Streamex Corp. (STEX) Earnings Call Transcript & Summary

Greetings, and welcome to the BioSig Technologies Conference Call. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to your host, Andy Ballou, Vice President of Investor Relations. Thank you, Andy. You may begin.

Thank you, operator. Good afternoon, everyone. Thank you all for joining us. On today's call, we'll be hearing from Ken Londoner, BioSig's Founder, Chairman and CEO; Gray Fleming, BioSig's recently appointed Chief Commercial Officer; and Jim Walker, President of Access Strategy Partners. Before we begin, I'll remind everyone that today's presentation may contain forward-looking statements, which may be preceded by the words intends, may, will, plans, expects, anticipate, projects, predicts, estimates, aims, believes, hopes, potential or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company's control and cannot be predicted or quantified. And consequently, actual results may differ materially from those expressed or implied by such statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties, difficulties in obtaining financing on commercially reasonable terms, changes in the size and nature of our competition, loss of one or more key executives or scientists and difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the company and the risk factors that may affect the realization of forward-looking statements is set forth in the company's filings with the Securities and Exchange Commission, including the company's annual report on Form 10-K and its quarterly reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's website, www.sec.gov. The company assumes no obligation to publicly update or revise forward-looking statements as a result of new information, future events or otherwise. And with that, I'll now turn the call over to Ken Londoner.

Welcome, everybody, and thank you for joining us today. We have some exciting news that we announced earlier today. BioSig has signed an agreement to be working closely with ASPI, Access Strategy Partners, led by Jim Walker, who will be speaking to you in a moment. Jim brings tremendous capability and talent to a very important area of our business, one that many of you are very interested in, which is our commercial plans and our commercial capabilities. Looking back at 2021, we had a pretty active year. Looks like we're going to end the year being in 17 hospitals approaching 1,800 procedures completed. We were able this year to get a very important clinical trial done and published in the Journal of Cardiac Electrophysiology (sic) [ Journal of Cardiovascular Electrophysiology ], which many of you are all aware of. We also hosted a webinar led by some of the industry leaders speaking about the results of our clinical trial and the word gold standard was utilized on that webinar basically suggesting that our technology platform could become the new standard of care in addition to the other technology and equipment that's used for cardiac ablation surgery. In terms of our commercial picture, we have always looked at our launch in 4 phases. First phase was initial market release, which we put our first system in the market in November of 2019 at St. David's Medical Center. The definition in our mind of initial market release was to get a perspective on how our technology would do in a number of centers and get all the insights that we needed to learn how to improve our standing so we could expand to the next phase. This year, we feel like we were in the beginnings of Phase 2, which is limited market release, which is a more commercially focused perspective where we're looking to not only place systems and have them evaluated but also look to collect to generate revenues. The Board of Directors had noted that our abilities and our capabilities needed to be enhanced. So we went out in the middle of the year looking for a way to do that. We're very delighted to announce today our partnership with Jim and his team, in addition to the fact that we have hired Gray Fleming as Chief Commercial Officer, and both of them are going to be speaking to you today about their plans for the company. I also wanted to remind everybody that on September 28 of this year, we announced our relationship with Plexus. Plexus is a Tier 1 manufacturer of medical devices globally. They're currently the lead manufacturer of medical device product for Medtronic, also for Ethicon, a division of Johnson & Johnson, as well as General Electric and many others. Transferring our production from Minnetronix to Plexus is not a simple task, but the transfer is going very well. We've been working on it daily to be able to reach full production, which we expect will be up and running by June of next year. We currently have an inventory position of approximately 50 units, plus or minus. So we have enough product to be able to serve the market while we're waiting for our first commercial production from Plexus. And with Jim and Gray and Plexus, we feel like the company has put ourselves in a great position on both supply and demand going into 2022. As many of you know, in 2021, we added 19 clinical account managers to a number of 3, which we ended last year at. So this new commercial team has a nice base to work with and to build off of. We've also expanded our technology team and we've rolled out new software. We have a lot more software in the pipeline to enhance our offering and be responsive to the voice of the customer. What we've already heard and what we expect to hear, we'd want to be very responsive. As many of you know, we've sold product to Mayo Clinic and to St. David's Medical Center, and we're currently working on a number of deals that are in the pipeline that we hope to close in the near future. The company said in our last 10-Q on November 15 that it had at least a year's worth of capital in the bank. Given market conditions, I'm glad that we're in that position. And the last thing I'll mention to you is that there is a lot of activity going on currently at NeuroClear, ViralClear, and you'll be looking to see visibility on our activity in the first quarter of 2022. We're looking forward to sharing some good news with you there in the not-too-distant future. I'd now like to turn the call over to Gray Fleming, who will make some prepared comments. Thank you.

