Biosig Technologies Inc to Host Business Update Conference Call

Operator 2: Greetings, and welcome to the BioSig Business Development Update Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Andrew Belo, Vice President of Investor Relations. Thank you. You may begin.

Thank you for your patience your cost for the live beginning and just a few moments.

And we want to thank you for your patience flow, we tried to get everybody into the conference away of the Guinea and just a few moments.

[music].

Greetings and welcome to the biopsy business development update call at the.

Operator: Greetings, and welcome to the BioSig Business Development Update Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Andrew Belo, Vice President of Investor Relations. Thank you. You may begin.

This time all participants are in the listen only mode and question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad.

Please note. This conference is being recorded I would now turn the conference over to your host and the below Vice President of it of Investor Relations. Thank you you may begin.

Good afternoon. Thank you for joining todays business update conference call on todays call kind of flat and our chairman and CEO of plastic technologies will review highlights and the company's third quarter of 2020, and discuss corporate initiatives, including ongoing Pureed P system installations and commercialization for.

Andrew Belo: Good afternoon. Thank you for joining today's business update conference call. On today's call, Kenneth Londoner, Chairman and CEO of BioSig Technologies, will review highlights from the company's third quarter of 2020 and discuss corporate initiatives, including ongoing PURE EP system installations, and commercialization outlook. Before we begin, I'll remind you that this call may contain forward-looking statements. 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. Consequently, actual results may differ materially from those expressed or implied by such forward-looking 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.

Andy Ballou: Good afternoon. Thank you for joining today's business update conference call. On today's call, Kenneth Londoner, Chairman and CEO of BioSig Technologies, will review highlights from the company's third quarter of 2020 and discuss corporate initiatives, including ongoing PURE EP system installations, and commercialization outlook. Before we begin, I'll remind you that this call may contain forward-looking statements. 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. Consequently, actual results may differ materially from those expressed or implied by such forward-looking 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.

And we begin I'll remind you that this call may contain forward looking statements 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. Consequently, actual results may differ materially from those expressed or implied.

Slide by such forward looking statements such risks and uncertainties include without limitation risks and uncertainties associated with the geographic social and economic impact of Coke and 19 on our ability to.

The conduct our business and raise capital in the future when needed more detailed information about the company and the risk factors that may affect the realization of forward looking statements and supports and the company's filings with the Securities Exchange Commission, including the company's annual report on form 10-K, and its quarterly reports on form 10-Q, the company assumes no obligation to <unk>.

Andrew Belo: 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. The company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events, or otherwise. I'll now turn the call over to Ken Lunder.

Andy Ballou: 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. The company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events, or otherwise. I'll now turn the call over to Ken Lunder.

The update or revise its forward looking statements and as a result of new information future events or otherwise on.

Now I'll turn the call over to channel on there.

Good afternoon, and thank you for joining us today.

Kenneth L. Londoner: Good afternoon, and thank you for joining us today. Since we filed our 10-Q on 5 November, we wanted to take this opportunity to update shareholders on our progress with both our core business and our ViralClear subsidiary. On 26 October, as everyone knows, we announced to the market that we were halting our clinical phase two clinical trial for merimepodib based on the recommendation of the safety monitoring committee. Based on the direction of the BioSig board of directors, management has undertaken two activities with regard to ViralClear. Number one, wind down the operations of the enterprise, given the results in the phase two. Number two was to start opening a dialogue with pharmaceutical or biotech companies that may find the program that we put together of interest to take forward. I'm pleased to report that on both fronts, we've made good progress.

Kenneth Londoner: Good afternoon, and thank you for joining us today. Since we filed our 10-Q on 5 November, we wanted to take this opportunity to update shareholders on our progress with both our core business and our ViralClear subsidiary. On 26 October, as everyone knows, we announced to the market that we were halting our clinical phase two clinical trial for merimepodib based on the recommendation of the safety monitoring committee. Based on the direction of the BioSig board of directors, management has undertaken two activities with regard to ViralClear. Number one, wind down the operations of the enterprise, given the results in the phase two. Number two was to start opening a dialogue with pharmaceutical or biotech companies that may find the program that we put together of interest to take forward. I'm pleased to report that on both fronts, we've made good progress.

Since we filed our 10-Q on November 5th we wanted to take this opportunity the update shareholders on our progress with book, our core business and our buyer will clear subsidiary.

On October 26 as the.

Everyone knows we announced to the market that we were halting our clinic phase two clinical trials for memory mapped the debt based on the recommendation of the safety monitoring Committee.

Based on the directional buys the board of Directors management has undertaken to activities with regard to buyer of clear number one wind down the operations of the enterprise.

Given the results in the phase two and number two what's the store opening of dialogue with pharmaceutical for biotech companies that may find the program that we put together of interest to take for it I'm pleased to report that on both fronts. We've made good progress on the wind down of the activities.

Kenneth L. Londoner: On the wind down of the activities, we have had clarity and success in talking to the consultants, the vendors, and the people who are supporting the trial. At the beginning of the year when we started 2020, our subsidiary, which was called NeuroClear, had a cash balance of approximately $4.1 million. Based on our progress on the wind down, we believe we'll have well in excess of that number at the end of the year, and the cash proceeds in the subsidiary will be used to fund the NeuroClear neurotechnology program that we had licensed from the Mayo Clinic in November 2019. We will have a NeuroClear update at some point in the near future. In terms of our discussions with pharmaceutical or biotechnology companies, we have had engagement with three organizations.

Kenneth Londoner: On the wind down of the activities, we have had clarity and success in talking to the consultants, the vendors, and the people who are supporting the trial. At the beginning of the year when we started 2020, our subsidiary, which was called NeuroClear, had a cash balance of approximately $4.1 million. Based on our progress on the wind down, we believe we'll have well in excess of that number at the end of the year, and the cash proceeds in the subsidiary will be used to fund the NeuroClear neurotechnology program that we had licensed from the Mayo Clinic in November 2019. We will have a NeuroClear update at some point in the near future. In terms of our discussions with pharmaceutical or biotechnology companies, we have had engagement with three organizations.

Well, we have had a clarity and success and talking to the consultants the vendors and the people who are supporting the trial at the beginning of the year. When we started 2020 of our subsidiary which was called neuro clear kind of cash balance of approximately $4.1 million.

Based on our progress on the wind down we believe we'll have well in excess of that number at the end of the year and the cash proceeds and the subsidiary will be used to fund the neural clear Neurotechnology program that we had license from the Mayo clinic in November of 2019 and.

We will have the neural clear update at some point in the near future the.

The terms of our discussions with pharmaceutical and biotechnology companies. We have had engagement the three organizations or two were well known NASDAQ companies and the third is a private concern.

Kenneth L. Londoner: 2 are well-known NASDAQ companies, and the third is a private concern. What we're looking for is someone who can take merimepodib and all the learnings from the phase two trial and be able to capitalize and see if they can meet the needs of the pandemic, which was the original reason back in March we decided to get into this business. Dr. Jerry Zeldis, who is an esteemed member of our board, had brought us the opportunity, and we jumped in with full vigor and was able to get well into a phase two trial, and we've learned quite a bit. We do expect to get cytokine data in December, which could offer some of these companies interest in understanding exactly what happened with our trial.

Kenneth Londoner: 2 are well-known NASDAQ companies, and the third is a private concern. What we're looking for is someone who can take merimepodib and all the learnings from the phase two trial and be able to capitalize and see if they can meet the needs of the pandemic, which was the original reason back in March we decided to get into this business. Dr. Jerry Zeldis, who is an esteemed member of our board, had brought us the opportunity, and we jumped in with full vigor and was able to get well into a phase two trial, and we've learned quite a bit. We do expect to get cytokine data in December, which could offer some of these companies interest in understanding exactly what happened with our trial.

What we're looking for is we're looking for someone who can take marrying that the debt.

And all of the learnings from the phase two trial and be able to capitalize and see if they can meet the needs of the pandemic, which was the original recent book.

Back in March we decided to get into this business Dr. Jerry sell this Lucy of steam member of our board on.

Brought us the opportunity and we jumped and look for bigger was able to get well into a phase two trial and we've learned quite a bit we do expect to get cytokine data.

In December which could offer some of these companies interest and understanding exactly what happened with our trial and based on the engagements that we've had so far the.

Kenneth L. Londoner: Based on the engagements that we've had so far, there is possible additional value we can achieve from these discussions. Obviously, when we achieve something, we will come back and report back. As we go into 2021, there'll be no further expenditures on ViralClear. The funds that we have in the subsidiary will all go towards value-creating events for our neurotech platform, which is making progress. On the BioSig side of things, we continue to do quite well since our last update call on 15 September. On 15 September, we were only installed in 2 sites, Texas Cardiac Arrhythmia Institute and Mayo Clinic Jacksonville in Florida. Since then, we have achieved 4 additional installations.

Kenneth Londoner: Based on the engagements that we've had so far, there is possible additional value we can achieve from these discussions. Obviously, when we achieve something, we will come back and report back. As we go into 2021, there'll be no further expenditures on ViralClear. The funds that we have in the subsidiary will all go towards value-creating events for our neurotech platform, which is making progress. On the BioSig side of things, we continue to do quite well since our last update call on 15 September. On 15 September, we were only installed in 2 sites, Texas Cardiac Arrhythmia Institute and Mayo Clinic Jacksonville in Florida. Since then, we have achieved 4 additional installations.

There is possible additional value we can achieve from these discussions obviously when we achieve something we will come back and report back but as we go into 2021 of there'll be no further expenditures on by repair the funds that we have and the subsidy or we'll all go go towards value creating.

The events for our Euro Tech platform, which is making progress.

On the bottom of six side of things, we continue to do quite well since our last update call on September 15th on.

On the 15th of September we're we're only installed and two sites.

Capex is cardiac arrhythmia Institute and Mayo, Jacksonville, and Florida. Since then we have achieved for additional installations.

Kenneth L. Londoner: We installed at the University of Pennsylvania, we installed at Massachusetts General Hospital in Boston, we installed at Deborah Heart and Lung Center in New Jersey, and we installed in Overland Park Regional Medical Center in Kansas City. All of the installations have gone very well. They are up and running and doing cases at all sites, except Massachusetts General Hospital will be starting this Friday. The results so far have been very encouraging. All the physicians who have used the system have given us very strong positive feedback, and we actually have seen great performance in certain cases, where we've had great success. To give you a little bit further indication of our progress, breaking it down by number, as of 11 November, BioSig has done 363 total procedures year to date on the PURE EP system.

We installed at the University of Pennsylvania, we installed the at mass General Hospital, and Boston, we installed the to bore a heart lung and New Jersey, and we installed and overland Hospital and Kansas City.

Kenneth Londoner: We installed at the University of Pennsylvania, we installed at Massachusetts General Hospital in Boston, we installed at Deborah Heart and Lung Center in New Jersey, and we installed in Overland Park Regional Medical Center in Kansas City. All of the installations have gone very well. They are up and running and doing cases at all sites, except Massachusetts General Hospital will be starting this Friday. The results so far have been very encouraging. All the physicians who have used the system have given us very strong positive feedback, and we actually have seen great performance in certain cases, where we've had great success. To give you a little bit further indication of our progress, breaking it down by number, as of 11 November, BioSig has done 363 total procedures year to date on the PURE EP system.

And all of the installations of gone very well.

The are up and running and doing cases at all sites, except the mass general we'll be starting this Friday and of the results. So far have been very encouraging for us.

All of the physicians for abuse the system have the given us very strong positive feedback and we actually have seen great performance. The in certain cases, where we've had great success and to give you a little bit further indication of our progress on breaking it down by number of.

As of November 11.

By the biggest on 363 total procedures year to date on the pure ERP system.

Kenneth L. Londoner: 188 of those procedures have been done in Texas Cardiac Arrhythmia Institute, 83 at Mayo Clinic, 30 at the University of Pennsylvania, 27 at Deborah Heart and Lung Center, and 6 at Overland Park Regional Medical Center in Kansas City. As I said, Massachusetts General Hospital will be starting this coming Friday, and we have high hopes at that center too. In addition to the number of cases, we've touched almost every procedural type that our industry has to offer patients today. We've done 129 persistent AFib cases, 92 paroxysmal AFib cases, 43 PVCs, 10 non-ischemic ventricular tachycardias, 4 VTs, 3 ischemic VTs, 10 typical flutters, 7 atypical flutters, 7 atrial tachycardias, 5 AVNRTs, 3 AVRT, and 4 SVT. We have 28 EP physicians using the system with Dr.

