachman – President and Chief Executive Officer

Julie Piton – Vice President - Finance and Administration and Chief Financial Officer

Analysts

Tom Gunderson – Piper Jaffray

Jason Mills – Canaccord

Matt Dolan – Roth Capital

Charley Jones – Barrington Research

Jan Wald – Morgan Keegan

Larry Haimovitch – HMTC

AtriCure, Inc. (ATRC) Q2 2011 Earnings Conference Call August 2, 2011 10:00 AM ET

Operator

Good morning and welcome to AtriCure Second Quarter 2011 Earnings Conference Call. My name is Regina and I will be your coordinator for the call today. At this time, all participants are in listen-only mode. We will be facilitating a question-and-answer session toward the end of today’s call. (Operator Instructions) As a reminder, this call is being recorded for replay purposes.

And I would now like to turn the call over to Mr. David Drachman, President and Chief Executive Officer of AtriCure. Mr. Drachman, please proceed.

David Drachman – President and Chief Executive Officer

Thank you, (Regina). Good morning and welcome to our second quarter earnings conference call. Joining me on the call today is Julie Piton, Vice President of Finance and Administration and Chief Financial Officer. At this time, I would like to turn the call over to Julie for a few introductory comments.

Julie Piton – Vice President - Finance and Administration and Chief Financial Officer

Thank you, Dave, and good morning, everyone. By now, you should have received a copy of the earnings press release. If you have not received a copy, please call Sarah Luken at 513-755-4136 and she will fax or e-mail you a copy.

Before we begin today, let me remind you that the company’s remarks may include forward-looking statements. These statements include, but are not limited to those that address activity, events, or developments that AtriCure expects, believes, or anticipates will or may occur in the future such as revenue and earning estimates, other predictions of financial performance, launches of new products and market acceptance of new products.

Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond AtriCure’s control, including, but not limited to the rate and degree of market acceptance of AtriCure’s products, governmental approvals and other risks and uncertainties described from time-to-time in AtriCure’s SEC filings.

AtriCure’s results may differ materially from those projected on today’s call and AtriCure undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additionally, we will refer to non-GAAP financial metrics. A reconciliation of these non-GAAP measures is included in our press release, which is also available on our website.

I would like to remind everyone on the call today that the Food and Drug Administration, or FDA, has not cleared our products for the treatment of atrial fibrillation or AF or for stroke reduction. The company and others acting on its behalf may not promote any of its products or train doctors for the surgical treatment of AF or for stroke reduction. These restrictions do not prevent doctors from student to use the products for the treatment of AF or stroke reduction or prevent AtriCure from engaging in sales and marketing efforts that focus only on the general attributes of the products for the current cleared uses. AtriCure educates and trains doctors in the proper use of its products and related technologies.

With that, I would like to turn the call back to Dave.

David Drachman – President and Chief Executive Officer

Thank you, Julie. Second quarter 2011 revenue was a record $16.8 million, an increase of $2.6 million or 18% over first quarter 2010. U.S. revenue was $12.7 million, up 7% and international revenue was a record $4.1 million, up 75%. These results reflect our commitment to execution, the impact of our outstanding product portfolio, and strong performance from Europe and Asia. Additionally during the quarter, we advanced our clinical regulatory and product initiatives, all of which positioned us to continue to achieve our near and long-term strategic priorities.

In reviewing the quarter in more detail, U.S. revenue increased 7% to $12.7 million driven by sales of the AtriClip system. U.S. ablation revenue decreased approximately $400,000 or 4% compared to the second quarter of 2010, which reflects a reduction in sales of our products used in minimally invasive procedures, partially offset by an increase in revenue from the sale of open-heart ablation products. The reduction in revenue from products used in minimally invasive procedures is partially a result of our plan to focus our U.S. sales organization and capitalizing on our first mover advantage with the AtriClip system, which is resulting in opportunities to increase adoption and share gains from open-heart ablation products.

In addition, during the second half of 2010 we made a proactive decision to limit our physician ablation training activities to FDA regulated clinical trials, which we believe has had the most significant impact on the physician adoption a product used in minimally invasive and hybrid procedures.

Sequentially revenue from minimally invasive products increased approximately $400,000. However, we continue to anticipate a decline in revenue from products used in minimally invasive procedures during 2011. But we project a return to growth with the commencement of our DEEP AF pivotal trials, which we anticipate initiating during the second half of 2012. We believe the transitioning from to [60s pivotal] site to approximately 35 pivotal investigational sites will expand our presence in the marketplace.

During the second half of the year, we expect the short-term moderation of minimally invasive trends to be more than offset by growth from the AtriClip system and market share gains in our open-heart ablation business, resulting primarily from new product introductions supported by an expanded sales force, enhanced training programs and strong momentum from our international markets.

AtriClip sales in the U.S. were $1.3 million. We are successfully executing our clip launch plan. To date we have received reorders from approximately half of our top 250 ablation accounts and during the quarter 30 new accounts reordered the clip. AtriClip sales were modestly down on a sequentially basis. We believe second quarter AtriClip sales were impacted by the significant investment of time required by our U.S. sales force to execute the Synergy Access and ICE BOX user preference evaluations both of which were completed during the quarter.

In addition, we implemented enhanced sales training activities to support these two products and our expanding product portfolio. As we look to the second half of 2011, we believe that AtriClip utilization will increase and sales will strengthen.