Thanks, Ken. First of all, words cannot express how incredibly excited I am to be part of the team. I've said the word serendipitous quite a few times over the past month, and I mean it as it pertains to this opportunity and my career. We'll start with that, a little history first. My experience at this point almost dates back 20 years to me starting as a clinical in the cardiac rhythm management space for St. Jude Medical specifically in 2002. I'm proud to say that since then, I've had multiple experiences, assuming leadership of either existing business units within St. Jude Medical and Abbott or the commercial operations of new businesses within the medical device industry over the past 2.5, 3 years. I'll rely on that experience to create what I would say is a definitive and tangible pathway to purchase. No product in the medical device space needs that more than capital equipment. Let me be clear, the definition of success for the entire BioSig commercial team is going to be simple, consistently and steadily expand the purchase footprint of the PURE EP product nationally and then globally. Again, I cannot be more excited to be leading the BioSig commercial effort as well as be working with Jim Walker and Access Strategy Partners. I look forward to answering any questions you have during the Q&A session at the conclusion of the call. Jim, I'll hand it over to you.

I'm Jim Walker. I'm the President and Co-Founder of Access Strategy Partners. I spent 35 years in the medical device business, half with Johnson & Johnson and the other half with Boston Scientific, where I was the Senior Vice President of Corporate Sales, responsible for building and executing their corporate sales capability in the U.S. and around the world. I was part of the team that grew the Boston Scientific business from $80 million to $8 billion, including the largest new product introduction in the history of medical devices, the TAXUS drug-eluting stent. In 2013, I created Access Strategy Partners to do the same thing we did at Boston Scientific, only this time for small start-up and medical device companies. Our goal is to take on large multinationals who use financial leverage to prevent new companies and great technologies from getting to the market. We call it a David versus Goliath strategy. Our company is 3 years old with 17 employees with strong backgrounds in medical devices, supply chain and GPOs. These backgrounds are critical since in today's marketplace administrators can influence up to 60% of all product decisions. Our goal for all of our clients is to ensure that their great technology can reach physicians who want to use it and patients who will benefit from it. Two of our first 8 clients have already achieved successful exits, CASMED and Misonix. With our assistance, CASMED was able to acquire the business at the Mayo Clinic. And with Misonix, in a period of 6 weeks, we were able to sign agreements with HCA, Vizient, Kaiser and other key buyers in the U.S., accelerating their business tremendously. As we select new clients, it's important that they have both strong clinical and economic value propositions. With BioSig, we believe they deliver both. Their technology can become a standard of care globally and we see that they have world-renowned EP support. We're excited by the fact that they can improve the ablation success rates that exists in the marketplace today and that they can do so in a cost-effective way. We're also excited to work with Ken, Gray and the impressive team that we've gotten to meet at BioSig. Success today requires clinical and economic value. Leading-edge technology combined with strong economic value are the requirements customers demand. We at ASPI in combination with the great BioSig team, bring the knowledge and relationships required today to accelerate our mutual success. We'll now turn it over to the operator for Q&A.

[Operator Instructions] Our first question comes from Yale Jen with Laidlaw & Company. [Operator Instructions] Our next question will come from Robert Carlson with Janney.

I wonder if you could talk a little about how you're handling the COVID situation. What effect that's having with operating moves and what problems that's causing you with the introduction of the PURE EP?

