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Good afternoon, and welcome to ShockWave's Third Quarter 2019 Earnings Conference Call. [Operator Instructions] We will be facilitating a question-and-answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes.
I would now like to turn the call over to Debbie Kaster from Gilmartin Group for a few introductory comments.
Thank you all for participating in today's call. Joining me are Doug Godshall, President and Chief Executive Officer of ShockWave Medical; and Dan Puckett, Chief Financial Officer of ShockWave Medical.
Earlier today, ShockWave released financial results for the quarter ended September 30, 2019. A copy of the press release is available on the company's website.
Before we begin, I'd like to remind you that management will make statements during the call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements. All forward-looking statements, including, without limitation, our examination of operating trends and our future financial expectations, which includes expectations of hiring, growth in our organization and regulatory affairs and guidance for revenue in 2019, 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 refer to the Risk Factors section of our S-1 on file with the SEC and available on EDGAR.
ShockWave 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, November 7, 2019.
And with that, I'll turn the call over to Doug.
Thanks, Debbie. Good afternoon, everyone, and thank you for joining us today. I am pleased to welcome you to ShockWave's call to review our results for the third quarter of 2019. We reported $11.3 million in revenue for the quarter, which was up $1.3 million over the prior quarter and an increase of $7.7 million or over 3x the third quarter 2018 revenue.
Before turning the call to Dan to provide more financial details, there are a few highlights that I would like to share. Starting with a quick thumbnail of our progress over the past few months. We completed the commercial launch of our S4 below-the-knee product earlier this week. We made encouraging progress on our CAD III U.S. IDE enrollment. We initiated the CAD IV study in Japan also this week. We presented and published data from our CAD II study. We received breakthrough designation on our C2, our coronary product. We restarted our PAD III randomized clinical trial and expanded the PAD III registered arm by 50%. We moved production into our new facility in Santa Clara. In a nutshell, the team has been very busy.
The launch of S4 is being well received at the VIVA conference this week and have followed the rigorous limited market release we have been managing over the past few months. The launch includes a 3, 3.5 and 4 millimeter sizes. And we have almost completed the limited release of the 2.5 millimeter version, which has also gone very well thus far. Assuming all continues to go as planned, we will add the 2.5 millimeter to the launch by the end of the year.
As a quick reminder, ShockWave S4 is our low profile IVL catheter, specifically designed to access and treat challenging calcified lesions in below-the-knee arteries that are frequently associated with the critical limb ischemia or CLI. We estimate that there are over 300,000 procedures per year for below-the-knee lesions, roughly 65% of which are heavily calcified. Many of these patients do not respond well to alternative endovascular treatments leading to repeat procedures or even limb amputation. There's a growing consensus in the clinical community that one of the leading causes of restenosis in below-the-knee vessels is vessel recoil, which occur shortly after the initial procedure and is likely caused in part by the high incidence of calcium. Anecdotally, many of the physicians who have used S4 thus far have commented that they are seeing less recoil than they are accustomed to seeing with traditional therapy, which had been our hope when designing the device.
Since the goal of CLI procedures is to restore flow quickly and with as few complications as possible, the exceptional safety profile and calcium-specific therapy we deliver makes for a compelling combination, and we look forward to continued feedback and data generation as we expand the clinical experience with S4.
The core of our U.S. business is still driven by our large-diameter M5 system for calcified peripheral disease in medium-sized vessels, which has now been used in over 10,000 patients. Usage continues to grow in SFAs, but it's growing even more rapidly in the other peripheral applications such as iliacs, common femorals, popliteal arteries, mesenterics and the like.
The vast majority of our U.S. sites now have the 300 pulse software for M5 and the improved procedural efficiency enabled by having the extra pulses and ability to treat longer, more complex lesions with 1 catheter has been seen as a major upgrade, almost like an entirely new product.
We spent a great deal of effort on product development. And we also continue to ramp our investment in clinical research, both for regulatory purposes as well as to support the expanded use of IVL. And we made significant progress in several studies during the quarter.