Revenue from our international markets was a record $4.1 million, up 75% over the second quarter 2010. We are encouraged by these results as we believe they reflect our investments in the expansion of our direct sales force in Europe, our focus on expanding the adoption of our minimally invasive product s and then increased in sales momentum from Asia. We are increasingly optimistic about our opportunities and progress in our international markets and we believe that our recent investments and ongoing efforts will continue to drive growth.

Now, turning to our investments in FDA approvals and clinical science, as you may recall the ABLATE clinical trial is designed to expand the product labeling of our core Isolator Synergy system from the ablation of cardiac tissue during cardiac surgery to include the treatment of atrial fibrillation. During the second quarter we worked interactively with the FDA and our physician advisors to respond to questions we receive from the agency during the first quarter of 2011.

Based on discussions with FDA, we are currently preparing for a panel meeting, which we anticipate will be scheduled in the near-term. In addition, we continue to enroll patients in our FDA approved ABLATE AF registry. To date we have enrolled 20 patients. We plan to complete enrollment of this 50-patient registry during the first quarter of 2011. We believe that the ABLATE AF registry along with the overall body of clinical evidence will support the conclusions of our ABLATE clinical trial in an AF indication. Meanwhile, we are preparing our educational and training plans in anticipation of a mid-year 2012 atrial fibrillation approval.

In terms of our DEEP AF feasibility trial, we enrolled our first patient in December 2010. To-date, 17 of the 30 patients approved for the trial have been enrolled. Our investigators are highly encouraged by the acute results and initial outcomes. We expect to complete enrollment in the DEEP AF feasibility trial during the first quarter of 2012 and initiate our pivotal trial during the second half of 2012. We believe that the initiation of our DEEP AF pivotal trial and the expansion to approximately 35 pivotal investigational sites will be an inflection point for our business.

With respect to our plans for our stroke clinical trial and support of the AtriClip platform, this week we are submitting an IDE for feasibility trial, which utilizes our current generation AtriClip system for minimally invasive sole therapy placement. The feasibility trial will evaluate the initial safety and effectiveness of the AtriClip system to protect against stroke in patients with non-valvular atrial fibrillation who are not suitable for anticoagulation therapy. We estimate the potential market for a standalone AtriClip system in the U.S. to be a multi-billion dollar opportunity.

Notably, effective October 1, 2011, the ICD-9 procedure code for surgical exclusion of the left atrial appendage will be expanded to include sole therapy, thoracoscopic, mini-thoracotomy, percutaneous, endovascular, and/or sub-xyphoid approaches. ICD-9 procedure codes are used by hospitals to report surgical procedures performed in the in-patient setting and are assigned to clinically relevant DRGs.

The medical severity DRG assignments for sole therapy left atrial appendage procedures reported with ICD-9 codes 3736, our pending release of Medicare’s full year 2012 in-patient prospective payment system final rule. This is expected to be published in the Federal Register this month and become effective in October of this year. CMS approval of hospital reimbursement for sole therapy thoracoscopic left atrial appendage procedures is a major step forward and is expected to reduce the cost of our clinical trials. We are currently planning to initiate our feasibility trial in the U.S. during 2012.

Moving to our planned product releases and pipeline, we recently received 510(k) clearance for our next generation open-heart bipolar radiofrequency clamping system, Isolator Synergy Access. Synergy Access has several competitive advantage including articulation with a pivoting clamp allowing surgeons to more easily position the clamp. Synergy Access provides our U.S. sales organization with the opportunity to gain new momentum in ablation market share.

During the second quarter, we completed our user preference evaluation process and at the end of the quarter we moved to full commercial release. Additionally, we received 510(k) clearance during the second quarter for the trial ICE BOX and completed our user preference evaluation in the U.S. and Europe. As a result of the user preference evaluation, we made minor modifications to ICE BOX, which required an additional 510(k) filing. In Europe, the modifications to ICE BOX were classified as minor changes. We completed the product modifications and recently launched the ICE BOX in Europe. We anticipate full U.S. commercial release by the end of the current quarter. As a remainder the ICE BOX places the ablation controls with the physician and simplifies the use of our cryoablation platform. ICE BOX replaces our existing cryo generator, which was part of our 2007 acquisition of the Frigitronics product line. It was designed and developed over 20 years ago.

The existing Frigitronics generator is technically challenging to operate, which has limited our ability to penetrate a significant number of new cryoablation accounts. We strongly believe that the ICE BOX in combination with our cryoICE ablation pro believe to share gains and growth in the U.S. and European markets.

In addition during the first half of 2012, we plan to launch an innovative disposable cryo-ablation platform ACE. The ACE is a novel cryo-ablation probe designed for less invasive open-heart approaches and can be positioned with grasper or robotically. We believe that the ACE cryo-ablation probe will further position AtriCure as the market leader.

Furthermore, during the first half of 2012, we plan to release a highly featured thoracoscopic self-therapy AtriClip platform for use in clinical trials. We believe that this innovative version of the AtriClip system will facilitate regulatory approvals and the long-term commercialization and widespread adoption of this novel epicardial approach.

As affirmation of the AtriClip opportunity in July we awarded $1 million grant the Ohio Third Frontier in support of the development and commercialization of self-therapy thoracoscopic AtriClip system. Over the last year, we have successfully secured approximately $2 million in support of further advancing our leading technologies.

