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spk07: Ladies and gentlemen, greetings and welcome to the Pulse IOSciences fourth quarter 2022 earnings conference call. At this time, all participant lines are in a listen-only mode. A brief 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. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Krip Taylor, Investor Relations. Please go ahead.
spk01: 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 30, 2023 only, and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations, and other information. 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. Our SEC filings can be found on our website or on the SEC's website. Investors 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 press release. Please note that this conference call will be available for audio replay on our website at pulsebiosciences.com on 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.
spk02: Thank you, Tripp. Good afternoon, everyone, and thank you all for joining us. On today's call, I will discuss our nanosecond pulse field ablation, NSPFA, development progress, and our 2023 corporate objectives. I will then turn the call over to our Chief Technology Officer, Darren Uecker, 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. Pulse Bioscience is going where we believe no company has gone before, accomplishing beneficial, first-of-a-kind effects that have yet to be achieved in the world of pulse field ablation. Our 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 and vision to pursue the use of NSPFA on the human heart. Our FDA clearance in the treatment of over 6,000 patients with tissue-related positive results in skin proved the viability of our technology, paving the way for differentiated cardiac applications. Our proprietary NSPFA technology has the potential to be disruptive in a unique, demonstrable, and consistent manner. While it's still early days and 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 in reprioritizing our efforts to focus on the most compelling opportunities for the application of our proprietary nanopulse stimulation technology. Building upon our R&D work in cardiology that began several years ago, our top focus is now on developing multiple devices to deliver nanosecond pulse field ablation, or NSPFA, to cardiac tissue for the treatment of atrial fibrillation. We made this decision based on our existing preclinical evidence that suggests NFPFA can potentially offer a leading safety and efficacy profile compared to thermal ablation modalities and newer PFA technologies. The treatment of AF 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 have adjusted our strategy and team to best pursue this opportunity. I could not be more excited to lead the company through this pivotal time. I am confident we have the technology, the team, and strategy in place to maximize the impact of NSPFA and create substantial value for patients, physicians, and stakeholders. Our complete existing understanding of NSPFA's impact on sales compared to thermal destruction led us to investigate 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 included the development and preclinical testing of a cardiac ablation clamp for the use in cardiac surgery and a cardiac ablation catheter for the use in electrophysiology. I will let Darren discuss 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 AF represents, in a broad sense, one of the largest and fastest growing markets in medical technology. Over 1.2 million catheters and surgical ablations 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 supporting treatment improvements and intervention. We expect, through the parallel development of our clamp and catheter devices, we can realize important technical, clinical, and eventual marketing synergies. Pulse Bioscience's portfolio of devices is both a demonstration of the versatility of cell effect system and an opportunity to address emerging collaboration between surgeons and electrophysiologists treating atrial fibrillation. There is a clear emerging consensus from treating physicians that PFA 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 AF 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 NSPFA technology for the treatment of AF. One, we intend to develop and advance our cardiac clamp through the appropriate FDA regulatory path. and two, complete all catheter product and regulatory milestones required to treat our early patients. Our goals are clear, and we understand they require time, know-how, patience, 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.