Starting with CAD III, our 442 patient U.S. Coronary IDE. As of the end of the quarter, we had 216 patients enrolled, which is exactly twice the enrollment we had at the end of June. The trial continues to enroll briskly, which has led us to pull our projected completion date forward for the second time. And we now expect to see enrollment completing in the first quarter of 2020 instead of the second quarter, as we had previously predicted.
As a result, we are now modeling the U.S. approval in the first quarter of 2021 versus the second quarter as we had initially -- had assumed. Also on the subject of C2, we are pleased to have received the previously announced breakthrough device designation by FDA. And while we do not expect this to impact the timing of our approval, it does potentially provide a lower threshold for reimbursement with CMS once we are approved. Ordinarily, when a medical device is being assessed for an add-on payment, CMS looks at 3 criteria: newness, substantial clinical improvement to alternative treatments and costs. However, for a device that has been granted breakthrough designation, the process has been streamlined somewhat.
For hospital inpatient procedures, one option for additional payment is to secure a new technology add-on payment or NTAP. For breakthrough devices. CMS has waived 2 of the 3 criteria when evaluating NTAP applications, newness and clinical improvement, leaving only the cost criteria to be met by the product. Additionally, just last week, CMS announced that they are also streamlining requirements for breakthrough devices in the outpatient setting when they are evaluating transitional pass-through applications. CMS will automatically deem breakthrough designated technologies to have met the substantial clinical improvement criteria. However, the device must still meet the newness and cost threshold requirements, demonstrating that a device represents a substantial clinical improvement has traditionally been the most subjective and difficult of the three criteria. This does not guarantee we will pursue any of these strategies for inpatient or outpatient payments, but it does suggest that having the breakthrough designation from FDA could improve -- could prove beneficial from a coronary reimbursement perspective.
Returning to clinical trials. We presented data from our CAD II registry to a standing room-only crowd at TCT. The results showed outcomes that confirm the low complication rates and strong safety and performance we witnessed in CAD I, but in twice the number of patients and at 3x the number of centers. In the 120-patient CAD II study, investigators were able to successfully deliver and use IVL on all patients and IVL facilitated successful stent delivery in all cases. The primary safety end point was met with 94.2% of the patients free from in-hospital major adverse cardiac events, and there were no reports of perforation, slow flow, no reflow or major dissections, which is almost identical to the results we witnessed in CAD I. The outcomes from CAD II reinforce our confidence in the performance of IVL in the coronaries and augurs well for the prospects of CAD III.
We are also happy to have initiated our CAD IV study in Japan, which we announced this morning. We held our investigators meeting in October and began CAD IV patient enrollment just this week.
Based on early feedback from our investigators, we believe the 64-patient cohort will enroll briskly, and we are planning for a mid 2022 approval in Japan, as previously discussed. Japan is likely to be a particularly strong market for ShockWave, given that, as a country, they have the highest utilization rate of atherectomy in the coronaries.
On the peripheral side, we restarted the randomized arm of PAD III this month. And just last week, reenrolled our 1,000 patients in the registry. So it is quite timely that we expanded the registry arm of PAD III to include 1,500 patients. We did not yet have enough feedback to know how quickly the randomized arm will ramp up and what, if any, impact to the DCB label changes we'll have on enrollment.
Based on what we know today, our assumption is that enrollment will take about a year, and we will, of course, stimulate enrollment as best we are able. The expanded registry is likely to enroll more rapidly than the randomized arm as there are very few restrictions on which patients can be enrolled other than the requirement that at least 200 patients in the registry will be treated with S4.
Following up on the earlier mention of TCT. Our team had a great showing and turnout at the conference in September, headlined by the unveiling of our CAD II data, along with several other events and presentations. Overall, the energy around ShockWave at TCT this year was similar to that of PCR in the spring with tons of buzz and multiple symposia 3 superb live cases, several events and over 25 presentations, which included ShockWave.
