Mar 28, 2018
Executives
Fred Colen - President and CEO Chris Clark - CFO Jeremy Feffer - LifeSci Advisors, LLC
Analysts
Danielle Antalffy - Leerink Partners Jason Mills - Canaccord Genuity
Operator
Good day, and welcome to the Neovasc Fourth Quarter and Full Year 2017 Earnings Call. Today’s conference is being recorded.
At this time, I’d like to turn the conference over to Jeremy Feffer. Please go ahead, sir.
Jeremy Feffer
Thank you, Melissa. At this time, all participants are in a listen-only mode.
Following the presentation, we will conduct a question-and-answer session. Instructions will be provided at that time for you to queue up for questions.
[Operator Instructions]. I would like to remind everyone that today's discussion includes forward-looking statements within the meaning of applicable U.S.
and Canadian Securities Laws that reflect Neovasc's current views with respect to future events including the company's plans and expectations relating to its business, financial results, litigation and other matters. Words such as expect, outlook, anticipate, exploring, may, might, will, should, estimate, continue, strategy, potential, intend, going to, believe, plan, opportunity, trend, growing, look forward, and similar words or expressions are meant to identify forward-looking statements.
Any such statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements. For more information on risks and uncertainties related to these forward-looking statements, please refer to the cautionary statement regarding forward-looking statements and Risk Factors section of Neovasc's Annual Information Form and a discussion in Neovasc’s MD&A which are available on SEDAR and EDGAR.
With that, I would like to turn the call over to Fred Colen, Neovasc's President and Chief Executive Officer. Fred?
Fred Colen
Thank you, Jeremy, and welcome everyone. With me this afternoon is Chris Clark, our Chief Financial Officer, and we will begin our call with Chris providing a quick summary of the financials and operations for 2017.
I will then provide an update on our Tiara and Reducer programs along with my vision for the company. We will then open up the call for some questions.
Chris?
Chris Clark
Thank you, Fred, and good afternoon, everybody. I'll remind everyone that our financial results are in U.S.
dollars and prepared in compliance with IFRS. I’m going to keep my comments brief, refer you to our full disclosure filed on SEDAR and EDGAR for a more fulsome review of our 2017 results.
I’ll start by focusing on our revenue from our ongoing business, the commercialization of the Reducer in Europe. Our revenue grew 12% year-over-year from $1 million in 2016 to $1.3 million in 2017.
We’re disappointed by this top line growth, but can point to a 38% increase in implantations from 174 in 2016 to 240 in 2017 as a sign that the underlying business is growing. Importantly, in the fourth quarter of 2017, we saw a doubling of the implant rate as compared to the same period in 2016.
We expect that orders from our distributors and our recorded revenue will trend toward this underlying growth rate in the coming periods. Further, as we have previously mentioned, after the sale as part of our tissue business to Boston Scientific in late 2016, we spent 2017 winding up that business and we’ll see no revenue from the consulting services or contracting manufacturing line items in 2018.
Also in 2017 and during the first quarter of 2018, we have been on a drive to reduce cost and refocus the company. We have reduced headcount from 210 prior to the Boston Scientific transaction total to 88 today.
Our overall departmental expenses were $34.1 million in 2017 compared to $39.2 million in 2016. Worthy of mention, we saw a $10.8 million reduction in litigation expense and a $1.9 million decrease in development expenses offset by a $5.4 million increase in administrative expenses in commissions related to the November 2017 financings.
Our overall loss for 2017 was $22.9 million or $0.28 loss per share as compared to $86.5 million or $1.28 loss per share in 2016. In 2016, we recognized substantially all the $112 million damages provision related to primary U.S.
litigation with CardiAQ offset by a $65 million gain on sale of assets in the Boston Scientific transaction. I’m pleased to report that the company has paid all the $112 million litigation damages related to the primary U.S.
litigation with CardiAQ and there is no provision for litigation damages as of December 31, 2017. If you remember, we had $70 million in escrow at December 31, 2016 leaving $42 million owed in 2017.
In November 2017, we completed the very difficult financing to raise $65 million, $42 million of which was used to pay the remaining damages and interest awards with the other $23 million used to fund ongoing operations and to pay associated issuance expenses in commissions. At the year end, we had $17.5 million cash on hand and with our cost reduction efforts we believe we can maintain the burn rate of around $5.2 million per quarter.
This should allow our cash on hand to support our operations through the third quarter of 2018. We are currently exploring financing options, another means to bring additional capital into the company.
