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Cardiovascular Systems Inc (CSII)
Q3 2019 Earnings Call
May. 01, 2019, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good afternoon. My name is Emily, and I will be your conference operator today. At this time, I would like to welcome everyone to the Cardiovascular Systems Fiscal Year 2019 Third Quarter Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. (Operator Instructions) Thank you.
Jack Nielsen, Vice President, Investor Relations and Corporate Communications. You may begin your conference.
Jack Nielsen -- Vice President, Investor Relations & Corporate Communications
Thank you, Emily. Good afternoon, and welcome to our fiscal 2019 third quarter conference call. With me today are Scott Ward, CSI's Chairman, President and Chief Executive Officer; Rhonda Robb; Chief Operating Officer; Jeff Points, Chief Financial Officer; and Dr. Ryan Egeland, Vice President of Medical Affairs.
During this call, we will make forward-looking statements. These forward-looking statements are covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements regarding CSI's future financial and operating results or other statements that are not historical facts. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties, including those described in our most recent Form 10-K and subsequent quarterly reports on Form 10-Q. CSI disclaims any duty to update or revise our forward-looking statements as a result of new information, future events, developments or otherwise.
We will also refer to non-GAAP measures because we believe they provide useful information for our investors. Today's news release contains a reconciliation table to GAAP results.
I will now turn this call over to Scott Ward.
Scott R. Ward -- Chief Executive Officer
Thank you, Jack. Good afternoon, everyone, and thank you for joining us today.
CSI continues to perform exceptionally well. Our third quarter was characterized by strong consistent growth in our domestic core atherectomy businesses, robust expansion in international markets and a disciplined execution of our key financial objectives.
I'm pleased to report that CSI achieved double-digit growth for the fourth consecutive quarter with revenue of $63.3 million, representing nearly a 14% increase compared to last year. Revenue growth was driven primarily by ongoing strength in our domestic atherectomy businesses, where we continue to gain market share and achieve double digit unit growth in both our peripheral and coronary franchises. Notably, revenue in our domestic coronary atherectomy business increased by 18%, powered by new product launches and exceptional customer support from our sales and clinical specialists teams.
The commercial launch of orbital atherectomy in international markets continues to gain momentum. We achieved $2.4 million in international revenue in Q3 driven by the rapid cadence of product launches in Asia, the Middle East and Europe, and strong performance in Japan, where we are now on pace to capture 20% market share within the next 12 months.
In addition to strong revenue growth, we are also executing on our key financial objectives. We were profitable again in Q3, and gross margin has remained strong at 81%. Our manufacturing operations teams continue to perform exceptionally well, delivering important cost reductions as we drive increased unit volumes.
CSI is a patient-centric and customer-focused organization, and we strive to be partners in healthcare, collaborating with our customers to deliver the high quality products, services and relationships that are required to assure the best possible outcomes for our patients. We are the market leader in peripheral and coronary atherectomy, and together with over 2,000 physicians worldwide, we achieved a significant milestone in Q3, conducting over 20,000 orbital atherectomy cases, and enabling physicians to enhance the quality of care for patients around the world.
In summary, Q3 was a straightforward quarter marked by strong growth and solid execution throughout our company.
Rhonda will provide additional information regarding our key growth drivers and commercial progress in a few moments. But first, Jeff will now provide details on our Q3 results and discuss the outlook for Q4. Jeff?
Jeffrey S. Points -- Chief Financial Officer
Thank you, Scott, and good afternoon, everyone. As Scott mentioned, third quarter revenue of $63.3 million represented a 14% increase compared to last year. It also represents sequential revenue growth of 5% compared to second quarter. In total, we sold over 20,000 orbital atherectomy devices during the quarter, representing a 17% increase compared to last year.
Worldwide peripheral revenue increased 10% to $45.2 million. Our worldwide peripheral units increased 16% compared to the prior year. Domestically, peripheral unit volumes increased 14%. As anticipated, we experienced a mid single-digit ASP decline, which is consistent with our expectations and recent periods.
Worldwide coronary revenue increased 24% to approximately $18.2 million. Domestic coronary revenues grew 18%, primarily driven by increased unit volumes. Coronary ASPs were flat with last year.