Kenneth Londoner: 188 of those procedures have been done in Texas Cardiac Arrhythmia Institute, 83 at Mayo Clinic, 30 at the University of Pennsylvania, 27 at Deborah Heart and Lung Center, and 6 at Overland Park Regional Medical Center in Kansas City. As I said, Massachusetts General Hospital will be starting this coming Friday, and we have high hopes at that center too. In addition to the number of cases, we've touched almost every procedural type that our industry has to offer patients today. We've done 129 persistent AFib cases, 92 paroxysmal AFib cases, 43 PVCs, 10 non-ischemic ventricular tachycardias, 4 VTs, 3 ischemic VTs, 10 typical flutters, 7 atypical flutters, 7 atrial tachycardias, 5 AVNRTs, 3 AVRT, and 4 SVT. We have 28 EP physicians using the system with Dr.

The 188 of the those procedures have been done in Texas cardiac Arrhythmia Institute 83 at Mayo Jacksonville 30 at the University of Pennsylvania, 27 at the Boral heart and lung and six of Overland Park, Kansas City as I said mass general we'll be starting this cash.

And Friday, and we have high hopes of GAAP Center. Two in addition to the number of cases, we've touched almost every procedural type.

That our industry has to offer patients today, we've done 129 per system, a fifth cases 92 power accessible eighth of cases 43 P. bdcs.

10 non of scheme of ventricular tech Carty as for the TS three scheme of fee piece.

10, typical flutters seven eight typical flutters seven eight real tech of cardio five hbr and teas.

Three hbr tea and for SBT.

Also we have 28, the peak positions using the system with Dr and the Tolley, who leads the Texas cardiac Arrhythmia Institute, having used on the system 110 cases and has been using it virtually every one of these cases to date.

Kenneth L. Londoner: Natale, who leads the Texas Cardiac Arrhythmia Institute, having used the system 110 cases, and has been using it in virtually every one of his cases to date. We're very encouraged with the progress that we've had with the installation. Now, we have 2 other installations coming up in the next few weeks. We will announce those centers after the installations are done and their hospitals have signed off on our use of their name. On 15 September, we promised we would be in 10 centers by the end of the year. Based on the COVID-19 pandemic, which now everybody knows, really taking off in many parts of the country, 2 of our installs look like they've been pushed into Q1.

Kenneth Londoner: Natale, who leads the Texas Cardiac Arrhythmia Institute, having used the system 110 cases, and has been using it in virtually every one of his cases to date. We're very encouraged with the progress that we've had with the installation. Now, we have 2 other installations coming up in the next few weeks. We will announce those centers after the installations are done and their hospitals have signed off on our use of their name. On 15 September, we promised we would be in 10 centers by the end of the year. Based on the COVID-19 pandemic, which now everybody knows, really taking off in many parts of the country, 2 of our installs look like they've been pushed into Q1.

So we're very encouraged with the progress that we've had with the installation now we have two other installations coming up in the next few weeks, we will announce those centers on after the installations are done and there and the.

Hospitals of signed off on our use of their name.

On September 15th we promised and we would be and 10 centers by the end of the year and.

And based on the co bid pandemic, which is now everybody knows really taking off in many parts of the country true.

Two of our installs looked like day been pushed into the first quarter. One is in the New York Tri State area and the other one is and the state of Ohio, and despite our best efforts and our entrepreneurial spirit. These two installs just cannot happen in December of this year, but they do want the system we have.

Kenneth L. Londoner: One is in the New York Tri-State area, and the other one is in the state of Ohio. Despite our best efforts and our entrepreneurial spirit, these two installs just cannot happen in December of this year. They do want the system. We have signed agreements, and we will be going in just as soon as they allow us in. As we've seen, patience is a virtue. We installed at Mass General, and we had to be very patient to start doing cases in Boston. Despite the pandemic, we're actually starting, and we're excited, as we said earlier. In terms of how we generate support for the commercialization of the systems, it's great to have case studies behind us.

Kenneth Londoner: One is in the New York Tri-State area, and the other one is in the state of Ohio. Despite our best efforts and our entrepreneurial spirit, these two installs just cannot happen in December of this year. They do want the system. We have signed agreements, and we will be going in just as soon as they allow us in. As we've seen, patience is a virtue. We installed at Mass General, and we had to be very patient to start doing cases in Boston. Despite the pandemic, we're actually starting, and we're excited, as we said earlier. In terms of how we generate support for the commercialization of the systems, it's great to have case studies behind us.

Signed agreements and we will be going interest the soon as they allow us and and as we've seen patience is a virtue of we installed the mass general and we have to be very patients to start doing cases in Boston and despite the pandemic, we're actually starting and were excited as as we said earlier.

In terms of how we generate.

The support for the commercialization of the systems.

It's great to have case studies.

Behind us as you know.

Kenneth L. Londoner: As you know, back in September, we unblinded the data from the first clinical study for PURE EP, which was geared to assess the quality and the clinical relevance of the PURE EP intracardiac signals when compared to other sources. Patients that were undergoing elective cardiac ablation were included in the blinded study, and we unveiled that data, and that data has since been published. In early September, the company announced the scientific abstract and poster entitled A Novel Cardiac Signal Processing System for Electrophysiology Procedures: Early Insights From the PURE EP Study, which was made available at the ESC Congress in Italy, in late August 2020. Since then, we published an abstract, and let me just give you a little overview of that. The background was to demonstrate the value of our intracardiac electrogram data.

Kenneth Londoner: As you know, back in September, we unblinded the data from the first clinical study for PURE EP, which was geared to assess the quality and the clinical relevance of the PURE EP intracardiac signals when compared to other sources. Patients that were undergoing elective cardiac ablation were included in the blinded study, and we unveiled that data, and that data has since been published. In early September, the company announced the scientific abstract and poster entitled A Novel Cardiac Signal Processing System for Electrophysiology Procedures: Early Insights From the PURE EP Study, which was made available at the ESC Congress in Italy, in late August 2020. Since then, we published an abstract, and let me just give you a little overview of that. The background was to demonstrate the value of our intracardiac electrogram data.

Back in September.

We unblind it the data from the first clinical study for pure repeat which was geared to assess the quality and.

And the clinical relevance of the pure EPA interest cardiac signals when compared to other sources.

Well the patients that were on growth undergoing elect the of cardiac ablation were included in the blinded study and we unveiled that data and that data has since been published.

In early September of the company announced the scientific abstracts and poster entitled a novel cardiac signal processing system for electrophysiology procedures early insights from the pure EPA study, which was made available at the FCC Congress in Italy.

Since then we published the abstract.

And let me just give you a little overview of that the background was to demonstrate the value of our interest cardiac electrogram data.

Kenneth L. Londoner: We took identical electrographic and intracardiac signal data, which were recorded during 15 AF ablation procedures. We were comparing BioSig's system to that of a traditional signal recording system and that of a 3D mapping system. The collected signals underwent blinded, controlled evaluation by 3 independent electrophysiologist reviewers to determine who had the superior signals and to characterize the superiority of the signals. The results were clear. In 35.5% of the cases, the reviewers selected BioSig signals where more components were visible. What we're seeing as we install systems and do cases is that these signals are translating not only into clinical benefit, but into helping the patients get a better procedure.

Kenneth Londoner: We took identical electrographic and intracardiac signal data, which were recorded during 15 AF ablation procedures. We were comparing BioSig's system to that of a traditional signal recording system and that of a 3D mapping system. The collected signals underwent blinded, controlled evaluation by 3 independent electrophysiologist reviewers to determine who had the superior signals and to characterize the superiority of the signals. The results were clear. In 35.5% of the cases, the reviewers selected BioSig signals where more components were visible. What we're seeing as we install systems and do cases is that these signals are translating not only into clinical benefit, but into helping the patients get a better procedure.

And we took identical electric graphic and intra cardiac signal data were true recorded during 15 after the ablation procedures.

And we were comparing biophysics system to that of a traditional signal recording system and that of the Threed mapping system.

The collective signals underwent blinded controlled the valuation by three independent Electrophysiologist reviewers to determine who have the superior signals and to characterize the superiority of the signals of.

The results were clear and 35.5% of the cases, the reviewers selected biases signals, we're more components were visible and what we're seeing as we install systems and do cases is that the signals are translating not only its clinical benefit put into helping the patient.

Scott a better procedure, and we and our marketing team of captured these winning cases and we're using them.

Kenneth L. Londoner: We and our marketing team have captured these winning cases, and we're using them to highlight and demonstrate that under certain conditions, using our technology, the physician can get a better procedural outcome. Those cases now are being used in sales and marketing materials. They're being used to train our clinical account managers as we go in and install new systems. The information is being shown to the physicians prior to them starting to do cases. As one example, and we have many, many of these examples, last week in one of the centers that were installed, a young adult presented with a very troubling case of AFib. This is an athlete who was having poor heart function.

Kenneth Londoner: We and our marketing team have captured these winning cases, and we're using them to highlight and demonstrate that under certain conditions, using our technology, the physician can get a better procedural outcome. Those cases now are being used in sales and marketing materials. They're being used to train our clinical account managers as we go in and install new systems. The information is being shown to the physicians prior to them starting to do cases. As one example, and we have many, many of these examples, last week in one of the centers that were installed, a young adult presented with a very troubling case of AFib. This is an athlete who was having poor heart function.

To highlight and demonstrate that under certain conditions using our technology the.

The physician can get a better procedural outcome and those cases now are being used and sales and marketing materials the being used to train our clinical account managers as we go in and install new systems. The information is being shown to the physicians prior to them starting to do cases.

As one example, and we have many many of these examples last week and one of the centers that were installed in the young adult are presented with a very troubling case of Ace said. This is an athlete and was having for heart function and using our system the EPA position. So.

Kenneth L. Londoner: Using our system, the EP physician told us that it was with our technology and the information we provided that he was able to put the patient back into normal sinus rhythm during the ablation procedure. The patient left the hospital same day, and upon follow-up, the patient is back to normal heart health. We will be following that patient to make sure that the ablation was durable and that the AFib doesn't come back. As we prepare for longer-term evaluation of our system, we're starting to prepare for 2021 clinical activity, where we're going to be doing investigator-initiated studies with leaders in our field with protocols that can show both the clinical and procedural value of our system. We are just planning our 2021 activities.

Kenneth Londoner: Using our system, the EP physician told us that it was with our technology and the information we provided that he was able to put the patient back into normal sinus rhythm during the ablation procedure. The patient left the hospital same day, and upon follow-up, the patient is back to normal heart health. We will be following that patient to make sure that the ablation was durable and that the AFib doesn't come back. As we prepare for longer-term evaluation of our system, we're starting to prepare for 2021 clinical activity, where we're going to be doing investigator-initiated studies with leaders in our field with protocols that can show both the clinical and procedural value of our system. We are just planning our 2021 activities.

Hold us that it was with our technology and the information we provided that he was able to put the patient back into norm of sinus rhythm during the ablation of procedure. The patient left the hospital same day and upon the follow up the patient is and back to normal heart health and we will be following that patient.

Make sure that the ablation was durable and that the if it doesn't come back and as we prepare for longer term evaluation of our system. We're starting to prepare for 2021 clinical activity. We're we're going to be doing investigator initiated studies with leaders and our field with protocols that can show.

Book, the clinical and procedural value of our system.

We are just planning our 2021 activities.

Kenneth L. Londoner: 2020 was supposed to be our first year of commercial rollout, which we called limited market release. In a limited market release, our goal was to be in 12 to 16 hospitals and to some of the top centers in our industry and show that our system had both clinical and procedural value. Despite the pandemic, as you see by the end of the year, we should be in 8 to 9 centers. We are showing the value we thought we would show. We just wanted to be in a few more centers.

