Q4 2022 Pulse Biosciences Inc Earnings Call
Ladies and gentlemen, greetings.
And welcome to the pulse Biosciences fourth quarter 2022 earnings conference call.
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A brief question and answer session will follow the formal presentation.
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It is now my pleasure to introduce your host Chris Halo Investor Relations. Please go ahead.
Thank you operator before we begin I would like to inform you that comments and responses to your questions. During today's call reflect management's views as of today March 30th 20, twenty-three only and will include forward looking statements and opinion statements, including predictions estimates plans expectations and other inform.
Patient.
Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued earlier today and in our filings with the Securities and Exchange Commission or SEC filings can be found on our website or on the SEC's website <unk>.
There's are cautioned not to place undue reliance on forward looking statements, we disclaim any obligation to update or revise these forward looking statements. We will also discuss certain non-GAAP financial measures disclosures regarding these non-GAAP financial measures, including reconciliations with the most comparable GAAP measures can be found in the.
A press release.
Please note that this conference call will be available for audio replay on our website at pulse Biosciences dotcom.
The news and events section on our Investor Relations page.
With that I would now like to turn the call over to President and Chief Executive Officer, Kevin Danahy.
Thank you trip and good afternoon, everyone and thank you all for joining us.
On today's call I will discuss our nanosecond pulsed field abrasion and S. P F <unk>.
<unk> progress and our 2023 corporate objectives.
Then turn the call over to our Chief Technology Officer, Gary <unk> to provide a detailed overview of our core technology and product development initiatives.
Then I will review, our fourth quarter financial results before concluding and opening the call for a question and answer session.
Pulsar Bioscience is going where we believe no company has gone before.
<unk> beneficial first Vic kinds of effects that have yet to be achieved in the world of pulse failed ablation.
<unk> technology has consistently demonstrated a high degree of safety efficacy and outcomes. In addition to the significant positive impact on patients. The knowledge gained during our previous FDA clearances has given us the present time confidence envision to pursue the use of N S. PFA on the human heart.
Our FDA clearance in the treatment of almost 6000 patients with tissue related positive results in skin prove the viability of our technology paving the way for a differentiated cardiac applications.
Our proprietary and S. PFA technology has the potential to be disruptive and a unique demonstrated inconsistent manner. While it's still early days in preclinical testing is ongoing we are encouraged by our progress to date.
2022 was a pivotal year for pulse Biosciences, we announced a strategic shift and re prioritizing our efforts to focus on the most compelling opportunities for the application of our proprietary nano pulse stimulation technology.
Building upon our R&D work in cardiology that began several years ago.
Focus is now on developing multiple devices to deliver nanosecond pulsed field ablation or N S. P F <unk>.
Cardiac tissue for the treatment of atrial fibrillation.
We made this decision based on our existing preclinical evidence that suggests an F. PFA can potentially offer a leading safety and efficacy profile compared to thermal ablation modalities and newer PFA technologies.
The treatment of atrial fibrillation is a large and established high growth market. We believe our ability to take share in this 8 billion market represents the most efficient path towards long term value creation and a viable business model we.
We have adjusted our strategy and team to best pursue this opportunity.
Could not be more excited to lead the company through this pivotal time I'm confident we have the technology the team and strategy in place to maximize the impact of N. S. P F <unk> and create substantial value for patients physicians and stakeholders.
Our complete existing understanding a N S. P F <unk> impact on cells compared to thermal destruction led us to invest a cardiac tissue ablation early on.
Initially, we sponsored and provided equipment to University research once the feasibility of the mechanism of action was proven in animal cardiac tissue, we initiated our own R&D projects. These are.
Included the development and preclinical testing of a cardiac ablation clearance for use in cardiac surgery and a cardiac ablation catheter for the use in electrophysiology.
I'll, let Darren discussed the details of the technology and product development progress shortly but I first want to provide context around the AF market and why we have prioritized this application for the technology going forward.
The treatment of a app represents in a broad sense, one of the largest and fastest growing markets in medical technology over $1 2 million catheter and surgical ablation are performed annually and this is expected to grow by more than 10% annually due to an aging population patient awareness epidemiology.
Increased clinical evidence and technical advancements avoiding treatment improvement in intervention.