The revenue breakdown between U.S. and international was as follows. Total U.S. revenue increased 11% to $60.9 million. Domestic peripheral revenue increased 9% to $44.6 million, and domestic coronary revenue increased 18% to $16.3 million. International revenue totaled $2.4 million.
In Q3, gross profit margin remained strong at nearly 81%. We remained focused on achieving manufacturing efficiencies and product cost reductions to offset the impact of lower peripheral domestic ASPs, and the growth of lower margin segments. Operating expenses of $50.6 million, increased about $5.5 million or 12% compared to last year.
R&D expenses associated with investments in new product development and enrollment in the ECLIPSE clinical trial increased 27%. We are accelerating our investment in R&D to broaden our product offering, expand the use of orbital atherectomy, and drive long term value. SG&A increased 9% due to physician training and medical education investments to support our international expansion.
We were profitable again in the third quarter with net income of $672,000 or $0.02 per share. Adjusted EBITDA increased to $4.1 million. We continue to maintain financial strength and flexibility as evidenced by a cash balance of $115 million, no long-term debt and a line of credit in place for borrowings up to $40 million, and a shelf registration in place to issue up to $350 million in equity.
This concludes my summary of our Q3 financial results. I will now discuss our updated annual guidance. With two months remaining in our fiscal year, we are tightening up our fiscal '19 financial guidance. For fiscal '19, we now anticipate revenues in the range of $245 million to $247 million, representing an annual revenue growth of 13% to 14%. Gross profit margin of 80% to 81%. Net loss between breakeven and 0.5% of revenue and positive adjusted EBITDA.
Rhonda will now discuss our commercial developments. Rhonda?
Rhonda J. Robb -- Chief Operating Officer
Thank you. As you just heard from Jeff, we again achieved strong financial performance in Q3. As we've demonstrated throughout fiscal '19, the key driver of our quarterly financial results has been the ongoing success of our domestic orbital atherectomy franchises. Bigger picture, our strategy to provide exceptional case support, with deep clinical acumen, continuous innovation, medical education and growing medical evidence resonates with our customers.
We have sustained strong growth over the past four quarters, and we believe the momentum achieved in our core business in fiscal 2019 can be sustained in the future based on the following factors. First, our physicians increasingly turned to orbital atherectomy due to its ease of use and flexibility. Physicians can use one device to treat short and long lesions with moderate to severe calcification throughout the vasculature.
Second, orbital atherectomy is the only atherectomy product in the market supported by strong medical evidence published in peer-reviewed journals that demonstrates safe and effective calcium removal, vessel preparation and improve patient outcomes.
And finally, reimbursement and provider economics remain stable and supportive for atherectomy. In fact, CMS released the proposed rules for inpatient atherectomy reimbursement last week. And the proposed DRG rates for both coronary and peripheral atherectomy procedures improved slightly in 2020. With those factors in mind, our worldwide peripheral business grew over 10% in Q3, driven by 14% unit growth in the core domestic peripheral atherectomy business.
We remain focused on several key initiatives that are delivering positive results. In peripheral, growth was driven by market development and continued success in the office-based lab market. Execution of long-term volume based contracts, increased case coverage, stable reimbursement and provider economics for atherectomy procedures, increased use of our new five French radial access device and medical education programs that generate new accounts and new users.
Last quarter, I detailed our strategy in the office-based lab or OBL market. OBLs are accelerating patient access to care and may account for approximately 50% of peripheral atherectomy procedures today. For six quarters now, we have targeted high volume OBL sites offering long-term volume-based contracts combined with increased procedure support. This strategy is working. And similar to Q2, our OBL revenue grew over 25% in Q3.
We also continue to win new peripheral business in both OBLs and hospitals. Compelling medical evidence is one way we win. Our ongoing investments in clinical trials help advance the body of evidence in support of the field and specifically for orbital atherectomy.
Our large sales channel can introduce our technology to new physicians by discussing peer-reviewed published data. This clearly differentiates CSI from our atherectomy peers. We added another publication in Q3 as the one year results of our LIBERTY 360 study were published in the Journal of Endovascular Therapy. We look to build on this landmark study in future quarters with new data that supports the clinical and economic benefits of orbital atherectomy.