Kenneth Londoner: 2020 was supposed to be our first year of commercial rollout, which we called limited market release. In a limited market release, our goal was to be in 12 to 16 hospitals and to some of the top centers in our industry and show that our system had both clinical and procedural value. Despite the pandemic, as you see by the end of the year, we should be in 8 to 9 centers. We are showing the value we thought we would show. We just wanted to be in a few more centers.

2020 was supposed to be our first year of commercial rollout, which we called limited market release.

Limited market release, our goal was to be and 12 to 16 hospitals.

And for some of the top centers our industry and.

And show that our system had both clinical and procedural value.

Despite the pandemic as you see by the end of the year, we should be an eight to nine centers.

And we are showing the value we thought we would show we just want it to be in a few more centers. So we hope to make up for the lost ground. The 2020 by expanding into more centers and 2021.

Kenneth L. Londoner: We hope to make up for the lost ground in 2020 by expanding into more centers in 2021. Currently, we're planning on recruiting additional people to our team in sales, marketing, and clinical roles so we can handle a greater number of centers in the United States. We do intend, because of the pandemic, to have more of a regional focus in 2021. We believe the markets of the Northeast, Florida, and Texas can keep us very busy in 2021, and we can penetrate a great number of centers while mitigating the traveling we have to do transcontinentally. We think that these places offer us plenty of opportunity, and we will come back to you in the next quarter to give you a specific update on how many centers we expect to be in.

Kenneth Londoner: We hope to make up for the lost ground in 2020 by expanding into more centers in 2021. Currently, we're planning on recruiting additional people to our team in sales, marketing, and clinical roles so we can handle a greater number of centers in the United States. We do intend, because of the pandemic, to have more of a regional focus in 2021. We believe the markets of the Northeast, Florida, and Texas can keep us very busy in 2021, and we can penetrate a great number of centers while mitigating the traveling we have to do transcontinentally. We think that these places offer us plenty of opportunity, and we will come back to you in the next quarter to give you a specific update on how many centers we expect to be in.

And currently we're planning on average.

Of recruiting additional people to our team and sales marketing and clinical roles. So we can handle the greater number of centers in the United States, We do intend to because of the pandemic to have more of the regional focus in 2021.

We believe the markets of the northeast.

Florida.

And Texas can keep us very busy and 2021 and we can penetrate a great number of centers, while mitigating the traveling we have to do trance continentally.

We think that these places off for us plenty of opportunity and we will come back to you.

On the next quarter to give you a specific update on how many.

How many centers, we expect to be and as.

Kenneth L. Londoner: As we noted on the 15 September call, we do expect our first commercial transaction this quarter. We never know there may be more than one, but we certainly see visibility now to more commercial transactions based on the success we've had in installing, training, and getting some of these leading physicians up and running. We believe we're starting to see the early promise fulfilled of the performance of the technology. We've seen a great number of cases where BioSig and the PURE EP system has been a difference maker, and the KOLs are starting to get excited about our technology.

Kenneth Londoner: As we noted on the 15 September call, we do expect our first commercial transaction this quarter. We never know there may be more than one, but we certainly see visibility now to more commercial transactions based on the success we've had in installing, training, and getting some of these leading physicians up and running. We believe we're starting to see the early promise fulfilled of the performance of the technology. We've seen a great number of cases where BioSig and the PURE EP system has been a difference maker, and the KOLs are starting to get excited about our technology.

As we noted on the September 15th call. We do expect our first commercial transaction this quarter and we never know there may be more than one, but we certainly see visibility now to more commercial transactions based on the success, we've had and installing training and getting some of these leading physicians up and running and we believe were.

Starting the see the early promise fulfilled of the performance of the technology, we've seen the great number of cases, where biopsy and the pure EPA system. It's been a difference maker and of the K wells are starting to get excited about our technology. One thing. We just learned is the.

Kenneth L. Londoner: One thing we just learned is that on 2 December and 3 December, the Texas Cardiac Arrhythmia Institute is going to host EP Live, which is a unique event in our industry that brings together hundreds of the top EP physicians in Austin, Texas, for two days of live cases and new technologies. We've been informed that this convention is actually going to take place and that people will be flying in despite the pandemic. There'll be people also dialing into their broadcast network to observe live cases. As currently contemplated, it looks like PURE EP will be in approximately 20% of the cases over the two days, which is great visibility for us into future customers and being able to show people the capability of PURE EP system.

Kenneth Londoner: One thing we just learned is that on 2 December and 3 December, the Texas Cardiac Arrhythmia Institute is going to host EP Live, which is a unique event in our industry that brings together hundreds of the top EP physicians in Austin, Texas, for two days of live cases and new technologies. We've been informed that this convention is actually going to take place and that people will be flying in despite the pandemic. There'll be people also dialing into their broadcast network to observe live cases. As currently contemplated, it looks like PURE EP will be in approximately 20% of the cases over the two days, which is great visibility for us into future customers and being able to show people the capability of PURE EP system.

On December 2nd and third.

The Texas cardiac Arrhythmia Institute is going to host E. P line, which is a unique event in our industry that brings together hundreds of the top EPA physicians in Austin, Texas for two days of live cases, and new technologies.

We have been informed that this convention.

It's actually going to take place and that people will be flying and despite the pandemic there'll be people also dialing into their broadcast network.

To observe live cases, and as currently contemplated it looks like pure EPA will be and approximately 20% of the cases.

Over the two days, which is great visibility for us into future customers and being able to show people the capability of the pure ERP system were very proud of being able to present, just such a group and we really think Dr and the Charlie and the Texas cardiac Arrhythmia Institute for including Us and such an important.

Kenneth L. Londoner: We're very proud of being able to present to such a group, and we really thank Dr. Natale and the Texas Cardiac Arrhythmia Institute for including us in such an important biannual presentation. I'd like to close today by highlighting some of the statistics in our 10-Q, published 5 November, and our financial strength now and going into 2021. In the third quarter, BioSig burned approximately $6.2 million, which was evenly split between ViralClear and BioSig PURE EP core med tech business. We burned approximately $3.1 million in the third quarter for PURE EP. We have been seeing on average a burn rate of just south of $1.4 million per month on PURE EP, and that doesn't include any revenues coming into the company.

Kenneth Londoner: We're very proud of being able to present to such a group, and we really thank Dr. Natale and the Texas Cardiac Arrhythmia Institute for including us in such an important biannual presentation. I'd like to close today by highlighting some of the statistics in our 10-Q, published 5 November, and our financial strength now and going into 2021. In the third quarter, BioSig burned approximately $6.2 million, which was evenly split between ViralClear and BioSig PURE EP core med tech business. We burned approximately $3.1 million in the third quarter for PURE EP. We have been seeing on average a burn rate of just south of $1.4 million per month on PURE EP, and that doesn't include any revenues coming into the company.

By the annual presentation.

I'd like to close to day by highlighting some of the statistics in our 10-Q published November 5th.

And our financial strength on.

Now and going into 2021 in the third quarter.

Basic burned approximately $6.2 million, which was evenly split between viral clear and bias the poor repeat core med tech business. So we burned approximately $3.1 million and the third quarter for pure repeat.

We have been seeing on average of burn rate of just south of $1.4 million per month on period.

And that doesn't include any revenues coming into the company. So as we start bringing revenue since of the company and we continue to manage our cash burn as we historically have with great care. We believe that the 32.7 million of cash we have on the balance sheet is more than enough to drive us through 2020.

Kenneth L. Londoner: As we start bringing revenues into the company and we continue to manage our cash burn as we historically have with great care, we believe that the $32.7 million of cash we have on the balance sheet is more than enough to drive us through 2021 and well into 2022. One other important thing to note is we've already paid for 65 units of commercial inventory. Based on our average selling price, we believe we can pull that revenue in over the next 12 months, thereby bringing our cash burn down even further, and that inventory is already paid for. We're optimistic as we go into 2021 from a financial perspective. With that said, operator, I'd like to entertain questions. Thank you.

Kenneth Londoner: As we start bringing revenues into the company and we continue to manage our cash burn as we historically have with great care, we believe that the $32.7 million of cash we have on the balance sheet is more than enough to drive us through 2021 and well into 2022. One other important thing to note is we've already paid for 65 units of commercial inventory. Based on our average selling price, we believe we can pull that revenue in over the next 12 months, thereby bringing our cash burn down even further, and that inventory is already paid for. We're optimistic as we go into 2021 from a financial perspective. With that said, operator, I'd like to entertain questions. Thank you.

On the well and well into 2022, one other important thing to note is we've already paid for 65 units of commercial inventory and.

And based on our average selling price we.

We believe we can pull that revenue and win over the next 12 months, thereby bringing our cash burn down even further and that inventories already paid for so we're optimistic as we go into 2021 from a financial perspective on.

With that said operator, I'd like to entertain questions. Thank you.

Thank you if you would like to ask the question. Please press star one on your telephone keypad.

Operator 2: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. Our first question is from Yao Chen with Laidlaw & Company. Please proceed.

Operator: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. Our first question is from Yao Chen with Laidlaw & Company. Please proceed.

For me should tell the indicate your line is and the question. Ken You May Press Star two if you would like to remove your question from the Q and.

For participants using speaker equipment and may be necessary to pick up the handset before pressing the star and he is.

Our first question is from Yale Jen will lay the and company. Please proceed.

Good afternoon, and congrats can think business.

Yao Chen: Good afternoon. Congrats, Ken. I think this is a very good start in terms of the PURE EP advancement. Here's a few quick questions. The first one is that in terms of the expense winding down, do you anticipate what kind of burn probably for Q4 of this year? Is that still roughly $5 million for the quarter? Just probably that will be the pace for going into 2021. I have some follow-up questions as well.

Yale Jen: Good afternoon. Congrats, Ken. I think this is a very good start in terms of the PURE EP advancement. Here's a few quick questions. The first one is that in terms of the expense winding down, do you anticipate what kind of burn probably for Q4 of this year? Is that still roughly $5 million for the quarter? Just probably that will be the pace for going into 2021. I have some follow-up questions as well.

Very good thoughts in terms of the cash.

Advancement so there's the.

Few quick two quick question.

First one is that the.

In terms of the expense wind the winding down do you anticipate.

What kind of from probably for the fourth quarter of this the invesco roughly five and.

Dollars for the quarter and Dan, it's probably that will be the.

On the Facebook going into the study and plenty.

On the one.

Yeah, I'll follow up questions as well.

So the Yale if I understand the question correctly, you're asking for the anticipated burn rate for the fourth quarter for the combined company.

Kenneth L. Londoner: Yao, if I understand the question correctly, you're asking for the anticipated burn rate for Q4 for the combined company?

Kenneth Londoner: Yao, if I understand the question correctly, you're asking for the anticipated burn rate for Q4 for the combined company?

Yes, yes, yes, so what I can share with you is like I said, we've been seeing on average of burn rate of approximately 1.4 million of.

Yao Chen: Right. Yes.

Yale Jen: Right. Yes.

Kenneth L. Londoner: What I can share with you is, like I said, we've been seeing on average a burn rate of approximately $1.4 million for PURE EP. We have significantly wound down the operations of ViralClear, so we don't expect any new invoices or any new billings with regard to ViralClear. We've pretty much cut that off, and we are, you know, clearing out the payables, you know, as best we can. If you take 1.4 and you multiply it by 3, you're probably gonna be in the neighborhood. However, as we've said, we expect our first commercial contract in Q4, and depending on when we collect that receivable, you know, that would be to our favor against the cash burn.

Kenneth Londoner: What I can share with you is, like I said, we've been seeing on average a burn rate of approximately $1.4 million for PURE EP. We have significantly wound down the operations of ViralClear, so we don't expect any new invoices or any new billings with regard to ViralClear. We've pretty much cut that off, and we are, you know, clearing out the payables, you know, as best we can. If you take 1.4 and you multiply it by 3, you're probably gonna be in the neighborhood. However, as we've said, we expect our first commercial contract in Q4, and depending on when we collect that receivable, you know, that would be to our favor against the cash burn.

For pure GP, we have significantly wound down the operations of viral clear. So we don't expect any new invoices or any new billing.

Billings with regard to viral clear.

So we pretty much cut down the off and we are clearing out the payables.

