Q4 2023 Pulse Biosciences Inc Earnings Call
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Operator: Greetings and welcome to the Pulse Biosciences 4th Quarter 2023 Earnings Conference. At this time, all participants are in a listen-only mode.
Greetings and welcome to the pulse Biosciences fourth quarter 2023 earnings conference call.
At this time all participants are in a listen only mode.
Operator: 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, Investor Relations. Thank you, sir. You may begin.
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 trip Taylor Investor Relations. Thank you. Sir you may. 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 'twenty eight 'twenty 'twenty four one.
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, March 28, 2024 only and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations, and other similar information. However, actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties.
<unk> and will include forward looking statements and opinion statements, including predictions estimates plans expectation and other similar 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.
Philip Taylor: 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. 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.
And in our filings with the U S Securities and Exchange Commission or 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.
Philip Taylor: 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 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. Thank you, Tripp.
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.
<unk> Sciences Dot com in 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 Danaher.
Kevin Danahy: Good afternoon, everyone, and thank you all for joining us on this call. I am excited to be here today with our team, including Darrin Uecker, Chief Technology Officer and Director, Mitch Levinson, Chief Strategy Officer, and Mike Koffler, Vice President of Finance. Our accomplishments in 2023 and early this year have been focused on our proprietary, designed, and engineered CellFX NSPFA energy delivery system and the three novel endofactor devices designed to deliver our CellFX NSPFA energy to different tissues in the body. We are pleased with our success. Today, I will highlight each of the three surgical opportunities we are currently focused on at Pulse Biosciences, the CellFX NSPFA percutaneous electrode, the NSPFA surgical clamp, and the NSPFA 360-degree cardiac catheter. I will then hand the call over to Darrin to provide a detailed product update on our cardiac device programs, and then Mitch will provide specific non-cardiac development progress. Finally, Mike will review our fourth quarter and end of year 2023 financial results before I conclude and open the call for a question and answer session.
Kevin Danaher: Thank you good afternoon, everyone and thank you all for joining us on this call I'm excited to be here today without a team, including Darrin yogurt, Chief Technology Officer, and director, Mitch Levinson, Chief strategy Officer, and Mike Kaufman, Vice President of Finance, our accomplishments in 2023 and early this year have been.
Kevin Danaher: Focused on our proprietary design and engineered cell effects N S. P F <unk> energy delivery system and the three novel and in fact their devices designed to deliver a solid facts N. S. P. F <unk> energy to different tissues in the body. We are pleased with our success.
Kevin Danaher: I will highlight each of the three surgical opportunities. We are currently focused on at pulse biosciences, the sell up X and S. P F. A percutaneous electrodes the.
Kevin Danaher: S P F <unk> surgical plan.
Kevin Danaher: N S. P F. A a 360 degree cardiac catheter.
Kevin Danaher: Then hand, the call over to Darren to provide a detailed product update on our cardiac device programs and then Mitch will provide specific non cardiac development progress.
Kevin Danaher: Finally, Mike will review, our fourth quarter and end of year 2023 financial results before I conclude and open the call for a question and answer session.
Kevin Danahy: First, I want to focus on the CellFX NSPFA Percutaneous Electrode. The Percutaneous Electrode, or PERC electrode, is designed for surgical soft tissue ablation, leveraging our proprietary design and engineered CellFX NSPFA energy delivery system. CellFX NSPFA energy creates potential patient benefit and surgeon value in the treatment of soft tissue nodules.
Darren: First I want to focus on the cell effects N S. P F a percutaneous electrodes.
Darren: Perfect Dainius electrodes ballpark electrodes is designed for the surgical soft tissue ablation, leveraging our proprietary design and engineered cell effects and that's P. F E energy delivery system.
Darren: The cell effects as Pepe energy creates potential patient benefit and surge in value in the treatment of soft tissue nodules, we believe cell effects N. S. P. F. <unk> has the potential to provide hospital and treating physicians with a new and exciting alternative for patients with a broad range of soft tissue nodules in need of therapy.
Kevin Danahy: We believe CellFX NSPFA has the potential to provide hospitals and treating physicians with a new and exciting alternative for patients with a broad range of soft tissue nodules in need of therapy. In November 2023, Dr. Stefano Spiazza, a leading thyroid surgeon and chief of the endocrine surgery division at Napoli Hospital Del Mare in Naples, Italy, completed our initial trial of 30 patients on the application of CellFX NSPFA percutaneous electrode for the treatment of benign thyroid nodules. He presented his excellent results in February at the 2024 NASA Annual Meeting.
Darren: Great.
Darren: In November 2023, Dr. Stefan noticeably Isa, leading thyroid surgeon in chief of Endocrine surgeries Division at Napoli Hospital down moderate in Naples, Italy completed our initial trial of 30 patients on the application of cell effects at S. P. F. A percutaneous electronics for the treatment of benign thyroid.
Darren: Nodules.
Darren: He presented his excellent results in February at the 'twenty 'twenty four NASDAQ annual meeting.
Kevin Danahy: Additionally, the percutaneous thyroid nodule study will be shared in detail via the podium presentation later this year demonstrating extremely promising feasibility results. In November of 2023, Pulse Biosciences concluded its preclinical studies and submitted a pre-market notification, 510K, with the U.S. FDA for clearance to commercialize the CellFX NSPFA percutaneous electrode. In March 2024, we received FDA 510K clearance for our Cellifex NSPFA percutaneous electrode system with a soft tissue ablation indication for the Cell Effect NSPFA surgical clamp. The NSPFA Surgical Clamp is specifically designed for general ablation of cardiac soft tissue, leveraging our proprietary designed and engineered CellFX NSPFA Energy Delivery System to be used by cardiothoracic surgeons during open or minimally invasive cardiac procedures. Our Chief Medical Officer, Dr. Gan Dunnington, and Chief Science Officer, Dr. Niv-Ad, have been instrumental in driving our progress in cardiac device development, preclinical work design, and the FDA application process. In December of 2023, we filed a 510-K for our CellFX NSPFA cardiac plan.
Darren: Additionally, the percutaneous thyroid nodule study will be shared in detail. The other podium presentation. Later this year demonstrating extremely promising feasibility results.
Darren: In November of 2023 pulse Biosciences concluded its preclinical studies and submitted a premarket notification five 10-K with the U S. FDA clearance to commercialize the cell effect N S. P. S. A percutaneous electronics.
Darren: In March 2024, we received FDA five 10-K clearance for our cell effects N F. P. F. A percutaneous electric system with a soft tissue ablation indication.
Darren: Regarding the cell effects at S. P F <unk> surgical plan.
Darren: The U S. P. S. A surgical class is specifically designed for general ablation of cardiac soft tissue leveraging our proprietary designed and engineered cell effects N. S. P. F. A energy delivery system to be used by cardio thoracic surgeons during open or minimally invasive cardiac procedures are.
Our Chief Medical Officer, Dr. Gan, Donaldson, and Chief Science Officer, Dr. Nevada have been instrumental in driving our progress in cardiac device development preclinical work design and the FDA application process in December of 'twenty to 'twenty, three we filed a premarket notification five 10-K for a seller.
And that's P F a cardiac plant.
Kevin Danahy: We believe CellFX NSPFA offers significant potential advantages over current energy modalities in the cardiac surgical space. Lastly, I want to discuss the CellFX NSPFA 360-degree cardiac catheter. The catheter is designed for use by electrophysiologists to isolate and ablate the pulmonary veins of the left atrium.