Finally, as we add new support devices to our offering, we are gaining traction with our radial access portfolio. In Q3, we launched the peripheral ViperWire Flex Tip and the VIPERCATH XC exchange catheter, this is the only 200 centimeter catheter on the market. Since the launch of the VIPERCATH in March, we have experienced an acceleration in radial revenue.
With 40% of coronary procedures performed using radial access, we believe physicians will also increasingly embrace radial access for their peripheral procedures. CSI is the only atherectomy company offering a low four, five French profile extended like device that can accommodate radial access and effectively treat lesions in large vessels above the knee.
On to coronary, our worldwide business grew 24% with strong growth in the core domestic business. Our strengthened coronary stems from the strategies we initiated last year, including dedicated coronary sales representatives, investments in expanding medical education programs, the commercial launch of our complex coronary toolkit and international growth.
As you recall, in certain high volume coronary markets, we direct our dedicated coronary sales rep to drive adoption in existing accounts. We're finding that the complex coronary patients that we helped to treat are increasingly aggregating at centers of excellence. For this reason, it makes sense to have dedicated coronary reps and clinical specialists supporting these high volume accounts and providing exceptional customer and procedure support in the cath lab every day.
In addition, providing medical education for new users in these locations increases penetration within current accounts. We also continue to receive a positive market response to our emerging coronary toolkit. Together this kit which currently includes the 1.0 millimeter Sapphire angioplasty balloon, the Q3 launch of the Teleport microcatheter and Diamondback with the Glide Assist feature improves the deliverability of the Diamondback crown to the lesion site.
In some cases, these products are enabling physicians to treat patients that were previously not candidates for an atherectomy procedure due to their complicated anatomy. We are now seeing over 33% of our coronary cases incorporate at least one of our balloons or catheters.
Turning to international, orbital atherectomy continues to receive an enthusiastic reception worldwide. In just over one year, we have now launched orbital atherectomy in nine countries across Asia, Europe, and the Middle East. At the end of Q3, we had over 80 physicians outside the U.S. certified to use orbital atherectomy, and we are on track to have over 100 certified by the end of June.
In Japan, the Q3 launch of coronary classic with the ViperWire Advance Flex Tip is receiving rave reviews from physicians, and our growth continues to accelerate in this important market.
Before discussing our Q4 guide wires, I will just quickly mention that we continue to make progress on our critical R&D initiatives. In February, we had a very constructive pre-submission meeting with FDA to discuss the pre-clinical and clinical requirements for our mechanical hemodynamic support device. We continue to target fiscal '21 for first in-human.
ECLIPSE enrollment is now over 800 patients, and we are thankful to our investigators for their continued strong execution of the ECLIPSE trial. This is an important trial for CSI and for the market. We intend to produce the evidence required to change guidelines and establish orbital atherectomy as the standard of care for patients with calcific coronary artery disease. And we are excited to announce that we are expanding ECLIPSE globally and we plan to add new sites in Japan and also in Europe upon received CE Mark. And finally we look forward to the LIBERTY 360 economic data presentation at the New Cardiovascular Horizons Conference later this month.
Looking ahead to Q4, incremental growth drivers will include our core atherectomy business, including medical education driving higher case volumes along with increased case support. Coronary support device sales led by Teleport and the Sapphire 1.0-millimeter balloon. And in peripheral, the VIPERCATH XC and radial expansion, and finally continued traction internationally, especially in Japan and an expected CE Mark for coronary in Europe.
That concludes my prepared remarks. I'll be happy to address your questions after Scott provides his closing thoughts.
Scott R. Ward -- Chief Executive Officer
Great. Thank you, Rhonda. As we conclude now our prepared remarks, I want to emphasize just a few key points. First, I think we've done a great job executing our plan. We have successfully accelerated revenue growth. And during the first nine months of fiscal 2019, revenues have increased 13.9% versus 3.9% during the comparable period one year ago. Consistent with that plan, CSI employees delivered strong performance in Q3 with double digit revenue growth, profitability and the successful execution of key operating objectives across our organization. Importantly, we entered Q4 with momentum and financial strength.