We expect through the parallel development of our clamping catheter devices, we can realize important technical <unk>.
Clinical and eventual marketing synergies.
<unk> biosciences portfolio of devices as both a demonstration of the versatility of cell effects system and an opportunity to address emerging collaboration between surgeons and electrophysiologist treating atrial fibrillation.
There is a clear emerging consensus from treating physicians that PSA is thought to be safer and faster than the present time treatment options, but we believe we can do better.
Our goal is to change how physicians treat and view a atrial fibrillation and in the process provide greater value to patients physicians and cardiac centers.
In the present time, we have focused the organization on two main goals to advance our N. S. P. F. <unk> technology for the treatment of a F. One we intend to develop and advance our cardiac plan through the appropriate F D. A regulatory path and to complete all cathode their product and regulatory milestones required to treat.
Our early patients.
Our goals are clear and we understand they require time knowhow patients and experience to execute properly.
We are focused on long term success and building the foundation for a viable business over the coming years.
I will now turn it over to Darren to discuss the technology and product roadmap.
Thank you Kevin.
I think it'll be helpful. Today to reiterate the underlying capability of our technology to better understand why it has great potential to improve the present state of cardiac tissue ablation for the treatment of F. Among other applications at.
Pulse Biosciences, we have developed a novel and proprietary tissue treatment platform based on S. P. S. A where ultrafast electrical energy pulses at nanosecond pulse durations from billions up to a millionth of a second are used to stimulate cellular effects that can lead to positive therapeutic outcomes.
NSP FAA is broadly considered a pulse field technology, but the use of nanosecond duration pulses leads to a highly differentiated cellular mechanism of action that can be applied to a number of important clinical applications with distinct and unique benefits to patients treating empties and post care trained staff.
We have demonstrated that when these incredibly fast energy pulses are applied to cells. They penetrate the cell and disrupt the function of the internal organelles other cell by creating small holes in the organelle membranes known inspiration.
These organelles include the mitochondria, which is the <unk> power plant and the endoplasmic reticulum, which plays an important role in protein synthesis.
When the function of these organelles has disrupted the cell go through a natural regulated cell that process. This ability to get inside the cell with non toxic application of electrical energy, while preserving the integrity of the outer cell membrane to initiate regulated cell death is a cornerstone of our N. S. P F <unk> technology.
This regulated cell death process leads to a more natural healing responses to the body's immune system is accustomed to dealing with cell death through this natural in a regulated mechanism as opposed to sudden necrotic cell death caused by other energy based therapies, which can lead to a significant inflammatory response that slows the return to normal tissue function.
We believe it is this ability to initiate regulated cell death through the temporary formation of pores and intra cellular Oregon cell membranes that importantly, differentiate N S. PFA from other energy based therapies, such as standard P. F E N radiofrequency ablation.
Another important and unique feature of pulse Biosciences N. S. P. F. E is the lack of impact it has on a cellular structures such as the extra cellular tissue that provides the tissue architecture in support of cellular and Oregon healing.
While thermal energy modality will destroy all tissue indiscriminately N S. P. F E. As a selective mechanism that impact cells that leaves the ace cellular structure, which typically is made up of collagen intact, allowing the tissue to heal and a more natural way.
N S. PFA also has been shown to spare nerve fibers or those parts of the nerve that carry electrical impulses as well as blood vessel architecture and tissue.
Another significant benefit when the therapeutic intent is to clear unwanted cells and promote healing and a return to normal tissue function.
This novel mechanism of action, that's been demonstrated in human clinical and preclinical studies across a large number of organs and tissue types evidence supporting this has been published in a number of peer reviewed publications such as the journal lasers in surgery and medicine, the journal of cosmetic and laser surgery and the journal of Dermatologic surgery.
We have determined that the underlying N S. P. F. A mechanism of action is uniquely suited to address the current challenges of cardiac tissue ablation.
Today, the treatment of a F requires the precise and safe ablation or hard tissue to block inhibit or otherwise prevent faulty electrical signals from causing an irregular heartbeat.
We believe the N S. PFA technology will prove to be highly differentiated from standard thermal energy modalities in use today.
S P. A face should be able to deliver faster ablation through thicker tissue than thermal modalities because it is not impacted by heat things such as the blood in the heart.