And I’ll provide public updates when appropriate. Next, I would like to comment on the significant drop in our share price.
To do this, I have to go back to the decision of the company to complete the financings in November 2017 and remind everybody of the precarious position the company was at that time. The company was faced with an extremely difficult decision.
The company had $42 million in damages that was due in payable within five days after exhaustion of all appeals. After pursuing multiple alternative options including a variety of strategic alternatives, the choice was either to do this financing on very difficult terms which I must point out was the only financing that was available to the company at the time or to file to bankruptcy protection.
The Board, including a committee of independent directors who are free from any interest in the financing, and management made a decision that in the best interest of the company and its stakeholders wished to complete the financing. In other words, we had to pick what we thought was the lesser two evils after rescinding [ph] the impact of both options on the company and its stakeholders.
The situation was indeed so bad that the company had to apply for and was granted use of the financial hardship exemption from the TSX to be allowed to complete this financing in a timely manner. The financing included future products warrants and notes with certain of the securities also containing full-ratchet anti-dilution features, which means that if we issue common shares at a price lower than the then applicable exercise of conversion price, those exercise and conversion prices are reset to the lower price, the details of which were disclosed in the press release and prospectus supplements and in the associated documents filed on SEDAR and EDGAR at the time of the transaction and included in the year-end filings that we made today.
In particular, we highlighted various risks to the company of such a transaction including the risk of some significant dilution to our existing shareholders if the future price features the warrants or notes or the full-ratchet anti-dilution features were triggered. For example, we disclosed at the time that if should share price drop to $0.20, the potential fully diluted share capital of the company could be 599.6 million shares.
Unfortunately, our share price has dropped even lower than that and the potential dilution to our shareholders even more significant notwithstanding other positive developments. I would like to update our shareholders on the current status of the instruments included in the financing and on our issued and outstanding and fully diluted share capital.
The 3.6 million D warrants have all been fully exercised for an equal number of common shares of the company. The 25.7 million A warrants, 10.3 million C warrants and 22.4 million E warrants have not been exercised and remain outstanding.
Please note, exercise of the C warrants would result in the issuance of additional common shares A warrants and B warrants. Of the initial 25.7 million B warrants, 11.2 million have been exercised using the cashless alternative net number mechanism for 149.4 million common shares of the company.
And similarly, of the 22.4 million F warrants, 21 million had been exercised using the cashless alternative net number mechanism for 223.4 million common shares of the company. Today, there are 14.5 million B warrants and 1.4 million F warrants outstanding representing approximately 56% and 6% of the original issuance of each warrant.
Together in aggregate, 67% of the B and F warrants have been exercised. Please note that the convertible notes also contain future price mechanisms where the notes can be converted according to an alternate conversion price thereby resulting in future potential dilution.
Our issued and outstanding share capital today is 477.4 million shares. Our fully diluted share capital today is 583.6 million shares.
Our fully diluted share capital at today’s price assuming all the currently outstanding B and F warrants are exercised using the cashless alternative net number and all the currently outstanding notes are converted using the alternative conversion price is 1.52 billion shares. Please also keep in mind that these diluted share capital estimates are based on the current share price and current exercise and conversion terms of the warrants and the notes which are subject to change.
If the company’s share price drops further, even more shares will be issued upon exercise of the B and F warrants. We believe the decline in our share price and dilution are a byproduct of the financing that we concluded in November 2017.
But because of that financing we were able to fully fund our legal obligations, while also retaining sufficient resources to fund our clinical programs and move our business development efforts forward. I would like to further add.
As disclosed in today’s filings, the Board and management of the company wrote approximately 5.6 million common shares and 5.7 million options in the company and did not hold any other warrants or other instruments. The 5.6 million common shares which represented 7.1% of the company prior to the financing have been diluted along with all other shares to represent 1.2% today.
The options are all out of the money and at today’s price have no value to the option holder. The decision to accept the very difficult financing terms was done in the best interest of the company and its stakeholders only.
It was a very difficult decision, but when the only other viable alternative was bankruptcy we believe it was the right one. Finally, I’d like to address the notices we have received from the NASDAQ regarding both minimum bid price value and minimum market value deficiencies.
As we laid out in our press releases, the company intends to monitor the minimum bid price and market value of the company and intends to initiate actions that might be sufficient to address the deficiencies within the prescribed grace periods or any available extensions. During the grace periods given by the Exchange, we expect the company’s common shares will continue to be listed and trade on a NASDAQ capital market.