The joint Abiomed training sessions were overflowing, and we had good, steady attendance at our peripheral training sessions, which is something new for TCT as they attempt to enhance their peripheral platform to complement their already strong coronary and structural programs.
Another interesting IVL presentation at TCT came from Golden Jubilee Hospital in Scotland, where they compared the resource utilization in ShockWave cases with those in rotablator cases. While this was an assessment of 2 distinct data sets, the analysis suggests that IVL cases consumed fewer resources than rotablator procedures. We do not expect these data will tilt use in our direction as we see rota and IVL generally treating different types of lesions. But it does give us a sense of what we might be able to show on a prospective analysis, which could help with international reimbursement in the future.
Turning to our U.S. sales organization. The expansion in our number of regions has enabled us to more efficiently recruit top talent in sales and clinical roles and to enhance our execution. As a result, the performance of our U.S. sales team is even stronger and more balanced than it had been at the beginning of the year, with the sales growth being more broad-based across the country. We have already reached our target of having 60 professionals in the field this year and so with the few more roles we are like -- we are actively recruiting for.
Internationally, we are seeing the immediate benefits from the addition of our 2 market development specialists who are helping to strengthen the performance of our 18 distributor partners and to broaden and deepen relationships across customers, sites and geographies. Some of our distributors are being the next step we were hoping to see. And that is that once IVL for coronaries becomes well installed in the country, they are moving to peripheral, starting with large bore access and planning to turn to below-the-knee next year.
That said, in most countries outside the U.S., we expect peripherals will be more of a market development effort than coronary has been, since peripheral interventions are generally performed at a much higher rate in the U.S. whereas coronary procedures are much less U.S.-centric.
On the patent front. We have had 7 new U.S. patents issued year-to-date, bringing our total to 35. And we have 19 applications awaiting office action by the U.S. PTO. As you are likely aware, CSI initiated an inter partes review or IPR of three of our patents at the end of last year, all of which were instituted a few months back. This week, we submitted our initial responses related to the IPRs and CSI now has three months to submit their response, which will be followed by a trial in April or May, and the final decision by the court in the July, August 2020 time frame.
If we prevail, the IPR process will be complete. And if not, we will have the right to an appeal, which will then take another year or so.
Now that we've had a chance to put our responses in PTAB, we are even more confident in the strength of our portfolio, both the patents in question and dozens of others issued and in process. All of this progress requires great people working effectively together. And at the end of the quarter, our employee count was at 260 compared to 162 at the beginning of the year. And we would not be surprised to break 300 by year-end.
As we mentioned on the last call, we had a very successful move to our new facility in Santa Clara. And while we had initially planned to open 2 new clean rooms this year. Demand has been so strong that we have moved forward with plans to equip and staff a third clean room ahead of schedule, which we expect will be coming online this quarter.
And with that, I would like to turn the call to Dan.
Thank you, Doug. Good afternoon, everyone. ShockWave Medical's revenue for the 3-month ended September 30, 2019, was $11.3 million, a 215% increase from $3.6 million in the same period of the prior year. U.S. revenue was $6.2 million in the third quarter of 2019, growing 204% from $2.1 million in the same period last year, all of which was derived from our peripheral products. This increase in U.S. revenue was driven by the expansion of our sales force, addition of new customers and greater utilization at existing sites. International revenue also saw a strong increase in the quarter, growing 229% to $5.1 million in the third quarter of this year from $1.5 million in the same period last year. The main driver of this growth was further penetration in existing countries and the expansion of our international distributor channel.
Looking at revenue by product line, peripheral products accounted for $7 million of the total revenue compared to $2.5 million in the same period last year. Coronary products accounted for $4.2 million of revenue compared to $1 million in the same period last year, all of which was international. In addition, the sales of generators, most of which was international, contributed $0.2 million in revenue in the third quarter of this year compared to $0.1 million in the same period last year.
Gross profit for the third quarter of 2019 was $6.9 million compared to $1.6 million for the third quarter of 2018. Gross margin for the third quarter of 2019 was 61% as compared to 45% in the same period last year. Contributors to gross margin expansion included continued improvements in production processes to drive efficiencies and greater absorption of fixed cost from increased production.