Second, the transformation of CSI from a single technology, single geography company to an innovative leader with worldwide reach is well under way. I am pleased that we are successfully executing our key growth initiatives by driving market leading performance with orbital atherectomy expanding into new geographic markets, launching new products and developing an innovative portfolio of new devices that will propel our growth for years to come.
We are pleased that our efforts to deliver strong and steady growth combined with financial discipline have now been recognized by the broader equity markets. In March, CSI was added to the S&P SmallCap 600. This index includes SmallCap financially strong companies that are recognized as some of the fastest growing emerging companies in the U.S. equity market.
Finally, I would like to thank all of our CSI employees for their extraordinary dedication and commitment to our mission and the patients that we serve. Our employees are excited and motivated to build this company and to collaborate with our customers as we improve the quality of care for patients with cardiovascular disease around the world. Thank you for your continued interest in CSI. We look forward to updating you on our progress.
We will now take your questions. So, Emily, if you would please repeat the instructions. Thank you.
Questions and Answers:
Operator
(Operator Instructions) Your first question comes from the line of Mathew Blackman with Stifel. Your line is open.
Mathew Blackman -- Stifel -- Analyst
Good afternoon, everyone, and thanks for taking my questions. Maybe to start on paclitaxel, Scott or Rhonda, any anecdotal feedback from the field on the impact of maybe starting on referrals and interventions, but I guess atherectomy volumes just in general?
Scott R. Ward -- Chief Executive Officer
Yes. I'll take that Matt, and good afternoon. First, I would say that the effective of the paclitaxel drug coated balloon issues have really probably been neutral to maybe a little bit positive for us. At this point in time, we aren't really seeing much of an impact in our marketplace. This came out in really the first week of March, so we're about six weeks into this new environment now, and I think it's continuing to evolve. So, we will see how this changes the market over the course of the next several months.
For CSI, the reason I say it's probably neutral for our company is that the paradigm for treating these patients really has not changed. As you'll recall, patients receive an atherectomy, then they are ballooned, the lesion is checked and a physician may or may not place a stent, that basic paradigm really hasn't changed. The use of a drug-coated balloon or a plain old balloon angioplasty device is now interchangeable there. But otherwise, we don't really see much of an impact on that.
The other thing is that really -- probably 60% plus of our peripheral business is below the knee, where drug coated balloons have not been approved for use and are not widely used in the United States. Also 25% of our peripheral business is in the OBL setting, where drug-coated balloons have not been reimbursed and are not widely used. So probably a bit of a long answer for you, but that gives you some explanation of why we think it's -- right now it's probably neutral and we'll just see how this evolves over time.
Mathew Blackman -- Stifel -- Analyst
Okay. I appreciate the long answer. And just a couple of quick follow ups. Again Scott, Rhonda, either one, just -- if you could comment just broadly on the peripheral atherectomy competitive landscape, and any notable changes in just market dynamics? And I think the most important, have you seen any change in your repatriation rates above and beyond normal levels? And then I have one quick follow up for Jeff.
Scott R. Ward -- Chief Executive Officer
Okay. Good. So in terms of the peripheral competitive landscape, it obviously hasn't really changed. I think at this point it's become a bit of a dynamic environment, somewhat driven by the impact from the drug-coated balloons. We'll see how -- you know remember, we compete against these large companies. We compete against Medtronic and Boston Scientific and Philips, and these happen to all be companies that also at least have a drug-coated balloon or had one in their pipeline.
So, you know, we are yet to see how they react to the gaps in their pipeline now, and that has the potential to change the competitive environment going forward. There are, of course, smaller players and emerging players that are not coming into this market segment. We are not seeing much of an impact from any of those companies at this point in time. This is a large and rapidly growing market, so we do expect to see competition coming in the future, but at this stage, we really -- our competitive landscape is fairly stable.
In terms of our sales attrition, really no difference. Our sales -- our sales rep attrition stays really quite stable and is consistent with where we've been in years past. So, we continue to do very well there in terms of sales rep retention, and I would say that our sales reps are very motivated and excited, not only by their performance in the company thus far, but also by the future vision for our company and where we're headed. And I think you may have had one more question for Jeff.
