BioCardia, Inc. (NASDAQ:BCDA) Q4 2022 Earnings Call Transcript

Peter Altman: So, actually I think all of the data is presented in the poster that’s available on our website. Kumar, and I appreciate the question. I think the inclusion criteria is that the patient is 20% to 40%. In addition, the follow up is the 35% would be on top of that. So, in my mind, I’m estimating it’s probably high 20% at baseline and probably wound up being high 30% at follow up, but I don’t have the data right here before me. I can shoot you that poster if you would like after this call.

Kumaraguru Raja: Okay. And also the range, it kind of fits in with the expected range of like 25% to 45% that is seen with other treatments for heart failure, I guess.

Peter Altman: So I think in general, so the one therapy in heart failure that can really enhance your heart function is biventricular pacing in some patients with a left bundle branch block. But in truth, most of the heart failure therapies where you still have the native part, and I’m excluding left ventricular assists devices and heart transplantation, but most of the therapies don’t significantly improve LV ejection fraction. Typically these patients are slowly deteriorating and so most other therapies in this space, in running a comparison, they’re comparing it against a group that doesn’t have that therapy and they’re showing that they’re better than that control group. Here in this rolling cohort, we show that the patients are actually better themselves than they were two years ago.

That’s not been done in heart failure. Now this is a very small data set and I don’t want to over interpret it, but it’s worth looking at and it was a blinded data set, I know that the Yale Echo core lab was blinded as to the time of these patients being treated and these are the results that they came out with.

Kumaraguru Raja: Okay. And with regard to the statistical analysis plan, you mentioned that it would require about 86 patients to 126 patients and in that context you also have eight patients under active consent and 15 patients under pre-consent. So with regard to the timing of the next DSMB, what would be the number of patients that would be analysed?

Peter Altman: So I don’t have the exact answer there, Kumar, but that’s a great question. So here’s the way I would suggest that folks think about it. So again, this is, to have a heart failure trial and this early is — would be very exciting, but at the same time, it’s a success if the DSMB with the number of patients we have in all the additional follow-up data set keep going. That’s a success. Yes, there’s a brass ring if they stop the trial or recommended stop early for efficacy. At our last DSMB review, we said that they have already looked at a 100 patients past the primary endpoint. And so in light of the fact, and I also had a shareholder letter that we released at the end of December, which we provided more color. One of the interesting things is the larger trial design was meant to address issues associated with patients lost a follow up or greater variability in measures in the trial because of it being many more centers doing the measurements in different, slightly different approaches, even though they’re all trying to do it in a very controlled fashion.