Darren: We believe cell effects N F. P. F 35 has significant potential advantages over current energy modality in the cardiac surgical space Lastly, I wanted to discuss the cell effects and that's P. F. A 360 degree cardiac catheter.
Darren: The catheter is designed to be used by Electrophysiologist isolating ablate, the pulmonary veins of the left atrium.
Kevin Danahy: We believe our unique and intended design of the CellFX NSPFA cardiac catheter allows physicians the versatility and flexibility in one single design to perform pulmonary vein isolation as well as enable important posterior wall isolation. Multiple Key Opinion Leaders, KOLs, are creating increasing awareness of the benefits of our novel CellFX NSPFA cardiac catheter throughout the clinical community and presenting its potential at prominent medical meetings. Podium presentations and the addition of new key opinion leaders are helping us build momentum as we execute on KOL development and clinical plans. Recently, at the AF Symposium on February 2nd, Dr. Vivek Reddy featured the CellFX NSPFA 360-degree cardiac catheter and showcased the first in human cases in a presentation that was well-received by Dr. Reddy's colleagues in the audience. We expect to have a strong presence at the Heart Rhythm Society, HRS, from May 16th to May 19th in Boston.
Darren: We believe our unique and intended design of the cell effects N. S. P. F. A cardiac catheter allows physicians to versatility and flexibility in one single design to perform pulmonary vein isolation as well as enable important post cereal wall isolation multiple key opinion leaders kols.
Darren: Ah, creating increasing awareness of the benefits of our novel cell effects N. S. P. F. A cardiac catheter throughout the clinical community and presenting its potential our predominant medical meetings.
Darren: Podium presentations and addition of new key opinion leaders are helping us build a millennium.
Darren: As we execute on K O L development and clinical plans.
Darren: Recently on the podium at the AF Symposium on February 2nd Dr. Vivek Reddy featured the cell effects N. S. P. F. <unk> 360 degree cardiac catheter and showcase the first inhuman cases, and a presentation that was well received by Doctor readies colleagues in the audience with.
We expect to have a strong presence at the heart Rhythm Society HRS may 16th to May 19th in Boston.
Kevin Danahy: We are pleased to report that we have completed 60-day post-procedure evaluations in February 2024, generated from the first in human catheter feasibility study. The very good news is that the remaps look almost identical to the immediate post-procedure maps, which demonstrates the early durability of high-quality lesions that our CellFX NSPFA 360-degree cardiac catheters are able to produce. These positive results were well received by all involved, including patients, physicians, and supporting staff. We plan to complete enrollment in our initial First in Human Feasibility Study of 30 subjects in the coming months. We also plan to initiate a study to support CE mark filing, which will complement our KOL development in the European market.
Darren: We are pleased to report that we have completed 60 days post procedure evaluations in February 2024 generated from the first in human catheter feasibility study there.
Darren: Very good news is that the rematch look almost identical to the immediate post procedure maps, which demonstrates the early on durability of high quality lesions that are sell effects and S. P. F. <unk> 360 degree cardiac catheters are able to produce these positive results were well received by all involved.
Darren: <unk> patients physicians and supporting staff.
Darren: We plan to complete enrollment of our initial first in human feasibility study of 30 subjects in the coming months.
Darren: We also plan to initiate a study to support CE, Mark filing, which will complement our K well development and the European markets.
Kevin Danahy: Each of the cell effect NSPFA devices we have discussed has the potential to revolutionize current standards of care in comparison to speed, efficacy, adverse events, and overall treatment outcomes. I will now hand the call off to Darrin to provide updates on our cardiac device development, including progress made in the lab and clinic. Thank you, Kevin.
Darren: Each of the cell effects and S. P. F. <unk> devices. We have discussed has the potential to evolution is current standard of care in comparison to speed efficacy adverse events and overall treatment outcomes.
Darren: I'll now hand, the call off to Darren to provide updates on our cardiac device development, including progress made in the labs and clinics.
Darren: Thank you Kevin.
Darrin R. Uecker: In the fourth quarter and in recent months, we are continuing to make significant progress advancing our cardiac catheter and clamp program. Data generated from our recent studies have continued to validate our expectations that the differentiated benefits of our CellFx platform and proprietary devices that leverage the novel characteristics of NSPFA technology and the CellFx system position us to be the next generation standard of care for the treatment of AF as well as other indications. Let me highlight again the important differences between our nanosecond PFA and existing microsecond PFA technology.
Darren: In the fourth quarter and in recent months, we are continuing to make significant progress advancing our cardiac catheter and clamp programs.
Darren: <unk> generated from our recent studies have continued to validate our expectations that the differentiated benefits of herself X platform and proprietary devices that leverage the novel characteristics of NSP FAA technology, and the cell effects system positions us to be the next generation standard of care for the treatment of a F as well as other.
Darren: <unk>.
Darren: Let me highlight again, the important differences between our nanosecond PFA and existing microsecond PFA technologies.
Darrin R. Uecker: The higher amplitude and shorter duration of NSPFA energy pulses are uniquely able to penetrate the cell membrane and alter the function of cellular organelles, leading to regulated cell death, rather than immediately destroying cells like most other energy modalities, such as standard PFA and thermal modalities like cryo, which uses extreme cold, or radiofrequency ablation, which uses extreme heat. NSPFA delivers about 20 times less energy over time to tissue than standard Because microsecond PFA delivers so much relative overall energy, these devices tend to operate close to the threshold of time-based thermal injury.
Darren: The higher amplitude and shorter duration of N. S. P. S. A energy pulses are uniquely able to penetrate the cell membrane and alter the function of cellular organelles, leading to regulated cell death.
Darren: Rather than immediately destroying cells like most other energy modalities, such as standard PFA and thermal modalities like cryo, which uses extreme cold or radiofrequency ablation, which uses extreme heat.
Darren: And S. PFA delivers about 20 times less energy overtime to tissue than standard P. F N.
Darren: Because microsecond PFA deliver so much relative overall energy. These devices tend to operate close to the threshold of time based thermal energy injury. So it is necessary to trade off speed depth of penetration in the amount of tissue that can be treated at once to ensure safety.
Darrin R. Uecker: So it is necessary to trade off speed, depth of penetration, and the amount of tissue that can be treated at once to ensure safety. However, our early data show that the CellFx NSPFA non-thermal mechanism of action can lead to beneficial outcomes in the clinical setting where physicians do not need to trade efficacy to ensure safety. We are developing cell effects and SPFA cardiac ablation solutions for use in open surgery by cardiothoracic surgeons and for use in electrophysiology labs by electrophysiologists, making us the only company we're aware of developing nanosecond PulseField products for both applications. I will first provide progress on our initial cardiac ablation catheter. Cell Effects, NSPFA, and the 360-degree catheter.
Darren: Our early data show that the cell effects and S. P. S. A a non thermal mechanism of action can lead to beneficial outcomes in the clinical setting where physicians do not need to trade it efficacy to ensure safety.
We are developing cell effects N S. P F. A cardiac ablation solutions for use in open surgery by cardio thoracic surgeons and for use in the electrophysiology labs by Electrophysiologist, making us the only company, we're aware of developing nanosecond pulse field products for both applications.
Darren: I will first provide progress on our initial cardiac ablation catheter the <unk> S. P. F. A 360 degree catheter this.