Before turning the call over to Fred, I would just like to take a minute and say how delighted I am that he has joined the team. As many of you are aware, this is his first investor call since joining Neovasc in late January.
Fred is a seasoned medical device executive who has established a reputation as a strong leader during his time as Chief Technology Officer and in leading the CRM division of Boston Scientific. His transition into the CEO role is a key element of our strategy for the commercialization of our new to market Reducer product in Europe and the advancement of the Tiara mitral valve clinical program.
Achieving these milestones has created a new level of excitement throughout the company and we are all excited to have Fred at the helm during this strategic transition. Fred?
Fred Colen
Thank you, Chris. I’m excited to be here today despite challenging times and to share my vision for Neovasc.
I want to start by discussing our activities over the past couple of months, my strategy for the company moving forward and then provide some near-term and longer-term milestones. I have spent the past couple of months taking a deep dive into all aspects of the company including a science, clinical approach, products, sales team and all operations.
My goal is to determine and execute the right turnaround strategy for the company to create real value for patients, customers, investors and employees to expand on the established foundation of the Reducer therapy and to bring the transapical Tiara mitral valve to the market while developing the transfemoral, trans-septal Tiara version in parallel. Neovasc has the benefit of having two unique, innovative cardiovascular medical devices in its portfolio and both have the potential to provide solutions for the treatment of large unmet medical needs; the Reducer for the treatment of refractory angina and the Tiara mitral valve for the treatment of mitral valve regurgitation.
The future of our Tiara mitral valve is much clearer now that primary U.S. litigation with CardiAQ has been concluded.
I will spend my time today discussing our path forward for both product platforms. Our Tiara mitral valve has shown its potential as a viable clinical treatment in the early results of our clinical science programs as well as in compassionate use cases for patients with severe mitral regurgitation and enlarged left ventricles, patients who are at high risk for surgery and we intend to focus on continued and increasing enrollment in our European TIARA II CE Mark clinical study.
In this TIARA II clinical study, we have implanted 12 patients with Tiara to-date with an additional two patients scheduled for implantation and several other patients currently under evaluation for eligibility. We believe the trial is on track to meet or exceed our goal of achieving full enrollment of 150 patients by the end of the third quarter of 2019.
In an effort to streamline and increase patient enrollment for this trial, we have worked hard to establish a solid, new, easy-to-use, local pre-screening process and tool, which has just now been finalized and its implementation in Europe is starting this week. We have also established more field clinical engineering support in Europe, which will allow us to support additional sites as well as reduce the time from when a site identifies a patient to when they are enrolled and scheduled to have the procedure.
Simultaneously, we are in the process of recruiting and qualifying additional clinical study sites in Germany, the UK, Spain and Israel. We currently have 10 clinical sites; five in Germany, three in Italy and two in the UK.
Our goal will be to add six clinical sites in the first list of countries over the course of the next several months, and we are in early stages of discussion with several additional clinical study sites in Germany and with one in the Netherlands. In an effort to keep our supporters in the medical and investment communities up to date on our progress as well as build greater awareness and excitement about the Tiara program, we are establishing a strategy of providing continuous clinical results updates.
This has already resulted in a presentation of the clinical results of 48 Tiara patients; 14 in TIARA I, 12 in TIARA II and 22 compassionate use cases by Dr. Anson Cheung at the Zurich Mitral Valve Meeting on February 27.
And we were just informed that we would also have the opportunity to present our clinical results at the EuroPCR Conference during May in Paris. Furthermore, Tiara clinical updates will be provided at the ISMICS meeting and the TVT meeting both occurring during June.
I’m very pleased to announce today that we have now reached the level of 50 total Tiara implants with two more recent implants in the TIARA I study. The 50th implant was successful and straightforward occurring last week at the Henry Ford Hospital in Detroit.
We are extremely pleased about the achievement of reaching 50 total Tiara implants and want to thank all implanting and supporting physicians for their contributions. The enthusiasm for the Tiara, its performance and ease of implantation is growing on a daily basis.
As you can see from the above, we look forward to building further momentum behind the Tiara clinical trials and the TIARA II clinical trial in particular through these focused activities and the development of Tiara in general. The second key strategic area of focus for us in the mitral valve space is the now initiated development of the transfemoral, trans-septal version of the Tiara mitral valve, the one that we believe has the potential to lead to a breakthrough for the optimal treatment of severe mitral valve regurgitation while providing a safe and broadly usable implantation technique.