As best we can so if you take 1.4 and you multiply it by three youre, probably going to be in the neighborhood. However, as we've said we expect our first commercial contract and the fourth quarter and depending on when we collect debt receivable that would reduce debt.

It would be to our favor against the cash burn.

Okay great.

Yao Chen: Okay, great. My next question is that, given PURE EP has been used in a number of centers and in a number of procedures, did you guys start to pick up or collect some feedback in terms of both sort of praise of the system as well as any kind of, I guess maybe, kinks people want to get additional improvement? Any kind of overall general comments?

Yale Jen: Okay, great. My next question is that, given PURE EP has been used in a number of centers and in a number of procedures, did you guys start to pick up or collect some feedback in terms of both sort of praise of the system as well as any kind of, I guess maybe, kinks people want to get additional improvement? Any kind of overall general comments?

Our next question is that.

Given the.

He had in tech being used and the number of centers and the number of the teachers.

Did you guys thought the pickup and collect the feedback in terms of both.

So the price of the and.

Well any kind of thought of it may be capex you on tool people want to get additional improvement any kind of the overall general comments.

Yes, the for some reason I had a little bit of a heart on hearing that question were you asking about pricing of the system.

Kenneth L. Londoner: Yeah. For some reason, I had a little bit of a hard time hearing that question. Were you asking about pricing of the system?

Kenneth Londoner: Yeah. For some reason, I had a little bit of a hard time hearing that question. Were you asking about pricing of the system?

No not of pricing the I'm, just the giving the that the used by a large number of BP lap at the moment been tested. This moment did you get any feedback for all use there in terms of both either of.

Yao Chen: No, not the pricing of the system. I'm just saying, given the system has been used by a large number of EP labs at this moment and been tested at this moment, did you get any feedback from users in terms of both either positive aspect of the system or maybe additional sort of improvement they'd like to see or advancement they would see?

Yale Jen: No, not the pricing of the system. I'm just saying, given the system has been used by a large number of EP labs at this moment and been tested at this moment, did you get any feedback from users in terms of both either positive aspect of the system or maybe additional sort of improvement they'd like to see or advancement they would see?

Positive.

Of the the system or maybe and maybe additional.

So the improve and they like the feel of beds. The I know that for the better.

Kenneth L. Londoner: Yeah. No.

Kenneth Londoner: Yeah. No.

Yao Chen: for the system.

Yale Jen: for the system.

Kenneth L. Londoner: Yeah, I got it. It's a good question. When we first went in earlier in the year, and actually we put our first system into the market in November of last year, we did have a few technical glitches we had to overcome. They were minor in nature, and we overcame them in the April timeframe. We have gotten some outstanding user feedback, which we have a process of how we digest that. We call that voice of the customer feedback, and some of that is actually being incorporated into a software upgrade that we'll be rolling out in January, February of next year. Our team is very good at turning feedback into software, and we've always been good at that.

Kenneth Londoner: Yeah, I got it. It's a good question. When we first went in earlier in the year, and actually we put our first system into the market in November of last year, we did have a few technical glitches we had to overcome. They were minor in nature, and we overcame them in the April timeframe. We have gotten some outstanding user feedback, which we have a process of how we digest that. We call that voice of the customer feedback, and some of that is actually being incorporated into a software upgrade that we'll be rolling out in January, February of next year. Our team is very good at turning feedback into software, and we've always been good at that.

Yeah, I got and it's a good question for when we first went in earlier in the year and.

Actually we put our for system into the market in November of last year. We did have a few technical glitches, we have to overcome the were minor in nature, and we overcame them and the April timeframe.

We have gotten some outside.

Outstanding user feedback, which we have a process of how we digest that.

We called up voice of the customer feedback and some of that is actually being incorporated into a.

Software upgrade that will be rolling out in January February of next year. Our team is very very good and turning feedback into into software and we've always been good at that so the customers I think it will be excited to see how responsive we are as the company in terms of the centers every doctor that we've worked with.

Kenneth L. Londoner: The customers, I think, will be excited to see how responsive we are as a company. In terms of the centers, every doctor that we've worked with is enthusiastic about the product. Several of the physicians have been so moved by our technology that they've actually offered to support us in making different videos that we can use. In fact, today, there's a video released out of University of Pennsylvania in the VT Symposium Technology Forum, and we can forward that video along, that link to anybody who would like to see it. Dr. Santangeli, who's used the system now for a little over five weeks, had an outstanding case several weeks ago where he was excited about the impact that PURE EP could make on a case.

Kenneth Londoner: The customers, I think, will be excited to see how responsive we are as a company. In terms of the centers, every doctor that we've worked with is enthusiastic about the product. Several of the physicians have been so moved by our technology that they've actually offered to support us in making different videos that we can use. In fact, today, there's a video released out of University of Pennsylvania in the VT Symposium Technology Forum, and we can forward that video along, that link to anybody who would like to see it. Dr. Santangeli, who's used the system now for a little over five weeks, had an outstanding case several weeks ago where he was excited about the impact that PURE EP could make on a case.

Is enthusiastic about the product.

Several of the physicians have been so move.

Moved by our technology that they've actually offered to support us and making different videos that we can use.

In fact today.

There is the video released out of University of Pennsylvania, and the BT Symposium technology for them and we can forward that video along.

Link to anybody who would like to see it on a doctor Santander, Chile has used the system now for little over five weeks had an outstanding case several weeks ago were.

He was excited about the impact that poor repeat could make on a case and he has given us about a three for a minute video that's now out there for the field to be able to see also Penn will be making a presentation. There will be doing the live case and any live on December 4th I believe.

Kenneth L. Londoner: You know, he's given us about a 3-4 minute video that's now out there for the field to be able to see. Also, Penn will be making a presentation. They'll be doing a live case at EP Live on 4 December, I believe, you know, using our system because they're enjoying the way the system is working so far. We also have gotten videos from Texas Cardiac Arrhythmia Institute, and we have other content coming from Deborah Heart and Lung. You know, we're getting a lot of positive response, and we're capturing that, and we're capturing what they're seeing, and we're putting into visualization software so others can learn what these first physicians are seeing.

Kenneth Londoner: You know, he's given us about a 3-4 minute video that's now out there for the field to be able to see. Also, Penn will be making a presentation. They'll be doing a live case at EP Live on 4 December, I believe, you know, using our system because they're enjoying the way the system is working so far. We also have gotten videos from Texas Cardiac Arrhythmia Institute, and we have other content coming from Deborah Heart and Lung. You know, we're getting a lot of positive response, and we're capturing that, and we're capturing what they're seeing, and we're putting into visualization software so others can learn what these first physicians are seeing.

Using our system because the they're enjoying.

The way the systems work and so far and.

And we also have gotten videos from Texas cardiac Arrhythmia Institute and we have other other content coming from the Bora heart and lung. So you know we're getting a lot of positive response, and we're capturing that and we're capturing what they're seeing and we're putting into visualization saw.

Elsewhere, so others can learn what these first physicians are seeing and so our marketing folks have been doing an outstanding job and it's absolutely been helping us on the commercial side.

Kenneth L. Londoner: Our marketing folks have been doing an outstanding job, and it's absolutely been helping us on the commercial side. There's been a lot of, you know, the physicians kind of see it right away when they use it. They're very excited about it. Of course, our team has to work very hard to convert all of that into commercial traction. One other thing I wanna mention is in the centers that we're installed in, and there's 6 currently, there'll be 8 by the first week of December. Just in the 6 we're in, if you add up the number of EP labs that they have or the number of units we can sell, we have a potential of 27 units in these 6 centers. Some of them are quite large.

Kenneth Londoner: Our marketing folks have been doing an outstanding job, and it's absolutely been helping us on the commercial side. There's been a lot of, you know, the physicians kind of see it right away when they use it. They're very excited about it. Of course, our team has to work very hard to convert all of that into commercial traction. One other thing I wanna mention is in the centers that we're installed in, and there's 6 currently, there'll be 8 by the first week of December. Just in the 6 we're in, if you add up the number of EP labs that they have or the number of units we can sell, we have a potential of 27 units in these 6 centers. Some of them are quite large.

Theres been a lot of.

The physicians kind of see it right away when they use it they're very excited about it and then of course our team has the worked very hard.

To convert all of that into commercial traction one of the thing I want to mention is in the centers that were installed and.

And there are six currently there'll be eight.

By the first week of December just on the six were in.

If you add up the number of EPA labs that they have of the number of units we can sell.

We havent of potential of 27 units in the six centers. So some of them are quite large.

Kenneth L. Londoner: You know, we don't know if we'll make 27 sales in these 6 centers, but we believe we'll be selling product in each one of these centers in 2021. It just depends on each center on how they wanna go. Right now at TCAI, they have 3 systems, and we think that represents pretty much the maximum potential in that site. Maybe there's room for 1 more. You know, at Mayo in Jacksonville, they have 1 unit, and maximum potential there is 2. Mayo in Rochester, we have the potential for 5, and then there's more in Arizona. That's how we get to 27. As we add more and more centers, that potential unit number grows.

And we.

Kenneth Londoner: You know, we don't know if we'll make 27 sales in these 6 centers, but we believe we'll be selling product in each one of these centers in 2021. It just depends on each center on how they wanna go. Right now at TCAI, they have 3 systems, and we think that represents pretty much the maximum potential in that site. Maybe there's room for 1 more. You know, at Mayo in Jacksonville, they have 1 unit, and maximum potential there is 2. Mayo in Rochester, we have the potential for 5, and then there's more in Arizona. That's how we get to 27. As we add more and more centers, that potential unit number grows.

We don't know if we'll make 27 sales in the six centers, but we will believe we believe we will be selling product and each one of the centers in 2021 and it just depends on each center on how how they want to go right now at GCA on the.

They have three systems, and we think that represents pretty much the maximum potential in that site, maybe there is room for one more.

At Mayo and Jacksonville, They have one unit and maximum potential there's two but male and Rochester, we have the potential for five and then theres more in Arizona. So that's that's how we get the 27 and as we add more and more centers that potential.

Unit number gross and so in 2021, we should have a very large addressable market to convert into revenues and we're optimistic.

Kenneth L. Londoner: In 2021, we should have a very large addressable market to convert into revenues. You know, we're optimistic.

Kenneth Londoner: In 2021, we should have a very large addressable market to convert into revenues. You know, we're optimistic.

Okay, maybe the last question again, congrats on that well go ahead of what you had one more.

Yao Chen: Okay. Maybe the last question here. Again, congrats on that.

Yale Jen: Okay. Maybe the last question here. Again, congrats on that.

Kenneth L. Londoner: No, go ahead.

Kenneth Londoner: No, go ahead.

Yao Chen: Uh, which is-

Yale Jen: Uh, which is-

Kenneth L. Londoner: Go ahead. One more.

Kenneth Londoner: Go ahead. One more.

Yao Chen: Okay. Which is that you already have about 8, and you will have probably 10. That's ninth and 10th coming next Q1 of next year quarter online and to be using it. What's currently in the queue in terms of the pipeline further expansion? In other words, further site expansion at this point. You can talk about that prepare for 2021.

Okay, which is that the.

Yale Jen: Okay. Which is that you already have about 8, and you will have probably 10. That's ninth and 10th coming next Q1 of next year quarter online and to be using it. What's currently in the queue in terms of the pipeline further expansion? In other words, further site expansion at this point. You can talk about that prepare for 2021.

The already half about you make about.

And the you will have probably 10 at night and 10 coming next first quarter of Nick.

Order online and to using it and what's currently into Q in terms of the pipeline for the expansion and other.

Per day site expansion at this point you can talk about that prepare for the 2021.

So if I understand you.

Kenneth L. Londoner: If I understand you, Yao Chen, site expansion, you know, we haven't

Kenneth Londoner: If I understand you, Yao Chen, site expansion, you know, we haven't

Site expansion.

We have taken on.

Yao Chen: Additional sites.

Yale Jen: Additional sites.

I'm sorry, yes.

Kenneth L. Londoner: I'm sorry?

Kenneth Londoner: I'm sorry?

Additionally, the size well I mean, I leave that Youre contemplating already have some initial contact.