Mathew Blackman -- Stifel -- Analyst
Yes. One for Jeff. I think Rhonda said the OBL growth was either 20% or 25%. Could you just clarify that? And either way, I think that math backs into hospital growth still in the double-digits. Am I doing that right ?
Jeffrey S. Points -- Chief Financial Officer
Yes. Mat, thanks for the question. So our OBL growth as Rhonda stated was above 25% again for the second consecutive quarter. We did still grow the hospital side of service well year-over-year and so both were healthy growth rates.
Mathew Blackman -- Stifel -- Analyst
Okay. Thanks so much, guys. I appreciate it.
Scott R. Ward -- Chief Executive Officer
Great. Thanks, Mat.
Jeffrey S. Points -- Chief Financial Officer
Thank you.
Operator
Your next question comes from the line of Danielle Antalffy with SVB Leerink. Your line is open. Please go ahead.
Danielle Antalffy -- SVB Leerink -- Analyst
Hey, good afternoon, guys. Thanks so much for (inaudible) thanks so much for taking the question, and congrats on a good quarter. Just you mentioned, you guys talked about the incremental in coronary over 33% of the cases using at least one balloon or catheter. Can you talk at a higher level how revenue per procedure has changed over the last few quarters in both the peripheral and coronary as you've added some of these ancillary devices?
Scott R. Ward -- Chief Executive Officer
Yes, I think, it's still a little bit early. We launched our support devices now, about a year ago, and I think that we're really fully launched in our first quarter of this fiscal year. So, it's still a bit early, but we are pleased with the uptake in coronary now. Our coronary businesses where we have a full balloon line. We also have the catheter line out there. And so we've got the kind of full product line there Danielle, and I think you can see with 33% penetration now, the uptake is good. We're doing well there. We do run up against challenges because obviously there's limited space in cath labs, and so getting our balloon, our full balloon line into these accounts can be difficult and it does take time. But we're making progress.
Now, as we look at our peripheral line, we will add peripheral balloons late next fiscal year, and so peripheral is a little bit slower, and it's coming online perhaps a little bit slower than coronary has. But we would anticipate that as we head through next fiscal year, we'll continue to see progress with our support devices. And in particular incremental growth and coming from the peripheral segment.
Danielle Antalffy -- SVB Leerink -- Analyst
Got it. That's very helpful. Thank you. And then just a follow up on the OBL growth still lots of momentum there I think last quarter it was 28%, this quarter you're seeing 25% plus. Can you talk about that the peripheral mix shift there between above and below the knee because it does seem like logically in the OBL, there would be less -- fewer CLI patients for example, but your bread and butter is really below the knees. Just trying to get a sense of the mix shift of types of procedures in the OBL? How that's changing and how you are attacking that? Thanks so much.
Scott R. Ward -- Chief Executive Officer
Yes. Thanks, Danielle. I think as we spoke about last quarter, and just to kind of remind you and remind everybody, our approach here is really to work with physicians that are treating CLI patients and really complex peripheral cases. So what we're doing is physicians who are performing these procedures in hospital as they are moving out to the OBL setting and are beginning to adopt, let's say the care of these more complex patients, we're following with them. We're putting in place these contracts and we're supporting them with greater procedure support. Really, I think, overall the segmentation of cases has remained about the same at 60%, 40%. Our OBL caseload is also probably consistent with that at 60% below the knee and 40% above the knee. So not much difference there. And I think that's largely because we're kind of tracking right with our customers who are performing these procedures now in the OBL segment. So I hope that answers your question.
Danielle Antalffy -- SVB Leerink -- Analyst
Yes.
Operator
Your next question comes from the line of Mike Matson from Needham & Company. Your line is open. Please go ahead.
David Saxon -- Needham & Company -- Analyst
Hi. Good afternoon. This is David on from Mike. Thanks for taking the questions. First just on radial, just wondering what it will take for radial to become the standard of care in peripheral and what you think is missing to drive faster adoption?