Now turning to other business updates. During the quarter, we went through a process of rationalizing our product offering in anticipation of our growth trends in our expanding product portfolio. As a result, we made a decision to discontinue manufacturing our Coolrail device, which was recently replaced with our multifunctional linear probe.

In addition, we plan to discontinue our Cryo1 device, which is being replaced with our cryoICE ablation probe. As a result of these decisions, we recorded approximately $250,000 or 150 basis points in nonrecurring expenses, which had a negative impact on gross margins for the quarter.

I would now like to turn the call over to Julie for review of our financial performance.

Julie Piton – Vice President, Finance and Administration and Chief Financial Officer

Thank you, Dave. I will begin today by providing information related to revenue. For the second quarter of 2011, revenue increased $2.6 million or 18% to $16.8 million. Revenue from product sales in the U.S. grew approximately 7% or $800,000 to $12.7 million.

Revenue from ablation related products sales in U.S. decreased by approximately $400,000 driven by decrease in sales of minimally invasive products. This decrease was partially offset by modest increase in revenue from open-heart ablation products. U.S. sales of the AtriClip system during the quarter were $1.3 million as compared to approximately $100,000 in the second quarter of 2010.

International revenue grew to a record $4.1 million reflecting a 75% increase or 63% on a constant currency basis over the second quarter of 2010. The increase in international revenue was driven primarily by growth in our direct European market as wells as an expansion in select Asian markets.

Our European growth was due to increased product sales in our direct markets and an increase in average selling prices or ASP driven primarily by going direct in the Benelux region during the third quarter of 2010. As a reminder, the second quarter of 2010 did not include revenue from the Benelux in anticipation of transitioning that market to a direct market.

Now, turning to gross margin, gross margin for the second quarter of 2011 was 73.2% as compared with 79.1% for the second quarter of 2010. The change in gross margin was primarily the result of an increased mix of revenue from the AtriClip system, which initially has a lower gross margin than our other single used product and increased mix of capital equipment sales and an increased mix of international sales from 16.5% of revenue for the second quarter of 2010 to 24.5% for the second quarter of 2011.

Sales international customers have lower ASP and the resulting lower gross margin than our U.S. product sales. Additionally during the quarter, margins were negatively impacted by non-recurring write off and expenses for obsolete inventory of approximately $250,000 or 150 basis points, due primarily to the plan discontinuance of Coolrail and Cryo 1, which have been replaced with next-generation products.

We continue to anticipate gross margins on a quarterly basis to be in the range of 74% to 77% with variations driven primarily by product mix, including capital equipment sales and the mix of revenue from international sales. For the next half of 2011, we would expect gross margins to be on the low end of that range however, due primarily to anticipated sales of cryoICE BOX and sales of Synergy Access, which has higher cost of goods than our other claims.

Next, an update on operating expenses. Operating expenses increased 12% and 18% increase in revenue from $11.7 million for the second quarter of 2010 to $13 million for the second quarter of 2011. Research and development expenses, which include clinical activities, increased 19% or approximately $450,000 from $2.4 million for the second quarter of 2010 to $2.9 million for the second quarter of 2011. The increase in R&D was primarily due to increased costs in support of our clinical trials and regulatory activities.

SG&A increased 10% or approximately $930,000 driven primarily by an increase in headcount and travel related expenses associated with the expansion of our worldwide sales and marketing team. Our operating loss for the quarter was approximately $800,000 and adjusted EBITDA was approximately $500,000. Our net loss was approximately $950,000 and our net loss per share was $0.06.

Now, turning to cash and few balance sheet items. In terms of cash from operation, year-to-date our cash used in operations by $1.4 million to approximately $500,000 due primarily to a reduction in our net loss and reduction in cash used and support of working capital needs.

Additionally during the quarter, our class action lawsuit was finalized and as a result our other assets and accrued liability each were reduced by $2 million during the quarter. There was no impact on cash it was funded and fold by our insurance carrier. We ended the quarter with $16.4 million in cash, cash equivalent and investments, an increase of $3.9 million as compared to year-end and we have $7.1 million and debt outstanding under our credit facilities. Additionally, we had approximately $8.2 million of borrowings capacity under the revolving portion of our credit facilities.

At this point, I would like to turn the call back to Dave.

David Drachman – President and Chief Executive Officer

Thank you, Julie. In terms of outlook, we believe the addition of the AtriClip platform enhanced training system support our sales force expansion a serious of novel ablation product introduction and anticipated U.S. atrial fibrillation approval and the continued development in geographic expansion of our international market opportunities will support short to mid term growth. Furthermore, we believe strongly that our investments in hybrid ablation and stroke approvals will provide the foundation for sustainable long-term growth.

In summary, we are confident in our people and the power of our strategic plan, which position us for growth during 2011 and beyond.

We will now open the call for your questions. Thank you.

Question-and-Answer Session

Operator

(Operator Instructions) And your first question today comes from the line of Tom Gunderson with Piper Jaffray.

Tom Gunderson – Piper Jaffray

Hi, good morning.

David Drachman

Good morning, Tom.

Tom Gunderson – Piper Jaffray

Dave I want to take a look a little bit more color from the field perspective on that AtriClip. Can you give us a sense of, first off you consider the sales force fully trained here number one, and then number two, how many procedures do they need to be in on before you have the surgeon free and clear and of the 250 how many would you estimate in that zone?