Total operating expenses for the third quarter of 2019 were $20 million, a 71% increase from $11.7 million in the third quarter of 2018.
R&D expenses for the third quarter of 2019 were $8.4 million compared to $5.5 million in the third quarter of 2018. The increase was primarily attributable to clinical study costs associated with CAD III IDE and CAD IV study in Japan.
Sales and marketing expenses for the third quarter of 2019 were $8.2 million compared to $4.8 million in the third quarter of 2018. The increase was primarily due to sales force expansion in the U.S. and internationally, as well as increases in marketing program spending.
General and administrative expenses for the third quarter of 2019 were $3.4 million compared to $1.4 million in the third quarter of 2018. This increase was primarily due to expenses associated with being a public company and legal costs related to the IPRs.
Net loss for the period was $13 million as compared to a net loss of $10.2 million in the same period last year. Net loss per share for the third quarter of 2019 was $0.46. We ended the third quarter of 2019 with $114.1 million in cash, cash equivalents and short-term investments.
Turning to our outlook for 2019. And based on the trends we have seen so far this year, we now expect full year 2019 revenue to be in the range of $41 million to $42 million, which would represent growth of 234% to 242% over full year 2018.
At this point, I'd like to turn the call back to Doug for closing comments.
Thanks, Dan. And thank you again for taking the time to join us today. In closing, we are encouraged by our third quarter results, which reflect the continued commitment of each member of the ShockWave team to execute at the highest level. Their accomplishments and outperformance, not just on the top line, but on the clinical and product front, in particular this quarter, continues to impress me every day. The enthusiasm we hear from the clinical community about the difference we are making for patients is what really keeps us all going. We have a lot of work ahead of us as we continue to build what we believe is the strong foundation that is necessary to achieve what we are striving for to provide the safest, most effective solution for patients with calcified cardiovascular disease and to globally facilitate the enhanced outcomes that IVL is uniquely able to deliver.
With that, I would like to open the line for questions.
[Operator Instructions] Our first question comes from David Lewis with Morgan Stanley.
Doug, just a couple of questions for me. The first is your 3Q dynamics, obviously, are well telegraphed, specifically outside the U.S., but the fourth quarter guide is much better than expected, obviously, above the Street, above us. So can you just bridge us to what you're seeing commercially from the third quarter to the fourth quarter?
Yes, sure. So as you indicated, and as we anticipated, we saw a meaningful softening in procedures in the summer, particularly in Europe. So -- and specifically, July, August, with a very encouraging recovery, frankly, overshooting what we expected the recovery would be in September. And so we're -- we are anticipating that, that expansion in procedures and the fact that we have a broader footprint with more users now, both in the U.S. and internationally, that we should benefit from what we believe will be a more sort of September-like procedure volume. And so it's a -- it's the culmination of the expansion, both in terms of number of centers, number of reps, number of distributors that we think will benefit -- will accrue to our benefit in the fourth quarter.
Okay, very clear. And then, Doug, I know it's early, but just given the early stage nature of the commercial build out and the relative growth rates are so high, is there anything you could share qualitatively on 2020. I mean you added $30 million of absolute revenue here in '19. Is that kind of contribution possible in 2020? And then I'll get back in queue.
Yes. So if you look at how the year has performed to date, we're certainly encouraged with the progress we've witnessed. If you look at your own model and any other models on the Street, there's a sizable contribution embedded for S4. We feel very comfortable with S4 performance, but it is -- it's still early in the launch. So before we provide an update on 2020 guidance, we want to get a little bit more experience under our belt with S4 to make and to finish out the year before we give a sort of quantitative response relative to sort of where the Street consensus is right now. So we're finalizing our internal financial models, and we'll be in a position end of this year to be providing, beginning next year, so after we finish the year to drive guidance on next year.
Our next question comes from Robert Hopkins with Bank of America.
