Q2 2024 Pulse Biosciences Inc Earnings Call

August 12, 2024

Speaker Change: Greetings, and welcome to the second quarter 2023 financial results conference call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation.

Operator: At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Tripp Taylor of Investigations. Thank you, and you may begin.

Operator: At this time, all participants are in a listen only mode. For the question and answer session, we'll follow the... If anyone should require operator assistance during a conference, please press star zero and telephone. As a reminder, this conference is being held. It is now my pleasure to introduce myself. I'm Kevin Danahy, and I'm Robert Lovgren. Thank you. 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, August 12, 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.

Speaker Change: 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 of Investigations. Thank you, and you may begin.

Tripp 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, August 12, 2024 only and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations, and other similar information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks are more fully described in our press release issued earlier today and in our filings with the U.S. Securities and Exchange Commission.

Kevin Danahy: 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.

Tripp Taylor: Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties.

Speaker Change: 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.

Tripp Taylor: Our SEC filings can be found on our website or on the SEC's website. However, investors are cautioned not to place undue reliance on forward-looking statements. We disclaim any obligation to update or revise these forward-looking statements. We will also discuss certain non-GAAP financial measures. Disclosures regarding these non-GAAP financial measures, including reconciliations with the most comparable GAAP measures, can be found in the press release. Please note that this conference call will be available for audio replay on our website at PulseBiosciences.com 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 Burke T. Barrett.

Speaker Change: 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.

Speaker Change: 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.

Speaker Change: 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, I would now like to turn the call over to President and Chief Executive Officer Burke T. Barrett.

Robert Lovgren: 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 Burke T. Barrett. Good afternoon, everyone, and thank you for joining us.

Burke T. Barrett: Good afternoon, everyone, and thank you for joining us. I'm glad to be on my first Pulse Biosciences earnings call since being appointed President and CEO of Pulse in May of this year. Today I'll provide updates on our continued business progress, and then Mike Koffler, Vice President of Finance, will review certain second quarter 2024 financial results. Then Bob Duggan, co-chair of the board, Darrin Uecker, chief technology officer and director, and Kevin Danahy, our chief commercial officer, will join me for a question and answer session.

Burke T. Barrett: I'm glad to be on my first Pulse Biosciences earnings call since being appointed President and CEO of Pulse in May of this year. Today I'll provide updates on our continued business progress, and then Mike Koffler, Vice President of Finance, will review certain second quarter 2024 financial results. Then Bob Duggan, co-chair of the board, Darrin Uecker, chief technology officer and director, and Kevin Danahy, our chief commercial officer, will join me for a question and answer session.

Speaker Change: Good afternoon, everyone, and thank you for joining us.

Speaker Change: I'm glad to be on my first Pulse Biosciences earnings call since being appointed President and CEO of Pulse in May of this year.

Speaker Change: Today I'll provide updates on our continued business progress and then Mike Koffler, Vice President of Finance, will review certain second quarter 2024 financial results.

Speaker Change: Then Bob Duggan, co-chair of the board, Darrin Uecker, chief technology officer and director, and Kevin Danahy, our chief commercial officer, will join me for a question and answer session. To begin, I want to briefly describe why I joined PULSE.

Burke T. Barrett: To begin, I want to briefly describe why I joined Pulse. I've been in the medical device space for more than 35 years, but the majority of that time spent pioneering medical devices and focusing my last 20 years on cardiology devices. I believe PULSE's pulse field ablation approach, called Nano-PFA, has the potential to be more transformative than any other innovation I've worked on throughout my career. When you consider all the currently available treatments that use heat, cold, radiation, and other approaches to kill undesirable cells in the body, and the fact that Nano-PFA has the potential to compete with and perhaps even someday supplant.

Burke T. Barrett: To begin, I want to briefly describe why I joined Pulse. I've been in the medical device space for more than 35 years, but the majority of that time spent pioneering medical devices and focusing my last 20 years on cardiology devices. I believe PULSE's Pulse Field Ablation Approach, called Nano-PFA, has the potential to be more transformative than any other innovation I've worked on throughout my career. When you consider all the currently available treatments that use heat, cold, radiation, and other approaches to kill undesirable cells in the body, and the fact that Nano-PFA has the potential to compete with and perhaps even someday supplant.

Speaker Change: I've been in the medical device space for more than 35 years, but the majority of that time spent pioneering medical devices and focusing my last 20 years on cardiology devices.