David Drachman

For all three questions, Tom, well first of all in terms of our sales force being trained, there are certainly different levels of training. One of the ways that we approach the AtriClip system is, we typically getting on the shelf at our current ASP, which is $1,100 and we sell the product for specific clinical indications. So, they’re different levels of training, in fact this past weekend we had a training course for the East Coast reps to go through the AtriClip system again. So, we’re continuously adding information and upgrading the core competencies of our training and our sales force capability to sell the clip and other products.

In terms of color, I think the rep being in AtriClip case, one case is probably enough to get the surgeon relatively comfortable with the product. In terms of driving changes in pattern and pattern recognition amongst the operating team to select the clip, I think that’s somewhere in the range of 5 to 10 procedures.

Julie Piton

Tom, we would estimate that of the 250 roughly half of those are stocking the clip. And so once they get to stocking they’ve been trained and enough to speed.

Tom Gunderson – Piper Jaffray

Got it. Thanks that’s good. Its good info particularly on the changing pattern just doing one doesn’t necessarily always get you there does it you have to change the way they think, but obviously moving the ball forward. And DEEP AF you’re in the feasibility study, you’re enrolling these feasibility patients had a pretty good rate. And you move into pivotal, but Dave is there anything that prevents an academic center from staring to do this on their own and are you aware as the word sort of gets outward of mouth and maybe some of the colleagues or former fellows of your clinical centers are staring to do this.

David Drachman

Tom I think the issue in terms of expansion of the DEEP AF procedure approach to other accounts outside the six feasibility sites that we have selected. I think the key issue is training. Hybrid is a – we think a very comprehensive approach to AF treatment obviously requires two sub specialties to merge together for an effective procedure. And training and training in the workflow at a procedure is really critical. To-date we have made a clear decision to limit our training to those centers that have been approved to participate in the FDA regulated DEEP AF trial. I do think as we get into a pivotal trial and assuming that we’re in approximately 35 investigational sites that physicians we’ll talk to physicians and develop their own network, learn different ways to train each other. But we will certainly expect to our compliance procedures, which I mention to focus on training in the investigational sites. I will say that in Europe both the trends were minimally invasive as well as in select parts of your hybrid or certainly trending in the right direction and we feel very good about our long-term to develop this market.

Tom Gunderson – Piper Jaffray

Got it. Thanks for that. That’s it for me for now.

David Drachman

Thank you, Tom

Operator

Your next question comes from the line of Jason Mills with Canaccord.

Jason Mills – Canaccord

Hi Dave and Julie thanks for taking the questions. Let me go back to AtriClip quickly if you don’t mind. could you Dave perhaps give us a bit more color on what you’re doing now in the US market to drive penetration of the product, drive sales particularly since you see AtriClip and opened sort of offsetting some of the planned pullback that you have on the MIS side. So, to drive overall growth AtriClip is an important component to that. what are you doing with your sales force in this back half of the year to penetrate new accounts, number one. And number two, you’ve talked previously about the opportunity if you’re putting the door some competitive accounts with AtriClip given that it’s a unique product in your portfolio especially to drive a pull-through of your ablation business. could you maybe talk about or give us an update on that as well.

David Drachman

Sure. I think the main issue is really educating our sales force how to sell from a procedural perspective. for example a simple concept would be in heart-pump CABG is where the clip is a much better technology and is more effective and safer than basically cutting and stapling. So, basically helping our reps understand which procedures add the most clinical benefit for the clip. Obviously the clip has overall benefits in terms of left atrial appendage exclusion, but we want to focus our reps on being able to talk at these reps sync with physicians about what procedure is being performed today and have the AtriClip system is going to simplify that procedure in terms of left atrial appendage exclusion and also reduce any potential risk.

The second thing that we are doing is we’re helping to education physicians on the risk of stroke associated with atrial fibrillation and we’re not going necessarily to stroke directly, but in our exclude-clinical trial which was a left atrial appendage technical endpoint, patients could be enrolled if they were 75 years of age or older, if they were 65 years of age and had a history of hypertension, if they had a previous cardioembolic stroke our reps to basically help physicians understand where the left atrial appendage should be removed based on these markers that got certain patients may have for developing stroke down the road. So, the general concept is train them on the procedures where the clip can happen most benefit system to using the clip which will drive more utilization and more procedures and then also focus on the markers for certain patients like age, like previous cardioembolic stroke, like hypertension, the markers that typically you want to be aware of when a patient is in the operating room that you have an opportunity to basically treat the appendage and reduce any long-term risk for that patient.

Jason Mills – Canaccord

Okay. And then just with respect to the competitive account part of the question.

David Drachman

In terms of competitive account this quarter we were really focused on the Synergy Access in the ICE BOX preference evaluation, that’s a fairly comprehensive process for us, because we have to train our reps first on new products. We have to coordinate engineers and reps into accounts, we collect data on every product and in fact during this quarter this is the first quarter that I can recall where we ran two significant user preference evaluations simultaneously. So, in terms of competitive account this quarter we focus more on Synergy Access, focused more on the ICE BOX made some modification to the ICE BOX, but going forward the AtriClip as you point out is a unique and novel technology and our competition doesn’t have a similar like product.