Maybe I'll start and then I'll pass it along to anyone else who wants to answer. Bob, thanks for the question. Last week, I was out in the field with Gray. We were in Houston, Texas, and we were also in Jacksonville, Florida. And I did not see any impact to their operations or hear of any impact in terms of patient cases or patient loads. I think the field has gotten used to dealing in this type of environment and from what we can assess the activity continues. Now this new Omicron variant, I guess we're all, everybody on this call are wondering what impact it's going to have. But it appears that because of the vaccination rates and the nature of the variant, people are not getting as hospitalized. So hospitalization rates have yet to really reflect that. So that's one perspective. The other perspective from a hospital purchasing and a hospital activity standpoint, maybe I can throw it over to Jim Walker for a comment.

Sure. Thank you, Ken. The hospitals at this point have become pretty effective at managing their way from a supply chain point of view through the COVID crisis. A number of them are remote, a fewer are face-to-face, but a number of them are remote. And their capital and value analysis committees generally don't allow manufacturers, despite your size, no matter who you are, to meet with those committees face to face. But one of the things we've done is we've created tools that we think are very effective. We actually develop the tools in collaboration with some key accounts. So that we can be very effective with these value analysis and capital equipment folks. So Gray seems to be able to still get great access into the labs. We'll be working collaboratively with him to make sure as he's working with the labs, we're also working with supply chain administration and with the value analysis committees to make sure we're continuing to move towards purchase as fast as we possibly can.

Do you think there's a reluctance of patients having procedures done at this time?

This is Gray. I'll take that. I think it's a great question because it reflects some of the struggles from about 1.5 years ago where you saw elective procedures take a dip due to either public perception or reality from a hospital perspective. That being said, I think the vaccine, particularly in the demographic that is typically seen in ablation where the vaccine is prevalent is something that we can sustain a high level of confidence of the elective procedures, which are obviously of major value to the hospitals won't see those dip again. Certainly not a promise, I can't promise that, but I can see how we got here, how we got out of it. And I have great confidence that the elective procedure volume, at least in this space will hold steady.

And this is Jim. I would say in any situation, I'll use the one I'm in right now. I'm calling in from Boston. So in Boston, the governor last week asked people to reduce procedures. You may have seen that a number of employees at Brigham and Women's complained in The Boston Globe that they weren't cutting back procedures enough. This morning, the governor came out and asked them to, again, reduce procedures at least to avoid unexpected overnight stays because as we all know, with COVID, everybody is worried about the capacities in all these hospitals. So it's incumbent upon us to become very easy to work with. And we've created tools and we're doing this with BioSig right now to make sure that we're very streamlined and very easy to work with, whether it's supply chain or anybody else who might be involved in the product decision.

Is there any reluctance from the hospitals meeting with your sales reps?

Yes. I'll take that answer. I think it doesn't matter what company, whether it's my old company, Boston Scientific or Johnson & Johnson or any other company, meeting time is at a premium going forward, at least for the next 2 to 3 months. I think that's the reality of it. Fortunately, in the case of my company, I would say our average person has 25 years experience. We have very deep relationships. I had a chance to negotiate literally every major contract that Boston Scientific has. I was the person who started corporate sales in 1994 at Boston Scientific. And so there, unless they've retired, pretty much I know most of the people doing these things. And fortunately, those relationships have been helpful. So we will have access. But at the same time, we're going to be respectful of everybody's time and everything they have on their plate. And I think by doing that we'll be treated favorably.

Our next question comes from Yale Jen with Laidlaw & Company.

I apologize I was on mute earlier. First, congrats, Jim, that you get this relationship. And my first question to you is that, I know you just started to be working, but what would you think, what was your initial thought about what you can offer to BioSig even at this early days in terms from both strategic and other aspects?

Yes. I would say the first thing I'd say is we can offer them access and a seat at the table. In this environment, getting a seat at the table is very difficult. If a company today was bringing in people that didn't have relationships and were fairly new to the business, I'm not sure they'd even get an appointment. So the first thing we do is we'll make sure that we have a seat at the table in every major IDN and every GPO in the U.S. For example, Vizient, which is the largest GPO in America, the person who built their purchasing program is a gentleman by the name of Dan Sweeney. He took early retirement and actually now works for my company, Access Strategy Partners. So we have that level of relationship. The head of our consulting practice, John Strong, was the founder of the Consorta purchasing group that was acquired by HPG and HCA. Prior to that, he was the President of Premier. So our relationships go deep. They've been sustained for a long time. The team that I've brought in here to Access Strategy Partners has successfully negotiated contracts. We've already had 2 exits from our clients by driving really nice top line growth. Without getting into my other clients, we've got others today where we're doing the same thing. So I think we've proven that we can get our clients to the table with the right people. And if the technology performs, which we believe the PURE EP system will definitely perform, then we think we're going to be hugely successful.