Yao Chen: Additional sites, what I mean, at least that you are contemplating or already have some initial contacts, that kind of activities.

Yale Jen: Additional sites, what I mean, at least that you are contemplating or already have some initial contacts, that kind of activities.

The kind of activities.

So we expect that to our sales and marketing team. We actually are preparing for quite a decent expansion in 2021 book those numbers haven't been solidified yet we want to make sure that we're able to handle the demand that's going to get generated by the events like every line of that is the big.

Kenneth L. Londoner: We expect to add to our sales and marketing team. We actually are preparing for quite a decent expansion in 2021, but those numbers haven't been solidified yet. We wanna make sure that we're able to handle the demand that's gonna get generated by the events like EP Live. That is a big event for us. You know, we also had an outstanding exposure at the VT Symposium, and a lot of these marketing videos that are coming out through different channels, like the one I just referenced with Dr. Santangeli at the University of Pennsylvania. You know, these do attract attention, and it wouldn't surprise us to see new inbound inquiries coming in. We can't quantify that just yet, because it's a little early in the process.

Kenneth Londoner: We expect to add to our sales and marketing team. We actually are preparing for quite a decent expansion in 2021, but those numbers haven't been solidified yet. We wanna make sure that we're able to handle the demand that's gonna get generated by the events like EP Live. That is a big event for us. You know, we also had an outstanding exposure at the VT Symposium, and a lot of these marketing videos that are coming out through different channels, like the one I just referenced with Dr. Santangeli at the University of Pennsylvania. You know, these do attract attention, and it wouldn't surprise us to see new inbound inquiries coming in. We can't quantify that just yet, because it's a little early in the process.

The event for us and.

And we also had an outstanding exposure at the BCP Symposium and a lot of these marketing videos that are coming out through different channels like the one I just referenced with doctors and tangibly that the University of Pennsylvania.

These do attract attention and it wouldn't surprise us the see new inbound inquiries coming in we can't quantify that just yet because.

It's a little early in the process, but as we get more and more users up on the system again, the number I mentioned in the presentation. We of 28 positions that of now used our system and human cases that.

Kenneth L. Londoner: As we get more and more users up on the system, again, the number I mentioned in the presentation, we have 28 EP physicians that have now used our system in human cases. That number is only gonna continue to grow and, you know, we've not heard anybody tell us negative things. You know, some have only used it one time. But, you know, we're optimistic based on what we've seen. The number of places we can go, I mean, we haven't even scratched the surface yet.

Kenneth Londoner: As we get more and more users up on the system, again, the number I mentioned in the presentation, we have 28 EP physicians that have now used our system in human cases. That number is only gonna continue to grow and, you know, we've not heard anybody tell us negative things. You know, some have only used it one time. But, you know, we're optimistic based on what we've seen. The number of places we can go, I mean, we haven't even scratched the surface yet.

That number is only going to continue to grow and.

We've not heard anybody tell us the.

Negative things.

Some of the of only used at one time.

But we're optimistic based on what we've seen so the number of of places. We can go I mean, we haven't even scratched the surface yet.

Okay, great. Thank loss expense political thing and the congrats.

Yao Chen: Okay, great.

Yale Jen: Okay, great.

Kenneth L. Londoner: Thank you, Yao.

Kenneth Londoner: Thank you, Yao.

Yao Chen: Thanks a lot. Thanks for everything, and congrats.

Yale Jen: Thanks a lot. Thanks for everything, and congrats.

Thank you.

Kenneth L. Londoner: Thank you.

Kenneth Londoner: Thank you.

Our next question is from Gary section.

Operator 2: Our next question is from Gary Schwartzbaum with Plum Tree Consulting. Please proceed.

Operator: Our next question is from Gary Schwartzbaum with Plum Tree Consulting. Please proceed.

With the Plum tree and consulting please proceed.

Thank you Ken Thank you, Andy and Ken for taking the time to update us.

Gary Schwartzbaum: Thank you, Ken. Thank you, Andy and Ken, for taking the time to update us. Ken, you mentioned with $32 million in the bank that this is enough money for all of 2021 into 2022. You mentioned you had 65 units that are paid for, and right now already. You said there have been more than 360 procedures. You mentioned that 188 were done at TCI, TCAI, and I, if I understand correctly, there are 6 surgeons there that are doing surgeries during the procedures. I'd like to get an idea of what the hospitals get. In other words, there's a range in what they charge the patient. There's a particular range of what they get.

Gary Zwetchkenbaum: Thank you, Ken. Thank you, Andy and Ken, for taking the time to update us. Ken, you mentioned with $32 million in the bank that this is enough money for all of 2021 into 2022. You mentioned you had 65 units that are paid for, and right now already. You said there have been more than 360 procedures. You mentioned that 188 were done at TCI, TCAI, and I, if I understand correctly, there are 6 surgeons there that are doing surgeries during the procedures. I'd like to get an idea of what the hospitals get. In other words, there's a range in what they charge the patient. There's a particular range of what they get.

Ken you mentioned with 32 million.

And the bank debt this is enough money for.

All of 2021 into 2022.

You mentioned you had 65 units that are paid for and.

And right now already.

If I can the focus.

On the you said there have been more than 300 and.

60 procedures.

You mentioned that 188 were non of Tc.

Hi, and I'm I understand correctly, there are six surge and there the doing surgeries during the procedures I'd like to get an idea of.

What the hospitals get another where the range.

And what the charge per patient day.

As of particular range of what they get I'd like to talk about.

Gary Schwartzbaum: I'd like to talk about what the hospitals are receiving, how many. I remember you said in 15 September, you said they were doing at one point at TCAI, 15 surgeries a week. That's bringing in quite a bit of money. I'd like to hear about that and the growth, and obviously that's 6 centers, 8 machines and other 2 to come. Can you talk about that and the kind of revenue that gives to the hospital and what we might see from them?

Gary Zwetchkenbaum: I'd like to talk about what the hospitals are receiving, how many. I remember you said in 15 September, you said they were doing at one point at TCAI, 15 surgeries a week. That's bringing in quite a bit of money. I'd like to hear about that and the growth, and obviously that's 6 centers, 8 machines and other 2 to come. Can you talk about that and the kind of revenue that gives to the hospital and what we might see from them?

The what the hospitals of receiving on.

And I remember you did on September 15, you said they were doing it so at one point and CCRI 50.

15 surgeries per week.

And that's bringing and quite a bit of money.

I'd like to hear about that and.

And and.

And the growth and obviously that's.

Six centers eight machines and other the to overcome can you talk about that and the kind of revenue debt that gives the the hospital and and.

What we might see from them.

Okay, Gary let me see if I can break that down us.

Kenneth L. Londoner: Okay, Gary, let me see if I can break that down. The Texas Cardiac Arrhythmia Institute is the number one volume center in our industry. They are the number one customer of J&J, who leads our industry. We're thrilled to be there. At TCAI, we've had quite a number of people using the system. It's actually more than 6 people who've used the system. We've become integrated into regular use by those that are doing cases there virtually every day. It varies between physicians how many cases they do, and they also don't do cases every week in a row. Dr. Natale, under normal conditions, travels around the country quite a bit and also does cases internationally.

Kenneth Londoner: Okay, Gary, let me see if I can break that down. The Texas Cardiac Arrhythmia Institute is the number one volume center in our industry. They are the number one customer of J&J, who leads our industry. We're thrilled to be there. At TCAI, we've had quite a number of people using the system. It's actually more than 6 people who've used the system. We've become integrated into regular use by those that are doing cases there virtually every day. It varies between physicians how many cases they do, and they also don't do cases every week in a row. Dr. Natale, under normal conditions, travels around the country quite a bit and also does cases internationally.

So the Texas cardiac Arrhythmia Institute as the number one volume center in our industry.

They are the number one customer of JNJ, who leads our industry and we're thrilled to be there and.

Yes, and TC AI, we've had quite a number of people using the system, it's actually more than six people who've used the system, but we've become integrated into regular use by those that are doing cases, they're virtually every day and it varies between physicians, how many cases, they do and the.

Also don't do cases every week and ROE, Dr and the Tali under normal conditions travels around the country quite a bit and also does cases internationally. So when he's there.

Kenneth L. Londoner: When he's there, we are with him, and we have two people stationed at TCAI supporting our systems and helping them learn how to bring our system, you know, to life and how we bring the most value through all the software and things that we offer. In terms of what they make, I don't have the specific information with TCAI, but the industry averages that we've been able to gather, if a cardiac ablation is done at a center and private insurance pays, we believe the hospital makes roughly $30,000 in operating profit. From an elective procedural process, these are very, very lucrative procedures in the hospital.

Kenneth Londoner: When he's there, we are with him, and we have two people stationed at TCAI supporting our systems and helping them learn how to bring our system, you know, to life and how we bring the most value through all the software and things that we offer. In terms of what they make, I don't have the specific information with TCAI, but the industry averages that we've been able to gather, if a cardiac ablation is done at a center and private insurance pays, we believe the hospital makes roughly $30,000 in operating profit. From an elective procedural process, these are very, very lucrative procedures in the hospital.

We are with him and we have two people of stationed at Tcf of supporting our systems and helping them learn how to bring our system.

To life and how we bring the most value through all of the software and things that we offer in terms of what they make.

I don't have the specific information with Ta, but the industry averages that we've been able to gather if.

If a cardiac ablation is done at a center and private insurance pays we believe the hospital makes roughly 30000 and operating profit and so from an elective procedural process. These are very very lucrative procedures in the hospital and you know.

Kenneth L. Londoner: You know, with the hits all these centers have taken in the pandemic, they have gotten back to full strength, doing these elective procedures because, one, people need them. We don't view these procedures as elective. If you have an irregular heartbeat, it's very dangerous, potentially lethal. You know, they're doing cases now. I can't tell you what the outbreaks of COVID are gonna bring, but I think the centers have all learned how to segregate COVID patients from their other patients. We have heard of none of our centers shutting down. There are 2 centers that have asked us to defer installments until early in Q1, but, you know, they are not shutting down by any means. They're just dealing with rising COVID cases.

Kenneth Londoner: You know, with the hits all these centers have taken in the pandemic, they have gotten back to full strength, doing these elective procedures because, one, people need them. We don't view these procedures as elective. If you have an irregular heartbeat, it's very dangerous, potentially lethal. You know, they're doing cases now. I can't tell you what the outbreaks of COVID are gonna bring, but I think the centers have all learned how to segregate COVID patients from their other patients. We have heard of none of our centers shutting down. There are 2 centers that have asked us to defer installments until early in Q1, but, you know, they are not shutting down by any means. They're just dealing with rising COVID cases.

With the hits all the centers have taken and the pandemic.

And they have gotten back the full strength on.

Doing these elective procedures, because one people need them, we don't view these procedures and selective if you have an irregular heartbeat is free dangerous potentially lethal.

And you know they're doing cases now I can't tell you what the outbreaks of co of it are going to bring on.

But I think the centers of all learned how to segregate cobot patients from the or other patients and we have heard of none of our centers shutting down there are two centers that have asked us to defer installments until early in the first quarter.

But the.

They are not shutting down by any means theyre, just dealing with rising Cove and cases in terms of.

Kenneth L. Londoner: In terms of the Medicare, Medicaid reimbursement, if a patient comes through with Medicare, Medicaid, the profit is lower for the hospital, you know, somewhere between $2,500 and 5,000, but it's still a positive for them. We think we're in the right area of the hospital, the right department. You know, we are selling the system, leasing the system or renting the system. You know, capital budgets vary from center to center. One thing we do when we go into a center is we have a matrix of how we qualify centers of where we'd like to go. Right now, we have more places asking for us to come than we have people. We're hiring, but you know, even still, there's gonna be great interest in using the system.

Kenneth Londoner: In terms of the Medicare, Medicaid reimbursement, if a patient comes through with Medicare, Medicaid, the profit is lower for the hospital, you know, somewhere between $2,500 and 5,000, but it's still a positive for them. We think we're in the right area of the hospital, the right department. You know, we are selling the system, leasing the system or renting the system. You know, capital budgets vary from center to center. One thing we do when we go into a center is we have a matrix of how we qualify centers of where we'd like to go. Right now, we have more places asking for us to come than we have people. We're hiring, but you know, even still, there's gonna be great interest in using the system.