So, every physician that we talk to wants to fundamentally learn more about how they can more safely and effectively exclude left atrial appendage so we can begin many of those conversations, now it’s Synergy Access, Ice Box cryoICE and the overall strength of the product portfolio we can pull products through. In addition to that we think the stroke trial really enhances our image in cardiac surgery. So, the fact that AtriCure is on the heals of what we believe is an AF indication is running as DEEP AF hybrid clinical trial which is a novel new procedure and is making an investment in the cell therapy left atrial appendage exclusion procedure from a corporate point of view we want to show the fact that we’re making investments in clinical science which we think brings patients and physicians over to AtriCure.

Julie Piton

That’s very helpful. Once more follow-up that AtriClip has, one other question about the US market. On the AtriClip Dave just simply given what you’ve said about your refocus on AtriClip in the second half of the year, and what your focus on the second quarter it took some of your sales force focus away from AtriClip in the near-term. Would you expect sequentially AtriClip revenues to improve quarterly through the balance of the year. And the other question and then I’ll get back in queue. Outside the US was very strong, clearly you’re seeing a benefit from your direct markets your expanded product line. From this level should we expect continued improvement in growth outside the US not necessarily in terms of your year-over-year growth percentage number from a nominal basis do you see any reason why outside the seasonality we would see any pullback in the momentum. Thanks guys.

David Drachman

Thank you. In terms of sequential growth, certainly seeing a strengthening of AtriClip sales in the second half of the year, always hard to factor in seasonality. But in general we see strong trends for the AtriClip system and a stronger second half of the year than the first half of the year. And in terms of inter managed care markets, we remain very excited. I think in Europe our investments in direct sales forces in Germany, Switzerland and Austria as well as the Benelux countries have made a significant impact in terms of growth. We see increased utilization from our stocking distributors and geographic expansion we saw growth from major markets in Asia or developing new markets we put one of our key executives and the physician to develop some of the Latin American emerging countries like Brazil. So, we’re very enthusiastic about the short and long-term prospect of continued growth in the international markets.

Julie Piton

With that Jason, I would just caution you that that is the market, that is the more success for both the seasonality for the third quarter. So, in terms of order sequential growth patterns there I would expect a seasonal bid in the third quarter and then there is nothing unusual in the second quarter that would have made rather reasonable jump off quite from there and the receptive quarters.

Jason Mills – Canaccord

Yeah, that makes sense unless we can change the implication patterns for stocks over there. Thanks guys.

David Drachman

Thank you.

Julie Piton

Thank you.

Operator

Your next question comes from the line of Matt Dolan with Roth Capital.

Matt Dolan – Roth Capital

Hey guys good morning.

David Drachman

Good morning.

Julie Piton

Good morning Matt.

Matt Dolan – Roth Capital

Dave I wanted to touch on new products a bit and sort of following up on that competitive question. Can you give us maybe your current market share profile and what your expectations are with Access, ICE BOX and ACE nearing into the story? And then maybe including to have some comments on pricing on those things?

David Drachman

Well one of the things that we’re proud of in terms of our market segments is our pricing on a year-over-year basis independent of the macroeconomic issues, but if you go back to 2010 versus 2011 pricing is certainly consistent. And obviously we launched a new product like AtriClip system our average selling price is still $1,100 for the AtriClip system. So, I think that’s positive strength of our products and the positioning of our product in the marketplace by our sales and marketing team. In terms of new products, certainly Synergy Access is a novel new product within our calculation phase which positions us more comfortably against Medtronic, which has a flexible head that was the main aim of that technology. I think the ICE BOX is a product that even though hardware typically is not a facilitator. In this case, this hardware is very elegant puts the controls with the physicians which is additions of late and we are removing and replacing a 20-year-old generator that the OR staff and physicians just struggle to use. So, I think ICE BOX is going to make a very significant we estimate our trial ablation market in the U.S. to be about 25% share, I think would be ICE BOX and some other innovations that we are planning for the first half of 2012 that we exit 2012 being in a 40% to 50% share in terms of the U.S. trial ablation market. So both these are significant new products.

The only comment I want to add to that is, the AF labeling. I think AF labeling is certainly achieved success with the agency and obtaining an AF label. We believe is that is a major catalyst that the markets are underpenetrated in the U.S. and that the ability to market and train is going to be a significant catalyst for the company going forward.

Matt Dolan – Roth Capital

Right, okay. And then following on that, I mean thinking about the significance of the ABLATE registry data it sounds like it won’t be available for the Adcom meeting. How necessary is that data relative to FDA's deficiency letter and its overall response for your pursuit of AF label?

David Drachman

You have to separate the FDA and panel. FDA has not asked us for any additional patients in the deficiency letter. There were focused on AF classification and we had the world leaders in AF classification to HRS consensus statements adjudicate each patient and put each patient in to the new nomenclature for AF classification. So, we feel very strong about our responses in terms of the deficiency letter and interactively discussing with FDA. The FDA given us the understanding that we are not going to receive any additional letters that we are going to work together to coordinate our plans for a panel meeting in the near-term.

Matt Dolan – Roth Capital

Okay. And then if I guess speak one more in on the stroke trial, do you have any thoughts on the size and scope there, maybe comparing to some of the other products that become gone through the process?