Okay. Great. That's very helpful. I really appreciate the highlights of the relationship. And then maybe just one more question here, which is that in terms of any other strategic suggestion or thought to BioSig, even at this early stage, do you have any you can think of? And I appreciate the comments.

Yes. Absolutely. We're working diligently right now to make sure we segment the market so that Gray and I go after the biggest and best opportunities as fast as we can. A good example would be an IDN like CommonSpirit that has around 214 hospitals, and they have 87 EP labs. I'm thinking Ken would want Gray and I to be going after CommonSpirit where we have an excellent relationship, by the way, and taking a look at those 87 EP labs and see where we might be able to bring in the PURE EP system to support their efforts. And we'll do that for, that's one IDN, but we've got that data. We've purchased databases. We know these customers. We'll have similar types of data for the top 70 IDNs in the U.S.

Our next question is from Steve Lepsky with Private Investor.

Two questions real quick. One is, I've been with the company quite a long time. Obviously, it's been frustrating for a lot of people as far as the lack of sales, lots of placements, great products and a lot of positive accolades from some of the top EP docs in the country. What kind of time frame do you see having been in the business a while? Obviously, you're just starting. But what kind of time frame would you put on seeing a turnaround in your strategic approach to be able to have the sales and the different markets that you're mentioning? That would be question number one. Question 2 is, Northeastern Ohio is where I'm at, and they've just stopped most elective procedures again due to overnight stays like we had mentioned earlier from the previous caller. What percentage of the procedures require an overnight stay versus same day? And then follow-up.

Yes, Jim, I'll take that one. And thanks for the question, Steve, this is Gray Fleming. For the first question, actually, I'll answer the second one first and then the first one last, the elective procedures that require overnight stays. When you think about the percentage, part of it has to do with anesthesia. And so not to get in the weeds here, but PURE EP, the majority of the value is seen in a complex ablation, which does require anesthesia. That doesn't mean the patient can't go home. It just means that the procedure needs to be done in the morning so that there's an appropriate amount of time to monitor the patient. So I think the context is appropriate for sure, but I also don't feel like it's a concern per se. And then as far as the first question, for me, that's really more about sales territories and not about how fast the turnaround. It's my intention to put every effort I've got towards standing up additional sales territories to what we have, assigning sales quota to those territories and then being hyper-accountable to those quotas.

Steve, this is Jim. I would also say that, I think the next, listen, the next 4 to 8 weeks are going to be tough with COVID. I actually think that plays to our benefit. We've developed and we're in the process of developing more marketing tools that we would like to use with supply chain, finance and the executive teams at these health systems. Many of whom probably don't even know BioSig yet. So if in the next 4 to 8 weeks, my team can use that time to introduce BioSig, educate our customers on why it's an important technology for them to have. I think that plays in our favor, actually. I don't think it hurts us. I think whether our pathway to purchase is 100 days or 90 days, you pick a number. I think the next 30 to 45 days in terms of ASPI is us introducing this great technology to every major IDN in the United States and every GPO as well, and that's what we intend to do. So I think that this is actually a good time for us what's happening.

Paul, I'll take 1 or 2 from the webcast while we queue up more on the phone line. Gray, from the webcast, you mentioned the pathway to purchase. What does that look like from beginning to end?