spk00: Thank you, Kevin. I think it will 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 AF, among other applications. At Pulse Biosciences, we have developed a novel and proprietary tissue treatment platform based on NSPFA, where ultra-fast electrical energy pulses at nanosecond pulse durations from billionths up to a millionth of a second are used to stimulate cellular effects that can lead to positive therapeutic outcomes. NSPFA 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 MDs, 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 of the cell by creating small holes in the organelle membranes, known as poration. These organelles include the mitochondria, which is the cell's power plant, and the endoplasmic reticulum, which plays an important role in protein synthesis. When the function of these organelles is disrupted, the cell goes through a natural regulated cell death 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 NSPFA technology. This regulated cell death process leads to a more natural healing response as the body's immune system is accustomed to dealing with cell death through this natural and 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 in intracellular organelle membranes that importantly differentiates NSPFA from other energy-based therapies, such as standard PFA and radiofrequency ablation. Another important and unique feature of Pulse Bioscience's NSPFA is the lack of impact it has on acellular structures, such as the extracellular tissue that provides the tissue architecture in support of cellular and organ healing. While thermal energy modalities will destroy all tissue indiscriminately, NSPFA is a selective mechanism that impacts cells but leaves the acellular structure, which typically is made of collagen, intact. allowing the tissue to heal in a more natural way. NSPFA 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 has 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 of Lasers in Surgery and Medicine, the Journal of Cosmetic and Laser Surgery, and the Journal of Dermatologic Surgery. We have determined that the underlying NSPFA mechanism of action is uniquely suited to address the current challenges of cardiac tissue ablation. Today, the treatment of AF requires the precise and safe ablation of heart tissue to block, inhibit, or otherwise prevent faulty electrical signals from causing an irregular heartbeat. We believe NSPFA technology will prove to be highly differentiated from standard thermal energy modalities in use today. NSPFA should be able to deliver faster ablation through thicker tissue than thermal modalities because it is not impacted by heat sinks, such as the blood in the heart. Thermal modalities experience charring on electrode surfaces, which prevent adequate ablations and can add undesired time and challenges to procedures. This has not happened with NSPFA because of the earlier mentioned attributes and its non-thermal nature. Because NSPFA ablation does not impact acellular tissue, such as collagen or cartilage, our technology has the potential to offer significant safety advantages over thermal modalities by allowing surgeons to ablate near and into vessels and valves without safety concerns of permanent damage. And finally, NSPFA ablation has been shown to spare nerves of any permanent damage even when treated directly, which is another concern with thermal modalities. With NSPFA, 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 AF as a result of its safety profile and potential to improve efficacy. NSPFA differs from standard PFA in that the pulse durations for NSPFA are much shorter, typically 10 to 10,000 times shorter, which translates to appropriate energy and a more energy efficient mechanism. In turn, less energy per NSPFA 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 PFA. Appropriate controlled energy and shorter duration pulses will stimulate less muscle contraction and nerve stimulation during treatment, and as such, reduces the need for stronger sedation and paralytics that are often used with standard PFA. For these reasons, we believe NSPFA will provide meaningful benefits in both efficacy and safety over standard PFA. 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 NSPFA technology will be incorporated in the design of both a surgical clamp for the treatment of AF in the operating room by cardiac surgeons and a catheter that is navigated into the heart through the vascular system for the treatment of AF by electrophysiologists in the EP lab. While these devices serve different physician specialties, they are both providing a highly differentiated solution for the treatment of AF and both make use of the core NSPFA 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 NSPFA cardiac ablation surgical tools And we now have achieved what we believe is an on-target initial commercial design for a cardiac ablation clamp. The cardiac ablation clamp is designed to be used in what is commonly referred to as the Cox-Mays procedure, a procedure performed by cardiac surgeons specifically for the treatment of AF. During this procedure, cardiac surgeons create lines of ablation in the heart in order to block aberrant electrical signals and cure the patient of AF. Today, this is done with thermal modalities, and we believe NSPFA 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 FDA, to discuss the regulatory requirements for a potential FDA clearance in order to market our cardiac clamp in the United States. This will be done as part of the FDA's standard Q submission process, also known as a pre-submission meeting. We expect that our first meeting on this topic with the FDA 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 feature should expedite treatment times compared to thermal modalities, especially when performing the common but challenging treatment approach of ablating 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 US, we expect the catheter will require an FDA premarket approval or PMA submission to achieve approval to market and sell the device. 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 NSPFA devices and the preclinical data we continue to produce is very encouraging. Notably, last month, the company highlighted a poster presentation at the prestigious 2023 AF Symposium in Boston. The poster was titled, Novel Nanosecond Pulse Field Ablation Compatible with 3D Mapping and Navigation System. The poster highlighted the integration of our NSPFA system with a compatible 3D mapping and navigation system. The preclinical study demonstrated the ability to navigate the catheter for accurate ablation and to create 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 NSPFA 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.