Rhonda J. Robb -- Chief Operating Officer
Yes, I'll take that. Thanks for the question. It's a really important one, and we're excited by the progress. And you know, as I've mentioned in my comments, you know today in the United States it represents about 40% of coronary procedures and other parts of the world, it's even higher than that primarily due to the reduction in complications and improved ambulation that patients get with that route of access.
And we're pleased with the uptake. We'd consider it still relatively early the launch of the VIPERCATH exchange catheter has been an important catalyst to help us take that launch further, but there are additional support devices, longer wires, longer balloons and sheets that are going to be needed ultimately for, I think, this route of access to ultimately realize the size of the coronary route of access, but we anticipate those products to be coming on the market over the course of the next 12 months to 18 months, and we'll continue to make progress you know with existing products that we have available today.
David Saxon -- Needham & Company -- Analyst
Okay. Thanks. And can you just give an update on the pipeline, and if there have been any significant changes since, I guess, last summer's Analyst day?
Rhonda J. Robb -- Chief Operating Officer
No, I mean we are executing per plan to the portfolio and timing expectations that were communicated last Summer. So I think the big updates this quarter that we wanted to make sure that we articulated was that the meeting with the FDA on the hemodynamic support pump and we were exceptionally pleased with how that meeting went. It's early days and there's a lot more work to do, but that's really kind of the biggest update this quarter, but everything else is on track.
David Saxon -- Needham & Company -- Analyst
Great. Thank you very much.
Operator
Your next question comes from the line of Brooks O'Neil with Lake Street Capital. Your line is open. Please go ahead.
Brooks Gregory O'Neil -- Lake Street Capital Markets -- Analyst
Good afternoon, and congratulations on a great quarter, and thank you for the much more robust review in your prepared remarks over across all your various initiatives. That was helpful. So...
Scott R. Ward -- Chief Executive Officer
That was great, Brooks. Thank you.
Brooks Gregory O'Neil -- Lake Street Capital Markets -- Analyst
Sure. The one thing I'm not sure -- one thing I'm not sure I heard much about was the relationship with OrbusNeich, and how that's going? Obviously you're seeing some uptake, but could you just comment on that specifically?
Scott R. Ward -- Chief Executive Officer
Yes, sure. OrbusNeich is our distributor outside of the United States and outside of Japan, and our relationship there is going exceptionally well. OrbusNeich is doing a great job for us. I think as we've described now we have launched in a very short period of time, really since August of last year, we have launched our business in Asia, Middle East and in Europe. You know, quite frankly that just could not have been done without a stronger partner as we have in OrbusNeich.
So they have an excellent global infrastructure. We are leveraging that. We of course continue to provide the medical education and training for physicians who are adopting our orbital atherectomy procedures, and we're collaborating with OrbusNeich for the sale and the physical distribution of the product. So, continues to grow -- go exceptionally well, we're looking forward now to the approval for coronary in Europe, and along with OrbusNeich, we're preparing to make that happen and make that a great success as well. So the OrbusNeich collaboration continues to go exceptionally well.
Brooks Gregory O'Neil -- Lake Street Capital Markets -- Analyst
Great. And then you had mentioned the competitive environment and I appreciate those comments. I noticed that a little company, I guess, Shockwave seems to be getting a lot of investor attention. I'm curious if you've seen much of them in your markets?
Scott R. Ward -- Chief Executive Officer
We really don't see them in the markets here. They've been in the commercial market in the United States in the peripheral segment for a couple of years. And we -- they have not affected our growth or our market share as you can tell from our results in particular over the course of the past year. So, no, we really haven't had much of an impact from Shockwave at this point.
Brooks Gregory O'Neil -- Lake Street Capital Markets -- Analyst
Okay. Cool. Thank you very much.
Scott R. Ward -- Chief Executive Officer
Okay. Thank you.
Operator
Your next question comes from the line of Margaret Kaczor with William Blair. Your line is open. Please go ahead.
Brandon Vazquez -- William Blair & Company -- Analyst
Hi, everyone. This is Brandon on for Margaret. Thanks for taking my question. First, I just wanted to focus on more of a high level for looking at the OAS business which is doing -- you know, continued its momentum, it's doing really well. Can you just talk about where you're seeing pockets of strength there, and particularly do you feel like things are going well there more in terms of the execution on your own internal plans or is kind of the market there growing on its own and starting to realize more of the benefits of vessel prep?
