Q1 2024 Pulse Biosciences Inc Earnings Call
Operator: Greetings and welcome to the Pulse Biosciences first quarter 2024 financial results conference call. At this time, all participants 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, Tripp Taylor. Please go ahead.
Greetings and welcome to the pulse Biosciences first quarter 'twenty 'twenty four financial results conference call. At this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation.
Philip Taylor: If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
Philip Taylor: As a reminder, this call is being recorded it is now my pleasure to introduce your host trip Taylor. Please go ahead.
Philip Taylor: 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, May 7, 2024, only and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations, and other similar information. 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.
Philip Taylor: 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 may seven 2024, only and will include forward looking statements and opinion statements, including predictions estimates plans expectation and other similar information.
Philip Taylor: 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 U S Securities and Exchange Commission or SEC filings can be found on our website or on the F. C.
Philip Taylor: <unk> web site.
Philip Taylor: Yes, there's you're 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.
Philip Taylor: Please note that this conference call will be available for audio replay on our website at pulse Biosciences Dot com in the news and events section on our Investor Relations page.
Philip Taylor: 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 in the news and events section on our investor relations page. With that said, I would now like to turn the call over to President and Chief Executive Officer, Kevin Danahy.
Philip Taylor: With that I would now like to turn the call over to President and Chief Executive Officer, Kevin Danaher.
Kevin Danahy: Thank you, Tripp. Good afternoon, everyone, and thank you all for joining us. I'm excited to provide today's condensed update, as our last call was just over five weeks ago. Mike Koffler, Vice President of Finance, will join me in the prepared remarks to review our first quarter 2024 financial results. Then Robert Duggan, Executive Chairman of the Board, Darrin Uecker, Chief Technology Officer and Director, and Mitch Levinson, Chief Strategy Officer, will join me for a question and answer session.
Kevin Danahy: Thank you good afternoon, everyone and thank you all for joining us I'm excited to provide today's condensed update how's that last call was just over five weeks ago.
Kevin Danahy: My Koffler, Vice President of Finance will join me in the prepared remarks to review our first quarter 'twenty 'twenty four financial results and Robert Duggan Executive Chairman of the Board Darren Euchre, Chief Technology Officer, and director and Mitch Levinson Chief Strategy Officer will join me for questions and answers.
Kevin Danahy: Fashion.
Kevin Danahy: During today's call, we will give you an update about our proprietary designed and engineered CellFX NSPFA energy delivery system and three novel proprietary end-of-factor devices. Q1 was a very active and productive quarter for Pulse Biosciences. As you know, we are making a material and significant commitment to the field of nanosecond pulse field ablation, addressing soft tissue ablation for human beings in need. Pulse Biosciences is pleased to bring into existence a novel electrophysiology and surgical treatment modality that focuses in the nanosecond up to billions of a second pulse duration range. This is up to two orders of magnitude faster than the millions of a second range currently deployed in the pulse field ablation area.
Kevin Danahy: During today's call. We will give you an update about our proprietary designed and engineered cell effects N. S. P. S. H energy delivery system and three novel proprietary Endo factor devices.
Kevin Danahy: Q1 was a very active and productive quarter for pulse Biosciences. As you know, we are making a material and significant commitment to the field of nanosecond pulse build a blasian addressing soft tissue ablation, the human beings and need.
Kevin Danahy: Pulse Biosciences is pleased to bring into existence, a novel electrophysiology and surgical treatment modality that focuses in the nanosecond. After billions of a second pulse duration range. This is up to two orders of magnitude faster than the millions if a second range currently deployed in the pulse field.
Kevin Danahy: Asia area.
Kevin Danahy: This increase in pulse speed in conjunction with the capacity to increase pulse amplitude is believed by us to potentially bring about material improvements in safety and efficacy, as well as overall significant improvements in treatment times and thus treatment outcomes. Additionally, NSPFA is a very patient, physician, and care provider friendly treatment option. Going forward, we are planning to do multiple clinical trials across different indications. It is important to note that, in the inclusive of 6,000 human dermatological skin lesions treated, not a single serious adverse event has occurred.