Thermal modalities experienced charring electrode surfaces, which prevent adequate ablation and can add undesired time and challenges to procedures.
This has not happened with N S. P F. A because of the earlier mentioned attributes and its non thermal nature.
Because N S. P F ablation does that impact a cellular tissue such as collagen or cartilage. Our technology has the potential to offer significant safety advantages over a thermal modalities by allowing surgeons to ablate near and into vessels and valves without safety concerns of permanent damage and finally and as PFA ablation has been shown to us.
Fair nerves of any permanent damage, even when treated directly which is another concern with thermal modalities.
With N S. PFA, we believe physicians can provide a more focused thorough treatment and thereby reduce their procedure times with the end goal to improve clinical outcomes and patient experience.
In recent years pulse field ablation has gained attention in electrophysiology for the treatment of a F. As a result of its safety profile and potential to improve efficacy N.
N S. P. F. A differs from standard P. S a and that the pulse durations for N. S. P. F are much shorter typically 10 to 10000 times shorter, which translates to appropriate energy and a more energy efficient mechanism.
In turn less energy per N. S. P. F. A pulse allows us to design larger footprint electrodes that can treat more tissue faster with reduced concern of thermal damage that can be an issue with standard P. F E.
Appropriate controlled energy and shorter duration pulses will stimulate less muscle contraction in nerve stimulation during treatment and as such reduces the need for stronger sedation and paralytics that are often used with standard PFA for.
For these reasons, we believe N S. PSA will provide meaningful benefits in both efficacy and safety over standard P. F E.
On the product development side, we are working with top kols to develop AF treatment solutions to be used in the catheter lab and in the operating room, the differentiated benefits of our N. S. PFA technology will be incorporated in the design of both a surgical cleanup for the treatment of a F. In the operating room by cardiac surgeons.
And a catheter that has navigated into the heart through the vascular system for the treatment of a F by Electrophysiologist in AEP lab, while these devices serve different physician specialties, they're both providing a highly differentiated solution for the treatment of a half and both make use of the core N. S. P. F. A technology so the development of.
These devices is highly leveraged.
Both devices are currently being tested in preclinical models.
Over the last several years, we have been researching and developing an S. P. F. A cardiac ablation surgical tools and we now have achieved what we believe is an on target initial commercial design for cardiac ablation cleanup.
Cardiac ablation clap is designed to be used and what is commonly referred to as the Cox maze procedure.
Procedure performed by cardiac surgeons, specifically for the treatment of a F.
During this procedure cardiac surgeons create lines of ablation in the heart in order to block aberrant electrical signals and cure the patient of a today.
Hey, this is done with thermal modalities and we believe that S. P. F. <unk> can offer a faster more precise safer and easier to perform ablation procedure.
In 2023, we plan to perform the necessary device testing, including continued preclinical testing to prepare for regulatory clearance and human clinical use.
In parallel with the continued device testing, we expect to meet with the U S food and drug administration or F. D. A to discuss the regulatory requirements for a potential FDA clearance in order to market, our cardiac lab in the United States.
This will be done as part of the F. D. A standard Q submission process also known as a pre submission meeting.
We expect that our first meeting on this topic with the F. D. A will take place in the second quarter of 2023.
After meeting with FDA, we expect to have better clarity on timelines to regulatory clearance and first in human clinical use.
Turning to our second product in development, the cardiac catheter ablation device.
Just like the clamp our catheter delivers an electric field as opposed to thermal energy to destroy heart muscle cells and should provide many of the same safety and efficacy benefits.
The catheter design is unique and enables a circumferential or circular ablation in a single treatment. This.
This feature should expedite treatment times compared to thermal modalities, especially when performing the common but challenging treatment approach of a bleeding around the pulmonary veins.
The catheter has also been in development for several years and we have accrued substantial learning while working with leaders in the electrophysiology field to optimize its design and evaluate performance in preclinical studies.
We believe our current design is suitable to pursue a first in human clinical study. Following currently planned additional preclinical safety studies.
In the U S. We expect the catheter will require an F D. A pre market approval or PMA submission to achieve approval to market and sell the device the.
The process to complete these trials will take several years, we strive to have a solid understanding of the device's performance as we go forward and we look forward to providing updates along the way.
We have accomplished a great deal with both of our N S. P F. A devices and the preclinical data we continued to produce is very encouraging.