David Drachman

Well certainly on the feasibility side, we typically would ask for five to six centers in 30 patients in terms of what’s going to be required from the pivotal trial I think one of the advantages that we have empowering the study is we are aiming for patients that are not suitable candidates for anticoagulation therapy. So, we are aiming for patients, who are higher risk of complications and higher risk of stroke. So, I think we do have some elements of the study design that would allow us to power in a way that we could hopefully reduce the number of patients. But at the end of the day, stroke (indiscernible) are large and I would anticipate that will be somewhere in the similar range as Watchman, which was 750 patients in their treatment group and 250 patients in their control arm.

Matt Dolan – Roth Capital

Great. Thanks a lot guys.

Operator

Your next question comes from the line of Charley Jones with Barrington Research.

Charley Jones – Barrington Research

Well, I was going to take that conservation offline, but I’m curious I was kind of wondering why you went and run two stroke trials here to include (indiscernible) and patients that were indicated for warfarin. So, since you are gone with this approach can you have a lower end point of a year or two a close to three years and then would you want to follow on an additional trial that included these other patients that would likely benefit from the clip and what kind of timing with that look like.

David Drachman

I think it’s too soon to really getting the details about, too many details about how we would power the study, number of patients, I think the question that Matt asked, we gave a general overview. But in terms of the market, Charley if you look at dabigatran, apixaban, so you have prominent inhibitors, you have Factor 10a inhibitors, you have a new series of anticoagulation drugs coming to market.

Our general feeling is that, when you look at a non-inferiority hypothesis comparing either Coumadin and now these new drugs like dabigatran and Factor Xa inhibitors, when you compare these new drugs to a device we think that many patients would rather go from Coumadin to a new drug and a series a new drugs versus undergoing a fairly invasive percutaneous procedure like endovascular Watchman or like devices. So we think the bigger market opportunity is actually for those patients that are not suitable candidates for anticoagulation treatment. We know that patients are living longer. We know that AF prevalence is greater in the elderly population. And this population of patients often are not suitable candidates for anticoagulation treatment. So, we actually think the more obvious market is a thoracoscopic approach, where you don’t penetrate the left atrium and don’t leave anything in the circulating web pool. And you can take patients immediately off of anticoagulation treatment and anti-platelet treatment if necessary. So, that’s our general hypothesis.

Charley Jones – Barrington Research

Okay, that’s helpful. Could you discuss your best estimate for panel date, it sounded like you are getting close, but you talked about this registry data take into Q1, but it sounds like maybe that’s not necessary for a panel? Is that right?

David Drachman

Well, first of all, we don’t have to complete the entire registry to have data to support the conclusions of our ABLATE trial. So if we were just as an example if we are somewhere in the mid to early fourth quarter and that began that just as an example, that’s the information I have in front of me. We would have 12 patients that were at the primary endpoint and about 28 patients that were through the safety endpoint. So, we don’t have to enroll all 50 patients to actually be able to utilize that data at the panel meeting to support the inclusions of our overall pivotal trial ABLATE. In terms of giving any more color, I think the best color is we are preparing for it and we believe it will be scheduled in the near term.

Charley Jones – Barrington Research

That’s very helpful. And just one more, I was hoping you could discuss your expectations for the rough dollar amount of the ICD-9 levels and will the change here you think affects physician’s ability do that, do they already have the ability to do different cross codes to able to get this procedure reimbursed. And do you think it will have a big effect on the potential opportunity for physicians to do this procedure?

David Drachman

We think it’s a major catalyst for physicians who want to perform procedures. In these – this ICD-9 code 37, 36 actually covers a broad range of approaches. So, it covers percutaneous approaches, xyphoid approaches, thoracoscopic approaches, so how CMS will decide to walk that over to a DRG and which DRG that will be. I wouldn’t want to speculate, because the approaches are too wide ranging, again including percutaneous xyphoid and minimally invasive and thoracoscopic approaches. So the DRG assignment, it could be percutaneous, it could surgical. Certainly, if it’s percutaneous, then we will continue to drive toward the separation of the thoracoscopic approach as we have done in other areas like minimally invasive thoracoscopic ablation.

Charley Jones – Barrington Research

But that will be in the 2012 register where people can be reimbursed for the procedure?

David Drachman

Effective October 1 of this year.

Charley Jones – Barrington Research

Great, thank you.

David Drachman

Thank you.

Operator

Our next question comes from the line of Jan Wald with Morgan Keegan.

Jan Wald – Morgan Keegan

Good morning Dave and Julie.

Julie Piton

Good morning Jan.

Jan Wald – Morgan Keegan

A couple of more or less follow-up questions I guess. In terms of the AtriClip, the minimally invasive timeline if you will, when will that clip kind of come out and what are the – if there were any opportunities for getting those – the minimally invasive clip involved in the clinical trials you have ongoing or you’re going to need a new set to prove it out?

David Drachman

Excellent question. So, the current clips that we have were designed for open use. The one of the current clips that we have is long and the other is short in terms of the deployment tool. But long deployment tool has been adopted by our DEEP AF investigators. All of our DEEP AF patients were implanted with the long disposable AtriClip system. So, we went back to FDA because of this trend and we asked FDA if they would amend the study and allow the use of the AtriClip system in the DEEP AF study since the physicians were using it. And this paper was written into the protocol, but the physicians much prefer the clip, even though it’s not specifically designed for minimally invasive or thoracoscopic use.