Sure, Andy. Thanks. Pathway to purchase in the med device world is a super common term, and it's one I mentioned in the recorded statements just to say really in capital equipment, there's not a more important area where pathway to purchase applies. And so here's what I'd say. A sales territory, again, being hyper-accountable to a quota creates the interest. And we'd like to see less evals necessary for purchase. But in this case, let's just say we have an eval. That needs to be a very well-defined process both tactically and practically for that hospital. So meaning, what are the right cases we'd like to see done, what's the frequency of the physician usage we'd like to see. And then moving towards a point of purchase where I think Jim's team is most helpful. I would refer to them as a gale force tailwind moving through that process. And moving through what hopefully is the value analysis committees and up to point of purchase, but that's not it. Adoption will be as important for the footprint to expand as is the point of purchase. And so my team is going to be very intentional about what adoption looks like so that then we can move through the process and everyone understands what the definition of success is for having PURE EP on-site. And so I would just say the pathway to purchase has to have a very definitive evaluation and/or sales and value prop delivered and then as intentional of an onboarding of the system. I can go deeper. But for there, I'll leave it at that point.

Okay. Great. I guess, following up on the heels of that, is it really Gray's job to write the strategy to purchase and Jim's job to speed up that process? Is that a fair representation? Question from the webcast.

Sure. And I'll, Jim, I'll go first, if you want to add on, certainly do. I would say as the Chief Commercial Officer, I'm 1,000% accountable to the strategy, both authoring, implementation and execution. Jim, as I just mentioned, most definitely is a gale force tailwind to that strategy. But I will be the one to author, implement and hire the team to execute. Jim's team speeds up execution for certain and again, pathway to purchase. As we sit now, we stand to walk into 2022 with a new strategy that I would say is commensurate to a different phase in the company. For the phase that was before my arrival, the job was well done. We got to a certain point. I'd like to say, if the plane got off the ground and got to 10,000 feet, it's my job to get it at cruising altitude of more like 37,000 feet, and that's what we plan to do.

And I would add to Gray's comments that we're going to work hand in glove. So when he's working on the clinical side, we're going to be working the administrative side at the same time. As you might imagine, nobody in supply chain or finance wants to be surprised and all of a sudden realize they have a 6-figure purchase in front of them that they have no information about. So our job is to make sure every step of the way they have that information so there's no surprises. And when the physician is done trying the product and says, geez, I'd really like to acquire this. I'd like to have it in my lab. We want that process to move from there. We don't want to be starting the conversation at that point. We want to be finishing the conversation at that point. So when Gray starts to move into a health system, we'll be moving in at the same time with him.

Great. Thank you. And a follow-up to that, Jim. Does Access Strategy have broad coverage of clients across all regions of the United States?

We do. We don't cover every single hospital in America because we've made a decision to go after most of the IDNs and the major health systems who we think drive 90% of the volume in America. So we're, but would you see us at Mass General, Brigham and Ascension and Northwell and Sutter and Trinity and all the major health systems. I think if you named one of them, you'd find that we were there. We'll also be there with all the major group purchasing organizations. And there are also regional alliances. For example, Mayo Clinic leads the Captis alliance. And that's going to have 200-plus hospitals as part of it. And they can be a gateway to those purchases. And by getting those relationships in place, we streamline and speed up the purchase process for other members of that organization. So we'll be on top of all of those things to make sure that we're increasing the speed to purchase.

Great. Thanks very much.

[Operator Instructions] Our next question comes from Kevin Davey, Private Investor.

Jim, welcome to BioSig family, and we look forward to seeing what you can do. Question comes to mind, it seems like you've got decades worth of strategy experience and pricing. I'm wondering if you have any initial thoughts on the pricing strategy and if there's anything that you would like to do with that.

Thanks, Kevin. Great question. We certainly have an opinion on it. Gray and I discussing exactly the best way to move ahead on the pricing strategy. What we want to do is we want to make it easy for customers to acquire the product. And there are a number of ways we can do that, whether it's purchase or lease or what have you. We have a number of existing relationships with companies that can assist us in some of those endeavors. And obviously, we will make those available to BioSig as well. In fact, we already have. Beyond that, since there could be competitors on the line, Kevin, I'm not, whether it's BioSig or any of my other clients, I'm generally not inclined to share our pricing strategy publicly.

Let's take one, Paul. I'll take one from the webcast here. Jim or Gray, what do you think is the PURE EP potential for 2022 to 2023? Again, not providing any specifics, but maybe a feel.

