Unidentified Analyst: That’s great. That’s all for me. Best of luck
Operator: [Operator Instructions]. Our next question is from Joe Smith with Alpha Street. Please go ahead.
Unidentified Analyst: Good afternoon, everyone. Can you hear me? This is [indiscernible] for Joe [indiscernible]. Thanks for taking my questions. So, I wanted to ask, if you can provide some color on the estimated timelines from data readouts, especially from CardiAMP HF2 trial, which has a minimum follow-up period of 12 months. Is there any chance that we may have an interim data readout or preliminary data readout before those time points during 2024?
Peter Altman: So, there’s always possibility. Right now, we’re focused on enrolling in that trial. My sense is it is a great question, when will everything be done. I think, I would say in 2024 we’re going to have the primary readout on BCDA-01, the trial we’ve just completed and we’re aiming to take that to Japan. I think that’s the biggest near-term news, and we’ll keep folks posted how we’re doing in enrollment in the CardiAMP Heart Failure II confirmatory study. As I’m sure you can appreciate, we have 20 centers around the United States that have great experience. They can see that they helped their patients in the last trial. That’s very helpful to us in enrollment. We also expect, we’ve done some things in the trial design to eliminate interim visits that we don’t see as necessary now that we have such a great safety data set, so the trial will be easier to perform.
And we also have the advantages that COVID is not omnipresent these days. So, we also think that’s going to significantly enhance our enrollment activities. I can share an anecdote that at some of the centers, one of the biggest lead times in contracting a center on a clinical trial is actually the contract. And our contract for this study at the centers where we’ve just been active, has potential to be as short as a half a page. that’s a much easier contract to get done. And so, we’ll be advancing CardiAMP Heart Failure II, and we’ll be sharing as we enroll patients and we add sites. Whether or not we introduce an interim analysis is TBD, I’d have, for now I’d have you assume that we will not, because I think we’ve got some pretty good clarity on the direction to go with respect to this and we’ve got a lot going on and implementing that adaptive design review last year was a huge effort, and it was a huge accomplishment by our team even though it did not result in great victory, but it did provide us with the value proposition that we have today that we have a very large data set that we’re using and we’re on target.
And we have hypotheses as to why some of the study design issues did not go our way. But I think that, we can’t we’re not trying to prove why things went wrong. We’re trying to prove why this therapy is right. And that’s where, we’re going ahead.
Unidentified Analyst: Perfect. That’s helpful. Thanks for the update.
Operator: And our next question is a follow-up from George Well. Please go ahead.
Unidentified Analyst: Peter, I’m sorry, I forgot if you already mentioned this and maybe I just didn’t hear it. Is BioCardia still on track to have a consultation with Japan the second or third quarter of this year?
Peter Altman: We have said that we will have additional consultations with Japan PMDA. I haven’t, I’m not currently tracking exactly when it’s going to happen. My focus today has been around the completion of the data, but as we get closer to mid-Q2, we will be assessing when we are going to be meeting with them. And it’s a process where you need to submit the requisite information and then they will schedule it a few weeks out. So, we don’t exactly have perfect control on when that occurs, but they’ve been very sophisticated in all our interactions with PMDA. We’ve been very impressed by them.
Operator: And that concludes our question-and-answer session. I’d like to turn the conference back over to Dr. Peter Altman for closing remarks.
Peter Altman : Thank you, Rocco. Our therapeutic candidates and technologies have significant potential to help millions of patients with heart disease. We now have five cardiac biotherapeutic programs in development including our biotherapeutic delivery partners. Each of these programs has the potential to provide meaningful returns for our investors. I thank all of you for participating in today’s call, for your interest in BioCardia and support you provide for our primary mission to treat heart disease. Have a great afternoon.
Operator: Thank you, sir. This concludes today’s conference call. We thank you all for attending today’s presentation. You may now disconnect your lines and have a wonderful day.