Darrin R. Uecker: This catheter is named 360° because it is uniquely engineered to harness NSPFA energy and perform a 360° circumferential ablation in as few as a single NSPFA cycle within as little as 5 seconds. In our opinion, the large footprint and unique versatility of this catheter provide a highly differentiated and beneficial solution for EPs performing cardiac ablation for the treatment of atrial fibrillation. As Kevin noted, we are pleased to report that we are currently validating the use of the system and its unique capabilities in our ongoing First in Human Feasibility Study. In December, we began enrolling patients in this study, and as of today, we have treated 19 patients out of 30 potential patients that the protocol is currently approved for. At this time, we are encouraged by the performance of the device and the safety profile that is emerging as we treat and follow these patients.
Darren: This catheter is named 360 degree because it it is uniquely engineered to harness N S PFA energy and to perform a three eight or 60 degrees circumferential ablation in as few as a single N. S. P. S a cycle within as little as five seconds.
Darren: In our opinion, the large footprint and unique versatility of this catheter provides a highly differentiated and beneficial solution for EPS performing cardiac ablation for the treatment of atrial fibrillation.
Darren: As Kevin noted we are pleased to report that we are currently validating the use of this system and its unique capabilities and our ongoing first in human feasibility study.
Darren: In December we began enrolling patients in this study and as of today, we have treated 19 patients of 30 potential patients that the protocol is currently approved for and at present time, we are encouraged with the performance of the device and the safety profile that is emerging as we treat and follow these patients.
Darrin R. Uecker: Dr. Vivek Reddy, one of the PIs in this study, reported some of the initial data during a presentation in February at the 29th Annual AF Symposium 2024 meeting in Boston. Dr. Reddy presented a video recorded procedure from one of the initial five procedures to the audience at the AF symposium meeting. A clip from Dr. Reddy's presentation can be viewed on the Pulse Biosciences homepage.
Darren: Dr. Vivek Reddy, one of the Pis in this study reported some of the initial data during our presentation in February at the 29th annual AF Symposium 2024 meeting in Boston.
Darren: Dr. <unk> already presented the video recorded procedure from one of the initial five procedures to the audience at the AF Symposium meeting a.
Darren: Hey, Cliff from doctors, Dr. <unk> presentation can be viewed on the pulse biosciences homepage.
Darrin R. Uecker: The study protocol includes an EP remapping procedure to evaluate the durability of the ablations as compared to the acute map performed at the time of the procedure, and we recently reported on the positive results from the first four patients that had these remaps. We are looking forward to the presentation of updated data from this study at the prestigious Heritage Society meeting in Boston in May.
Darren: The study protocol includes an EP re mapping procedure to evaluate the durability of the ablation as compared to the acute map performed at the time of the procedure and we recently reported on the positive results from the first four patients that have had these re maps we're.
Darren: We're looking forward to the presentation of updated data from this study at the prestigious heart Rhythm Society meeting in Boston in May.
Darrin R. Uecker: The results from this study will inform subsequent trials. In parallel with completing enrollment in our feasibility study, we are also planning future trials in Europe for the CE mark and in the U.S. for FDA approval. We will provide details of these studies on a timely basis. We believe the strength of our results is attributable to our novel catheter design and the highly differentiated properties of NSPFA. The benefit of our circumferential treatments is that EPs don't need to repeatedly reposition and retreat to connect the dots, like they do with other PFA and thermal technologies. In our opinion, the greater depth of our electric field creates reliable transmural lesions, even in thick tissue, further differentiating Pulse Biosciences' cardiac catheter products in regard to patient therapeutic value and surgeon ease of use.
Darren: The results from this study will inform subsequent trials in parallel with completing enrollment of our feasibility study. We are also planning future trials in Europe for the CE Mark and in the U S. For FDA approval, we will provide details of these studies on a timely basis.
Darren: We believe the strength of our results is attributable to our novel catheter design and the highly differentiated properties of N. S. P. F E.
Darren: The benefit of our circumferential treatments is that EPA is don't need to repeatedly reposition and retreat to connect the dots like they do with other PFA and thermal technologies.
Darren: In our opinion, the greater depth of our electric field creates reliable trans marrow lesions, even in thick tissue further differentiating pulse biosciences cardiac catheter products in regard to patient therapeutic value and surgeon ease of use.
Darrin R. Uecker: The clinicians performing the procedures have been impressed with the maneuverability and versatility of the catheter. For example, they have been able to treat the atrial wall in addition to the pulmonary vein. The fact that they are able to use our catheter to map the atrium has reduced patient procedure time and improved surgeon ease of use. The all-in-one nature of the catheter is an additional differentiating feature that resonates well among the EP community. We intend and believe this procedure will be easier to perform with significantly reduced procedure times, all of which will improve patient safety and overall therapeutic efficacy. As we have described previously, our 360-degree catheter is engineered to integrate with current mapping and navigation systems used in EP laboratories. The initial first-in-human procedures have validated this capability, and we are continuing to explore the use of these and other systems to demonstrate our system flexibility. We are working with approximately 90% of the installed base for mapping and navigation.
The clinicians performing their procedures have been impressed with the maneuverability and versatility of the catheter they have been able to treat the atrial wall. In addition to the pulmonary veins.
Darren: Fact that theyre able to use our catheter to map the atrium has reduced patient procedure time and improve surgeon ease of use.
Darren: The all in one nature of the catheter is an additional differentiating feature that resonates well along in the EP community.
Darren: We intend and believe this procedure will be easier to perform with significantly reduced procedure times, all of which will improve patient safety and overall therapeutic efficacy.
Darren: As we have described previously our 360 degree catheter is engineered to integrate with current mapping and navigation systems used in EP labs.
Darren: Initial first in human procedures have validated this capability and we are continuing to explore the use of these and other systems to demonstrate our system flexibility.
Darren: We are working with approximately 90% of the installed base for mapping and navigation systems.
Darrin R. Uecker: Aside from the initial system we used, we've also used the CARDO system from J&J, and we are planning to also use the Insight system from AVID. Going forward, we continue to evaluate multiple possibilities, and we will do what is best for patients and physicians. The awareness of NSPFA continues to grow as presentations by our lead investigator, Dr. Vivek Reddy, are garnering significant interest from the clinical community. Four abstracts were accepted on our catheter technology for the Heart Rhythm Society 2024 meeting in Boston, May 16th through the 19th. We're pleased to see the acceptance of our proprietary design and engineered CellFX NSPFA energy delivery system and for our partners to be given the opportunity to present data from preclinical and clinical studies using our novel devices at this important scientific meeting.
Darren: From the initial system. We used we have also use the cargo system from J&J and we are planning to also use the insight system from Abbott.
Darren: Going forward, we continue to evaluate multiple possibilities and we will do what is best for patients and physicians.
Darren: Yeah.
Darren: The awareness of NSP FAA continues to grow as presentations by our lead investigator Dr. Vivek Reddy are garnering significant interest from the clinical community.
Darren: Four abstracts were accepted on our catheter technology for the Heart Rhythm Society 2024 meeting in Boston May 16 through 19, we're pleased to see the acceptance of our proprietary design and engineered cell effects and S. PFA energy delivery system and for our partners to be given the opportunity to present data from preclinical.
Darren: In clinical studies using our novel devices at this important scientific meeting.
Darrin R. Uecker: Now I will provide an update on our novel proprietary cardiac surgical clamp. We believe our CellFX NSPFA surgical clamp has the potential to significantly change the way cardiac surgical ablation is done in cardiac surgery. Our preclinical data demonstrate the potential for the clamp to improve safety, effectiveness, ease of use, and treatment speed. The data demonstrate the NSPFA clamp can produce continuous, transmural, durable lesions in 1.25 seconds, independent of tissue thickness or type, as compared to 15 to 30 seconds for thermal ablation modalities, which are highly dependent on tissue thickness, type, and vasculature. And due to the non-thermal mechanism of action, the CellFX NSPFA clamp has no risk of thermal damage to collateral tissue, which is a known risk with current thermal technology.