This is Kyle Pezzi on for Bob. Just a quick question to kind of follow up to David. Obviously, earlier this month, you announced below-the-knee is now being launched in several geographies. And I just kind of wanted to get a sense of what the rollout is going to look like by geography? And when we should start to think about a bit of a broader rollout in the United States and other key geographies? So basically, just to sum it up, trying to get a sense for how you see that ramping over the coming months?
Thanks. We are now in full release, albeit, three of the four sizes and fully anticipating that we'll be launching the fourth size in coming weeks, and that's the smallest size, but that's not regulating our rollout. It's really more sort of pure selling, blocking and tackling. Fortunately, we have a much more meaningful installed base, obviously, then of the M5 as we roll out S4 than when we first we're commercializing the above-the-knee product. And so we'll be focusing on existing happy above-the-knee customers since they should be somewhat of a path of least resistance for the product. And they were certainly the ones that we utilize for our limited release that we did this -- later this sort of through the summer. It will be a U.S.-centric launch with selective commercialization that really more as at an account-by-account rollout internationally. There are certain idiosyncrasies of international below-the-knee volumes, like there are a few sites in Italy that do a lot of below-the-knee volume, and then there are other countries where it's biased very heavily towards amputation or surgery and very little endovascular procedure. So we'll be very selective sort of country-by-country and account-by-account in our international experience. But at this juncture, we have a sales team that has been trained for some time and eager to have full access to S4. And we had a sort of compensation structure that assumes that it is an active launch, and we're anticipating a fairly strong sort of reception to the technology, albeit there are fewer below-the-knee cases and there are above-the-knee cases. So we'll -- we anticipate we'll always be biased towards overall in the portfolio more above-the-knee business for the coming quarters, at least.
Just a quick follow-up. I just wanted to ask a question to get a sense for where ShockWave is being used today or rather where you expect things to go from a vessel preparation perspective? What percent of the time do you think ShockWave will be used alone? Or what percentage of the time do you think it will be used in conjunction with some other vessel type device?
So I'll try to avoid going through every single vessel because it really is different by vessel. In iliacs, it's almost always stent prep or you're opening up the iliac for TAVR. In common femoral, it tends to be stand-alone. In the SFA, sort of depends on if you're using DCBs or not, or if you like using stents, some people love them. Some people hate them. Below-the-knee, more likely than not stand-alone. We'll see if Bard gets there or Becton gets there below-the-knee DCB approved, then maybe it'll be used in concert. So it really is, I guess, I did go vessel by vessel. So it's hard just to give an answer because it depends. Sometimes stand-alone often stand-alone, but also often prep, and in the coronaries, we're always used pre-stent.
Our next question comes from Larry Biegelsen of Wells Fargo.
This is Kevin Farshchi on for Larry Biegelsen. I guess the first one, you touched on it a bit in the prepared remarks, but just wanted to put a finer point on some of the DCB concerns as it relates to the business. You had updated us on the last call that you'd seen little to no impact. And then a few months ago at the various conferences, you mentioned you have seen some improvement in the market since the FDA letter. Any updates to your thoughts on the market? And then how are you thinking about the impact of DCBs to DISRUPT PAD III going forward? Again, I know you touched on it in the prepared remarks, but any other color would be helpful on the trial.
Yes. So we don't know on DISRUPT PAD III, if it will have any impact whatsoever because we're just getting sites sort of started up this week, in fact, for the randomized arm. So sites that we have spooled up, have indicated that they're back to using DCBs, and they intend to enroll and are enthusiastic about the restart of the trial. So at least in the clinical trial context with a very small sample size, we're hopeful that the sort of warning language around DCB mortality risk does not create a governor on enrollment. But we'll see. In terms of the overall market, having just been at VIVA earlier this week. The conversations I had with physicians, sounded like they were generally using DCBs more than they were a few months back, which I think we've all heard that fairly consistently. I've only bumped into 1 or 2 who said, now that I don't use DCBs anymore, et cetera, et cetera. So that seems to be much more the exception than the rule and certainly is less common than what I was hearing 6 months ago. So I think my best guess was DCBs would be at about 75% utilization relative to where they were at their high watermark. So in the era of Paclitaxel, DCBs prior to sirolimus DCBs, whenever they come available. And I think that still feels about right. I haven't heard anything that suggests it would be north of that. But luckily for us, whether they use DCBs or not, it appears to be irrelevant to our business.