These development activities are taking place both in our Vancouver as well as in our New Brighton, Minnesota facilities. We are building on our internal technical and clinical expertise, complemented by key outside available knowhow, input from physicians working with us, as well as from receiving and reviewing our clinical database with experience of our current Tiara device.
We plan to move quickly on this new product and outside of the development of the unique and innovative delivery system, we will make a few minor but meaningful changes to our current Tiara valves in order to enable trans-septal delivery and deployment as well as to further increase the suitable patient population while maintaining the core features and functionality of the current valves as to leverage clinical and technical performance data. We expect to have the first version prototypes available in the next two weeks and we are currently scheduling the first round of animal and cadaver feasibility studies before June.
We will keep you updated on the timeline for this clinical value driver and key Tiara product. Now turning to the Reducer.
Millions of patients worldwide suffer from refractory angina. We see a solid market Reducer market opportunity for the sub-patient population with severe refractory angina who typically lead severely restricted lives as a result of their debilitating symptoms and its incidence is growing.
With current indications, we estimate that the Reducer can address about 160,000 patients with severe refractory angina in Europe and in the United States. We currently do not face any other permanently implanted device competition for the Reducer to treat severe refractory angina.
At current European list prices and other expected prices we believe that this results in a significant market potential for the Reducer with current indications. One of my initial tasks was to review the activities of our admittedly small sales and marketing team in Europe.
I believe that since launching the product in Europe, the team has established a solid foundation of Reducer users. This activity is steadily building awareness for Reducer within the European clinical community.
The feedback I have received from physicians is very positive with most reporting improvements in the patients that they implanted with Reducer and once physician stating, “Our last half dozen patients have all had such a fantastic response, many totally transformed.” We furthermore noticed a recent German newspaper story with the translated headline, with hourglass device back to life, the hourglass device referring to the hourglass shape of the Reducer device as implanted in the coronary sinus.
With that said, I see a lot of room for us to further improve on the Reducer therapy development. After recently receiving the NUB 1 Status by the German institute for the Hospital Remuneration System and observing the increased enthusiasm in the European market, we conducted an additional review of our Reducer revenue plan for EMEA and concluded that it is reasonable to improve our 2018 plan to achieving a doubling of implants throughout Europe and the Middle East, including a tripling of Reducer implants in Germany over 2017.
The NUB 1 Status enables over 100 clinics in Germany during 2018 to negotiate reimbursement for the Reducer procedure and we are focused on supporting the process to achieve a good reimbursement level for the clinics and the Reducer product in Germany. We are also pleased to report that Neovasc has the opportunity to devote a dedicated symposium at the EuroPCR conference in May for the European physicians to present their clinical experience with the Reducer.
Furthermore, the Reducer therapy will be presented in April during a symposium at the Mannheim conference in Germany. On the clinical side, we continue to generate data in our REDUCER-I Observational post market real world study which is our multi-center, multi-country, three-arm study collecting long-term data from European patients.
Currently, 147 patients have been enrolled across 18 centers that are active in Italy, Germany, Belgium, The Netherlands, the United Kingdom and Switzerland. The study is expected to enroll up to 400 patients.
A review of the REDUCER-I data to-date confirms the angina class improvement outcome for Reducer patients of their randomized, placebo clinical study and a review of 25 patients with available baseline data for emergency department visits during the 12 months time period after the Reducer implantation compared to emergency department visits during the 12 months time period prior to the Reducer implantation showing an 81% reduction in emergency department visits and 52% less patients visiting the emergency department after the Reducer implantation. We furthermore expect independent publications by physicians regarding their own experience in clinical results during 2018.
While we see a growing level of enthusiasm in Europe for the Reducer therapy based on our own sales and marketing activities, clinical results and general therapy development activities, including reimbursement, we are getting to a point where it becomes obvious that this therapy has a lot of potential but that Neovasc can only take this therapy so far. We are therefore open to considering strategic alternatives for the Reducer including potential alliances in order to broaden and deepen therapy penetration in Europe and the Middle East, the USA and the rest of the world.
It is also in the context of the COSIRA-II IDE study and approximately 380-patient clinical study to be conducted at up to 35 centers in the United States which was approved by the FDA in late 2017 and for which the principal investigator and the co-principal investigator are already appointed but for which the company lacks funding. Such potential strategic collaborations could dramatically improve the time to market for this device in the U.S.
while broadening the approach as well as potentially improving the company’s cash flow. From an operations standpoint, we streamlined the organization over the past couple of months with a focus on a lean and much flatter organizational structure.