Darren: Now I will provide an update on our novel proprietary cardiac surgical clam.
We believe our cell effects S. PFA surgical clamp has the potential to significantly change the way cardiac surgical ablation is done in cardiac surgery.
Darren: Our preclinical data demonstrate the potential for the clamp to improve safety effectiveness ease of use and treatment speed.
Darren: The data demonstrate the NSP FAA clamp can produce continuous transmitter all durable lesions in 125 seconds independent of tissue thickness or tight as compared to 15 to 30 seconds for thermal ablation modalities, which are highly dependent on tissue thickness type and vasculature.
Darren: And due to the non thermal mechanism of action the cell effects N. S. PFA clamp has no risk of thermal damage to collateral tissue, which is a known risk with current thermal technologies importantly.
Darrin R. Uecker: Importantly, shorter treatment times could eliminate the need for on pump treatments, making it a much more acceptable procedure for cardiac surgery. The CellFX NSPFA clamp is designed in a familiar form factor to what is currently being used by cardiac surgeons using radiofrequency ablation. And we expect this familiarity will enable a seamless transition from current radiofrequency ablation devices to our CellFX NSPFA clamp. We are currently planning our first in-human feasibility clinical study for the CellFX NSPFA Surgical CLAM and expect to enroll our first trial patients in the middle of the year. Preclinical data on the CellFX NSPFA clamp will be presented at two important upcoming scientific meetings. Two abstracts have been accepted for presentation at the American Academy of Thoracic Surgeons 104th Annual Meeting in Toronto, April 27th through the 30th.
Darren: Importantly, shorter treatment times could eliminate the need for <unk> treatments, making it a much more acceptable procedure for cardiac surgeons.
Darren: The <unk> NSP FAA clamp is designed in a familiar form factor to what is currently being used by cardiac surgeons using radiofrequency ablation and we expect this familiarity will enable a seamless transition from current radiofrequency ablation devices to our cell effects NSP FAA clam.
Darren: We are currently planning our first in human feasibility clinical study for the <unk> NSP FAA surgical claim and expect to enroll our first trial patients in the middle of the year.
Darren: Preclinical data on the cell effects NSP FAA clamp will be presented at two important upcoming scientific meetings.
Darren: Abstracts have been accepted for presentation at the American Academy of thoracic Surgeons, 104th annual meeting in Toronto April 27 through the 30.
Darrin R. Uecker: The data for one of the abstracts, generated by Pulse Biosciences, will be presented by Dr. Gann Duddington, our Chief Medical Officer of Cardiac Surgery, and the other by the Cardiothoracic Surgery Research Team at Washington University, a research partner of ours led by Dr. Ralph Damiani. Two abstracts have also been accepted to the Heart Rhythm Society 2024 meeting in Boston, both presented by Pulse Biosciences. On the regulatory front, we submitted a 510K for the CellFX NSPFA clamp at the end of December. We recently received an additional information letter from the FDA regarding this submission and had an initial meeting to discuss the letter with the FDA. The meeting was productive, and we expect a follow-up meeting with the FDA to discuss whether additional data will be required.
Darren: The data for one of the abstracts generated by pulse Biosciences will be presented by Dr. Gan Dunnington, our chief Medical officer, cardiac surgery and the other by the cardio thoracic surgery research team at Washington University, a research partner of ours led by Dr. Ralph Damiano.
Darren: Two abstracts have also been accepted to the heart Rhythm Society 2024 meeting in Boston.
Darren: Both presented by pulse Biosciences.
Darren: On the regulatory front, we submitted a 500 10-K for the cell effects NSP FAA clamp at the end of December. We recently received an additional information letter from the FDA regarding the submission and had an initial meeting to discuss the letter with the FDA. The meeting was productive and we expect a follow up meeting with the FDA to discuss whether additional data.
Darren: Will be required.
Darrin R. Uecker: At this point in time, we remain in the 510K process and look forward to working through the regulatory process with the FDA in a collaborative manner. The performance of both our cardiac ablation clamp and catheter has strengthened our confidence that our proprietary designed and engineered CellFX NSPFA energy delivery system is the next generation in PFA technology, with the potential to transform the treatment of atrial fibrillation. And as Mitch will describe, we believe the CellFX platform has the potential to transform general surgical ablation via the use of our recently cleared percutaneous electrodes. Thanks, Darrin.
Darren: At this point in time, we remain in the five 10-K process and look forward to working through the regulatory process with the FDA in a collaborative manner.
Darren: The performance of both our cardiac ablation clamp and catheter have strengthened our confidence that our proprietary designed and engineered cell effects <unk> energy delivery system is the next generation in PSA technology with the potential to transform the treatment of atrial fibrillation and as Michel described we believe.
Darren: <unk> platform has the potential to transform general surgical ablation via the use of our recently cleared percutaneous electric.
Darren: Mitch. Thanks, Darrin, we continue to believe that <unk> NSP FAA energy will broaden treatment horizons for many applications with its unique and effective mechanism of action as Darren outlined.
Mitchell E. Levinson: We continue to believe that CellFX NSPFA Energy will broaden treatment horizons for many applications with its unique and effective mechanism of action, as Darrin outlined. As Kevin mentioned, we recently received FDA 510K clearance for our proprietary Cellifex NSPFA percutaneous electrode system for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures. This clearance represents our entrance into a new set of clinical applications where our technology can improve the standard of care. The Cellifex NSPFA percutaneous electrode system consists of a percutaneous needle electrode powered by our proprietary designed and engineered Cellifex NSPFA energy delivery system. This percutaneous electrode is intentionally designed for non-cardiac tissue ablation applications. As we have mentioned, we have numerous soft tissue ablation targets in the process of evaluation, one of which is benign soft tissue nodules. As we previously discussed, the standard of care for benign thyroid nodules is thyroidectomy, removal of part or all of the thyroid gland, which comes with surgical risks, visible scarring, and often lifelong hormone replacement therapy.
Darren: As Kevin mentioned, we recently received FDA five 10-K clearance for our proprietary <unk> N S. PFA percutaneous electrode system for use in the ablation of soft tissue in percutaneous and intra operative surgical procedures.
Darren: This clearance represents our entrance into a new set of clinical applications, where our technology can improve the standard of care.
Darren: <unk> is PSA percutaneous electrode system consists of a percutaneous needle electrodes powered by our proprietary designed and engineered cell effects and as PSA energy delivery system.
Darren: This percutaneous electrode is intentionally designed for non cardiac tissue ablation applications.
Darren: As we've mentioned we have numerous soft tissue ablation targets in the process of evaluation, one of which is benign soft tissue nodules.
Darren: As we previously discussed the standard of care for benign thyroid nodules is thyroidectomy removal of part or all of the thyroid gland, which comes with surgical risks visible scarring and orphan lifelong hormone replacement therapy.
Mitchell E. Levinson: Thermal ablation using radiofrequency or microwave is other treatment options but carry with them the risks of collateral thermal damage to nerves, vessels, the esophagus, trachea, and skin. For these reasons, many patients with unwanted benign soft tissue nodules forgo surgery or thermal ablation and simply choose to live with the condition. We believe Pulse Biosciences' NSPFA technology can potentially bridge the watchful waiting gap and potentially service these unmet needs. We've completed enrollment of 30 patients in our Italian study of patients with benign thyroid tumors with our NSPFA percutaneous electrode using ultrasound guidance. The procedures we performed appear to be comfortable for patients with little or no reported post-procedural pain or swelling.