Okay, that's fair. And then coming out of VIVA, it was asked, but just on the relaunch of the BTK products, you mentioned the 2.5 could be added at the end of the year in the prepared remarks. I guess the question is what exactly do you need to see in order for that occur -- to occur? And then can you kind of frame things up in terms of how reps are feeling and docs are feeling coming out of the VIVA conference?
Yes. So we're trying -- I'd say probably 70% of the folks on my team think 2.5 is ready to go already based on the limited release we've seen thus far. But we are trying to be sort of true to our plan and do enough cases, which we have sort of internal metrics to confirm that the durability that we believe we engineered in is proving out in the clinic. So far so good. And it's certainly what we witnessed in the 3.0, when we did the limited release of that, and we started with the 3.0 first, just to make sure we focus on that. We knew we needed to have the 3.0 to launch. We would prefer to have the 2.5. I think we will sometime later this quarter, but we just want to get through and be consistent with our limited release plan before we launch it.
In terms of the clinician response, I think the response that's more relevant even than the response from physicians coming through the booth or sitting through our symposium yesterday at the VIVO, which went really well. The response of the physicians who have used it, some of whom were on the panel for us yesterday is -- has been very consistently positive. They are more often than not encouraged by the deliverability of the system, which we have electronics in our system to make it challenging to create a high-performing catheter and they're more often than not impressed by the deliverability, but they're more impressed by the safety and the sort of nice, clean, open vessels that they see post treatment.
And as I mentioned earlier, at least based on anecdotal observation, they're feeling like there's less recoil, which is a very common phenomenon in below-the-knee vessels when you just use straight angioplasty. So it would appear, at least, by their observation, it would appear that the active crack in the calcium enable the vessel to stay open at least acutely better than if you didn't have the lithotripsy.
Our next question comes from Jason Mills with Canaccord Genuity.
This is actually Cecilia on for Jason. I just wanted to ask about the coronary, the strength we saw recently in CAD III and what's driving that? But also just coming out of TCT, what type of feedback from physicians have you heard? And then just the impact that you're seeing in Europe from that risk data?
I think CAD II data was validating versus sort of transforming kind of data set, a challenge when you only have 60 patients in a study like we did with CAD I, and it's only 5 centers. People are -- like it, but there's always the -- sort of it's only 60 patients. And so now if you aggregate those 60 with the 120 in CAD II, now you're in 15 centers instead of just 5. It's -- it validates that, that initial study wasn't just luck. And for anyone who's used it internationally, the data is no surprise whatsoever because they experience the safety, simplicity and efficacy of our system as one of our -- actually, our PI in the U.S. Dean Kereiakes, when his team started using ShockWave for peripheral applications. He told them all, you're just going to have to get used to zeros with ShockWave because you just get zeros in terms of complications. And now of course, we're going to have some minor ones and from time to time, just because you're doing an interventional procedure, you'll have an adverse event, but our rates are so incredibly low across all vessel beds. And I think that's really what you saw with CAD II. But in terms of CAD III enrollment, we now have a good -- I don't remember exactly how many sites enrolling now, but we're sort of north of 40 sites enrolling. So the trial really is at a point where you have a steady drumbeat of cases on a pretty much daily basis. And it's always a good sign, products that work well and roll fast, products that don't work well will tend to struggle with enrollment provided that you've got a good easy-to-use protocol, and you like to see studies that pick up momentum over the course of time because the investigators all talk to each other and then investigators get experience and then they work harder to find patients, et cetera. So the trial is doing what you -- what one would hope to see a trial do.
Great. And then, I guess, if I could just ask about the sales force, where you are currently in the U.S. hitting your plan, coming out of Q3. Just what your expectations for 2020 are as you look out? And then also with the BTK launch, just any additional resources or hurdles and nuances that you expect in teaching physicians in that segment versus ATK.