Kevin Danahy: This increase in pulp speed in conjunction with the capacity to increase pulse amplitude is believed by us.
Kevin Danahy: Essentially bring out material improvements in safety and efficacy as well as overall significant improvements in treatment times and that's treatment outcomes.
Kevin Danahy: Additionally, N S. P. S. A is a very patient physician care provider friendly treatment option.
Kevin Danahy: Going forward, we are planning to do multiple clinical trials across different indications.
Kevin Danahy: It is important to note that inclusive of 6000, human Jeremy geological skin lesions treated not a single serious adverse event has occurred.
Kevin Danahy: In March 2024, we received FDA 510K clearance for our non-cardiac cell effects NSPFA percutaneous system for soft tissue ablation indication. Soft tissue ablation is used by physicians in a wide range of procedures, including treating the thyroid, liver, breast, and other areas of the body. Currently, we have treated 30 patients in need of soft tissue ablation for thyroid disease. Dr. Stefano Spiazza, Chief of the Endocrine Surgery Division at Napoli Hospital Damari in Naples, Italy, our key opinion leader in the field of thyroid, in collaboration with Dr. Ralph Trafano, Medical Director, Head and Endocrine Surgery, Sarasota Memorial Health Care System, have successfully performed soft tissue ablation procedures on 30 patients with the CellFX NSPFA percutaneous system in Italy.
Kevin Danahy: In March 'twenty 'twenty four we received FDA five 10-K clearance for our non cardiac cell effects N S. P F <unk>.
Kevin Danahy: Catania system for soft tissue ablation indication.
Kevin Danahy: Soft tissue ablation is used by physicians in a wide range of procedures, including the thyroid liver breast and other areas of the body.
Kevin Danahy: Currently we have treated 30 patients in need of soft tissue ablation of thyroid disease.
Kevin Danahy: Doctor Stefanos Piazza Chief of Endocrine surgery Division at Napoli Hospital, Tomorrow, and Naples, Italy, a key opinion leader in the field of thyroid and collaboration with Doctor Ralph to final medical director had any endocrine surgery, but Sarasota Memorial Health care system have successfully performed.
Kevin Danahy: Tissue ablation procedures on 30 patients with the cell effects S. P. A a percutaneous system in Italy.
Kevin Danahy: The first patient was treated in April 2023, and the last patient in January 2024. All procedures were thyroid. Per amended protocols, at our request, we have observed patients as early as one week and, up to this point, as late as 180 days. Patient follow-ups are weekly for the first four weeks, then 30, 60, 90, 180, and 360-day time points following the procedure. No evidence of scarring or injury to the surrounding tissue has been observed, and patients treated have been judged to be successful.
Kevin Danahy: The first patient was treated in April 2023, and the last patient in January 2020 for all procedures, where thyroid.
Kevin Danahy: Our amended protocols at our request we have observed patients as early as one week and up to this point as of late is 180 days pay.
Kevin Danahy: Patient follow ups, our weekly for the first four weeks, then 30 60, 90, 180, and 360 day time points following the procedure.
Kevin Danahy: No evidence of scarring or injury to the surrounding tissue has been observed in patients treated have been judged to be successful.
Kevin Danahy: Moving on to the updates of our cardiac indications, starting with our surgical clamp. In the past few weeks, we have communicated with the FDA regarding our Cell Effects NSPFA surgical clamp for cardiac procedures. The FDA has requested clinical data prior to rendering a final decision in pursuit of our request for FDA 510K clearance. As of today, only preclinical animal work has been performed.
Kevin Danahy: Moving on to the updates of our cardiac indication.
Kevin Danahy: With our surgical plan.
Kevin Danahy: In the past few weeks, we have communicated with the FDA regarding our cell effects N S. P F a surgical clamp for cardiac procedures.
Kevin Danahy: F D. A has requested clinical data prior to rendering a final decision in pursuit of a request for F. D. A five 10-K clearance.