Notably last month the company highlighted in a poster presentation at the prestigious 2023 AF symposium in Boston.
The poster is titled novel Nanosecond Pulsed field ablation compatible with three D mapping and navigation system.
The poster highlighted the integration of our N S. P F. A system with a compatible three D mapping and navigation system.
Preclinical study demonstrated the ability to navigate the catheter for accurate ablation and screen pre and post ablation voltage maps with the same catheter.
To further increase awareness of our technology among the cardiology community. We have submitted multiple abstracts highlighting N S. PFA for presentation at the upcoming Heart Rhythm Society meeting in May we look forward to sharing more updates on our progress in the future as we accomplish the next important milestones.
Now I'll turn the call back to Kevin for an update on our financial results.
Thank you Darren.
We did not recognize revenue in the fourth quarter of 2022, moving down the income statement I will focus my comments on non-GAAP results I encourage you to review today's earnings release for the detailed reconciliation of non-GAAP measures to the most comparable GAAP measures.
In the fourth quarter 2022, we reduced non-GAAP total costs and expenses by $9 1 million to $7 7 million compared to $16 8 million in the third quarter of 2022 and by $4 7 million year over year compared to $12 3 million in the prior year period.
The decrease in operating expenses were driven by the discontinuation of the commercial dermatology activity in the prior head count reduction and restructuring.
non-GAAP net loss for the quarter ending December 31, 2022 was $8 1 million compared to $11 5 million for the quarter ending December 31 2021.
Cash cash equivalents and investments totaling $61 1 million as of December 31, 2022, compared to $28 6 million as of December 31, 2021 and $69 2 million as of September 30th 2022.
Cash used in the fourth quarter of 2022 totaled 8 million and was reduced compared to about $13 4 million used in the same period in the prior year and $10 6 million used in the third quarter of 2022.
As a result of tightening corporate strategic focus in 2023, we expect quarterly cash burn to be approximately $8 million consistent with the fourth quarter results. We have amended the terms of our loan agreement with Robert diving extending the maturity date until September 30 of 2024, we have the capital needed to finance that.
First in human clinical trials and remain confident we will achieve the optimal capital structure to advance our strategy and growth trajectories.
Now I will provide some closing remarks.
The addressable market for a F intervention is a multibillion some dollars and growing.
With a management team that has deep experience and a strategy in place execution as the present time focus we understand that global regulatory approvals and evaluation to needed management has experienced in the field of robotics in energy ablation and maintain a proven track record of a development achieving regulatory.
Approvals and launching disruptive new medical devices.
Additionally, the financial leadership team has excellent depth of experience and is working diligently to optimize the company's capital structure and fund our future.
As an innovative bioelectric medicine company committed to health innovation and increasing quality life. We are confident we can have a meaningful impact on patients are.
Our recent accomplishment Stone's discussed today are propelling us towards development completion clinical work and ultimately delivery patients in need the benefit of pulse Biosciences N S. P F N.
We look forward to providing progress updates on the next call.
Today, we would like to invite investor questions and with that operator, Please open the call for questions.
Thank you.
Ladies and gentlemen at this time, we will be conducting a question and answer session.
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.
Ladies and gentlemen, we request you to restrict your one question per participant.
Hey, Kevin so it wouldn't be participating along with you in this session.
Yes. Thank you so much operator, joining me today is executive chairman of the Board, Robert Duggan, and Chief Technology Officer, Darin yogurt, and I am Kevin Danahy, President and CEO .
Yeah.
So we did have a couple of questions that came in online out I'll lead off with this and the first question that came in was wide pivot to cardiac.
So I'll jump in on this one and then I'll ask Darren or Bob if they would like to.
Give a little bit more color.
Our complete N S PFA impact understanding on how we compare to thermal destruction, let us really to investigate cardiac ablation early on.
Actually responded like we said in the script today.
University Research and then once we have the feasibility of the mechanism of action and what it was proven on cardiac tissue in animals, we started our own R&D projects.
After that we took this information and we started doing our own preclinical testing, which led to the development of the cardiac ablation clamped for cardiac surgery and cardiac ablation catheter for the use in electrophysiology.
So this wasn't really a pivot it's something that we've been working on for a long period of time.