Burke T. Barrett: Many of these currently available treatments, which translates to Pulse having the opportunity to significantly improve many patients' lives. This is possible because nano-PFA has the potential to kill cells in a better way than heat, cold, radiation, and even currently available micro-PFA.

Speaker Change: I believe PULSE's Pulse Field Ablation Approach, called NanoPFA, has the potential to be more transformative than any other innovation I've worked on throughout my career.

Speaker Change: When you consider all the currently available treatments that use heat, cold, radiation, and other approaches to kill undesirable cells in the body

Speaker Change: and the fact that Nano-PFA has the potential to compete with and perhaps even someday supplant. Many of these currently available treatments

Speaker Change: That translates to Pulse having the opportunity to significantly improve many patients' lives.

Speaker Change: This is possible because nano-PFA has the potential to kill cells in a better way than heat, cold, radiation, and even currently available micro-PFA.

Burke T. Barrett: It's the core of what Pulse does, and as we will describe in a moment, it is showing great promise in the three product lines currently being studied clinically. Beyond these three current products or product lines, I believe that nano PFA energy has the potential to advance the standard of care for the treatment of multiple other disease states and disorders across the human body. The technology is solidly protected by intellectual property and know-how.

Speaker Change: It's the core of what PULSE does, and as we will describe in a moment, it is showing great promise in the three product lines currently being studied clinically.

Speaker Change: Beyond these three current products or product lines, I believe that nano PFA energy has the potential to advance the standard of care for the treatment of multiple other disease states and disorders across the human body.

Speaker Change: The technology is solidly protected with intellectual property and know-how.

Burke T. Barrett: The last reason I joined Pulse is because of the fantastic employees and stakeholders associated with Pulse. The culture at Pulse is patient-focused, results-oriented, and transparent. It's a true privilege to work alongside and support the great Pulse team.

Speaker Change: The last reason I joined PULSE is because of the fantastic employees and stakeholders associated with PULSE.

Speaker Change: The culture at Pulse is patient-focused, results-oriented, and transparent.

Burke T. Barrett: It's a true privilege to work alongside and support the great Pulse team. Pulse is rapidly advancing this next generation nano PFA technology. We have all the foundational elements in place to drive adoption. Proptive Technology College, including scientific expertise, intellectual property, and industry and product know-how.

Speaker Change: It's a true privilege to work alongside and support the Great Pulse team.

Burke T. Barrett: Pulse's team is rapidly advancing this next generation nano PFA technology. We have all the foundational elements in place to drive adoption. For more information, Thank you, including scientific expertise, intellectual property, and industry and product know-how. Pulse Biosciences is the pioneer organization focusing on bringing its novel nanopFA technology to patients since commencing work on it approximately 10 years ago. The pre-company scientific genesis of Pulse's Nano PFA dates back another decade before the founding of Pulse.

Speaker Change: Paul's team is rapidly advancing this next generation nano PFA technology.

Speaker Change: We have all the foundational elements in place to drive adoption of disruptive technology.

Speaker Change: including the scientific expertise intellectual property and industry and product know-how.

Burke T. Barrett: Pulse Biosciences is the pioneer organization focusing on bringing its novel nano-PFA technology to patients since commencing work on it approximately 10 years ago. The pre-company scientific genesis of Pulse's nano-PFA technology dates back another decade before the founding of the company. To date, Pulse has generated massive amounts of preclinical and initial clinical data demonstrating the effects of differentiated nano-PFA energy across different tissue types in the human body. This includes the approximately 6,000 human dermatological skin lesions treated using our cell effect system with a strong safety profile. To my knowledge... Pulse has the largest library of high-quality preclinical images showing the effects of various Nano-PSA energy delivery parameters on numerous types of tissue.

Speaker Change: Pulse Biosciences is the pioneer organization focusing on bringing its novel nano PFA technology to patients.

Speaker Change: since commencing work in it approximately 10 years ago.

Speaker Change: The pre-company scientific genesis of Pulse's Nano PFA dates back another decade before the founding of the company.

Burke T. Barrett: To date, PULSE has generated massive amounts of preclinical and initial clinical data demonstrating the effects of differentiated nano-PFA energy across different tissue types in the human body. This includes the approximately 6,000 human dermatological skin lesions treated using our cell effect system with a strong safety profile. To my knowledge... Pulse has the largest library of high-quality preclinical images showing the effects of various nano-PSA energy delivery parameters on numerous types of tissue. Importantly...