Kevin Danahy: As of today only preclinical animal work has been performed.
Kevin Danahy: No patient has been treated, as of yet, with our CellFX NSPFA Surgical Clamp. At this time, however, we have submitted to the Ethics Committee in the Netherlands an application to start a first-in-human feasibility study with the CellFX NSPFA surgical clamp. We anticipate their response within the next several weeks. The study is designed to treat up to 30 patients in several centers in the Netherlands. This study will provide information on first-in-human effectiveness and safety of our device.
Kevin Danahy: No patient has been treated as of yet without cell effects and S. P F a surgical clamps.
Kevin Danahy: And present time, however, we have submitted to the ethics committee in the Netherlands and applications that start first in human feasibility study with the cell effects N S. P F a surgical cleanup.
Kevin Danahy: We anticipate their response within the next several weeks. The study is designed to treat up to 30 patients in several centers in the Netherlands.
Kevin Danahy: This study would provide information on first in human effectiveness and safety without device.
Kevin Danahy: Our second device for cardiac indication is our CellFX NSPFA 360-degree cardiac catheter. We are pleased to announce that 24 of 30 patients have been successfully treated in Prague by Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at Mount Sinai Hospital, New York, and Dr. Peter Neuzil, Chief of Cardiology at Hamoka Hospital, Prague, and his team in Prague. The remaining six patients are expected to be treated within the next 45 days. The primary endpoints for this study are acute effectiveness at the time of the procedure and add up to 30 days for safety.
Kevin Danahy: A second device for cardiac indication as a cell effects N. S. P. F. A 360 degree cardiac catheter. We are pleased to announce that 24 or 30 patients have been successfully treated in Prague by Dr. Vivek Reddy director of cardiac arrhythmia services at Mount Sinai Hospital in New York.
Kevin Danahy: Dr. Peter neutral chief of Cardiology at her Moca Hospital Prague, and his team have brought.
Kevin Danahy: The remaining six patients are expected to be treated within the next 45 days. The primary endpoint for this study are acute effectiveness at the time of the procedure and add up to 30 days for safety.
Kevin Danahy: Discussions with the FDA are ongoing at the present time, and we will provide updates in a timely manner. Pulse Biosciences will have a strong presence at the upcoming Heart Rhythm Society HRS meeting, May 16th to the 19th in Boston. Our cell effects NFPFA energy delivery system will be featured in a total of six poster presentation abstracts, as well as a live case presentation.
Kevin Danahy: Discussions with the FDA are ongoing at present time, and we will provide updates in a timely manner.
Kevin Danahy: Pulse Biosciences will have a strong presence at the upcoming heart Rhythm Society HRS meeting may 16th to the 19th in Boston I sell effects N F. P. F. A energy delivery system will be featured in a total of six poster presentation abstracts as well as a live case presentation.
Kevin Danahy: Before turning the call over to Mike, I will now provide additional details on our efforts to strengthen our balance sheet through the Right Talk. This offer serves as a stockholder-friendly avenue for Pulse Biosciences to secure the necessary capital to advance our novel end-of-life factors towards market entrance while offering our existing stockholders a potential non-dilutive opportunity to continue to support the company's growth. The Board of Directors has approved a rights offering of up to 60 million units that will be available to all holders of record of the company's common stock as of the specified record date.
Kevin Danahy: Before turning the call over to Mike I will now provide additional details on our efforts to strengthen our balance sheet through the rights offering.
Kevin Danahy: This offer.
Kevin Danahy: As a stockholder friendly Avenue for pulse biosciences to secure the necessary capital to advance our novel and it factors towards market entrants, while offering our existing stockholders are potential non dilutive opportunity to continue to support the company's growth.
Kevin Danahy: The board of Directors has approved a rights offering of up to $60 million worth of units that will be available to all holders of record of the company's common stock.
Kevin Danahy: As of the specified record date.