Darren do you have anything you would add to that.
No I think that's a that's perfect and then I think it was really we were led to these applications by physicians and really the outcomes that we saw in preclinical data.
Alright.
I'll make a comment.
And I go back over 20 years in a row.
Robotics and at the earlier moment.
In the life of the opportunity to evaluate the opportunity for robotics in human health care cardiac seemed to be that the area most opportunity.
Then over time proved to be incredibly difficult.
To pull that off but we did learn quite a bit about heart and importance of the heart and essentially.
Art is energy based it's critical and essential to the heart's function. So with the now pulled steels, we have an ability to use energy to complement.
The heart's function or to correct misfunction and the heart. So it's a it's a one off opportunity that we feel is outstanding in terms of size, it's not been penetrated by anyone else.
At the fields and the power of energy and the speed of that energy, if we can bring to the table. So.
That's why we're in it.
And I complement your your comments and Dan's comments.
Earlier here about the size of that market the significance of it.
And the challenge that did get it cleared and to prove it to be effective.
Which is what we're going after in the next 12 months and as.
As you said earlier, we'll keep our stakeholders apprised as to our progress in development, but I can assure you. We're approaching this was a tremendous amount of confidence.
And excitement.
Potentially the outcomes will be could be iconic in.
Mike turned us into a very disruptive and powerful technology for all involved.
Awesome. Thank you bought another question that came in was just to ask how how should we view success for pulse Biosciences in 2023, and I think as we mentioned.
On the call today that we really have two main goals in 2023 to advance NSP MAA in the treatment of a yeah. No number one we intend to develop and advance our cardiac clamped through the appropriate FDA regulatory path and number two we hope to complete all of the catheter product and regulatory milestones required treat out early patients.
So I think that's how we're measuring ourself and how I would say that we should be measured.
Anything Bob are down to add to that.
Okay and then the last question.
I'll jump in.
Yeah, So basically heart procedures come about in three ways.
Open procedure, which could be incredibly invasive I've had the honor of being present in up to 50 of those and I would rather Washington and be a part of it but it is challenging but it is also through precision.
Our approach in the use of the technology available things such as a coronary artery bypass graft proved to be a patent for almost 20 years. It's an incredible procedure created by doctors at the Cleveland clinic years ago, and Darren I happened to become very friendly with a number of them, let's say a value added opportunity for.
Bionics. There. So then you have less invasive surgery and then you have catheter base. So the catheter based are you would recognize stance and the placement of stents are early on as something that was effective but.
Very less challenging and traumatic to the patient so that's really the business of <unk>.
Pairing.
Grafts and arteries with graphs I came over to onto the stent side. So we believe we've got the best of all worlds here. We can help in open procedures. Most of the procedures that take place involve either the presence of or the risk of creating a ablation and Asa ablation in the heart so.
While the Heart's open you can apply a clamped to this and and and generate the ablation areas that are needed and necessary with the clamp that we have under study.
Some of the top doctors from robotics 20 years ago are now the top doctors and performing these procedures. So Kevin knows them. They know Kevin I know myself Darrin is is very close with the most most of these teams. So it's worth great excitement that they're walking walking us back into their lives. So where are we're thrilled with the opportunity.
And it's pretty exciting and you'll hear more from us.
As we achieve success in that in first in humans.
On the outside of the catheter, that's that's a very very challenging opportunity, but you know we had into factors creators at R. R. R. R. R. A computer motion company and they were right on the Mark and that was where we had a very strong patent base.
Prior to merging with intuitive surgical.
Which has created tremendous success in its own right in the area of robotics, and and has some activity decent activity in the area of heart valves and heart valve repair. So these are areas. We're familiar with we're very excited about it.
Electrophysiologist that we're working with view this as a disruptive distinctly different and nicely improved technology.
We're excited about it and we look to get the first in human because that's really the validation and since these procedures will be opened.
We all know what's happened right. After the procedure, there's not like a phase III drug trial, where you might have to note 2000 patients.
Bring your statistics to bear after the completion of those patients have been thoroughly evaluated.
This unit when the person gets off the table are on the table you know, how well youre doing with that patient. So we're.
We're pursuing that that activity as.
As we speak and I would think during over the next year.
We will be able to come back to you with the results.
Two things here.