Darren: Ablation, using radiofrequency or microwave or other treatment options, but carry with them the risks of collateral thermal damage to nerves vessels, the esophagus trachea in skin.
Darren: For these reasons, many patients with unwanted benign soft tissue nodules, forego surgery, where thermal ablation and simply choose to live with the condition.
Darren: We believe pulse biosciences, and PSA technology could potentially bridge, the watchful waiting gap and potentially service these unmet needs.
Darren: We've completed enrollment of 30 patients in our Italian study of patients with benign fibroid tumors with our <unk> PSA percutaneous electrode using ultrasound guidance.
Darren: The procedures, we performed appeared to be comfortable for patients with little or no reported post procedural pain or swelling.
Mitchell E. Levinson: We are continuing to conduct patient follow-ups at 90, 180, and 360-day time points following the procedure. Initial procedure results are extremely encouraging. Treated tissue was rapidly resorbed in just weeks after treatment with no evidence of thermal damage or residual scar in the treated areas at 30 days and all the way out to 180 days post-treatment. As noted, our principal investigator, Dr. Stephanos Pietia, plans to provide a readout of the latest data at an upcoming scientific meeting later this year. The increasing evidence indicates that NSPFA energy is an extremely promising alternative to surgery or thermal ablation modalities like RF or microwave.
Darren: We are continuing to conduct patient follow ups at 90, 180, and 360 day time points following the procedure.
Darren: Initial procedure results are extremely encouraging treated tissue was rapidly resorbs and just weeks after treatment with no evidence of thermal damage or residual scar in the treated areas at 30 days and all the way out to 180 days post treatment.
Dr Stefanos: As noted our principal investigator Dr Stefanos.
Dr Stefanos: <unk> plans to provide a readout of the latest data at an upcoming scientific meeting later this year.
Dr Stefanos: The increasing evidence indicates <unk> energy is an extremely promising alternative to surgery or thermal ablation modalities like RF microwave.
Mitchell E. Levinson: At the 2024 NASIT annual meeting in February, Dr. Spietziat presented groundbreaking early data from our thyroid nodule study offering a new horizon in the non-thermal, minimally invasive treatment of thyroid nodules, which was well received by his physician peers. We're pleased that awareness and understanding of Pulse Biosciences technology continues to grow amongst the clinical community. As we pave the way into non-cardiac applications with a current physician focus on the treatment of benign thyroid nodules, we are pleased to be guided by experienced medical professionals. Dr. Ralph DeFano, a world-renowned pioneer in head and neck surgery, has accepted a role as Senior Advisor and Scientific Advisory Board Chair, Head and Neck Surgery.
Dr Stefanos: At the 2024 and Massad annual meeting in February Dr. <unk> presented groundbreaking early data from our thyroid nodule steady offering a new horizon in the non thermal minimally invasive treatment of thyroid nodules, which was well received by his position peers.
Dr Stefanos: We're pleased that awareness and understanding of pulse Biosciences technology continues to grow amongst the clinical community.
Dr Stefanos: As we pave the way into non cardiac applications with our current position and focus on the treatment of benign thyroid nodules. We are pleased to be guided by experienced medical professionals Dr.
Robert Lovgren: Dr. Ralph to final at World renowned pioneer in head and neck surgery has accepted a role as senior adviser and scientific Advisory Board Chair head and neck surgery.
Mitchell E. Levinson: Dr. Tufano currently holds the positions of Clinical Professor of Surgery at the Florida State University College of Medicine and Medical Director Head in Endocrine Surgery for the Sarasota Memorial Health Care System in Sarasota, Florida, and brings extensive expertise in novel treatment techniques for thyroid and parathyroid surgery. Dr. Tufano will perform the first commercial cases using the Cellifex NSPFA percutaneous electrode system and will help in selecting and training our first set of early users throughout the balance of the year. We have been preparing internally for this 510K milestone. Our launch program will pair members of our team with key opinion leaders who are experts in ultrasound-guided ablation. We expect initial training to be straightforward as the system and procedure are intuitive and similar to existing RF ablation procedures.
Robert Lovgren: Factor to final currently holds the positions of clinical professor of surgery at the Florida State University College of Medicine, and medical director head and endocrine surgery for the Sarasota Memorial healthcare system in Sarasota, Florida and brings extensive expertise in novel treatment techniques for thyroid and parents.
Robert Lovgren: <unk> surgery.
Robert Lovgren: Dr. <unk> will perform the first commercial cases, using the <unk> and its PFA percutaneous electric system and will help in selecting and training. Our first set of early users throughout the balance of the year.
Robert Lovgren: We have been preparing internally for this five 10-K milestone our launch program will partner members of our team with key opinion leaders, who are experts in ultrasound guided ablation. We expect initial training to be straightforward as the system and procedure are intuitive and similar to existing RF ablation procedures.
Robert Lovgren: We expect to leverage the expertise of early users to create a reproducible process in clinics to ensure optimal clinical outcomes.
Michael Koffler: We expect to leverage the expertise of early users to create a reproducible process in clinics to ensure optimal clinical outcomes. Later this year, we plan to initiate a U.S. IDE post-market study in benign thyroid treatments and a European study to support a CE mark, opening the opportunity to commercialize in Europe. Now, I'll pass the call over to Mike Koffler for an update on our financial resources. Thank you, Mitch.
Robert Lovgren: Later this year, we plan to initiate a U S E post market study and benign thyroid treatments and a European study to support CE Mark opening the opportunity to commercialize in Europe.
Robert Lovgren: Now I'll pass the call over to Mike <unk> for an update on our financial results.
Michael Koffler: Mitch moving down the income statement I'll focus my comments on our non-GAAP 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: Moving down the income statement, I'll focus my comments on our non-GAAP results. I encourage you to review today's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. In the fourth quarter of 2023, non-GAAP total costs and expenses increased by $1.2 million to $8.9 million, compared to $7.7 million in the prior year period. The increase in total costs and expenses was primarily driven by an increase in research and development expenses to support the advancement of our CellFX and SPFA devices. Non-GAAP net loss in the fourth quarter of 2023 was $8.3 million, compared to $8.1 million in the prior year period.
Michael Koffler: In the fourth quarter of 2023, non-GAAP total costs and expenses increased by $1 2 million to $8 9 million compared to $7 7 million in the prior year period the.
Michael Koffler: The increase in total costs and expenses was primarily driven by an increase in research and development expenses to support the advancement of our cell FX and S. Psa devices.
Michael Koffler: non-GAAP net loss in the fourth quarter of 2023 was $8 3 million compared to $8 1 million in the prior year period.
Michael Koffler: Cash and cash equivalents totaled $44 4 million as of December 31, 2023, compared to $50 4 million as of September 32023.
Cash used in the fourth quarter of 2023 totaled $6 9 million and was reduced compared to 8 million used in the same period in the prior year and $8 7 million used in the third quarter of 2023.
None: Earlier today, the company filed a universal shelf registration with the SEC, we believe maintaining a shelf is consistent with good corporate practices for a public company.