Rhonda J. Robb -- Chief Operating Officer
Yes, I will go ahead and take that. I think there's different dynamics taking place between the peripheral and the coronary business. And I think as we articulated in the comments, our unit growth was 14%. So, we're doing really well in the peripheral market. And it really gets back to market development.
I think that the emergence of the office-based lab is really driving more patients to receive care. So that's a very positive dynamic, and of course, our presence, you know, significant presence in the two sites of service, both the hospital as well as the office-based lab. The volume-based contracts that we put in place, the people that we put in place to support case coverage really has positively affected our ability not only to grow with the market, but to capture share in that segment.
And I think, additionally, we discussed the concept of stable reimbursement. The recent information that just came out suggest that that's going to continue to be very stable, if not even more positive moving forward. So I think it's really a combination of a lot of things, but clearly there's a lot more to do in that market, just due to the significant under penetration of the peripheral market and the degree to which amputations still occur.
Coronary strength is also really exceptional this quarter. And I think, there the strategy has been a little bit different. We see these large centers of excellence really taking on more complex procedures, and that's exactly where we have our dedicated coronary sales representatives and clinical specialists planted to work with those physicians on their cases. And that combined with the differentiation and focus of our medical education in addition to the launch of this coronary tool kit, have really put us in a strong position there, and then we mentioned later on international on top of that. So those are really kind of dynamics in the coronary segment.
Brandon Vazquez -- William Blair & Company -- Analyst
Great. Thank you. And then in terms of OBL that you were touching on in the prepared remarks, you had mentioned 50% of all peripheral cases are in the OBL setting now, where do you guys envision that market going to? Does it stay at 50%? Is it growing? And if it's growing, what's kind of the growth rate would be OBL market? And another good quarter of 25% plus growth there. Are you guys seeing growth from more opening new centers and getting new OBL accounts or from account penetration or maybe a mix of the two? Thank you.
Scott R. Ward -- Chief Executive Officer
Yes. Great question. So I do think we're going to continue to see growth preferentially in the OBL segment. I think there's limited access or limited capacity really in the in-hospital segment. And as Rhonda mentioned in the United States and perhaps around the world, we're really facing an epidemic of PAD and critical limb ischemia. And the only way that can be managed is by having more physicians who can care for these patients. If we look at the United States alone, it's estimated that there's 2 million CLI patients. So you know there has to be an alternative mechanism for managing the care of these patients. And I think, the OBL segment is where this is going to continue to go to.
Now what we're seeing and where we come into play here is when physicians in that OBL segment decide to treat patients that have a higher burden of disease. That is the circumstance where we can get involved and where we collaborate more closely with those accounts. So that's really where we're focused. And I would say that over the course of probably the past couple of quarters, most of our growth in the OBLs has come from going deeper or having deeper penetration in our existing accounts. And that's largely because we've put out a fair amount of -- a large number of clinical specialists and we provide procedure support in these accounts in order to assure the proper use of our device and good outcomes for our patients. So I guess that's a pretty good summary. We do expect to see continued strong growth in that OBL segment over time.
Brandon Vazquez -- William Blair & Company -- Analyst
Great. Thank you.
Operator
Your last question comes from the line of Bob Hopkins with Bank of America. Your line is open. Please go ahead.
Robert Adam Hopkins -- BofA Merrill Lynch -- Analyst
Well, thanks, and good afternoon, and congrats on a really solid quarter. I guess I just want to ask two questions. One, I appreciate the update on the pump. But could you just remind me, what was the purpose of the meeting with the FDA? And then maybe just from a big picture perspective, like, what are the key things that need to happen with the technology from here? We still kind of in the early design phase? Or just anything from a big picture perspective that you would be willing to disclose would be helpful?