Yes, sales force, we're -- I'm very impressed with the -- consistently impressed with the caliber of the folks that we're able to attract to the company and that are attracted to the company. So it's been a real encouraging sign that both the sales, clinical specialists and leadership talent that has heard about and interested in joining ShockWave is putting us in a great position, building a great base of a team that we can build out on as we move through below-the-knee launch and in anticipation of coronary. So far, so good. We'll keep working hard to find the right folks and continue improving our training programs. In terms of the below-the-knee training. It's -- the technology is the same, basically. So it's very easy to train the nuances of below-the-knee treatments and therapy is different than above-the-knee. But then again, above-the-knee, we've created a vastly different above-the-knee clinical continuum than is the norm and in peripheral therapies anyway, whether it's large-bore or common femoral-s or iliac or mesenterics or all the other stuff that we get to do that are non-standard for a lot of, at least calcium modification type products.
The thing that we'll sort of figure out over the course of this quarter and then moving forward is how does one balance the longer procedure times of below-the-knee cases to make sure that we don't sort of get bogged down in the lab for multiple hours in cases and balance that with some of the easier to schedule cases like large bore access. And we're kind of excited to use this experience with both above-the-knee and below-the-knee as a test drive in some ways for what it's going to be like when we also have a coronary because you're going to have a totally different experience with coronary than you have above-the-knee, just like below-the-knee is a bit different than above-the-knee. And so as we continue our plan to have multiple products flowing through the same sales and clinical specialist team, how do we take on a new product and roll it out efficiently, get adoption as to be as sticky as possible so that the -- we're able to continue covering the right number of cases and not be obligated to cover every single case as is the norm for some peripheral products. So we're excited to see and learn about our below-the-knee rollout because I think it's going to inform how we're going to continue to build out multiple products into the future.
Our next question comes from Adam Maeder with Piper Jaffray.
My first question was just on the U.S. growth. I was hoping you could parse out new centers versus increased utilization? And then, just hoping to get some context around the number of U.S. centers that you're in today, how you see that playing out over time? And should we think about the roughly 600 U.S. TAVR centers as the goal for the company? Or is that not the right way to think about things? And then I had a follow-up.
So most TAVR centers also do peripheral. I don't know any that don't, but maybe there are. It's a -- that is a helpful subset of the centers that we think are important and relevant to our business. And they are particularly helpful because of our sales strategy, which we've talked about before, using large-bore access to facilitate an efficient back process and purchasing process at the hospital. But at the end of the day, pre-TAVR, pre-EVAR, pre-Impella, et cetera, is less than 20% of our business. We do more symptomatic iliac cases than we do pre-TAVR cases. It's hugely helpful in terms of accelerating the sales process and a very important business for us, but it is not the core of our business. And so do we use TAVR centers as a targeting list? Sure. Do we use that as the exclusive list? No, we do have centers that don't do TAVR and do buy ShockWave. And so the universe of the sort of biggest peripheral customers is in the sort of 800, we've always used 800 as the number. We still have, I think, more than half of those yet to go to make them sort of recurring purchasing customers of ours. So we have tremendous upside, both at our existing customers to expand users from 1, 2, 3 doctors to 4, 5, 6, 10, however many physicians do peripheral cases at a center. And so we have looking forward, at least, lots of new centers that we still intend to and expect to have adopted ShockWave while also having meaningful upside both on above-the-knee and now, particularly below-the-knee since that's greenfield utilization.
Over the past quarter, I'd say our -- and I'll see if Dan wants to augment. Our growth, which was back-end loaded in the quarter because of the summer slowdown, but at least in the U.S., we picked up a good number of new centers. Some of our new centers have performed exceptionally well this year. I think in part because we're now more of a known quantity. So once we get adopted, some centers can adopt us and start using much faster than they were, say, a year ago when they were trying to figure out if ShockWave was a real thing or not. I think now there's reasonably wide consensus that we are indeed a real thing. But in addition to the new centers, we -- I don't think we have any customer where we feel like they are taking full advantage of all the capabilities of ShockWave. So we -- I think we can look at every account and say, we could do better, and we did see a nice pickup in utilization of many of our centers as well.