Michael Koffler: Cash and cash equivalents totaled $44.4 million as of December 31, 2023 compared to $50.4 million as of September 30, 2023. Cash used in the fourth quarter of 2023 totaled $6.9 million and was reduced compared to $8 million used in the same period in the prior year and $8.7 million used in the third quarter of 2023. Earlier today, the company filed a universal shelf registration with the SEC. We believe maintaining a shelf is consistent with good corporate practices for a public company. I will now turn the call back over to Kevin. Thank you, Mike. I will now provide some closing remarks. As we continue in 2024, our focus as a company is to continue building on the momentum of 2023. With the recent 510K FDA clearance for the percutaneous electrode, it is our intention to further create the internal and external architecture and support amongst KOLs to ensure and enhance our adoption campaign.
None: I will now turn the call back over to Kevin.
Kevin Danaher: Thank you Mike I will now provide some closing remarks.
Kevin Danaher: As we continue in 2024, our focus as a company is to continue building on the momentum of 2023.
Kevin Danaher: With the recent 500 10-K FDA clearance for the percutaneous electro it is our intention to further create the internal an extra turn on architecture and support amongst kols to ensure and enhance our adoption campaign.
Kevin Danaher: To fund our future operations as detailed in our press release. The company has filed a preliminary registration statement with the U S Securities and Exchange Commission, the SEC to establish a universal shelf pursuant to which once it is effective the comfort on company may from time to time sell an aggregate of 50.
Kevin Danaher: Worth of its common stock preferred stock depositary shares warrants debt securities are units. Additionally earlier today, the company announced that the board of directors has approved a rights offering of up to $60 million worth of units available to all holders of record of the company's common.
Kevin Danaher: Stock as of the close of the market on the record date in April to be announced as soon as practicable.
Kevin Danaher: Each unit will consist of one share of common stock and warrants to purchase a total of one share of common stock.
Kevin Danaher: The subscription price per unit Shelby equal to the lesser of a $10 per unit, which we will refer to as the initial price or be the 10 day wrap of the Companys common stock immediately prior to the expiration date of the offering the route is a volume weighted average price.
Michael Koffler: To fund its future operations, as detailed in a press release, the company has filed a preliminary registration statement with the U.S. Securities and Exchange Commission, the SEC, to establish a universal shelf pursuant to which, once it is effective, the company may, from time to time, sell an aggregate of $50 million worth of its common stock, preferred stock, depository shares, warrants, debt securities, or units. Additionally, early today, the company announced that the Board of Directors has approved a rights offering of up to $60 million worth of units available to all holders of record of the company's common stock as of the close of the market on the recorded date in April, to be announced as soon as practicable. Each unit will consist of one share of common stock and warrants to purchase a total of one additional share of common stock. The subscription price per unit shall be equal to the lesser of A, $10 per unit, which we will refer to as the initial price, or B, the 10-day VWAP of the company's common stock immediately prior to the expiration date of the offering. VWAP is the volume-weighted average price.
Kevin Danaher: The subscription price will determine the final number of units issuable and subsequently the pro rata number of units to which a stockholder can subscribe.
Kevin Danaher: Each warrant will have a per share exercise price equal to 110% of the subscription price for the unit the company intends to distribute to all holders of common stock as of the record date, a non transferable subscription rights to purchase units at the price provided.
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 would receive additional proceeds up to $66 million. The rights offering will include an oversubscription right.
Kevin Danaher: To permit each rights holders that exercises its basic subscription rights in full to purchase additional units that remain unsubscribe at the exploration of the offering.
Kevin Danaher: The availability of the Oversubscription rights will be subject to certain terms and conditions to be set forth in the offering documents.
Kevin Danahy: The subscription price will determine the final number of units issuable and, subsequently, the pro rata number of units to which a stockholder can subscribe. Additionally, each warrant will have a per share exercise price equal to 110% of the subscription price for the unit. The company intends to distribute to all holders of common stock as of the record date a non-transferable subscription right to purchase units at the price provided. 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, would receive additional proceeds of up to $66 million.
Kevin Danaher: Bob Duggan, our executive Chairman and majority stockholder has indicated that he is in support of the rights offering and expects to participate the company intends to register the rights offering with the SEC by filing a prospectus on form S. Three when available a copy of the prospectus may be obtained at the website.
Kevin Danaher: Maintained by the SEC at Www Dot SEC Dot Gov. The rights offering will be made pursuant to the registration statement on form S. Three containing the detailed terms of the rights offering to be filed with the SEC.
Kevin Danaher: Any offer will be made only by means of a prospectus for a part of the registration statement.
None: We look forward to providing additional updates on our next call joining me for our question and answer session. Today are executive Chairman of the Board Robert Duggan, Chief Technology Officer, and director, Darren <unk>, Chief Strategy Officer, Mitch Levinson, and Vice President of Finance might Koffler operator, Please open the call for questions.
None: <unk>.
None: Thank you Kevin.
None: Now we're going to address a few questions. We've received over email then we'll open up the line for questions from the audience.
Kevin Danahy: The rights offering will include an oversubscription right to permit each rights holder that exercises its basic subscription rights in full to purchase additional units that remain unsubscribed at the expiration of the offering. The availability of the oversubscription right will be subject to certain terms and conditions to be set forth in the offering document. Bob Duggan, our Executive Chairman and Majority Stockholder, has indicated that he is in support of the rights offering and expects to participate. The company intends to register the rights offering with the SEC by filing a prospectus on Form S-3. When available, a copy of the prospectus may be obtained on the website maintained by the SEC at www.sec.gov.
None: The first question is.
None: What is the timeline for the commercialization of the percutaneous electrode what are your revenue expectations for this year.
None: Yes. Thanks, Ed This is Mitch I can take that one so this percutaneous electrode with its general ablation clearance is going to be useful for a lot of soft tissue applications, but as I mentioned the.
Mitchell E. Levinson: Primary application, we're going to start with is in benign thyroid nodule ablation.
None: This technology is highly differentiated as brand new to this space, it's going to be disruptive.
Ed: And so what we're gonna be doing first thing is to be working with our key opinion leaders who are experts in ultrasound guided.
Kevin Danahy: The rights offering will be made pursuant to a registration statement on Form S-3 containing the detailed terms of the rights offering to be filed with the SEC. Any offer will be made only by means of the prospectus for a part of the registration statement. We look forward to providing additional updates on our next call. Joining me for a question and answer session today are Executive Chairman of the Board, Robert Duggan, Chief Technology Officer and Director, Darrin Uecker, Chief Strategy Officer, Mitch Levinson, and Vice President of Finance, Mike Koffler. Operator, please open the call for questions. Thank you, Kevin.
Ed: Percutaneous ablation, we're going to be optimizing the procedure, we're going to be working towards the ideal outcomes. We're going to ensure that this procedure is reproducible it's teachable.
Ed: We're going to be building, our internal or external structures and as soon as we understand all of those and have all those pieces in place and we've got our structure, we're going to be hitting the gas and we're going to be accelerating we're very excited to get this product out as soon as we're ready to into.
As many patients as we can and we're looking forward to updating you on a quarter over quarter basis, and we will keep you posted and Mitch I'll just jump in and just to add a little bit more we have been working extensively on the internal and external architecture to support this five 10-K clearance.
Operator: 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 question is... What is the timeline for the commercialization of the percutaneous electrode? What are your revenue expectations for this? Yeah, thanks. This is Mitch. I can take that one.
Mitchell E. Levinson: We're excited too.
Mitchell E. Levinson: Report that we have many surgeons that have reached out to us we've been working with them and again, we're just putting that architecture in place that we can show that it's reproducible and teachable and we know it's better than existing technology to get it out there and we will update on a quarterly basis on where we stand.