Kevin Danahy: This week, the company determined to initiate the rights offering in June or July, not in May, so that the early record date of May 16th will most likely be changed to a date in mid-June. The date will be selected by our board and announced once all the necessary filings have been completed. Subscriptions may begin immediately once the company commences the rights offering, most likely in June. It is important to note that the subscription rights will expire and have no value if they are not exercised prior to the expiration date of the offering, which date will also be announced by the company once the necessary filings have been completed.
Kevin Danahy: This week the company determined to initiate the rights offering in June or July not met so that the early record date of May 16, we will most likely be changed to a date in mid June.
Kevin Danahy: The date will be selected by our board and announced once all the necessary filings have been completed.
Kevin Danahy: Subscriptions may begin immediately once the company commenced as the rights offering most likely in June is important to note that the subscription rights will expire and have no value if they're not exercised prior to the exploration date of the offering which date will also be announced by the company once the necessary fine.
Kevin Danahy: <unk> have been completed.
Kevin Danahy: Assuming that the rights offering is fully subscribed at the initial price, the company will receive gross proceeds of up to $60 million, less expenses related to the rights offering, and upon exercise of all the warrants, a potential to raise up to $126 million. A fully subscribed rights offering would fund the company's growth plans into the first quarter of 2026. Please refer to our release on the rights offering for more information. Now, I will pass the call over to Mike Koffler for an update on our financial results. Thank you, Kevin.
Kevin Danahy: Assuming that the rights offering is fully subscribed at the initial price the company will receive gross proceeds up to $60 million less expenses related to the rights offering and upon exercise of all the warrants are potential to raise up to 126 million.
Michael Koffler: Our fully subscribed rights Harpoon would fund the company's growth plans into the first quarter of 2026, please refer to our release on the rights offering for more information.
Kevin Danahy: Now I will pass the call over to Mike Koffler for an update on our financial results.
Michael Koffler: Total non-GAAP costs and expenses in the first quarter of 2024 increased by $0.3 million to $8.6 million, compared to $8.3 million in the prior year period. The increase in total non-GAAP costs and expenses was primarily driven by an increase in research and development expenses to support the advancement of our CellFX NSPFA devices. Gap net loss in the first quarter of 2024 was $10.1 million compared to $9.8 million in the prior year period; non-gap net loss in the first quarter of 2024 was $8.1 million compared to $8.6 million in the prior year period.
Michael Koffler: Thank you, Kevin. Today, I will highlight our GAAP and non-GAAP financial results. I encourage you to review today's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. For example, in the first quarter of 2024, total GAAP costs and expenses increased by $1 million to $10.6 million, compared to $9.6 million in the prior year period. The increase in gap costs and expenses was primarily driven by an increase in non-cash stock-based compensation expense, which was $1.8 million in the first quarter of 2024, compared to $0.9 million in the prior year period.
Michael Koffler: Thank you Kevin today, I will highlight our GAAP and non-GAAP financial results I encourage you to review today's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures.
Michael Koffler: In the first quarter of 2024 total GAAP costs and expenses increased by 1 million to $10 6 million compared to $9 6 million in the prior year period the.
Michael Koffler: The increase in GAAP cost and expenses was primarily driven by an increase in noncash stock based compensation expense, which was $1 8 million in the first quarter of 2024 compared to 0.9 million in the prior year period.
Michael Koffler: Total non-GAAP costs and expenses in the first quarter of 'twenty 'twenty four increased by 0.3 million to $8 6 million compared to $8 3 million in the prior year period.
Michael Koffler: The increase in total non-GAAP costs and expenses was primarily driven by an increase in research and development expenses to support the advancement of our cell effects and S. PFA devices.
Michael Koffler: GAAP net loss in the first quarter of 2024 was $10 1 million compared to $9 8 billion in the prior year period.
Michael Koffler: non-GAAP net loss in the first quarter of 2024 was $8 1 million compared to $8 6 million in the prior year period.