The Medicare Medicaid reimbursement, if a patient comes through with Medicare Medicaid.

The profit is lower of for the hospital.

Somewhere between 20 505000, but it's still a positive for them. So we think we're in the right area of the hospital the right Department and you know.

We are selling the system leasing the system of renting the system and you know capital budgets vary from center. The center one thing we do when we go into a centers we have the matrix of how we qualify centers of where we'd like to go right. Now we have more places asking for us to come.

Then we have people and we are hiring but even still.

Theres going to be great interest and.

Using the system, but we have a matrix, where we have to understand how many line.

Kenneth L. Londoner: We have a matrix where we have to understand how many labs they have, how long we think it'll take them to get up and running. Our installation contracts are starting to narrow in terms of the time we're allowing these centers to use the system. We're finding that they really immediately see the value in the system. After, like, three weeks, they see the full value of the system. The need for these long evaluation timelines are not as necessary as they were when we first started. Some of these new contracts that'll be coming in Q1 will be 60- to 90-day evaluation agreements, and our commercial teams will be going in, evaluating before we even install the likelihood of us being able to transfer ownership from BioSig to the hospital, meaning we get paid.

Kenneth Londoner: We have a matrix where we have to understand how many labs they have, how long we think it'll take them to get up and running. Our installation contracts are starting to narrow in terms of the time we're allowing these centers to use the system. We're finding that they really immediately see the value in the system. After, like, three weeks, they see the full value of the system. The need for these long evaluation timelines are not as necessary as they were when we first started. Some of these new contracts that'll be coming in Q1 will be 60- to 90-day evaluation agreements, and our commercial teams will be going in, evaluating before we even install the likelihood of us being able to transfer ownership from BioSig to the hospital, meaning we get paid.

Labs they have.

How long, we think it will take them to get up and running our our installation of contracts are starting to narrow in terms of the time, we're allowing the centers to use the system. We're finding that the really immediately see the value in the system and after like three weeks they see the full value of the system. So the need for these low.

On the valuation timelines are not as necessary as they were when we first started so some of these new contracts that will be coming and the first quarter will be 60 to 90 day evaluation agreements and our commercial teams will be going in.

Evaluating before we even install the likelihood of us being able to transfer ownership from bias to the hospital, meaning we get paid and so thats a factor and our decision making on of where we're going and how we're going to do things, but because the 2020 was not what we consider the full year, we wanted it to.

Kenneth L. Londoner: That's a factor in our decision-making of where we're going and how we're going to do things. Because, you know, 2020 was not what we consider the full year we wanted it to be, you know, with the pandemic, every business has been affected. We think 2021 will be a year where you see a lot more activity from us. Then we all assume 2022, we're thinking the pandemic's gonna be gone, and we'll be going at full strength. You know, we see ourselves ramping from this year into next. The good news from this call is the initial sites that are using the system are seeing value, a lot of value in the system. We've not had one center that hasn't said that to us. Thank you, Gary.

Kenneth Londoner: That's a factor in our decision-making of where we're going and how we're going to do things. Because, you know, 2020 was not what we consider the full year we wanted it to be, you know, with the pandemic, every business has been affected. We think 2021 will be a year where you see a lot more activity from us. Then we all assume 2022, we're thinking the pandemic's gonna be gone, and we'll be going at full strength. You know, we see ourselves ramping from this year into next. The good news from this call is the initial sites that are using the system are seeing value, a lot of value in the system. We've not had one center that hasn't said that to us. Thank you, Gary.

To be with the pandemic every business has been affected we.

We think 2021 will be or will you see a lot more activity from us and then we all assume 2022.

We think and the pandemic is going to be gone and we will be going at full strength. So we see ourselves ramping from this year into next and the good news from this call is the initial sites.

Sites that are using the system are seeing value a lot of value on the system. We've not had one center that has and said that to us.

So thank you Gary next question please.

Kenneth L. Londoner: Next question, please.

Kenneth Londoner: Next question, please.

As a reminder of star one on your telephone keypad. If you would like to ask the question. Our next question is from Sanjay come on and private Investor. Please proceed.

Operator 2: As a reminder, star one on your telephone keypad if you would like to ask a question. Our next question is from Sanjay Kamani, Private Investor. Please proceed.

Operator: As a reminder, star one on your telephone keypad if you would like to ask a question. Our next question is from Sanjay Kamani, Private Investor. Please proceed.

Yes, Hi, Dan. Thank you for the update and about the space and the about the pure GP for instance, and planned on.

Sanjay Kamani: Yeah. Hi, Ken. Thank you for the update and about, especially about the PURE EP projections and plans. I'm wondering about the ViralClear investments. The people who invested directly into the ViralClear, how that investment is going to be handled. I'm wondering, you know, how the investors going to be, you know, if there is any, you know, plan for that.

Sanjay Kamani: Yeah. Hi, Ken. Thank you for the update and about, especially about the PURE EP projections and plans. I'm wondering about the ViralClear investments. The people who invested directly into the ViralClear, how that investment is going to be handled. I'm wondering, you know, how the investors going to be, you know, if there is any, you know, plan for that.

I'm wondering about the light and here in the.

This mems and some of the equal in the.

Adjusted EBITDA into the wider you all.

All of the investment is going to the Haendel and wondering how.

And the distance Glen can be and that.

That is ending.

And the plan for that.

Thank you Sanjay so those that invested in the viral clear on their percentage of these subsidiary biases currently owns 69.5% of.

Kenneth L. Londoner: Thank you, Sanjay. Those that invested in the ViralClear own their percentage of the subsidiary. BioSig currently owns 69.5% of the subsidiary. Right now in that subsidiary, at the end of the year, there'll be cash, which will be used to drive our Mayo Clinic projects forward on all the neurotech that we've been developing for years. We are looking to find ways to bring value through placing the VX-497 program in someone else's hands, and we'll have to see how that plays out. The ViralClear investors will own a stake in our neurotech program. We are gonna do another call, we didn't wanna do it today, where we can take everybody through our NeuroClear program.

Kenneth Londoner: Thank you, Sanjay. Those that invested in the ViralClear own their percentage of the subsidiary. BioSig currently owns 69.5% of the subsidiary. Right now in that subsidiary, at the end of the year, there'll be cash, which will be used to drive our Mayo Clinic projects forward on all the neurotech that we've been developing for years. We are looking to find ways to bring value through placing the VX-497 program in someone else's hands, and we'll have to see how that plays out. The ViralClear investors will own a stake in our neurotech program. We are gonna do another call, we didn't wanna do it today, where we can take everybody through our NeuroClear program.

Of the subsidiary.

Right now and Thats subsidiary at the end of the year there'll be cash.

Which will be used to drive our Mayo clinic projects forward on all the neurotech that weve been developing for years.

We are looking to find ways to bring the.

Value through the.

Two of placing the VX four nights seven program and someone else's hands and we'll have to see how that plays out.

So the borrower clear investors will own a state and our Neurotech program.

We are going to do another call, we didnt want to do it today, where we can take everybody through a number of clear program. We have advanced the nuclear assets considerably this year and we havent talked much about it because most of the discussion was focused on the buyer of clear program, but we had a team advancing that technology and we do think.

Kenneth L. Londoner: We have advanced the NeuroClear assets considerably this year, and we haven't talked much about it because most of the discussion was focused on the ViralClear program. We had a team advancing that technology, and we do think that in 2021, there'll be several value events for the neurotech assets. You know, to get into it now, we don't have the time, and I'm more than happy to answer it for you. You will own a stake in that. In terms of monetizing that stake, you know, we, as a leadership team, are working on that plan for 2021. We understand the investment was made in a ViralClear asset.

Kenneth Londoner: We have advanced the NeuroClear assets considerably this year, and we haven't talked much about it because most of the discussion was focused on the ViralClear program. We had a team advancing that technology, and we do think that in 2021, there'll be several value events for the neurotech assets. You know, to get into it now, we don't have the time, and I'm more than happy to answer it for you. You will own a stake in that. In terms of monetizing that stake, you know, we, as a leadership team, are working on that plan for 2021. We understand the investment was made in a ViralClear asset.

And in 2021, there will be several value events for the Neurotech assets, what you know to get into it now we don't have the time and the more than happy to answer for you. So you will on a stake in that in terms of monetizing that stake.

We as a leadership team are working on that plan for 2021 and we we.

We understand the investment was made and borrow of our real clear asset.

Kenneth L. Londoner: Just like all of our other shareholders, we're gonna be working hard to create value, and we understand, you know, that that's our obligation. That's the best I can share with you right now.

And.

Just like all of the or all of our other shareholders were going to be working hard to create value and we understand.

Kenneth Londoner: Just like all of our other shareholders, we're gonna be working hard to create value, and we understand, you know, that that's our obligation. That's the best I can share with you right now.

You know that that's our obligation. So that's the best I can share with the right now.

Our next question is from Fred Leoni private Investor. Please proceed.

Operator 2: Our next question is from Fred Leone, Private Investor. Please proceed.

Operator: Our next question is from Fred Leone, Private Investor. Please proceed.

Okay and good afternoon, thanks for having this call and thanks for taking my question a quick question regarding the.

Fred Leone: Ken, good afternoon. Thanks for having this call, and thanks for taking my question. I've got a quick question regarding the revenue of the unit itself. Is there revenue besides that revenue for the unit? Is there an ongoing software cost that per unit that each of these centers are gonna have to pay on a monthly basis?

Fred Leone: Ken, good afternoon. Thanks for having this call, and thanks for taking my question. I've got a quick question regarding the revenue of the unit itself. Is there revenue besides that revenue for the unit? Is there an ongoing software cost that per unit that each of these centers are gonna have to pay on a monthly basis?

The revenue of the unit itself is there revenue besides that revenue for the unit is due and ongoing software.

Cost of that per unit that each of these centers of the past to pay on a monthly basis.

Thanks, Thanks for the question Freddie Thanks for your investment.

Kenneth L. Londoner: Thanks for the question, Freddy. Thanks for your investment. We are selling the hardware. We actually have plans that we offer these hospitals, and we have what we call a service contract, which will include installation, training, clinical support, access to any software upgrades when they come. We are going to be getting a contract in place for that. They'll buy the hardware, and then they'll buy the service contract, and we're marketing each differently. There are also accessories that get sold. You know, we have special wires and connectors and things of that nature. We have these all in a package, and when we get a purchase order, all of the elements are detailed out in what the hospital's committing to.

Kenneth Londoner: Thanks for the question, Freddy. Thanks for your investment. We are selling the hardware. We actually have plans that we offer these hospitals, and we have what we call a service contract, which will include installation, training, clinical support, access to any software upgrades when they come. We are going to be getting a contract in place for that. They'll buy the hardware, and then they'll buy the service contract, and we're marketing each differently. There are also accessories that get sold. You know, we have special wires and connectors and things of that nature. We have these all in a package, and when we get a purchase order, all of the elements are detailed out in what the hospital's committing to.

We are selling the hardware, we actually have plans that we offer these hospitals and we have a.

What we call a service contract, which will include installation and training clinical.

Clinical support and.

Access to any software upgrades when they come on.

And we are going to be.

Getting a contract in place for for that so they'll buy the hardware and then they'll buy the service contract and.

We're marketing each differently. There also accessories that gets sold we have special wires and connectors and things of that nature. So we have these all in the package and when we get a purchase order.

All of the elements are detailed out and with the hospitals committing to so yes. There are two there are two lines of business, if you will and so.

Kenneth L. Londoner: Yeah, there are two lines of business, if you will. Ultimately, as we get this business launched, the hardware is the razor, and the software will be the blades. We have a lot of software to deliver the industry. We have a very robust product development pipeline we've been building for years. Next year, we're, you know, working right now to determine how much software we wanna release because we have so much. You know, the industry can only absorb so much. We're ahead of the curve in terms of the products that we've created. They're all clinically valuable. You know, that's gonna serve us well as we go deeper into commercialization. Thanks for your question, Fred.