Speaker Change: To date, pulses generated massive amounts of pre-clinical and initial clinical data demonstrating the effects of differentiated nano-PFA energy across different tissue types in the human body.

Speaker Change: This includes the approximately 6,000 human dermatological skin lesions treated using our CellFX system with a strong safety profile.

Speaker Change: To my knowledge,

Speaker Change: FALT has the largest library of high-quality preclinical images showing the effects of various nano-PSA energy delivery parameters on numerous types of tissue.

Burke T. Barrett: Importantly, this solid scientific foundation could lead to accelerated product and clinical development timelines. We are currently focused on developing the path to commercializing devices for soft tissue ablation, epicardial or surgical ablation, and endocardial or catheter ablation. In each of these three clinical categories, there are significant areas of unmet need where Nano-PFA has the potential to improve upon currently available products in terms of overall user experiences and patient outcomes. Our general approach to developing products using Nano-PFA is to produce compelling clinical data to clearly demonstrate the performance of each product.

Burke T. Barrett: This solid scientific foundation could lead to an accelerated product and clinical development timeline. We are currently focused on developing the path to commercializing devices for soft tissue ablation, epicardial or surgical ablation, and endocardial or catheter ablation. In each of these three clinical categories, there are significant areas of unmet need where Nano-PFA has the potential to improve upon currently available products in terms of overall user experiences and patient outcomes. Our general approach to developing products using Nano-PFA is to produce compelling clinical data to clearly demonstrate the performance of each product.

Speaker Change: Importantly, this solid scientific foundation could lead to accelerated product and clinical development timelines.

Speaker Change: We are currently focused on developing the path to commercializing devices for soft tissue ablation.

Speaker Change: epicardial or surgical ablation and endocardial or catheter ablation.

Speaker Change: In each of these three clinical categories, there are significant areas of unmet need where Nano-PFA has the potential to improve upon currently available products in terms of overall user experiences and patient outcomes.

Speaker Change: Our general approach to developing products using Nano-PFA is to produce compelling clinical data to clearly demonstrate the performance of each product.

Burke T. Barrett: Investing in understanding and bringing wide awareness to the science of nanopFA as well as demonstrating clinical performance in a compelling way will, we believe, ultimately lead to more streamlined regulatory review pathways, more differentiated and competitive products, and allow us to compete well in multiple markets from a reimbursement point of view. Clinical data is and will continue to be an important currency at Pulse. Consistent with our plan to invest heavily in compelling clinical data, we plan to pursue regulatory pathways that allow us to label our products with specific indications for use.

Speaker Change: Investing in understanding and bringing wide awareness to the science of nano PFA as well as demonstrating clinical performance in a compelling way will, we believe, ultimately lead to more streamlined regulatory review pathways.

Speaker Change: more differentiated and competitive products.

Speaker Change: and allow us to compete well in multiple markets from a reimbursement point of view.

Speaker Change: Clinical data is and will continue to be an important currency at Pulse.

Speaker Change: Consistent with our plan to invest heavily in compelling clinical data, we plan to pursue regulatory pathways that allow us to label our products with specific indications for use.

Burke T. Barrett: In the U.S., these pathways may include 510ks with clinical data, so-called de novo classification requests, or PMA applications, and this will vary by indication. In general, seeking specific labeled indications as part of the regulatory approval process, while sometimes taking more time, has the following benefits.

Speaker Change: In the U.S., these pathways may include 510ks with clinical data, so-called de novo classification requests, or PMA applications.

Burke T. Barrett: In general, seeking specific labeled indications as part of the regulatory approval process, while sometimes taking more time, has the following benefits. First, the gathered clinical evidence gives clinicians, patients, and other stakeholders increased confidence in the device's safety and effectiveness profile. Second, it will allow for marketing the device as a specific treatment option, rather than as a tool that supports a general tissue type, which is only a general indication state. And third...

Speaker Change: And this will vary by indication.

Speaker Change: In general, seeking specific labeled indications as part of the regulatory approval process, while sometimes taking more time, has the following benefits.

Burke T. Barrett: First, the gathered clinical evidence gives clinicians, patients, and other stakeholders increased confidence in the device's safety and effectiveness profile. Second, it will allow for marketing the device as a specific treatment option, rather than as a tool that supports a general tissue type, which is only a general indication. And third...