The fact that the DEEP AF investigators adopted the clip without us driving toward that on their own gave us the incentive or the confidence I should say to go forward with the feasibility trial using the current generation clip. So, the success that the DEEP AF investigators have had implanting our current generation clip which is really designed for open, but they are using it in a minimally invasive fashion and they are being successful with it, give us the confidence to go forward with a current generation clip in a feasibility trial while we design a totally thoracoscopic product that’s highly featured. That totally thoracoscopic product it’s highly featured will be ready for clinical trials during the first half of 2012.

So under the best case scenario, we start our feasibility trial maybe complete the feasibility trial with the current generation clip and then amend the pivotal trial to include the thoracoscopic clip which is designed and intended for this procedure.

Jan Wald – Morgan Keegan

Okay, thanks. And I guess just maybe another follow-up question, in terms of the European market from what you had said earlier, it sounded as if – if we assume the seasonality we should sort of step up what our assumptions are for the European market growth and revenues, but how could we look at the European market, what are the key drivers in that market and how should we see that market growing over the next year to two years?

David Drachman

I think the key drivers in the market, first of all, is just the fact that we didn’t have any, for example, European station until 2006, so we opened up our European B.V. on the heels of our IPO in 2005 and began to make some investments. And then we made investments in direct people. Now, we have direct people in some of the major countries like Germany and the Benelux. So we are making significant headway. Those markets are under-penetrated in terms of market share compared to the U.S. markets. So, we have superior products, broader range of products, and our direct people are being very successful in the major markets.

In addition, minimally invasive is taking off especially in the Benelux and in certain areas of Germany, we still have some reimbursement challenges to overcome, but there is a significant trend towards minimally invasive procedures and in certain cases hybrid procedures. So, the direct markets – the investment in those direct markets, the investment in training for our stocking distributors since we have more people on the street to enable training for our stocking distributors in Europe and the movement to minimally invasive hybrid procedures particularly in our direct markets, but also in certain areas outside of direct markets in Europe has been the foundation for growth in Europe.

We are also seeing growth from some mature markets like Japan. Japan is a market that we have about 50% market share, obviously the population there is atrophying and cardiac surgery is not growing. However, they are still continuing to pickup share. We just launched the synergy access in Japan and we believe that, that will stimulate growth in Japan and then China is an emerging market obviously for most all medical device companies and AtriCure is included in that as well. And we are seeing nice growth trends in China and we’ll have to make some decisions about what investments we make in that marketplace. And then again, we are beginning to get into places like Brazil on developed strategies and some of the major Latin American markets and other emerging markets outside the major areas that we are currently selling in.

So, I think it’s a combination of more direct people over time, continued success in our direct markets, continued education with our stocking distributors, geographic expansion, new products, and minimally invasive momentum.

Jan Wald – Morgan Keegan

Thanks David. Congratulations on the good quarter.

David Drachman

Thank you, sir.

Operator

Your next question comes from the line of Larry Haimovitch with HMTC.

Larry Haimovitch – HMTC

Good morning, Dave and Julie.

David Drachman

Good morning, Larry.

Julie Piton

Good morning, Larry.

Larry Haimovitch – HMTC

Those are some tough (indiscernible) to followers or good questions we have been getting. On the minimally invasive side, one wanted to get a little more color on that. You mentioned that the revenue was down, is anything Dave or Julie going on competitively that might account for that or is it in your mind strictly that you have deemphasized that activity relative to other things you are working on?

David Drachman

We are not seeing any competitive activity this having an impact. I think it just a matter of deemphasizing not training in that basically doing some of the activities that historically we were doing relative to our products in those minimally invasive accounts. So, I think the stricter healthcare compliance environment, the stricter compliance and enforcement environment in our developing healthcare complaint procedure is the main reason for some of the atrophy in our minimally invasive business.

Larry Haimovitch – HMTC

And then following up on sort of the competitive environment if you look at the base business the open-heart surgery business, of course Medtronic acquired ATS I guess it was probably year and year and half ago. I’m sure that created some disruptions. How do you view that side of the competitive ledger at this point, I know for a while it have to be benefiting you with some disruptions. What do you see out there now a day?

David Drachman

Well, yes Medtronic is certainly a very strong competitor in terms of surgical ablation. I think they gone a little back and forth in terms of their investments in the space. Right now we view them in the open-heart market to be a strong competitor there anywhere with their valves.

We do believe that Synergy Access, the ICE BOX, the serious of cryo-ablation probes, the AtriClip System particularly in the AF labeling. We do think that we are doing all the right things and very well positioned to take significant share from Medtronic, which is really our number one and only significant competitor right now in the marketplace.

Larry Haimovitch – HMTC

Dave one more question on Medtronic, there was a time not that long, when they were doing some clinical trials on an AtriClip type device. As I recall last time, we talked or you talked on the call, it look like there maybe had pullback on that. Do you any update on their competitive activities in the clip area?

David Drachman

We had a cardio blade (indiscernible), which was in hovering like device. We look for the similar technology as you know the appendage of the elliptical structures for try to get key closure or even chronic closure were hovering like system on the upside of the heart might be challenging. We heard from some of the key investigators that perhaps it didn’t make the technical endpoint of their clinical, which was acute later atrial appendix exclusion and exclusion at three months for the CT Scan. So, we heard that maybe their clinical trial did not achieve the end points that they or aiming for and that product might be on hold.