Sure. I'll take this one, Jim. I think and I've had this question, I've had the pleasure of already spending time with the Board and it's a popular question. So I appreciate the intent. I'll go back to this piece right here. Whatever potential is that exists, it doesn't happen without sales territories. And I would say that I have proposed to the Board and Ken and that's all, that we'll have numerous aggressive sales territories up and running in addition to what we have now. We'll have aggressive sales quotas attached to those territories and we'll be hyper-accountable to those quotas. So I apologize being a little bit ambiguous, but without the sales territories, it's sort of a moot point to me. I've got to get those stood up in a hurry.

Yes. The only comment I would make, Kevin, I'm sorry, it was not Kevin. Is that Steve this time?

Andy.

Andy, sorry.

From the webcast. It's from the webcast.

Yes. I'm very pleased with some of the people who Gray and I are bringing to BioSig and who are interested in joining us in this endeavor. We obviously have lots of relationships. We've been doing this for a long time. And we're not having much trouble getting people to share our excitement and our vision for what this can be. So we can't do it alone. We need to have other players come and join us, A players, people who know how to get it done. And I think you'll be pleased that we're able to bring those types of people to BioSig.

Thank you. Paul, we can go back to the dial-in.

Our next question is from Ryan Harper with Victoria Capital Management.

Great call. Congratulations on the new deal. I have a basic question, kind of simple, but I kind of look at growth as the job board. So how many jobs are you looking to fill right now and how do you see that going forward?

Probably that's a BioSig question. But I can tell you from the, go ahead.

So what's going on right now, Ryan, is Gray has been with the company now, I think, 2 weeks. We were talking to him prior. So he has a good understanding. And we went out into the field together with the brand. By the end of the year, he'll have the sketches of the plan. And the Board of Directors will be looking at that plan early in the new year, and then we'll be in a better position to talk about exactly how many people. Gray speaks about standing up additional territories. So we're currently, as you know, in Florida, we're in Texas, and we are in the Northeast from a commercial standpoint. And Gray has expertise in those markets as well as the Midwest. So you're going to see expansion. And then, of course, Jim brings a whole other dynamic to the table. But I think you'll see a more clear picture and an answer from us probably going into February. And we'll be executing against the plan that the Board approves. One other thing I want to say, and I think some of you on this call have some form of expectation. Gray, myself and Jim to some extent are working on the existing places where we have systems. As many of you know, we're in approximately 17 centers. And there have been evaluations out there for a period of time. And you're going to see those centers do 1 of 2 things: either take ownership of the system or give the system back to us for making it available to somebody else who has the intention of paying for the system. So that process will be ongoing here in the near term, and you can be looking for basically that to play itself out and that will help us get through the first, into the second quarter of when we receive our next commercial shipment of inventory that will fuel Gray's expansion from an inventory perspective.

And then, Ken, I'd also add this because, Ryan, it's a great question. I think it brings up an interesting point and you look at this sort of Phase 2 or whatever phase you want to call it, sort of getting to cruising altitude with an extended footprint. And it also goes back to the question of like resistance getting in the hospital, resistance to supply chain. I would say it's never been a more important time as we look to fill jobs and as we look to manage COVID or manage any resistance to have the utmost amount of relevance in the field. I'm not over here beating my own drum of relevance. I'm just saying on one side of the commercial component, you have me with 20 years in the EP space. And I've done literally hundreds of procedures with many of the authors of the clinical evidence. And that network expands out greatly, having managed the majority of the Central time zone and worked in the space in the United States for many years in senior management. And then you got Jim with like 40 years of experience in supply chain. Jim helps in that. But between those 2 components, it's a lot easier to get access than if you're a brand new or if you've sort of homogeneous to the industry, which is unfortunately a problem because you grow up in the business in either space and you spend a lot of your time wherever you were brought up. I'll just quickly offer. In my case, there are a few people, I grew up in one spot. I was a regional director in a different spot. I did the job twice, once in Tulsa, Oklahoma covering the Midwest; once in Houston, Texas, a huge geography. And then moving all the way up to the headquarters of St. Jude in Minneapolis covering much of the United States. So my point there is, a lot of the either job fillings, my phone is ringing off the hook or the network Jim has to be able to have trust in the game and expedite some of that is super helpful.

Great. And then Randy has the next question.

Our next question comes from Randy Bonito with J.H. Darbie.