spk02: 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 earning release for the detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. In the fourth quarter of 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 and the prior headcount reduction in 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 equivalent in 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 30, 2022. Cash used in the fourth quarter of 2022 totaled 8 million and was reduced compared to both $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 Dugging, extending the maturity date until September 30, 2024. We have the capital needed to finance our 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 AF intervention is a multi billions of dollars and growing. With a management team that has deep experience and a strategy in place, execution is the present time focus. We understand that global regulatory approvals and evaluations are needed. Management is experienced in the field of robotics and energy ablation and maintain a proven track record of 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. Our recent accomplished milestones discussed today are propelling us towards development completion, clinical work, and ultimately delivering patients in need the benefit of Pulse Biosciences and SPFA. 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.
spk07: 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 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. Ladies and gentlemen, We request you to restrict to one question per participant. Hey, Kevin, who would be participating along with you in this session?
spk02: Yes, thank you so much, Operator. Joining me today is Executive Chairman of the Board, Robert Duggan, and Chief Technology Officer, Darren Euchre, and I am Kevin Danahy, the President and CEO.
spk08: So we did have a couple of questions that came in online.
spk02: I'll lead off with this. The first question that came in was, why 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 NSPFA impact understanding on how we compare to thermal destruction led us really to investigate cardiac ablation early on. Initially, we sponsored, like we said in the script today, university research. And then once we had 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 clamp for cardiac surgery and cardiac ablation catheter for the use in electrophysiology. So if 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?
spk00: No, I think that's perfect. I mean, I think it was really, we were led to these applications by physicians and really the outcomes that we saw in preclinical data.
spk03: I'll make a comment. Darren and I go back over 20 years in robotics And at the early moment in the life of opportunity, evaluating opportunity for robotics and human health care, cardiac seemed to be the area of most opportunity. And then over time proved to be incredibly difficult to pull that off. But we did learn quite a bit about heart and the importance of the heart. And essentially, the heart is energy based. It's critical and essential to the heart's function. So with the nanopulse field, we have an ability to use energy to complement the heart's function or to correct misfunction in the heart. So 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 field and the power of energy and the speed of that energy that we can bring to the table. So that's why we're in it. And I compliment your comments and Darren's comments earlier here about the size of that market, the significance of it, and the challenge to get it cleared and to prove it to be effective, which is what we're going after in the next 12 months. And as you said earlier, we'll keep our stakeholders apprised as to our progress and development. But I can assure you we're approaching this with a tremendous amount of confidence and excitement as potentially the outcomes could be iconic and turn this into very disruptive and powerful technology for all involved.
spk02: Awesome. Thank you, Bob. Another question that came in was just to ask, how should we view success for pulse biosciences in 2023? And I think, as we mentioned in the call today, that we really have two main goals in 2023 to advance NSPFA and the treatment of AF. Number one, we intend to develop and advance our cardiac clamp through the appropriate FDA regulatory path. And number two, we hope to complete all the catheter product and regulatory milestones required to treat our early patients. So I think that's how we're measuring ourselves and how I would say that we should be measured.
spk08: Anything, Bob or Darren, to add to that? Okay, the last question.