Larry Haimovitch – HMTC

Okay. Thanks Dave.

David Drachman

Thank you.

Operator

Your next question comes from the line of Jason Mills with Canaccord.

Jason Mills – Canaccord

Thanks for taking the follow-up, Dave. Larry actually asked one of the follow-up questions I had on the MIS side, perhaps just and update if you will on your direct sales organization both worldwide and then broken up by geography how is that changed over the last six months. You talked qualitatively about it, but quantitatively can you give us some color?

David Drachman

Sure. We basically hired in additional 10 people beginning in 2011 it came into the year with about 55 people which was where we were in the third, fourth quarter of 2008. So, we added new people. Now we added basically ablation specialist and sales managers. We went from 30 to 39 territories.

What’s different about that, is that in the past, we had group of reps that we called market development representatives, they were basically selling our products to electrophysiologists and basically bringing electrophysiologists and surgeons together for them to understand the attributes of our products.

And that role we have removed from the sales organization from a combination of different reasons fundamentally spending from the healthcare compliance perspective we didn’t want to be proceed as promoting the disease versus promoting the technology. So, that was a significant change. So, what we have today is 39 self territories and a series of ablation specialists that are primarily focused on the open heart business and selling the attributes of our clip in our ablation portfolio.

Julie Piton

That’s on the U.S. side Jason.

Jason Mills – Canaccord

Okay. So, that’s on the U.S. side. Dave, what are your plans going forward with some early success going direct in some of the regions in Europe. Should we expect status quo for a bit as those mature and you learn new things before you start sort of a second move to go direct in other countries or those kinds of things and the works now just any additional color on front would be helpful?

David Drachman

Well, I think we are definitely going to make some investments in the international market, particularly Europe. Now, whether it’s sales reps or whether its physicians, for example, they can help drive minimally invasive from an educational perspective, reimbursement consultants. I think there are definitely some adds to be made. We are trying to basically get together what our operating plan is going to be for 2012 in terms of direct employees for our European B.V. It’s very possible that we will pickup a sales header too. I think that is a very possible scenario, but it’s also we want to consider these other potential supported physicians with the marketing. We can hire physicians in Europe to help stimulate minimally invasive. We need to have some reimbursement support in certain countries. So, we’re going to be looking at both direct sales as well as market development activities and headcount.

Jason Mills – Canaccord

Great. Thanks guys.

David Drachman

Thank you.

Julie Piton

Operator, we’ll take one more call please, if there is one in the queue.

Operator

Your finial question is from Charley Jones of Barrington Research.

Charley Jones -- Barrington Research

Thank you for the follow-ups. Still if a physician had been doing minimally invasive last year and is not currently enrolling patients who are planning to enroll patients in any of your clinical trials. Can – and they already train, they already feel like they know how to do a procedure. Are your reps allowed to be there or they even allowed to buy, I maybe able to mention be allowed to buy the products from you given the other uses?

David Drachman

We wouldn’t restrict the sale of our products. We just wouldn’t be in the account necessarily promoting and supporting the training activity. So, for example, when we launch a new product like the multifunctional linear pen, typically, and these gone by we would focus our minimally invasive surgeons on the attribute of a new technology. Now, our minimally invasive users in the U.S. were really not educating them on how to apply, for example, new technologies or new techniques to minimally invasive standalone procedures. And that fact is I think is what is again at the core of some of the atrophy you are seeing at minimally invasive and again we think the movement to a DEEP AF pivotal will be an inflection point for our business.

Charley Jones -- Barrington Research

And that was my second follow-up, could you – I guess any specifics you can revise, but I was hoping you can discuss your expectations for when do you actually start enrolling patients in that pivotal phase and if you could discuss some of your pre-IDE enrollment completion timelines and whether or not you need to review that data to be able to start enrolling patients? Thanks a lot.

David Drachman

I think we’re very actually pleased with enrollment. We’ve started enrollment in December of 2010. In this environment to get IRB approvals, contract approvals, and CMS approvals in major centers like we are working with and our feasibility trial is not a simple process. In addition, this is a new procedure for these accounts. So, they are required to do a number of running cases, typically, its five running cases. So, the 17 patients are just patients that have been enrolled, but it include running cases. In addition in the feasibility trial in most safety and feasibility trials, you started off with more strict criteria for inclusion and exclusion. So, we’ve enrolled 17 patients, but I think when we get to our pivotal trial, we’ll sort of loosen up some of the criteria whether it’s BMI or ejection fraction. Some of these areas that have limited some patient enrollment will likely loosen up some restrictions once we have the safety and feasibility data and once the centers have a little bit more experience and we have a little bit more experience in terms of teaching these centers how to perform the procedure. So, in terms of actually starting the pivotal trial we said all along and we continue to believe that the second half of 2012, it will initiate enrollment in the DEEP AF clinical trial.

Charley Jones -- Barrington Research

Thanks a lot.

Julie Piton

Thanks Charley.

David Drachman

Thank you.

Operator

And this does conclude the question-and-answer portion of the event today. Would management like to make some closing remarks?

David Drachman – President and Chief Executive Officer

Thank you for your participation in the call today and we look forward to the upcoming third quarter call.

Operator

Ladies and gentlemen, this does conclude the presentation and you may now disconnect. Have a wonderful day.

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