Kenneth Londoner: Yeah, there are two lines of business, if you will. Ultimately, as we get this business launched, the hardware is the razor, and the software will be the blades. We have a lot of software to deliver the industry. We have a very robust product development pipeline we've been building for years. Next year, we're, you know, working right now to determine how much software we wanna release because we have so much. You know, the industry can only absorb so much. We're ahead of the curve in terms of the products that we've created. They're all clinically valuable. You know, that's gonna serve us well as we go deeper into commercialization. Thanks for your question, Fred.

So ultimately as we get this business launched the hardware is the razor and the software will be the blades and we have a lot of software to deliver the industry.

We have the very robust product development pipeline, we've been building for years and next year. We're.

Working right now the determine how much software we want to release, because we have so much and you know the industry can only absorb so much. So we're we're ahead of the curve in terms of the products that we've created and now and they're all the all clinically valuable so you know.

And that's going to that's going to serve us well as we go deeper into commercialization.

Thanks for your question Fred.

Tim Miller: Of course. No problem.

Fred Leone: Of course. No problem.

For for them.

Our next question is from Jeffrey Kaminski with JK consulting. Please proceed.

Operator 2: Our next question is from Jeffrey Kaminsky with JJK Consulting. Please proceed.

Operator: Our next question is from Jeffrey Kaminsky with JJK Consulting. Please proceed.

Hi, Good afternoon, Ken and thank you for taking my question.

Jeffrey Kaminsky: Hi. Good afternoon, Ken, and thank you for taking my question. Kind of a follow-up to the last question. I'm just trying to put pen to paper here. You had mentioned the sale of hardware and then an annual software upgrade or software fee that goes with it. Could you give us a sense of actual dollars here? In past discussions, you had said that you were entertaining a rent-to-buy model or a lease model. Now you're discussing the purchase of the hardware, and then as a follow-up, the software, the upgrades, and the maintenance that you described. What will that cost?

Jeffrey Kaminsky: Hi. Good afternoon, Ken, and thank you for taking my question. Kind of a follow-up to the last question. I'm just trying to put pen to paper here. You had mentioned the sale of hardware and then an annual software upgrade or software fee that goes with it. Could you give us a sense of actual dollars here? In past discussions, you had said that you were entertaining a rent-to-buy model or a lease model. Now you're discussing the purchase of the hardware, and then as a follow-up, the software, the upgrades, and the maintenance that you described. What will that cost?

Kind of a follow up for the last question and just trying to prepare.

And for paper here and you had mentioned the shale and hardware and the non on.

On an annual software.

Upgrade on software for you. The goes were could you give us the sense of actual dollars here.

And passed the discussions you had said that you were entertaining a renter by model or at least tomorrow.

Now you're discussing the purchase of the hardware and then as a follow up the software and the upgrades and the maintenance. The you described.

What will that cost in other words if Simon.

Jeffrey Kaminsky: In other words, if I've got it installed, I like it, I'm using it, and I want it, what am I paying for it, you know, on the onset, and what am I paying every year? In other words, what revenue is the device gonna generate?

Jeffrey Kaminsky: In other words, if I've got it installed, I like it, I'm using it, and I want it, what am I paying for it, you know, on the onset, and what am I paying every year? In other words, what revenue is the device gonna generate?

Got it installed I like it and using it and I want it and one of my paying for on the.

The onset and one of my paying every year.

The other was what's what revenue is the end of the is the device for the generate.

Thank you for the question so.

Kenneth L. Londoner: Thank you for the question. Because of the pandemic, we're trying to be as flexible as possible to be able to get an installed base. Because of the installed base of the hardware, we have the ability each year to come back and sell additional software. This is a business model that's well accepted. Our friends at Biosense Webster, who pioneered this market, have done an outstanding job showing us the way in the industry by being able to put hardware into the market and then consistently bringing additional software value. That software is sold in two ways. It's sold in a package where they get the basics, which are installation training, basic system upgrades. You know, these are operating software upgrades. We have our own operating software with the system.

Kenneth Londoner: Thank you for the question. Because of the pandemic, we're trying to be as flexible as possible to be able to get an installed base. Because of the installed base of the hardware, we have the ability each year to come back and sell additional software. This is a business model that's well accepted. Our friends at Biosense Webster, who pioneered this market, have done an outstanding job showing us the way in the industry by being able to put hardware into the market and then consistently bringing additional software value. That software is sold in two ways. It's sold in a package where they get the basics, which are installation training, basic system upgrades. You know, these are operating software upgrades. We have our own operating software with the system.

We.

Worse because of the pandemic, we're trying to be as flexible as possible to be able to get and install base because on the installed base of the hardware we have the ability each year to come back and sell additional software and this is the business model that is well accepted our friends at five cents Webster who price.

And your this market of done an outstanding job showing us the way and the industry by being able to put hardware and to the market and then consistently bringing additional software value and that software is sold into ways. It's sold in a package, where they get the basics, which are installation and training basic system of.

Grades of these are operating software upgrades, we have are on operating software with the system. So as we find improvements feature improvements by buying the software package and get the upgrades automatically and then we sell modules modules are specific softwares almost like if you think about when you book.

Kenneth L. Londoner: As we find improvements, feature improvements, by buying the software package, they get the upgrades automatically. We sell modules. Modules are specific softwares, almost like if you think about when you buy an Apple computer or a Dell, you will pay extra for Microsoft and all the, you know, Windows, PowerPoint, Excel, et cetera. You pay a separate fee for that. We will also have another fee for specific software modules. If you wanna think of the model, the base is the hardware. You have the operating software and that annual fee that they pay. On top of that, we will have distinguished modules that we create or we already have created that can help them do more in their procedure that are in addition to the core base system.

Kenneth Londoner: As we find improvements, feature improvements, by buying the software package, they get the upgrades automatically. We sell modules. Modules are specific softwares, almost like if you think about when you buy an Apple computer or a Dell, you will pay extra for Microsoft and all the, you know, Windows, PowerPoint, Excel, et cetera. You pay a separate fee for that. We will also have another fee for specific software modules. If you wanna think of the model, the base is the hardware. You have the operating software and that annual fee that they pay. On top of that, we will have distinguished modules that we create or we already have created that can help them do more in their procedure that are in addition to the core base system.

And Apple computer for Dell, you will pay extra for Microsoft and all the Windows, Powerpoint et cetera, et cetera, you pay the separate fee for that so we will also have another fee for specific software modules. So if you want to think of the the model the base is the hardware.

And then you have the operating software and that annual fee that they pay and then on top of that we will have distinguished.

Modules that we create or we already have created that can help them do more in their procedure that are in addition to the core base system, and then lastly, and and we have highlighted this and the past we've been working very diligently this year on artificial intelligence offerings.

Kenneth L. Londoner: We have highlighted this in the past. We've been working very diligently this year on our artificial intelligence offerings, and we filed quite a few patents in this arena. We would like to bring one AI module to market next year if we can. Again, though, there's only so much the market can digest for us. Our corporate strategy is to use the full basis of 2021 to grow as large an install base as we can get, where we will get paid for that install base. That will be another building block towards an even bigger base in 2022. It's base hardware, software, modules and AI offerings on top of that.

Kenneth Londoner: We have highlighted this in the past. We've been working very diligently this year on our artificial intelligence offerings, and we filed quite a few patents in this arena. We would like to bring one AI module to market next year if we can. Again, though, there's only so much the market can digest for us. Our corporate strategy is to use the full basis of 2021 to grow as large an install base as we can get, where we will get paid for that install base. That will be another building block towards an even bigger base in 2022. It's base hardware, software, modules and AI offerings on top of that.

And we filed quite a few patents in this arena.

And we would like to bring one on AI.

Hi module to market.

Next year, if we can again, though there is only so much the market can digest for us our large corporate strategy is to use the full basis of 2021 to grow as large and installed base as we can get where we will get paid for that installed base and then that will be another bill.

Moving block towards and even bigger base and 2022, so its base hardware software modules and day AI.

AI offerings on top of that in terms of the specific pricing you know because we think we may have some competition on the call we try not to get into that so much at this point.

Kenneth L. Londoner: In terms of the specific pricing, you know, because we think we may have some competition on the call, we try not to get into that so much at this point. But the average selling price, the value we're offering the system is in the ballpark of what they're paying for these type of technologies. You know, you guys will see as our future goes along, you'll probably be able to back into what we're able to get. Thank you for the question.

Kenneth Londoner: In terms of the specific pricing, you know, because we think we may have some competition on the call, we try not to get into that so much at this point. But the average selling price, the value we're offering the system is in the ballpark of what they're paying for these type of technologies. You know, you guys will see as our future goes along, you'll probably be able to back into what we're able to get. Thank you for the question.

But the average selling price of the value. We're offering system is in the ballpark of what they're paying for these type of technologies and.

You know you guys will see as far as our future goes along you'll probably be able to back into what we're able to get.

So thank you for the question.

Our next question is from Tim Miller of private Investor. Please proceed.

Operator 2: Our next question is from Tim Miller, Private Investor. Please proceed. Tim, your line is live.

Operator: Our next question is from Tim Miller, Private Investor. Please proceed. Tim, your line is live.

Tim Your line is price.

Sorry about that.

Kenneth L. Londoner: Hi, Tim.

Kenneth Londoner: Hi, Tim.

Tim Miller: Sorry about that. Afternoon, Ken.

Tim Miller: Sorry about that. Afternoon, Ken.

Afternoon Kim.

Hi, Tim.

Kenneth L. Londoner: Hi, Tim.

Kenneth Londoner: Hi, Tim.

So obviously.

Tim Miller: Obviously, you've 300+ patients. The blind study has demonstrated the superiority of the signal. Any color in terms of the efficacy of using the PURE EP system versus standard of care in terms of, you know, the duration of the procedure versus historical norms?

Tim Miller: Obviously, you've 300+ patients. The blind study has demonstrated the superiority of the signal. Any color in terms of the efficacy of using the PURE EP system versus standard of care in terms of, you know, the duration of the procedure versus historical norms?

Obviously, you of 300 plus patients the blind study has demonstrated the superiority of the signal.

Any color in terms of the efficacy of using the pure ERP system versus standard of care in terms of.

The duration of the but the procedure versus the historical norms.

Yes, Thats a great question and we're we're just on the beginnings of the.

Kenneth L. Londoner: Yeah, that's a great question. We're just in the beginnings of detailing out the efficacy. These videos that I've referred to, and we can send you the ones that we've produced. In each case, this is a case where the additional information that our system provides have given the EP physician new ablation targets that they would not have had before. By selecting and following the information to those targets and burning in those locations in the atrium or even the ventricles, they've been able to-

Kenneth Londoner: Yeah, that's a great question. We're just in the beginnings of detailing out the efficacy. These videos that I've referred to, and we can send you the ones that we've produced. In each case, this is a case where the additional information that our system provides have given the EP physician new ablation targets that they would not have had before. By selecting and following the information to those targets and burning in those locations in the atrium or even the ventricles, they've been able to-

Detailing out the efficacy, but these videos that I referred to and we can send you the ones that we produce.

In each case this is a case, where the additional information that our system provides have given the EPS position, new ablation targets that they would not have had before and by selecting and and following the.

The information to those targets and burning in those locations and the atrium or even the ventricles they've been able to.

Please note that we are having some technical difficulty.

Operator 2: Please hold on, we are having some technical difficulty. We will be getting in just one moment. Again, hold on, we are having some technical difficulties. Once again, thank you for your patience. We will be beginning momentarily. Okay, you are back in. You may continue.

Operator: Please hold on, we are having some technical difficulty. We will be getting in just one moment. Again, hold on, we are having some technical difficulties. Once again, thank you for your patience. We will be beginning momentarily. Okay, you are back in. You may continue.

No.

The beginning and just one moment and again of Dan we're having some technical difficulties.

[noise].

Okay.

Once again, thank you for your patience, we will see beginning momentarily.

Okay, you are back and you may continue.

Sorry about that Tim we just lost the call what I was saying is the information.

Kenneth L. Londoner: Sorry about that, Tim. We just lost the call. What I was saying is, the information that we're providing and these new ablation targets that they're seeing are either able to put the patient back into normal sinus rhythm or help them complete the procedure on a more timely basis. The more of this we see, the more excited they get. We get excited as well, and we believe ultimately this will translate into system acquisition. In terms of what we're learning in the field from all of this experience, we are working on a plan to do what's called investigator-initiated clinical trials.