Mitchell E. Levinson: So this percutaneous electrode, with its general ablation clearance, is going to be useful for a lot of soft tissue applications. But, as I mentioned, the primary application we're going to start with is benign thyroid nodule ablation. This technology is highly differentiated. It's brand new to this space.
Mitchell E. Levinson: Alright. The next one is can you provide more detail on the first in human study for the cardiac clamp.
Mitchell E. Levinson: Yes. This is darrin I'm happy to do that yes, we announced today that we're going to be doing a first in human feasibility study start.
Mitchell E. Levinson: It's going to be disruptive. And so what we're going to be doing, first thing, is to work with our key opinion leaders who are experts in ultrasound-guided percutaneous ablation. We're going to be optimizing the procedure. We're going to be working toward ideal outcomes. We're going to ensure that this procedure is reproducible, and it's teachable. We're going to be building our internal and external structures. And as soon as we understand all of that and have all those pieces in place, and we've got our structure, we're going to be hitting the gas, and we're going to be accelerating.
Darrin R. Uecker: Starting in the middle of the year and really this is just in response to a couple of things number one just the substantial interest that we've had from cardiac surgeons.
On this clamp and this new technology in their high interest in getting it into the clinic and really based on all the success, we've had with our catheter feasibility study as well as the success with our percutaneous electrode and the feasibility study.
Darrin R. Uecker: That we did with that we just felt like the time was now too to do our first in human study feasibility study with our client and so we're well on our way to doing that and we have to go through.
Mitchell E. Levinson: We're very excited to get this product out as soon as we're ready for as many patients as we can. And we're looking forward to updating you on a quarter-over-quarter basis, and we'll keep you posted. Yeah. And Mitch, I'll just jump in just to add a little bit more.
Darrin R. Uecker: The regulatory bodies to get this study approved we expect to do that outside the U S and again.
Kevin Danahy: We have been working extensively on the internal and external architecture to support this 510K clearance, and we're excited to report that we have many surgeons that have reached out to us. We've been working with them, and again, we're just putting that architecture in place so we can show that it's reproducible and teachable, and we know it's better than existing technology to get it out there. And we will update you on a quarterly basis on where we stand. Alright, the next one is, can you provide more detail on the first in human study for the cardiac clamp? Yeah, this is Darrin.
Darrin R. Uecker: And again, we're going to do that starting in the middle of the year. So it's really just based on all the excitement around it and the success we've had running feasibility studies with some of our other devices.
None: Alright, the next question.
None: You mentioned using the insight and cargo systems with the catheter can you elaborate on the mapping integration strategy.
None: Yeah. This is Darren again so.
None: I think we.
Darren: With our catheter the goal is to make sure that electrophysiologist have.
Darren: We are well integrated solution in their labs to be able to treat their patients effectively and so we listen to those electrophysiologist and try to understand what kind of tools they need what kind of tools they are using.
Darrin R. Uecker: I'm happy to do that. Yeah, we announced today that we're going to be doing a first in human feasibility study starting in the middle of the year. And really, this is just in response to a couple things.
Darren: We want to be compatible with all of those tools. So we started in our feasibility study with our catheter integrated with mapping and navigation and and have seen what we think are very encouraging results.
Darrin R. Uecker: Number one, just the substantial interest that we've had from cardiac surgeons on this clamp and this new technology and their high interest in getting it into the clinic. And really, based on all the success we've had with our catheter feasibility study, as well as the success with our percutaneous electrode and the feasibility study that we did with that, we just felt like the time was now to do a first in human study feasibility study with our clamp. And so we're well on our way to doing that. We have to go through regulatory bodies to get the study approved. We expect to do that outside the U.S., and again, we're going to do that starting in the middle of the year.
Darren: In conversation with a number of the EPS, who have been involved with that they requested that we work on integrating with other mapping and navigation systems to really.
Create a.
Darren: Our system, where we can be compatible with almost every EP lab in the world. Today. So there are several mapping and navigation systems out there there are a couple which we've talked about and that sort of dominate this space in.
In particular, the cargo system from J&J and the insight system from Abbott and so it's incumbent on us to work to be compatible with those systems. So that we can provide EPS with fully integrated solutions to treat their patients. So that's that's our current strategy.
Darrin R. Uecker: So it's really just based on all the excitement around it and the success we've had running feasibility studies with some of our other devices. Alright, the next question is: you mentioned using the NCITE and CARTOS systems with the catheter. Can you elaborate on the mapping integration strategy? Yeah, this is Darrin again.
None: Alright, operator, let's now open the line from questions from our listeners.
None: Thank you.
None: At this time, we will now 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.
Darrin R. Uecker: So, you know, I think we, with our catheter, the goal is to make sure that electrophysiologists have a well-integrated solution in their labs to be able to treat their patients effectively. And so we listen to those electrophysiologists and try to understand what kind of tools they need, what kind of tools they're using, and we want to be compatible with all those tools. So we started our feasibility study with our catheter integrated with mapping and navigation and have seen, you know, what we think are very encouraging results. In conversation with a number of the EPs who have been involved with that, they requested that we work on integrating with other mapping and navigation systems to really create a system where we can be compatible with almost every EP lab that's in the world today. So, you know, there are several mapping and navigation systems out there.
None: May press Star two if he would like to remove your question from the queue.
None: Ask that you limit yourself to one question and a follow up so that others may have an opportunity to ask questions.
None: It disappoints using speaker equipment, it may be necessary to pick up your handset before pressing the starkey.
None: One moment, please while we poll for question.
None: Okay.
None: Our first question comes from Anthony Petrone with Mizuho Securities. Please proceed with your question.
None: Hey, there guys, how you're doing you have Brad Bowers on for Anthony today.
Anthony Petrone: Just wanted to kind of hear first off about the thyroid indication it seems like you've kind of a pretty broad indication there with them with the recent approval. So wanted to kind of hear more about the strategy of going after the thyroid markets first is it something about the size of the market the opportunity versus incumbents or something about ease of entry in the market just wanted to hear about that thank you.
Darrin R. Uecker: There are a couple, which we've talked about, that sort of dominate this space, in particular the CARDO system from J&J and the Insight system from Abbott. And so it's incumbent on us to work to be compatible with those systems so that we can provide EPs with fully integrated solutions to treat their patients. So that's our current strategy. All right, operator, let's now open the line for questions from our listeners. Thank you. At this time, 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 that your line is in the queue. You may press star 2 if you would like to remove your question from the queue.
Anthony Petrone: Yeah.
Anthony Petrone: Yes, Hey, thanks, Brad This is Mitch thanks for that question, yes. The fibroid nodules are benign thyroid nodules in particular represents a very large market that we believe is mostly untapped because the technology has not really been there to meet that unmet need.
Anthony Petrone: And it also is a it's an.
Anthony Petrone: It's a nice benign tumor that is.
Anthony Petrone: <unk> performed by our our technology in a with ultrasound guidance and it's a really good step forward out into soft tissue ablation.
Operator: We ask that you limit yourself to one question and a follow-up so that others may have an opportunity to ask questions. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button. One moment, please, while we poll for questions. Our first question comes from Anthony Patron with Mizuho Securities. Please proceed with your question. Hey there, guys. How are you doing? You have Brad Bowers on for Anthony today.
Anthony Petrone: The tumor so that's why we've decided to start there.
Anthony Petrone: We expect that people in parallel with that and subsequently after we have got some initial experience we will be using this in all sorts of soft tissue applications.
Robert W. Duggan: That's helpful Bob.