spk03: I'll jump in. Yeah, so basically, heart procedures come about in three ways. Open procedure, which can be incredibly invasive. I've had the honor of being present in up to 50 of those, and I would rather watch than be a part of it. But it is challenging, but it is also through precision approach. and the use of the technology available, things such as a coronary artery bypass graft proved to be patent for almost 20 years. It's an incredible procedure created by doctors at the Cleveland Clinic years ago, and Tanner and I happened to become very friendly with a number of them as they evaluated an opportunity for robotics there. So then you have less invasive surgery, and then you have catheter-based. So the catheter-based are, you would recognize stents and the placement of stents early on as something that was effective, but very, very less challenging and traumatic to the patient. So really the business of repairing grafts and arteries with grafts came over 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 open procedures that take place involve either the presence of or the risk of creating ablation and affibrillation in the heart. So while the heart's open, you can apply a clamp to this and generate the ablation in 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 in performing these procedures. So Kevin knows them. They know Kevin. They know myself. Darren is very close with most of these teams. So it's with great excitement. that they're welcoming us back into their lives. So 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 other side of the catheter, that's a very challenging opportunity, but we had end effectors, creators at our 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 on its own right in the area of robotics 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. The electrophysiologists 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 to first in human because that's really the validation. And since these procedures will be open, we'll know what's happened right after the procedure. This is not like a phase three drug trial where you might have to dose 2,000 patients and bring your statistics to bear after the completion of those patients have been thoroughly evaluated. When the person gets off the table or on the table, you know how well you're doing with that patient. We're pursuing that activity as we speak, and I would think during over the next year, we will be able to come back to you with results. Two things here. If we hit obstacles that we think increase the risk or diminish the return, as soon as we validate that, we will be back out to our stakeholders. As we achieve success, we'll make sure that on a timely basis, as is appropriate, We'll relate that to the stakeholders as well. So that's where we stand on these issues. If you catch the excitement in my voice, it's real. The team that is working on this, if I'm excited, they're like excited squared. So this is going to be the real fun year for our company. Back to you, Kevin.
spk02: Yep. Thank you, Bob. Last question that came in, and I'll give this one over to Darren, is what was the significance of the AF symposium poster?
spk00: Yeah, that's a good question. So the AF Symposium is, you know, really one of the top meetings, scientific meetings in the treatment of AF that's held annually. And I think typically there are between three and maybe 5,000 attendees, which are, you know, the top electrophysiologists around the world and healthcare 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 is the potential of the technology. We were honored and very pleased to be a part of that important meeting. We had a lot of great conversation with a number of electrophysiologists who are excited to see it. We got a mention from the podium. about the potential of NSPFA from one of the key physicians. So it was really a great meeting for us. It's great to be able 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 as something that they want to hear about and get excited about going forward.
spk08: Thank you, Darren. All right, operator, we can open up the questions.
spk07: Thank you. Our first question comes from the line of Robert Laugrain from Medical Hope Productions. Please go ahead.
spk04: Yes, I'm glad to hear the good result at the AF symposium in Boston. Well, first of all, the first thing I'm going to ask you is, are you secure in your patents, your ownership of patents or regulation from ODU? And I guess in terms of other people who have gone on to Mayo Clinic and Washington University, are you pretty secure in that and holding those patents? Is that an economic – excuse me, a business – you're heading the business that other people are because you already hold the patents.
spk00: Yeah. Hey, Bob, it's Darren. 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 about seven or eight years ago on a pretty broad and foundational IP portfolio related to NSPFA. 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 loosely affiliated with those universities. We started with a pretty significant patent portfolio. 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 some are yet to come out. But we feel really good about, I think, where we are in terms of our patent portfolio and what we've done to secure a pathway for ourselves in a lot of these different applications using this very unique technology. You know, Bob and I, as he mentioned, lived 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 and the importance of patents in securing a path forward for these platform technologies. And we certainly have spent a lot of time and energy on that. So I think, you know, 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.
spk03: Darren, if I might add, and you correct me if I'm wrong here, I believe we have over 100 patents granted and then plus another 100 filed, and it's a very dynamic phenomena year to year. We'll be growing patents, you know, all the way from here on out.
spk00: Yeah, that's right, Bob.
spk08: Those numbers are accurate for sure.
spk07: Our next question comes from the line of James Hollingsworth and private investor. Please go ahead.