We also made reductions in the workforce on the manufacturing side and in the overall building footprint for the organization while maintaining the capacity and the capability to support both the Reducer and Tiara programs. I will remind everyone that while we have cash on hand that we expect will be sufficient for the first three quarters of 2018, our clinical and technical development of the current Tiara and the transfemoral, trans-septal version of Tiara and our plan to grow enthusiasm for an adoption of the Reducer will likely require additional capital and there is no certainty that we will be able to raise this capital on favorable terms or at all.
I look forward to initiating actions in the next few weeks and months, including engagement with the parties who participated in last November’s financing to see if we can address some of the challenges created by our current financial structure which is clearly holding the company back. Ultimately, we may also need general shareholder approval.
Our objective would be to make changes that should enable us to attract new longer-term investors to the company. All of this is based on our turnaround strategy with a renewed focus on the effective execution of our key value drivers, namely our promising Reducer and Tiara products.
Overall, I am pleased with the changes we have made to-date; however, we still have a lot of work ahead of us and challenges to overcome. I look forward to updating you on our progress.
With that, we would be happy to take some questions. May I turn it over to the operator?
Operator
Thank you. [Operator Instructions].
We’ll take a question from Danielle Antalffy with Leerink Partners.
Danielle Antalffy
Hi. Good afternoon, guys.
Thanks so much for taking the question. I actually had a question on Reducer and then wanted to ask about how to think about OpEx.
So, Chris, you mentioned the Reducer implant growth rate and the sales growth rate which was much lower in 2017 versus the implant growth rate. What’s the disconnect there and how can you reduce that gap, get those more in line with each other?
Chris Clark
Well, I think you have to remember that we have a lot of our revenues driven by our distributors. And so while we have seen a growth in the underlying rate of implants, I think the absorption of that is by the distributors.
And as they start needing more inventory, we will see our recorded revenue match the rate of growth that we’ve seen in the implantation rate.
Danielle Antalffy
Got it, okay, that makes sense. And then on OpEx, given your decision to continue pursuing the commercialization of Reducer without – yet I appreciate you will look to partner that.
But in the meantime it sounds like you’re going to continue to commercialize that. You’re ramping investment in the Tiara trials and you’re developing a trans-septal Tiara system.
How do we think about OpEx growth and how much OpEx is tied to – I don’t know if you can give directional color here, tied to Tiara versus Reducer and why the decision to continue commercializing regardless of a partnership? Sorry, that was a long question.
Fred Colen
Danielle, hi, this is Fred. Let me just answer that from my side.
So first of all, we are committed to continuing these operations with a quarterly budget of about 5.2 million. That’s for the foreseeable future, certainly for the first – for each of the first three quarters in 2018.
And we have put together the budget that reflects all these activities within this number that I just mentioned. Now as it relates to why we are doing this?
There is such an enthusiasm in the market for Reducer in Europe, in particular. Again, we believe and we are planning on a tripling of implants in Germany where we are direct.
That’s a direct operation that we have. And so EMEA, Europe and the Middle East, we are planning on a doubling of the implants in '18 over '17.
So we are seeing quite a dramatic improvement in terms of uptick of the therapy. We also believe that it’s important to continue to show the progress of the therapy development including reimbursement in Germany and the drastically improving enrollment numbers or implantation numbers in order to convey the enthusiasm in the marketplace and to really facilitate the point that we strongly believe which is that the Reducer has a very viable opportunity and also a very viable business opportunity in the marketplace.
And that activity helps us in the discussions with strategic partners. So I think that’s really the foundation for why we continue to serve the patients with this product.
Danielle Antalffy
Got it. That makes sense.
Thanks so much, guys.
Fred Colen
Thanks, Danielle
Operator
Thank you. We’ll take a question from Jason Mills with Canaccord.
Jason Mills
Hi, guys. Thank you.
Can you hear me okay?
Fred Colen
Yes, Jason.
Jason Mills
Super. I’m sorry, I’m in an airport [ph] with some background noise.
Thank you. Fred and Chris, could you talk about Tiara enrollment?
And give us specifically an update on how first quarter progressed both TIARA II and then in total? And then maybe give us some assessment, I know you said you continue to expect enrollment to complete by the third quarter of next year.
How should we see that progress gate over the course of let’s say the next couple of quarters with the addition of some of these new centers? Has your thought process changed with respect to the cadence accelerating over the next couple of quarters?
Fred Colen
Yes, Jason, let me address that. So we clearly have seen an uptick in enrollment for Tiara in Q1.