Kenneth Londoner: Sorry about that, Tim. We just lost the call. What I was saying is, the information that we're providing and these new ablation targets that they're seeing are either able to put the patient back into normal sinus rhythm or help them complete the procedure on a more timely basis. The more of this we see, the more excited they get. We get excited as well, and we believe ultimately this will translate into system acquisition. In terms of what we're learning in the field from all of this experience, we are working on a plan to do what's called investigator-initiated clinical trials.

We're providing and these new ablation and targets that they are seeing are either able to put the patient back into normal sinus rhythm or help them complete the procedure on a more timely basis. So the more of this we see the more excited they get we get excited as well and we believe ultimately this will translate into system acquisition.

And in terms of what we're learning in the field of.

From all of this experience we are working on a plan to do what's called investigator initiated clinical trials. So these are things that they are seeing and they because they have this new tool. They think that we can demonstrate efficacy in the certain sub segment of patients.

Kenneth L. Londoner: These are things that they're seeing, and because they have this new tool, they think that we can demonstrate efficacy in a certain subsegment of patients, you know, with these patient categories, where they're going to come to us with protocols and we are going to fund these protocols, and they'll do multicenter randomized blinded studies that are investigator-initiated by the investigator. We will provide the PURE EP system, they will provide the protocol, and they will go out and recruit the patients under IRB approval, and we will get that information back. We have many ideas, and we have many categories that we want to study. Unipolar signals, pulmonary vein isolation improvements, tissue viability, and so on and so forth.

Kenneth Londoner: These are things that they're seeing, and because they have this new tool, they think that we can demonstrate efficacy in a certain subsegment of patients, you know, with these patient categories, where they're going to come to us with protocols and we are going to fund these protocols, and they'll do multicenter randomized blinded studies that are investigator-initiated by the investigator. We will provide the PURE EP system, they will provide the protocol, and they will go out and recruit the patients under IRB approval, and we will get that information back. We have many ideas, and we have many categories that we want to study. Unipolar signals, pulmonary vein isolation improvements, tissue viability, and so on and so forth.

With these patient categories, where theyre going to come to us with protocols and we're going to fund these protocols and they'll do multi center randomized blinded.

Studies that are initiated by the investigator. So we will provide the purity P system day will provide the protocol and they will go out and recruit the patients under IR be approval and we will get that information back we have not we have many many of ideas and we have many.

Many categories that we want to study.

Unipolar signals of pulmonary vein isolation improvements tissue viability and so.

So on and so forth. These are all areas, where we can make improvements through our technology and in and the way things are done and thats pretty exciting pretty exciting stuff and we will get back to you on the next call with regard to our clinical trial by the way the second leg of our.

Kenneth L. Londoner: These are all areas where we can make improvements through our technology in the way things are done. It's pretty exciting stuff. We will get back to you on the next call with regard to our clinical trial. By the way, the second leg of our PURE EP Study, the one that was unblinded, is underway, and we expect to have data from the study. It's basically a continuation from the first data that was published. We did 15 patients. We're going to try to get up to 100 patients in the second leg of that study, and that data we're hoping to unblind by the Heart Rhythm Society meeting in July of next year.

Kenneth Londoner: These are all areas where we can make improvements through our technology in the way things are done. It's pretty exciting stuff. We will get back to you on the next call with regard to our clinical trial. By the way, the second leg of our PURE EP Study, the one that was unblinded, is underway, and we expect to have data from the study. It's basically a continuation from the first data that was published. We did 15 patients. We're going to try to get up to 100 patients in the second leg of that study, and that data we're hoping to unblind by the Heart Rhythm Society meeting in July of next year.

Pure EPA study of the one that was on blinded.

Is underway and.

And we expect to have data from the study it's basically a continuation.

From the.

From the first data that was published we did 15 patients and we're going to try to get up to 100 patients in the second leg of that study and that data, we're hoping to unblind by the heart Rhythm Society meeting in July of next year.

Okay. Appreciate the obvious the exciting in terms of the technological advancement given that Canada and from a from a procedural standpoint is the is there efficiency here in terms of time of the procedure I.E. the being shorter given the the clarity of the signal.

Tim Miller: I appreciate that. Obviously, exciting in terms of the technological advancement. Given that Ken, from a procedural standpoint, is there efficiency here in terms of time of the procedure, i.e., they being shorter given the clarity of the signal? Then, you know, in terms of obviously you're able to to attack the arrhythmia in terms, is there a lower reoccurrence of a rate of the arrhythmia coming back, or is the data still too young?

Tim Miller: I appreciate that. Obviously, exciting in terms of the technological advancement. Given that Ken, from a procedural standpoint, is there efficiency here in terms of time of the procedure, i.e., they being shorter given the clarity of the signal? Then, you know, in terms of obviously you're able to to attack the arrhythmia in terms, is there a lower reoccurrence of a rate of the arrhythmia coming back, or is the data still too young?

And then.

Terms of obviously, you're able to to.

Attack the arrhythmia and terms is there lower re occurrence of of rate of the arrhythmia coming back or is the the data still to you on.

Yes on the data still too young to measure recurrent sold though and working with TCAD given how busy of center that is and also pen.

Kenneth L. Londoner: Yeah, the data is still too young to measure recurrence. Although in working with TCAI, given how busy a center that is and also Penn, you know, we're discussing registries where we can follow these patients and follow them through the databases of these large, and, you know, operating facilities. So there's going to be focus there, absolutely. In terms of, you know, the data and how it comes out, we're going to have an abundance of data, and we're going to have an abundance of evidence for the industry. We already have more than we ever expected this year. It just hasn't been visible to the investor community.

Kenneth Londoner: Yeah, the data is still too young to measure recurrence. Although in working with TCAI, given how busy a center that is and also Penn, you know, we're discussing registries where we can follow these patients and follow them through the databases of these large, and, you know, operating facilities. So there's going to be focus there, absolutely. In terms of, you know, the data and how it comes out, we're going to have an abundance of data, and we're going to have an abundance of evidence for the industry. We already have more than we ever expected this year. It just hasn't been visible to the investor community.

We're discussing registries, where we can follow these patients and follow the them.

Through the databases of these of these large teaching and and operating facilities.

So there's going to be there's going to be focus there absolutely in terms of.

In terms of.

The the data and how it how it comes out.

We're going to have an abundance of data and we're going to have an abundance of evidence for the industry, we already have more than we ever expected.

This year.

It's just hasn't been visible to the investor community like I said today.

Kenneth L. Londoner: Like I said today, there was a video that came out from the University of Pennsylvania. We've only been in that center, I believe, for about six weeks. So the fact that they'd be willing to make a video highlighting a great case and the value of our system, you know, this is the hard work of our team, the hard work of the physicians that are using the system. It's early days, but the early feedback that's coming in is encouraging, very encouraging to us. It, it's what keeps us going. You know, it's what keeps us all very excited. It's early days, you know, it's early days.

Kenneth Londoner: Like I said today, there was a video that came out from the University of Pennsylvania. We've only been in that center, I believe, for about six weeks. So the fact that they'd be willing to make a video highlighting a great case and the value of our system, you know, this is the hard work of our team, the hard work of the physicians that are using the system. It's early days, but the early feedback that's coming in is encouraging, very encouraging to us. It, it's what keeps us going. You know, it's what keeps us all very excited. It's early days, you know, it's early days.

There was the video that came out from the University of Pennsylvania, We've only been and that center I believe for about six weeks. So the fact that they'd be willing to make the video highlighting a great case and the value of our system you know the.

This is the hard work of our team the hard work of the physicians that are using the system and its early days, but the the early feedback that's coming in is encouraging very encouraging to us and it's what keeps us going on so we're keeps us all very excited and its early days.

It's early days, we because we have seen consistency and each center.

Kenneth L. Londoner: Because we've seen consistency in each center, you know, I mean, the system, you know, our clinical account managers who are in there with the system and the physician, they're all doing an outstanding job. This is an excellent team we have, and we look forward to growing that team. As that team grows, we'll be able to go into more and more centers, and we believe we'll probably have consistency of experience. Then at some point, we're gonna have quite a backlog of places that want us to come in there and install systems. We're working hard to get to that point. Of course, there's a conversion and how long it takes from a hospital to get the system to conversion. In a pandemic, we have to see.

Kenneth Londoner: Because we've seen consistency in each center, you know, I mean, the system, you know, our clinical account managers who are in there with the system and the physician, they're all doing an outstanding job. This is an excellent team we have, and we look forward to growing that team. As that team grows, we'll be able to go into more and more centers, and we believe we'll probably have consistency of experience. Then at some point, we're gonna have quite a backlog of places that want us to come in there and install systems. We're working hard to get to that point. Of course, there's a conversion and how long it takes from a hospital to get the system to conversion. In a pandemic, we have to see.

I mean, the system you know our clinical account managers, who were in there with the system and the physician and they're all doing and outstanding job. This is an excellent team we have and we look for to growing that team as that team growth will be able to go into more and more centers and we believe will probably have consistency of experience and then some.

On point, we're going to have quite a on.

Backlog of of places that want us to come in there and install systems. So we're working hard to get to that point and of course, there is the conversion and how long of takes from the hospital to get the system to conversion and a pandemic we have to see but the places we're going to we're choosing very selectively based on their propensity to be.

Kenneth L. Londoner: The places we're going to, we're choosing very selectively based on their propensity to become commercially paying customers. I just wanna remind you of that. In summary, thank you everybody for joining us today. I wanted to just remind everyone, we've closed out the quarter with the strongest balance sheet in our history. We've installed systems in six centers, and we'll be adding many more going forward. Of the strong physician feedback we have regarding PURE EP and the cases that we've been seeing are creating some excitement and some momentum that you will see the benefits of, this quarter and going forward. The clinical information we've already gathered is creating our ability to focus these physicians when we outreach to them.

Kenneth Londoner: The places we're going to, we're choosing very selectively based on their propensity to become commercially paying customers. I just wanna remind you of that. In summary, thank you everybody for joining us today. I wanted to just remind everyone, we've closed out the quarter with the strongest balance sheet in our history. We've installed systems in six centers, and we'll be adding many more going forward. Of the strong physician feedback we have regarding PURE EP and the cases that we've been seeing are creating some excitement and some momentum that you will see the benefits of, this quarter and going forward. The clinical information we've already gathered is creating our ability to focus these physicians when we outreach to them.

Mhm commercially paying customers. So I just want to remind you of that and in summary. Thank.

Thank you everybody for joining us today I wanted to just remind everyone. We closed out the quarter with the strongest balance sheet and our history, we've installed systems and six centers and we'll be adding many more going forward of the strong physician feedback we have regarding peer repeat and the cases that we've been seeing.

Our creating some excitement and some momentum that you will see the benefits of.

This quarter and going forward.

On the clinical information, we've already gathered is creating our ability to focus on these physicians when we outreach to them.

And the and last point I'll make is although we halted the trial for memory map of dip for safety. There is the subcommittee of the board looking for potential partners that might be interested in acquiring or licensing m. MPD and the X two to two and we are having those conversations now and as we learn more there.

Kenneth L. Londoner: Last point I'll make is, although we halted the trial for merimepodib for safety, there is a subcommittee of the board looking for potential partners that might be interested in acquiring or licensing MMPD and VX-222. We are having those conversations now, and as we learn more there, we will report back to everybody. You know, we think the outlook is bright for us. Thank you for your support, everyone.

Kenneth Londoner: Last point I'll make is, although we halted the trial for merimepodib for safety, there is a subcommittee of the board looking for potential partners that might be interested in acquiring or licensing MMPD and VX-222. We are having those conversations now, and as we learn more there, we will report back to everybody. You know, we think the outlook is bright for us. Thank you for your support, everyone.

We will report back to everybody but.

We think the outlook is bright for us and thank you for your support for everyone.

Thank you. This does conclude today's conference you may disconnect. Your lines at this time and thank you for your participation.

Operator 2: Thank you. This does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.

Operator: Thank you. This does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.