Congrats. It's good to see the new team. I've been on a lot of these calls for years. Going forward, are we going to set some time frame or expectations as far as sales go? I know we brought in a new sales team last year, did some hiring. Are some of those guys still on board? Is there going to be a transition with Gray's new presence, which we're happy to have. And how is that going to go forward as far as you guys rearranging the process on how you sell, get to the table and so forth?

Gray, maybe you take the procedural element and I can talk about the prospect of guidance.

Sure. I just want to make sure, Randy, I'm following, the question is going forward, we're going to set time frame or expectations. And then the team that's currently on board, will there be a transition? Is that correct?

Yes. Yes. I know last year, they hired a new team, and we've seen now that you're here, is some of that old team going to be here? Is it going to be a new expense added on, bringing in new people because there will be some new sales channels and focus under your guidance, which should deliver the proper results.

Exactly. Thanks for clarification. I just want to make sure I'm answering the right question here. I would say, first, in that Phase 1 area, I really like what BioSig did. You see a lot of businesses that get excited. And like I told, Ken, you sort of build a mansion before you actually have the need for one. And so what I mean by that, it's no secret to the call. If you're in the med device market, Florida and Texas are great places to start. So I really like what in that Phase 1 Ken and the leadership team did of being hyper-intentional of putting people in those places. And so we absolutely need those people in those places, and there's not a suggestion of sort of "ghosting" or hitting reset in those markets. We'll have BioSig representation there and continue to reinvest there. As we look to build out those markets from the Texas and Florida and really Northeast corridor, you may have already seen some specific information as far as public releases go about investment in the Midwest, specifically Kansas City. So there's activity there. But again, I think really the breadth of the clinical evidence and the like amazing credibility of the physicians that worked on it between Mayo in Austin and Jacksonville, Florida, et cetera, allow us the opportunity to be very prescriptive where we go next. And I'll just say this to the call, having a lot of experience in the business, you might be surprised where the next best place to go is. Yes, it's great to have Jim Walker on board and have access to some of those massive supply chains. But I also understand that there's a certain amount of, I'll use the word excitement for us to grow the footprint. I might even say impatience. And so we'll go with a combination of interest as well as that pathway to purchase being acknowledged and where we're partnering with hospital and physician to expedite that pathway to purchase. And so that's a bit of a longer answer to the question. But I think as you look at how that architectural framework builds itself out, I'm excited to say I've got experience in this process and I'm excited to say that my plan is very aggressive as it should be. And I look to being accountable to the information that we put forth. Ken, I'll pass it over to you for the last part of that.

Yes. Let me answer part of Randy's question. So we don't anticipate a significant increase in headcount. Gray is going to work within the confines of the existing team. He may add around the edges in markets where we can get relatively quick results and show both the investors and customers our ability to execute and then we'll grow from there. We think that we'll see some results from Gray and Jim's arrival and then we'll build intelligently as we always have. If you're expecting to see us double the size of the company by doubling the headcount and doubling the overhead, you're not going to see that. You're going to see it being done in the spirit of how we've always done it. And if we get hit with more demand than we expect, Jim Walker has a considerable team of experts that we can lean on, that he can help us get up and running without those people being on our overhead. So it's, we're going to take a unique hybrid approach, which we think will be very effective. It has been for many of Jim's other clients.

Yes. We're going to take one. I'll take one here from the webcast. Jim and Gray, would like your thoughts and opinion on having sufficient qualitative and quantitative data to enable sales. So I guess that's referring to the clinical data that we've produced and also the procedural data that we're capturing through those 1,800 procedures year-to-date.