Robert W. Duggan: Yeah, Bob Bob This is Bob let me make a comment here, we have clearance from the FDA with regard to soft tissue ablation.
Mitchell E. Levinson: Just wanted to kind of hear first off about, you know, the thyroid indication. You seem like you kind of have a pretty broad indication there with the recent approval. So I wanted to kind of hear more about the strategy of going after the thyroid market first. Is it something about the size of the market, the opportunity versus incumbents, or something about, you know, the ease of entering the market?
Robert W. Duggan: We do not have a specific label for thyroid thyroid falls under the umbrella of soft tissue ablation. So it is customary in this business for the treating physician to choose the soft tissue.
None: They they would like to approach so everything else is as Mitch laid it out, but we want to make very sure. We're not claiming that we have a clearance for thyroid but soft tissue includes thyroid. So we will we market. This in the direction of soft tissue ablation clearance.
Mitchell E. Levinson: Just wanted to hear about that. Thank you. Yeah. Hey, thanks, Brad. This is Mitch.
Mitchell E. Levinson: Thanks for that question. Yeah, the thyroid nodule, benign thyroid nodules in particular, represents a very large market that we believe is mostly untapped because the technology has not really been there to meet that unmet need. And it also is a nice benign tumor that is well performed by our technology with ultrasound guidance.
None: Understood. Thank you for the clarification, there and then one on.
None: On the <unk> product just wanted to kind of hear about some of the commercially commercialization plans that you can kind of do here, while the submission is underway.
Robert W. Duggan: And it's a really good step forward into soft tissue ablation in a tumor. So that's why we've decided to start there. And then, in parallel with that, and subsequently, after we have got some initial experience, we'll be using this in all sorts of soft tissue applications. This is Bob Duggan. Please, let me make a comment here. We have clearance from the FDA with regard to soft tissue ablation; however, thyroid falls under the umbrella of soft tissue ablation.
None: <unk> talked about some of the advantages versus the incumbent technologies and just wanted to kind of hear about your view of the opportunity and how you think about taking advantage of that out of the gate here. Thank you.
None: Yeah. This is Kevin. Thank you for the question as is same with the percutaneous electrode. We continue to look at the internal and external requirements that are going to be needed to launch any of our products and one of the things that we take very serious is just what is the architecture of support that is going to be needed in the operating room and some of our predecessors.
Robert W. Duggan: So it is customary in this business for the treating physician to choose the soft tissue that they would like to approach. So everything else is as Mitch laid it out, but we want to make very sure we're not claiming that we have clearance for thyroid. But soft tissue includes thyroid, so we market this in the direction of soft tissue ablation clearance.
None: Be there for all cases, we want to be in a place that we put a program in place that allows the account to absorb the information is talk correctly and that we can have a walk away that we transfer the knowledge over to them to empower them to do the cases on their own so as we build out our architecture, we want to be very aware of.
Kevin Danahy: Understood. Thank you for the clarifications there. And then one on the CLAM product, just wanted to kind of hear about some of the commercialization plans that you can kind of do here while the submission is underway. You know, you talked about some of the advantages versus the incumbent technologies. So I just wanted to kind of hear about your view of the opportunity and how you think about taking advantage of that right out of the gate here. Thank you. Yeah, this is Kevin.
None: What is needed in order for them to be become really secure in the procedure and then what is going to be needed in an ongoing basis. So those are still in design is as we work with the FDA for clearance and with the claim specifically, but at the same type of philosophy that we're going to use with all indications that we bring.
Kevin Danahy: Thank you for the question. As with the percutaneous electrode, we continue to look at the internal and external requirements that are going to be needed to launch any of our products. And one of the things that we take very seriously is just what the architecture of support that is going to be needed in the operating room. And some of our predecessors might have been there for all cases. We want to be in a place that we put a program in place that allows the account to absorb the information, be taught correctly, and that we can have a walk-away that we've transferred the knowledge over to them to empower them to do the cases on their own. So as we build out our architecture, we want to be very aware of what is needed in order for them to become really secure in the procedure, and then what is going to be needed on an So those are still in design as we work with the FDA for clearance and with the clamps specifically, but it's the same type of philosophy that we're going to use with all indications that we bring. Thank you. Yep.
None: Thank you.
None: Yep.
None: As a reminder, if you'd like to ask a question. Please press star one on your telephone keypad.
None: Okay.
None: Yeah.
None: It appears that there are no further questions at this time I would now like to turn the floor back over to Kevin Johnson for closing comments. Thank.
Thank you operator, and thank you all for joining us today as we reflect on 2023 and we look to 2024, we're extremely proud of the accomplishments that we've had and the milestones that we've achieved but we know that we're just at the beginning of this journey and we're excited that you have all decided to take this journey with us nanosecond pulsed field ablation.
None: Is a paradigm shift and we believe that this energy is going to change the way that surgery is done in multiple domains and we're excited to bring that update to you on a quarter to quarter basis. So please stay tuned stay on this journey with US there is tremendous excitement coming and we're excited that you're all part of this so thank you for joining on this call today, and we look forward to talking to you.
Operator: As a reminder, if you'd like to ask a question, please press star 1 on your telephone keypad. It appears that there are no further questions at this time. I would now like to turn the floor back over to Kevin Danahy for closing comments.
Kevin Danahy: Thank you, Operator, and thank you all for joining us today. You know, as we can reflect on 2023 and we look to 2024, we're extremely proud of the accomplishments that we've had and the milestones that we've achieved. But we know that we're just at the beginning of this journey, and we're excited that you've all decided to take this journey with us. Nanosecond pulse field ablation is a paradigm shift, and we believe that this energy is going to change the way that surgery is done in multiple domains.
Soon.
None: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
None: Yeah.
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None: [music].
Operator: And we're excited to bring that update to you on a quarterly basis. So please stay tuned, stay on this journey with us. There's tremendous excitement coming, and we're excited that you're all part of this. So thank you for joining us on this call today, and we look forward to talking to you soon. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
None: Hum.
None: Hum.
None: Uh-huh.
None: Okay.
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None: Okay.
None: [music].
None: Hum.
None: [music].
None: Okay.
None: [music].
None: Mhm.
None: Okay.
None: Hum.
None: Hello.
None: Oh.
None: Uh-huh.
None: Okay.
None: [music].
None: Yeah.
None: [music].
None: Oh.
None: [music].
None: Hum.
None:
None: Yeah.
None: Hum.
None: Yeah.
None: Hum.
None: Yeah.
None: Hum.
None: Hum.
None: [music].
None: Hum.
None: Mhm.
None: [music].
None: Uh-huh.
None: Yes.
None: Mhm.
None: Hum.
None: Hum.
None: Okay.
None: Hum.
None: [music].
None: Yeah.
None: [music].
None: Hum.
None: Hmm.
None: Uh-huh.
None: Okay.
None:
None: Uh huh.
None: [music].
None: Okay.
None: [music].
None: Hum.
None: [music].
None: Uh huh.
None: [music].
None: Mhm.
None: Hum.
Hum.
None: [music].
None: Hum.
None: Hum.
None: [music].
None: Mhm.
None: [music].
None: Hum.
None: Oh.
None: Mhm.
None: Yes.
None: [music].
None: Oh, Oh Oh.
None: [music].
None: Hum.
None: Yeah.
None: Yeah.
None: Hum.
None: Yeah.
None: [music].
None: Yeah.
Hum.
None: Yeah.
None: Hum.
None: Hum.
None: [music].
None: Hum.
None: Mhm.
None: [music].
None: Hum.