Michael Koffler: Cash and cash equivalents totaled $34.9 million as of March 31, 2024, compared to $44.4 million as of December 31, 2023. Cash used in the first quarter of 2024 totaled $9.5 million compared to $7.2 million used in the same period in the prior year and $6.9 million used in the fourth quarter of 2023. The sequential quarterly increase was driven mainly by $2 million in the 2023 annual cash bonus payout. I will now turn the call back over to Kevin. Thank you, Mike.
Michael Koffler: Cash and cash equivalents totaled $34 9 million as of March 31, 2024, compared to $44 4 million as of December 31, 2023.
Michael Koffler: Cash used in the first quarter of 'twenty 'twenty four totaled $9 5 million compared to $7 2 million used in the same period in the prior year and $6 9 million used in the fourth quarter of 2023.
Kevin Danahy: The sequential quarterly increase was driven mainly by $2 million in 2023 annual cash bonus payouts.
Michael Koffler: I will now turn the call back over to Kevin.
Kevin Danahy: Thank you Mike.
Kevin Danahy: It is an exciting year for Pulse Biosciences as we continue to advance our novel platform technology into the hands of more physicians for the benefit of more patients. If you have any questions, we will provide real-time updates on events and interactions as they unfold. Joining me for the question and answer session today are Executive Chairman of the Board, Robert Duggan, Chief Technology Officer and Director, Darrin Uecker, and Chief Strategy Officer, Mitch Levinson. Operator, please open the call for questions.
Kevin Danahy: It is an exciting year for pulse biosciences, as we continued to advance our novel platform technology into the hands of more physicians to the benefit of more patients.
Kevin Danahy: Calls, we will provide real time updates on events and interactions as they unfold.
Speaker Change: Joining me for the question and answer session. Today are executive Chairman of the Board, Robert Duggan, Chief Technology Officer, and director of Darin, Euchre, and Chief strategy Officer, Mitch Levinson.
Kevin Danahy: Operator, please open the call for questions.
Kevin Danahy: Thank you, Kevin. Now we're going to address a few questions we've received via email. Then we'll open up the line for questions from the audience. The first one is... How's the pilot launch going in the U.S. with the percutaneous electrode now that it's approved? What's the interest level, and when can we anticipate a full commercial launch?
Speaker Change: Thank you Kevin now we're going to address a few questions. We've received over email then we will open up the line for questions from the audience.
Kevin Danahy: The first one is how does the pilot launch going in the U S with the percutaneous electrode now that it's approved.
Kevin Danahy: What's the interest level and when can we anticipate a full commercial launch.
Mitchell E. Levinson: Yeah, hey Tripp, this is Mitch. I can take that one.
Kevin Danahy: Yeah, Hey trip. This is Matt I can take that one.
Mitch: Since our five 10-K clearance, we got a few weeks ago, we've reached out to the Kols that we were targeting for our pilot program and the interest has been just really high we've got a lot of physicians at major institutions want to evaluate our system for soft tissue ablation.
Mitchell E. Levinson: Since our 510K clearance we got a few weeks ago, we've reached out to the KOLs that we were targeting for our pilot program, and the interest has been really high. We've got a lot of physicians at major institutions that want to evaluate our system for soft tissue ablation. As some of you may know, at institutions like this and hospitals, there's an approval process. It usually takes several weeks, sometimes longer, to approve the introduction of new technologies.
Mitchell E. Levinson: Some of you may know in institutions institutions like this in hospitals, there's an approval process. It usually takes several weeks sometimes longer to approve bringing in new technologies. We've got multiple kols currently working through that approval process and we expect our teleflex percutaneous system is going to be used in a.
Mitchell E. Levinson: We've got multiple KOLs currently working through the approval process. We expect our CellFX percutaneous system to be used in a number of prominent hospitals and clinics by the end of this year. Right now, we are really focused on building the appropriate training around the system, providing strong clinical support, and just ensuring that we are doing everything we can to help our physician customers get the best possible clinical outcome.
Mitchell E. Levinson: A number of prominent hospitals and clinics by the end of this year right.
Mitchell E. Levinson: Right now we are just really focused on building the appropriate training around the system.
Mitchell E. Levinson: <unk> strong clinical support.