I'll take this one as it's down my main street, if you will. I think the data is fantastic. The fact that a lot of times you show up with a novel product and the first question is, how many cases or how many patients have you enrolled and have actually been on the end of walking in with a fairly low number and that doesn't fly. And so the fact that we have, from a quantitative standpoint, a very high number is great. And from a qualitative standpoint, I think we're right where we need to be referencing back to that 10,000 foot and climbing altitude. As we get to that higher altitude, we need to get into some more sophisticated data, and I don't want to share that with the entire group at this point, forward-looking or otherwise. But I can say there's some sophisticated data on the horizon that I think will be extremely impactful. There's also been, just in my experience in the business, having been here a very short period of time. We made some suggestions about how to make, add a layer of tangibility to what we do, too, which I think will be super helpful. And listen, the box is sophisticated by itself. So it's just a matter of getting out of it what we want, which I think is there. So I love the question. I'm sorry, I can't be more specific, but I'll just say this, I wouldn't be here if I didn't think that it was there, either existing today or there for the taking/publication in the future. And that's how we take credit for our work. I've talked a lot to Ken and team about it and having come from the CRM and EP business for a very long time and even been in a little bit of med device retail, I can promise you, I understand about taking credit for our work, and we'll do that via the clinical evidence that we have created, the clinical evidence that we'll continue to create as we expand our partnerships and moving forward. That's a great question.

Our next question is from Yale Jen with Laidlaw & Company.

Follow-up questions. Basically, we understood that let's just assume the near-term COVID situation probably not to consider. What has been the experience you guys get from the client or from either physician or administrator, the major pushback for the product, even we thought the product is quite outstanding. But was any pushback there? And if so, what's the strategy you can think of at this moment?

I'll take that one, too. The pushback thus far has really been more sort of where is the technology going? And I'm resolute on this. I'll tell all of you on the call. The first-line goal is to create relevance and credibility with PURE EP. And we have manufacturers calling us. We have mapping companies asking questions, but our intention is to create a very relevant incredible footprint of PURE EP in the market, cleaning and taking the raw initial signal and giving it back to the physician so that they can do what they will from an interventional standpoint. And that's, I'm not here to point out inadequacies in each mapping system. I'm just here to say that the signal is the most important thing in every case. If it weren't for the signal, we probably wouldn't be here, much of the industry wouldn't. And so I'm extremely convicted to deliver the value prop of a process signal that improves the physician's information as they make intervention to a heart. And that's a very nice way of saying burning it in the majority of cases. And so that's what we're here to do first and foremost. After that, where it goes, we'll see. But that's my, I would say, passionate answer towards a good question, but there's not much there.

Yes. And Gray, if I can just chime in. Just remind everybody that hospital administrators and supply chain executives are looking to support their physicians and surgeons. They're not looking to give them a difficult time. This is a good week to think about all the supply chain executives will be going to holiday parties. They're not talking about how much they save. They're telling their friends about the great technology their hospitals have and what great things they're doing for patients. So at the end of the day, it's incumbent upon Gray and me to make sure that we do 2 things really well. We need to articulate the clinical and economic value propositions that we're bringing to these health systems. If we do that well and the equipment, PURE EP performs as we know it can and will, we're going to be very, very successful. That's the job in front of us, and that's the job we intend to do.

Our next question comes from Seth Shaw with Tauriga Sciences.

Sorry, I was on mute. I'm really sorry, guys. I have one question that I'm asking on behalf of a fund manager that could not be on the call. And the question is about second-generation product, like, for example, his question he asked me to ask was, obviously, what's been done so far is exceptional. The company has created a technology that can save lives over the past 13 years, and now it's hitting the market. The question that, that fund manager had was, is there anything right now on the drawing board that could be like a next generation or an improved second-generation product 1, 2, 3, 4 years down the road? That's the question that I was asked to ask today. And I think you guys are doing a great job.

Thanks. I'll address that. So we have an engineering team, as you know, in Los Angeles. So we're working on hardware improvements as well as software and data products. And release dates and what have you or defining it specifically, we wouldn't do at this point in time for competitive reasons, but this team has been working on advances because like every technology that we have in our lives, you can start in one place, but it has to continue to evolve. And if you're not prepared to do that with your own team, then you really have no business being an independent company. So we do have a pipeline. At some point, we'd love to show the investors that pipeline when the time is right. Right now, we're focused on getting this team up and running, starting to deliver more commercial traction. And then the new product development will be more clear. Operator, one more question and then we've got to go unless that person just dropped off, it looks like.

There are currently no more phone questions. If there are any webcast questions?

No. I don't have any more webcast questions.

If there are no more questions, I would like to just turn the call back over to management for any closing remarks.

We want to thank everybody for their time today, and we look forward to following up with you in the future.

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.