Scott R. Ward -- Chief Executive Officer
Sure. Thanks, Bob. So just as a reminder, and we indicated this in our call last quarter. We had our first pre-submission meeting with the FDA to review our pre-clinical and clinical plans. We took them through the design of the device, the features of the device, the pre-clinical work that we had done, the validation testing that we intend to do, the animal research that we intend to do, and then we introduced our clinical research program to them, had very good feedback, very collaborative meeting as is always the case in these pre-sub meetings. And so we were really pleased with the outcome. Right now, I think, Bob, the focus on is first in-human, and we are continuing to be on track as Rhonda indicated to achieve our first in-human use in 2021. So, I think that's really the next key objective to look at, and at this point, it's not that far away.
Robert Adam Hopkins -- BofA Merrill Lynch -- Analyst
Okay. And then so is the next major step in the process then going into animals?
Scott R. Ward -- Chief Executive Officer
We are in animals now. So we're basically entering into the phase where we are performing design work, a design validation and animal testing. And obviously that is -- those things all go hand in hand. We've not yet started GLP animal testing and we would anticipate doing that in the near future.
Robert Adam Hopkins -- BofA Merrill Lynch -- Analyst
Great. That's super helpful. And then Scott, one more for you from a big picture perspective. Obviously, the business has good momentum. You guys are executing well on your plan. Can you just talk at maybe a high level about your confidence in being able to sustain and maintain the momentum in the business and the double digit revenue growth that you guys have been delivering of late into next year and beyond?
Scott R. Ward -- Chief Executive Officer
Yes. I mean it's a little bit hard for me to project into next year and beyond. But I think you know from our strategic plan that we presented last year that we are projecting that by leveraging our international expansion, our new product pipeline and continued strength in our core business, that we can deliver growth in the mid teen range, and that's what we continue to drive toward. We've delivered on that this year. We go into Q4 with good strong momentum. And as we've said, I think, we're doing a good job in executing against our internal milestones.
And our sales organization is just doing a great job executing our key programs. The combined impact as Rhonda spoke about, the combined impact of customer service, customer support, the really solid medical evidence that we have and the unique mode of action of orbital atherectomy just continues to provide great strength to our sales in the marketplace. Those are probably the key factors, and right now, we are executing extremely well. I'm really proud of where we're at.
Robert Adam Hopkins -- BofA Merrill Lynch -- Analyst
And then maybe lastly, Rhonda on the radio side, what's the right way to think about that? Is that -- could you mentioned that early days but started to see some good results maybe later in the quarter. Is that incremental business, or I mean, obviously just it's an alternative path to get to the same place. But would you look at that as kind of an incremental growth opportunity to the growth you're driving today?
Rhonda J. Robb -- Chief Operating Officer
I would just again point back to the 14% unit growth in the core peripheral business that we saw. We see radio as a contributor to that. Obviously, there are lots of factors in the peripheral market contributing to our success. But radio is one of those. And I just look to the coronary segment of being like 40% of cautionary procedures in the United States. So, being the only company that really can offer radio at this point in time, it's a significant differentiator, but I think again a ways to go in terms of having a full complement of products to fully support the radial procedure, but we've been pretty pleased with the uptake so far.
Robert Adam Hopkins -- BofA Merrill Lynch -- Analyst
Okay, great. Thanks for the time.
Scott R. Ward -- Chief Executive Officer
That's great. Thanks, Bob.
Operator
We have no further questions at this time, I will now turn the call back over to Scott Ward for his final comments.
Scott R. Ward -- Chief Executive Officer
Great. Thank you very much, and thanks everybody for your continued interest in CSI. We look forward to updating you again next quarter. Have a great day.
Operator
This concludes today's conference. You may now disconnect. Have a great day.
Duration: 43 minutes
Call participants:
Jack Nielsen -- Vice President, Investor Relations & Corporate Communications
Scott R. Ward -- Chief Executive Officer
Jeffrey S. Points -- Chief Financial Officer
Rhonda J. Robb -- Chief Operating Officer
Mathew Blackman -- Stifel -- Analyst
Danielle Antalffy -- SVB Leerink -- Analyst
David Saxon -- Needham & Company -- Analyst
Brooks Gregory O'Neil -- Lake Street Capital Markets -- Analyst
Brandon Vazquez -- William Blair & Company -- Analyst
Robert Adam Hopkins -- BofA Merrill Lynch -- Analyst
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