spk05: Yes, thank you very much. Bob, it's 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 a set of power tools And they all run on a battery. And I'm going to suggest that our nanopulse technology is like the battery. And that battery plugs into a saw or a drill or some other type of device. And it seems to me that our NPS and all these patents and our nanopulse generator is like that battery. But what we're dependent upon is the applicator, the apparatus that actually does the work on the patient. And I think that that was the problem with our dermatology. I firmly believe in nanopulse 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, the devices that actually touch the patient? It seems to me that that's where our problem lies and our opportunity lies, is that we have the nanopulse generator, but we don't have the apparatus that could treat the patient. So are we going to collaborate with other companies that build these applicators or are we going to develop our own?
spk03: Kevin, I'll take that. I've known Dr. Hollingsworth for quite a while. He's an outstanding scientist and doctor in his own right and kind of grew up with us at Computer Motion. So he's familiar with a lot of these things. But I would say we're very much different. than a battery. We are a tunable device that can scale, shift, and adjust as is needed and appropriate energy and place it in a very pinpointed area. It'd be like comparing a battery to a radio. There are some similarities, but it's clearly not identical and the similarities are reasonably few. In terms of the application and dermatology, we had some spectacular results in dermatology. We had no adverse events, no reportable events to the FDA. Patients walked out of the facility with the potential to have a cleared lesion that went well beyond what normal treatments could provide to them. So you might say, well, it appeared to fail because you weren't able to generate the revenues. You know, what happened was over 6,000 patients were 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 you could come in with a slice in your arm and either they could put a Band-Aid on it or suture it. and the Band-Aid is so less expensive than the suture that they put the Band-Aids on. We really got a lot of plaudits well-deserved from patients and physicians and dermatologists alike from that field. So that product succeeded. Our business plan did not succeed, and we'll take our own hit for that. We thought there would be a faster assimilation of the product, stronger uptake, And we could cross over into the world of viability. And while things were improving as we moved along, we did have other alternatives. And as you know, for many companies that I've started to work with, the 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 outside funding and financing. So with that in mind, we had to pivot and we did. And we pivot over to an area that has benefited greatly from an FDA-approved device, has benefited greatly from the viewpoint and the knowledge and the confidence that this device can work, can deliver energy of high volume at high speed and do so and go right to the cellular aspect of a tissue that is needed in repair and not hit acellular structures. So when you're dealing with a heart, that becomes critically important. We're taking a win on the DERM, but we've got an order of magnitude larger opportunity. We've got a product very specific to that, and we're really ready to go here. So I hope that addresses the question. I appreciate the question, too.
spk08: Thank you, Bob. Appreciate that, Bob. Next question.
spk07: Our next question comes from the line of Andy Service, a private investor. Please go ahead.
spk06: Hey, guys. Hi, friends. Hey, Andy. Hi. How are you doing? I'm good. Good. I have two questions. One is, is there any possibility on the breakthrough you had on basal cell, what do you call it, carcinoma, can that be licensed off or given to another entity to take it further or pay back some money on it? No? No.
spk02: Yeah, I'll jump in, and then if Darren or Bob want to jump in. Right now, as we mentioned in our last call, we are exploring all opportunities with Durham. As Bob just said 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 that we're exploring and we're continuing to talk with. So we're excited to continue to look at that.
spk06: That answers my question. Thank you.
spk08: Operator, I think we lost him.
spk07: Yes, that's correct. The line's dropped. Okay. Ladies and gentlemen, we have reached the end of the question and answer session, and I would like to turn the conference over to Devin Danahy, Chief Executive Officer, for closing comments.
spk02: Thank you very much, and thank you, Darren and Bob, for joining me today. And we're excited about where we are today, and we like the format here where we had the opportunity to answer some of your questions. Hopefully you felt like the conference call answered a lot of your questions. Just want to let everyone know that as we move forward, we're going to be head down in our preclinical and product development throughout the closing quarters, and we will update everyone as our new data and the potential of NF and as 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 that are 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.
spk07: Thank you. The Conference of Pulse Biosciences has now concluded. Thank you for your participation. You may now disconnect your line.
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