Mitchell E. Levinson: And just ensuring that we are doing everything we can to help our our physician customers get the best possible clinical outcomes that they can't with our technology.
Operator: Great. Operator, can you please open the line for questions now?
Speaker Change: Great Operator can you. Please open the line for questions now.
Operator: Thank you. We will now 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. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key.
Speaker Change: Thank you we will now be conducting a question and answer session.
Operator: You would like to ask a question. Please press star one on your telephone keypad.
Operator: All information portable indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue.
Operator: Participants using speaker equipment, it may be necessary to pick up your handset before.
Operator: Your first question comes from Anthony Petroni with the Mizzou Hope Group. Please go ahead. Thank you.
Operator: Your first question comes from Anthony Petrone with Mizuho. Please go ahead.
Operator: Thank you and congratulations on the progress here. You know, maybe a little bit on the FDA dialogue. It sounds like that's moving in the right direction. They've sort of given a little bit of guidance here, I think, on just kind of the clinical pathway going forward. And so maybe anything you could add on, you know, how broad-based a pivotal program could look like, you know, how many sites, how many patients, and I guess your early views on the timing of when this could be launched. And I'll have one follow-up.
Anthony Petroni: Thank you and congratulations on the progress here.
Operator: Yeah, maybe a little bit just on the FDA dialogue.
Operator: Sounds like that that's moving in the right direction are they.
Operator: They they sort of given a little bit of guidance here I think on just kind of the clinical pathway going forward.
Operator: And so maybe anything you could add there on you know how how broad based are you know.
Operator: Our pivotal program could look like you know how many sites how many patient setting.
Operator: I guess your early views on on timing of when this could be launched in a one follow up thanks.
Operator: Right.
Operator: Yeah.
Darrin R. Uecker: Darrin, do you want to take that?
Operator: Darren you want to take that.
Darrin R. Uecker: Yeah, yeah, sure. Thanks, Anthony. This is on the clamp, right? I apologize.
Speaker Change: Yeah, Yeah sure. Thanks, Anthony this is on the clamp right I apologize.
Darrin R. Uecker: Yeah, that would that would be right on the cardiac clamp. Yep. Yeah.
Darrin: Yeah that would that would be alright, cardiac claim yeah, yeah. So.
Darrin R. Uecker: Yeah. So.
Darrin R. Uecker: You know, as we discussed on our last call, we received an additional information letter from the FDA that led to a couple of meetings with FDA, one that we had very recently and a very collaborative, great discussion with FDA as we're moving this forward. As of today, as we mentioned, you know, we remain in the 510K process. After receiving the AI letter, that goes on hold with regard to the review cycle, as you probably know.
Darrin: You know I think as we discussed on our last call. We received an additional information letter from the FDA that led to.
Darrin R. Uecker: A couple of meetings with FDA, one that we had very recently.
Darrin R. Uecker: And very collaborative great discussion with FDA as we're moving this forward.
Darrin R. Uecker: As of today as we mentioned we remain in the 500 10-K process.
Darrin R. Uecker: After receiving a letter that that goes on hold with regard to the review cycle.
Darrin R. Uecker: As you probably know and you know I think we had good dialogue with FDA about.
Darrin R. Uecker: And, you know, I think we had good dialogue with FDA about the need or request for human clinical data, and so we're really in the process of discussing that with FDA and coming to some agreement on what that clinical program would look like, and likewise, you know, the regulatory path going forward. Right now, we really don't have much to report on that in terms of timing. One of the things on the clinical side that we have discussed is a first in human feasibility study for our clamp, which will happen in Europe and the Netherlands and that we've submitted to the ethics committee there.
Darrin R. Uecker: The need or request for human clinical data and so we're really in the process of discussing that with F. D. A.
Darrin R. Uecker: And coming to some agreement on what that clinical program would look like and and likewise, the regulatory path going forward right. Now we really don't have much to report on that in terms of of.
Darrin R. Uecker: Timing I'm one of the things on the clinical side that.