No, I agree, Doug. I mean, it's nice to see in the last couple of months, that trend in that distribution continue on both those. So it's exciting.
Okay. I appreciate all that color guys. And then for my follow-up, you've obviously been able to put up strong growth despite current reimbursement dynamics. So my question is, how much does reimbursement come up in discussions with administrators or physicians? Are you getting pushed back there. And I think you touched on this a little bit, but can you talk about the company's plan to build or collect evidence around the economic value of IVL?
Yes. I mean, I've yet to find anybody who wants us to raise our prices. But I think I could say that about every product I've ever sold. So -- and in general, whereas a decade or 2 ago, doctors didn't care what things cost. They never ask you what they cost and hospitals didn't care much what they cost either. Certainly, you're going to talk about reimbursement and payment, et cetera, almost -- with almost any product you sell. So it comes up I would say it comes up and is more easily diffused today by an order of magnitude than it was 18 months ago. And that's for a variety of reasons. We're -- as mentioned before, we're sort of a known quantity now. So many centers are using us that physicians don't feel like they're going out on the limb for a product that they're not sure if they want it or not, now they know they want it. And so part of the reimbursement or payment objection is it's just a way of preventing physicians from forcing hospitals to just buy anything they want. I think physicians are able to go with much greater conviction now, like I have to have ShockWave because it can do these things that nothing else can do. And that's particularly the case when it comes to large-bore catheter access because it's the sort of economics and clinical benefits are so profound relative to any alternative at a hospital that it's hard for anyone to figure out why you would say no and make a patient go through a cut down on the carotid or a transcable or what have you when you could go transfemoral, everybody wants to go transfemoral. ShockWave enables you to go transfemoral and save cost and hospital stay, et cetera.
And so by having large-bore access be the lead sales strategy that has probably done more than anything to diffuse the reimbursement pushback. Once you're on the shelf, we aren't used on every single case, because we are sort of generally used for the most complex, most challenging cases, which are -- which also tend not to be particularly profitable for the hospitals. So having a sort of cost containment, very efficient way to treat these calcified patients without complications or runaway costs, we rarely get pushed back on utilization once we're on the shelf. And you're able to expand utilization in an appropriate -- clinically appropriate manner.
Long term, we are collecting cost data in our PAD III randomized trials. So that will certainly be something we'll be eager to take a look at when we're done with the study. And hopefully, the combination of great data from that trial, which we're hoping to see and anticipating in seeing as well as cost data will hopefully provide evidence for us to support reimbursement in the future, although we don't believe we need in the U.S. at least, we don't believe we need a randomized data set for reimbursement, and we're sort of actively engaged with societies to try to understand what strategies we might embark upon over the coming years as they look to -- or they are asked to reassess codes, which we anticipate will happen sometime in the next couple of years. We want to make sure we have a seat at the table to at least have a shot at improving payment for ShockWave cases. We're not planning on it. We're not depending on it. I think we've demonstrated we can build a business under the existing reimbursement architecture, could only get better if we get better payment. So we're keenly aware of that opportunity and working hard on it, but we realize it's not a -- it's not the kind of thing where you can flip a switch and suddenly have a new code next year that's going to take time, and we're putting in the effort now, so we're in the right position in the future.
Ladies and gentlemen, this does conclude the Q&A portion of today's conference. I'd like to turn the call back over to the company.
Thank you, and thanks, everybody, for joining our call. We're encouraged by the enthusiastic support we continue to see from our customers around the world and certainly appreciate the support we've had from everyone on this call, look forward to sharing results with you as I see you in coming weeks and again on our call next quarter. Thanks very much, everybody.
Ladies and gentlemen, this does conclude today's presentation. You may now disconnect, and have a wonderful day.