We are 50 implants overall. We were a bit disappointed – there was a bit of a disappointment as it relates to how that was divided up over the different buckets; compassionate use I, TIARA II.
We would have loved to have seen more uptick in TIARA II in particular. And to address that and to really get to an increasing number of enrollment in particular in a TIARA II trial, this is why we have incorporated several actions; the first one being more on the ground clinical engineering support in Europe.
That’s the first one. The second one to initiate a strategy to get our clinical data refreshed on a regular basis.
So for example, the presentation at the Zurich valve conference was extremely important to demonstrate that Neovasc is back that we alive and well and that we are enrolling patients and that the clinical results are actually looking quite decent for our Tiara program. So that’s the second one.
The third one is that we need to further improve our screening procedures to enroll the correct type of patients in our clinical trial. So therefore we’ve worked hard in the last month on providing what we call pre-screening process and tool to easier and at a local level in the hospitals in Europe already figure out in advance of sending in the patients which are the most likely patients that will be accepted.
So all these actions we believe will enhance enrollment in particular in a TIARA II trial. So we do believe that this will continue to go up quarter-over-quarter every quarter this year.
And we are still on track to get to the total enrollment completed by the end of the third quarter of 2019.
Jason Mills
Okay, that’s helpful. And then can you speak to TIARA II specifically in Germany, you’ve talked about in the past adding some resources there and maybe just specifically what increase or what enrollment you expect to get from some of the newer centers that are perhaps just going through the protocols right now, maybe haven’t even done their first implant, just your thoughts or feedback from these centers specifically with respect to how they expect to entertain Tiara within their clinical trial [indiscernible] they’re not just doing this job, they’re doing others.
And then maybe also just to close with that, comment as best you can about the competitive landscape? We’ve heard some companies pausing their CMVR platform and all medicines [ph] and other things you hear in the market, we’re interested to hear your thoughts and feedback based on the due diligence you’ve done with respect to competitive platforms and progress there?
Thanks, Chris.
Fred Colen
Yes, Jason, so first of all as it relates to additional clinical sites, so after – in particular after the presentation at the Zurich valve conference where the medical community in Europe understood that Neovasc is back and alive with an exciting program, we clearly have seen an uptick in enthusiasm of clinical sites to join our program. And so as I said in my remarks, we currently have 10 clinical sites in Europe and within about a month we had another 10 clinical sites in Europe, most of them in Germany expressing an interest in becoming a clinical center for the Tiara valve.
That then started a process of discussion and formal qualification of the clinical site to make sure that the clinical site will meet our expectations as it relates to compliance and being able to enroll sufficient patients. That is a process that does take a few months.
So that is not something like you start one day and you’re done the next month. It takes some time to do that.
But just to show the level of enthusiasm and to demonstrate that when Vicki, our Head of the Clinical Group visited these sites in Germany in the first quarter, she left a first set of documents behind that needs to be filled out by the site to start the qualification process. And just to show the level of enthusiasm, we got from the 10 sites we go the qualification reports back filled out within a week after she actually left them at these clinical sites.
So that is just a sign that I think is very powerful to show you that these sites are indeed quite interested in working with us. As it relates to competition, the one thing that I would mention is that from my standpoint from what I’ve seen, our biggest competition is actually the mitral clipping procedure more so than other programs because the mitral clipping procedure is actually a reimbursed procedure in Europe and therefore clinics are getting paid for treating the patients in this way first as participating in the clinical trial for which they don’t get paid and it’s extra work, the largest obstacle or difficulty for us to speed up enrollment outside of all the other factors that I mentioned before.
Indeed we have added clinical support staff, in particular in Germany with two additional people. And if you compare that with the situation before, we have to actually fly one person in from the U.S.
to provide that. So I think to have two people on the ground as opposed to one flying in from the U.S.
we believe that’s going to also provide for quite a bit of a difference in terms of support and enrollment speed. So I think that’s pretty much what I can say about the things you wanted me to mention to give you an overview of what we see in the marketplace in Europe as it relates to the Tiara clinical trial.
Jason Mills
Yes, that’s helpful. Thank you, Fred.
Thanks, Chris.
Fred Colen
Thanks, Jason.
Operator
Thank you. That does conclude today’s question-and-answer session.
At this time, I’ll turn the conference back to Fred Colen for any additional or closing remarks.
Fred Colen
I think that concludes the call, Melissa, thank you very much. And thank you all for your participation today.
Goodbye.
Operator
Thank you.