Darrin R. Uecker: We have discussed is a first in human feasibility study for our clamp, which will happen in Europe in the Netherlands and that we've submitted to the Ethics Committee. There we expect to hear back from the Ethics Committee within the next several weeks.
Darrin R. Uecker: We expect to hear back from the ethics committee within the next several weeks and then commence that study soon thereafter. And so, you know, we've got a lot going on on that side. FDA is aware of that study, and we'll just be working with FDA over the next period of time to finalize what's going to be required for the clamp in the United States.
Darrin R. Uecker: And then commence that study.
Darrin R. Uecker: Soon thereafter, and so you know we've got a lot going on on that side FDA is aware of that study and and you know, we'll just be working with FDA over the next period of time to to finalize what's going to be required for the client in the United States.
Kevin Danahy: That's helpful, and then a follow-up would be just on HRS looking ahead. Here you have a live case with CellFX that's being presented post the presentations, as well as the market here in the United States is now, you know, officially underway with Pulse Select and Faropulse out there, so what are you expecting out of HRS, and, I guess, from the perspective of Pulse Biosciences? You know, are you surprised at the rate of adoption by the early PFA catheters? you know, maybe just the expectations for physician feedback for cell effects.
Speaker Change: That's helpful. And then a follow up would be just on on HRS. Looking ahead here you have a live case with cell effects.
Kevin Danahy: That's being presented poster presentations as well the the market.
Kevin Danahy: Here in the United States is now officially underway with pulse select.
Kevin Danahy: And Farah pulse out there so.
Kevin Danahy: What are you expecting out of HRS, and and and I guess from the perspective of pulse Biosciences.
Kevin Danahy: You know or are you surprised that the rate of adoption by the early PSA catheters.
Kevin Danahy: And.
Kevin Danahy: Maybe just the expectations on physician feedback for cell effects out of HRS. Thanks again.
Kevin Danahy: Yeah.
Kevin Danahy: Yeah, thanks, Kevin. Yeah, I would, I guess I would say we're really looking forward to HRS. You know, we have six abstract presentations, as you mentioned, and those are both on the catheter and our clamp. So, you know, that is something that is very encouraging to get both of our products into HRS for this important meeting. And then, as you mentioned, we have a live case at the PFA Summit at the beginning of the meeting.
Speaker Change: Yeah, Anthony Yeah. Thanks, Kevin.
Kevin Danahy: Yeah, I would I guess I would say you know we're.
Kevin Danahy: Really looking forward to HRS, we have six abstract presentations and as you mentioned and those are both actually on the catheter and our clamp.
Kevin Danahy: So that is something that is very encouraging to get both of our products into HRS for this important meeting and then and then as you mentioned, we have a live case.
Kevin Danahy: And the PFA summit.
Kevin Danahy: At the beginning of the meeting.
Kevin Danahy: And as it relates to PFA in general, I think we're not surprised by the progress of PFA and the progress that we're seeing in the United States with those other devices. I think it seems the data is pretty clear that PFA offers some pretty significant advantages over current modalities. What we're excited about and looking forward to at HRS is talking about nanosecond PFA and our view that it's sort of a next generation as it relates to PFA and what the differentiation is in terms of the lesions that we create, the integrity and durability of those lesions, the depth of those lesions, and the speed with which EPs are able to create those lesions.
Kevin Danahy: And you know as it relates to <unk> in general.
Kevin Danahy: We're not surprised by the progress of PFA and the progress that we're seeing in the United States.
Kevin Danahy: By those other devices I think.
Kevin Danahy: It seems the data is pretty clear that PFA offers some pretty significant advantages over current modalities.
Kevin Danahy: What we're excited.
Kevin Danahy: Excited about and I'm looking forward to in HRS is talking about nanosecond PFA and you know our view that it's a sort of a next generation as it relates to PFA and what the the the differentiation is in terms of the lesions that we create.
Kevin Danahy: The the integrity and durability of those lesions the depth of those lesions the speed with which <unk> are able to create those lesions. So all those things. We think are going to be really important to both physicians and patients.