If if we hit obstacles that we think increase.
Increase the risks or diminish the return soon.
As soon as we validate that we will be back out to our stakeholders.
As we as we achieve success, we will make sure that on a timely basis as is appropriate.
That does it the stakeholders as well so that's where we stand on on these issues. If you catch the excitement in my voice. It's a real the team is working on this if I'm excited there like excited square. So this is gonna be the the real fun year for our company.
Back to you Kevin.
Thank you Bob.
Last question that came in and I'll give this one over to Darin is what was the significance of the AF symposium poster.
Yeah. That's a good question so the AF symposium is.
Really one of the top meetings scientific meetings in the treatment of AAF that's held annually.
And I think typically there are between three and maybe 5000 attendees, which are the top electro physiologists around the world.
And health care providers and people from industry.
The acceptance of our poster I think was a real validation of the technology.
And what the organizers of the meeting believe it has the potential of the technology. So we were.
Honored and I'm very pleased to be a part of that important meeting.
A lot of great conversation with a number of Electrophysiologist, who are excited to see it and we got a mention from the podium are about the potential of N. S. PFA from one of the key physician. So it was really a great meeting for us, it's great to be able to to demonstrate.
What we've been doing pre clinically and to show that to the scientific community and to have it.
Accepted by the scientific community is something that they want to hear about and and get excited about going forward.
Thank you Dan.
Operator, we can open up for your questions.
Thank you.
First question comes from the line of Robert Lofgren Medical whole productions. Please go ahead.
Yes, I'm glad to hear the.
There is.
There was good result at the.
The athletes symposium in Boston.
<unk>.
Well first of all the first thing I'm going to ask you is are you secure your patents are your ownership of patents or or regs.
Our regulation from over to you and I guess in terms of other people, who have gone onto a Mayo clinic and.
Washington University are you pretty secure in that and holding those patents is that is that a economic excuse me a business.
Yeah.
You're heading into business with other people that other people because you already hold hold the patents.
Yeah, Hey, Bob it's Darren and thanks for calling in and thanks for the question good to hear your voice.
Yeah. So as you know I think you know this company was really founded.
It's about seven or eight years ago on a pretty broad and foundational IP portfolio related to N. S. P. F <unk> and many of those patents came from two universities old Dominion University on the East Coast and the University of Southern California here in California.
And then two small companies that were sort of loosely affiliated with those universities.
So we started with a pretty significant patent portfolio and over the last many years as a company we've invested significantly in our patent portfolio as we develop this platform. We've developed a lot of patents along the way and some are obviously public and in some.
Yet to come out, but we feel really good about I think where we are in terms of our patent portfolio and and what we've done to to secure a pathway for ourselves in a lot of these different applications using this very unique technology.
Bob and I as he mentioned moved through the early days of medical Robotics, and you know a lot of experience and knowledge was gained along that way as it relates to patents in the important importance of patents in securing a path forward for these platform technologies and we.
We certainly have spent a lot of time and energy.
On that so I think we feel good in terms of where we're at our work's never done there. So we continue to expand that portfolio as we move along.
Darren if I might add and you correct me if I'm wrong here I believe we have over 100 patents granted.
Plus another 100 files and it's a very dynamic.
Phenomena year to year will be growing patents all the way.
All the way from here on out.
Yeah, that's right Bob those members are accurate for sure.
Yeah.
Okay, Operator next pressler.
Our next question comes from the line of James Hollins book and private Investor. Please go ahead.
Yes.
Thank you very much.
Bob its good to hear your voice again, thank you for participating.
I'm going to use an analogy.
About power tools.
If you go to home depot, you can buy.
Set of power tools.
And they all run on a battery.
And I'm going to suggest that our nano pulse technology is like the battery.
And that battery plugs into a sore or drill.
Or some other type of device.
And it seems to me that we that our M. P S and all of these patents.
And our nano pulse generator is liked that battery.
But what we're dependent upon is the applicator the apparatus that actually does the work on the patient.
I think that that was the problem with our dermatology.
Firmly believing in nano pulse technology, but our applicator was faulty.
And it seems to me that what we're getting into now is that we must collaborate with the people that build the catheters and the other applicators.
So.
Are we going into the development of these applications are the devices that actually touch the patient.
It seems to me that that's where our.
