Sensus Healthcare, Inc. (NASDAQ:SRTS) Q2 2023 Earnings Call Transcript

So, we’re starting to hear some good rumblings from the field. We’re excited for them that we seem to believe that the market is coming back based on their feedback. And I think that’s what we’ve been saying all along that the second half will be a much better half as people get back to incorporating whatever economic situation they’re experiencing is part of life and the way we move on.

Scott Henry: Okay, great. Thank you for taking the questions.

Joseph Sardano: Thank you, Scott.

Michael Sardano: Thanks Scott.

Operator: Our next question comes from Anthony Vendetti with Maxim Group. Please go ahead.

Anthony Vendetti: So, on the – just shifting gears back to the transdermal infusion system that you’ve developed on your own now, just where is the status with the 510(k)? Maybe just an update on where that’s at and what your expectations are in terms of the clearance there?

Joseph Sardano: Yes. We’ve gone through all of the regular testing through the government programs that have required it. And, so those testing, those reports are we’re waiting for. We expect those reports to be incorporated into an FDA submission within the next 30 to 45 days, and we expect FDA clearance before the end of the year. 1 of the things that we’ve added, which I think everybody would expect us to add was the Sentinel capabilities into this program so that the Sentinel Cloud and all of the opportunities with Sentinel attached to this device as well. So it clearly will give our customers the best options possible in providing this kind of drug delivery system, if you will. So we’re very, very excited for it.

Anthony Vendetti: Okay. So, the addition of the Sentinel system that the IT piece that you’re putting with it has the combination of the two is why it’s taking a little bit longer, but you’re expecting within the next 45 days to submit and then approval by the end of the year. Is that right?

Joseph Sardano: Yes. And it hasn’t – that wasn’t what delayed it. It was the testing by the third-party agencies as designated by the FDA. You have to have those. And there’s quite a line of people lining up to bring product to market through the FDA, and they’ve got a backlog. But all of those testings have been completed and the reports are being finalized. So that was the delay. And when I say delay, it was maybe a 30-day delay overall.

Anthony Vendetti: Okay. And then, just going back to the SRT systems. And as I guess, the sales force has been speaking to clients. I know you’ve kept consistent with the 60 systems in total by 2023. But as we enter the second half, just in conversations with dermatologists, what are you hearing in terms of their appetite for new systems as we move through the rest of this year? Are you hearing that, that’s increasing just in general, as we’re dealing with higher interest rates and so forth, whether it’s for the SRT or for other systems, is there a sense that dermatologists are reticent or scaling back their purchases or even leasing? Or are things now back to what – I’m not going to say normal, but have returned in terms of what you would consider a normal appetite for new systems into their practice?

Joseph Sardano: I don’t think that there’s any question that they’re coming back. And so, we’re getting feedback that things are going to start moving in the second half. We’re seeing signs of that almost every day. So, we’re encouraged by talking to our customers. And I think, during these tough times, just like it was when we were going through COVID, for instance, it gave us an opportunity to get even closer to our customers because they’re always looking for solutions, and it gave us more opportunity to have dialogue with them. And so, I think they knew that we were there for them during the tough times – were there with them during the good times, just like we were during COVID. So, I think that the feedback that we’ve been getting has been very, very positive, and it’s been very, very secure in how we’re feeling towards the second half of the year. So, we’re excited.