Kevin Danahy: So all those things, we think, are going to be really important to both physicians and patients. And we're looking forward to HRS to be able to talk about them and present both our preclinical and clinical data that supports those different benefits. So, you know, we think it's going to be a really exciting meeting for PFA in general, but also, of course, for nanosecond PFA and Pulse Biosciences.
Kevin Danahy: And and we're looking forward to HRS to be able to talk about that and present, our both both our preclinical and clinical data.
Kevin Danahy: That supports those different benefits so.
Kevin Danahy: We think it's going to be a really exciting meeting for PSA in general, but but also of course for nanosecond PFA and pulse biosciences.
Speaker Change: That's very helpful. Thank you.
Operator: Next question: Robert Lovgren with Medical Hope Productions, please go ahead.
Kevin Danahy: Next question, Robert Lofgren with medical pulp production. Please go ahead.
Robert W. Duggan: Yes, this question is for Bob, a little preliminary: this ablation and catheters and so on is a real surgical coming. Basically, UBOPs feel, though, that you have all the patents and the heads of all the other people, plus, of course, the machine itself. Do you think you're the tip of the spear?
Robert Lovgren: Yes. This question is for Bob.
Speaker Change: A little preliminary.
Robert W. Duggan: This this ablation catheters.
Robert W. Duggan: Catheters and so all of those are real surgical.
Robert W. Duggan: Coming.
Robert W. Duggan: Basically do Bob's feel though that you have all the patents and the.
Robert W. Duggan: Ed.
Robert W. Duggan: Head of all the other people plus of course the machine itself.
Robert W. Duggan: Or you think you are the tip of the spear.
Robert W. Duggan: Well, ahead of Bob and the TIB, it would be somewhat similar, right? But you really put your patent base together, and evaluate it thoroughly, which we're constantly doing. At this point, we're very pleased with what we have and what we are generating. The acid test is, when you bring it to market, it's not against the law to develop anything you want. You can copy, you can alter, you can go de novo. But when you bring it to market, that's where patents really swing in.
Robert W. Duggan: Well.
Robert W. Duggan: I had of Bob and the typically would be somewhat similar right.
Robert W. Duggan: But do you really put your patent base together.
Robert W. Duggan: <unk> thoroughly which we're constantly doing at this point, where we're very pleased with what we have and what we are generating.
Robert W. Duggan: The acid test is when you bring it to market, it's not against a lot of developed anything you want you can copy you couldn't alter but you can go de novo, but when you bring it to market, that's where the patents really swing in so where we will find out but I am yes, I'm, Bob Duggan I'm confidence there.
Robert W. Duggan: So, we will find out. But, yes, I'm Bob Duggan. I'm confident that we're in a good position there, and I like the speed at which we continue to evolve our patent base. I hope that answers the question, Bob.
Robert W. Duggan: We're in a good position there and I liked the speed at which we continue to evolve our patent base I hope that answers your question Bob.
Speaker Change: Thank you.
Robert W. Duggan: Welcome.
Kevin Danahy: I would like to turn the floor over to Kevin Danahy for closing remarks.
Robert W. Duggan: I would like to turn the floor over to Kevin Danaher for closing remark.
Kevin Danahy: Thank you, operator. In closing, I just want to thank you all for continuing to support and giving us the confidence that we have in our company. We are dedicated to delivering value and growth with NSPFA, and we look forward to the opportunities that lie ahead. Thank you for joining us today, and we remain committed to driving success for this company. Thank you. This concludes today's teleconference. You may disconnect your lines at this time. And thank you for your participation.
Kevin Danahy: Thank you operator in closing I just want to thank you all for continuing to support and giving us the confidence that we have in our company. We are dedicated to delivering value and growth with N. S. P. F. <unk> and we look forward to the opportunities that lie ahead. Thank you for joining us today and we remain committed to driving success for this.
Kevin Danahy: Company. Thank you.
Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Kevin Danahy: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Operator: Okay.
Operator: [music].