Our problem lies in our opportunity lies.
Is that are we have the nano pulse generator, but we don't have.
The apparatus that.
But to treat the patients so are we going to collaborate with other companies that build these.
Applicators are are we going to develop our own.
Kevin I'll take that.
Uh huh.
Doctor Hollinsworth for quite a while is the outstanding scientists and doctors in the zone right.
Kind of grew up with us at a computer motion. So he is familiar with a lot of these things.
But I would say, we're very much different than a battery.
A tunable device that can scale shifts and adjust as needed and appropriate energy and.
And place it in a very pinpointed area.
It would be like comparing a battery tour radio there. It's there are some similarities but it's clearly not identical and the similarities are reasonably Hugh.
In terms of application and dermatology, we had we had some spectacular results in dermatology, we had no adverse events no reportable events to the F. D. A ah patients walk out of the facility with the potential to have a cleared.
<unk> that went well beyond what normal treatments could provide to them.
So you might say well.
Here to tell because you weren't able to generate the revenues you know what happened in over 6000 patients who are treated treated well treated effective the device proved its workability, it's still the only device of its kind of that nature in that business. It just was not viable in terms of.
Relative to the other procedures that were being performed.
It was like well you can come in with a slice in your arm and either they can put a band aid on it our suture it and the mandate is still less expensive than the suture that they put the band AIDS on.
We really got a lot of plot its well deserved from patients and physicians and dermatologists are like from that field. So that products exceeded our business plan did not succeed and we will take our own hit for that we.
We thought there would be a faster assimilation of the product stronger uptake and we could crossover into the world of viability and and while things were.
Proving as we moved along we did have other alternatives and as you know for many companies and I've started to work with.
First few words are to build a viable those first four words, which means that you can create sustainable future out of what you really do and you're not dependent on an outside funding and financing so with that in mind, we had to pivot and and we did and we pivot over to an area that that has benefited greatly from an FDA approved.
This has benefited greatly from the viewpoint and the knowledge on the confidence that this device can work can deliver energy.
High volume at high speed and do so and and go right to the cell your aspect of the of the of a.
The tissue that is needed in repair and not hit a cellular structures. So when you're dealing with a heart that becomes critically important. So we're taking a win on the on the derm.
But we've got an order of magnitude larger opportunity, we've got a product very specific to that and where we're really ready to go here.
I hope that addresses the question I appreciate your question too.
Thank you Bob I appreciate it thanks Bob.
Operator next question.
Our next question comes from the line of Andy Service, a private Investor. Please go ahead.
Hey, guys I have friends.
And he's habits.
How are you doing good.
I have two questions one is.
Is there any possibility and the breakthrough you had phases. So.
As wilco carcinoma can that be licensed so forgive us leather.
Anthony.
Taken further.
Pay back some money on it.
No.
Yeah, I'll jump in and identify Darrin, if Bob wants to jump in right.
Right now as we mentioned in our last call. We are exploring all opportunities with derm as Bob just said I'm very well that we were very proud of the results that we got from our system right. Now it's just a matter of the commercialization architecture that we didn't have in place to support that and other companies might have that.
We're exploring and we're continuing to talk with so.
We're excited to continue to look at that.
That answers my question. Thank you my second one.
We lose them.
Operator, I think we lost him.
Yes, that's correct Outflanks dropped.
Okay.
Ladies and gentlemen, we have reached the end of the question answer session and I would like to turn the conference over to Kevin Danaher, Chief Executive Officer for closing comments.
Thank you very much and thank you Darren and Bob for joining me today.
We're excited about where we are today and and we liked the format here, where we had the opportunity to answer some of your questions. Hopefully you felt like the the conference call answered a lot of your questions. Just wanted to let everyone know that as we move forward or where you're gonna be head down in a preclinical in product development throughout the closing, Florida, and we will update everyone.
As a new data and the potential of N F and S. PFA comes out.
And the significant progress that we're going to make and we will continue to report quarterly and communicate updates in a timely and transparent manner.
Material to the business through public communication calls and press releases, so with that I would like to thank everyone and we look forward to talking to you all soon.
Yeah.
Thank you.
Conference of Pulse Biosciences has now concluded. Thank you for your participation you may now disconnect your lines.
Okay.
Okay.
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