Ed Woo: For some of those who are not as familiar, it’s typically for drugs that are — therapeutics that are approved. Is there — like how intensive is the monitoring post-FDA approval?
Lishan Aklog: Very intensive. So these approvals are in a sense conditional, right? So they are — they found them to be [indiscernible] effective in their — typically PMA trials and, and they’re — sorry, their Phase 3 trials, but they’re coming out for real world use with a very stringent requirements for surveillance where data has to be collected to demonstrate in real-world use that the safety profiles that were demonstrated in the Phase 3 studies are replicated in the real world. So there’s a significant amount of data being collected. There are significant periods of market surveillance. And the way that the drugs are being delivered are under very strictly defined care pathways. So all of that lends itself to a digital health companion platform.
So if you have your approved, your drug approved, and the agreement with FDA is that you offer it, let’s say, as fourth-line therapy, and you have an actual protocol, so the pathway that patients are supposed to undergo, what kind of testing they’re supposed to undergo, what their dosing is supposed to be, how their complications are being monitored and reported. All of that is explicitly described in a care pathway that comes with the approval. And so, all of that is very amenable and works well within a digital health platform that we would seek to capture. And then, again, just to reiterate, the real commercial opportunity for the companies is that, if they come out of the gates as a third or fourth line drug, the market is much smaller.
And the goal is to use this post-market surveillance phase to demonstrate that the drug should move up the chain of therapy to first or second line drugs, which expands the market dramatically. So really, we think it’s a great opportunity, and it’s one that we think will benefit for modern digital health tools such as our platform.
Ed Woo: Great. Well, thanks for answering my questions and I wish you guys good luck. Thank you.
Lishan Aklog: Thanks, Ed. I appreciate it.
Operator: And our next question will come from Anthony Vendetti with Maxim Group. Please go ahead.
Lishan Aklog: Good morning, Anthony.
Anthony Vendetti: Good morning, Dennis. Good morning, Lishan.
Lishan Aklog: Anthony, how are you? Good. How are you? So, just to follow up on the major academic cancer centers, obviously that sale cycle is probably fairly lengthy. Would it be accurate to say it’s probably somewhere in the six to 12 month range? Could it be longer?
Lishan Aklog: Yes, I think — I’m sorry. Go ahead.
Anthony Vendetti: Yes, and then I know you said a number of centers that you’re speaking with. How many total centers are there that you’re having conversations with? And sort of — would you qualify those as part of a qualified pipeline you have, or some of them early stage in various forms, maybe just a little more color on that.
Lishan Aklog: Yeah, I’ll try to give you some, at least qualitative — a more deeper qualitative sense of that. So, yes, active discussions, several, I would say, and these are amongst the largest cancer care centers in the country. You’re right, lead times can be long, but lead times are going to generally be long for the first one, right? So there’s an advantage of being the first one, but there’s also more work to get somebody to buy in to being the first one. So I think you referred to it as a qualified pipeline. Yes, I would definitely describe it as that. There are ones in there that are — where we’ve made enormous progress, working up through the C-suite, getting people to sign off on, and we think we’re making excellent progress to actually consummating, and there are others that are more in — more early stages of the discussion.
I worked in academic medicine for two decades, and I know they’re competitive, and we certainly feel like once one has signed on and can brag about their cancer-specific platform that their patients benefit from, there will be some potential competitive juices flowing for others. So yes, I think this is not — I think there are some potential near-term wins here, and we are filling a pipeline of others along the way, and we’ll continue to expand the conversations we have.
Anthony Vendetti: Okay. And then just switching to the device, I think you provided a lot of color on the opportunity to integrate the Veris platform in clinical trials as well as in the actual post-marketing of these new drugs that are in various stages of coming to market. Maybe just talk about the device itself, the software, there’s always — we hear obviously always about security breaches and there’s a lot of unsecured firms out there trying to prevent that. Maybe talk about the development of the software, the monitoring. How comfortable do you feel about the security of that and the HIPAA compliance at this stage, or is that part of the process you’re working on at this point.
Lishan Aklog: I mean, I’m glad you brought that up. Let me just maybe do a little bit deeper dive of the actual sort of what the device is and how it works and how we’ve been talking to the FDA about it. So this is effectively the equivalent of the predicate we’re using — predicates we’re using are implantable cardiac monitors that are primarily designed for cardiac monitoring. And so, the whole landscape, the whole FDA process, and as well as we’ll get to in a second, the standards with regard to cybersecurity are well established for those devices. They’ve been around for years, and we’re just following in that path. So what our device, how our device differs is that it includes, in addition to the baseline cardiac monitoring, other parameters that we’ve — that I enumerated earlier, and it has a form function that allows it to be implanted in conjunction with a vascular access part.