Speaker Change: First, the gathered clinical evidence gives clinicians, patients, and other stakeholders increased confidence in the device's safety and effectiveness profile.

Speaker Change: Second, it will allow for marketing the device as a specific treatment option.

Speaker Change: rather than as a tool that supports a general tissue type and that's only a general indication statement.

Burke T. Barrett: It will generally permit more flexibility to market, sell, and train users for a specific approved indication that can enable quicker clinician adoption and market penetration, as well as the democratization of adoption and use when the device is in well-trained hands. This is a very exciting time for Pulse. We had an extremely productive second quarter.

Speaker Change: And third,

Speaker Change: It will generally permit more flexibility to market, sell, and train users for a specific approved indication that can enable quicker clinician adoption and market penetration.

Speaker Change: as well as the democratization of adoption and use when the device is in well-trained hands.

Burke T. Barrett: Some key highlights include, we have delivered major progress on our three devices, completing our first U.S. soft tissue ablation cases following FDA clearance, receiving breakthrough device designation from the U.S. FDA, enrolling in FDA's TAP program, and completing the first in human cases for the company's cardiac surgery system for atrial fibrillation or AF, by presenting a live case with a 360 catheter in a patient with atrial fibr We also expanded our leadership team, moved our headquarters to Miami, Florida while maintaining our Hayward office, and significantly strengthened the balance sheet through our successful rights offering, which transacted in early Q3.

Speaker Change: This is a very exciting time for PULSE.

Burke T. Barrett: Some key highlights include: we have delivered major progress on our three devices, completing our first U.S. soft tissue ablation cases following FDA clearance, and receiving breakthrough device designation from the U.S. FDA. Enrolling in FDA's TAP program and completing the first human cases for the company's cardiac surgery system for atrial fibrillation or AF, by presenting a live case with a 360 catheter in a patient with atrial fibrillation at the prestigious Heart Rhythm Society meeting in May.

Speaker Change: We had an extremely productive second quarter.

Speaker Change: Some key highlights include we have delivered major progress on our three devices, completing our first US soft tissue ablation cases following FDA clearance.

Speaker Change: receiving breakthrough device designation from the US FDA.

Speaker Change: enrolling in FDA's TAP program and completing the first in human cases for the company's cardiac surgery system for atrial fibrillation or AF.

Speaker Change: and presenting a live case with a 360 catheter in a patient with atrial fibrillation at the prestigious Heart Rhythm Society meeting in May.

Burke T. Barrett: We also expanded our leadership team, moved our headquarters to Miami, Florida, while maintaining our Hayward office, and significantly strengthened the balance sheet through our successful rights offering, which transacted in early Q3. As you may know, the exercise of warrants issued in the rights offering could bring in up to an additional $66 million into the company. Notably, the company has the ability to redeem half of these warrants, with the potential to raise up to $33 million if our volume-weighted share price is at $1,650 or more for 20 consecutive trading days, as well as the ability to redeem the second half of these warrants, with the potential to raise up to an additional $33 million if our volume-weighted share price trades at or above $22 for 20 consecutive days.

Speaker Change: We also expanded our leadership team, moved our headquarters to Miami, Florida, while maintaining our Hayward office, and significantly strengthened the balance sheet through our successful rights offering, which transacted in early Q3.

Burke T. Barrett: As you may know, the exercise of warrants issued in the rights offering could bring in up to an additional $66 million into the company. Notably, the company has the ability to redeem half of these warrants, with the potential to raise up to $33 million if our volume-weighted share price is at $1,650 or more for 20 consecutive trading days, as well as the ability to redeem the second half of these warrants, with the potential to raise up to an additional $33 million if our volume-weighted share price trades at or above $22 for 20 consecutive days.

Speaker Change: As you may know, the exercise of warrants issued in the rights offering could bring into the company up to an additional $66 million.

Speaker Change: Notably, the company has the ability to redeem half of these warrants.

Speaker Change: with the potential to raise up to $33 million if our volume-weighted share price is at $1650 or more for 20 consecutive trading days.

Speaker Change: as well as the ability to redeem the second half of these warrants.

Speaker Change: with the potential to raise up to an additional 33 million if our volume weighted share price trades at or above $22 for 20 consecutive days.

Burke T. Barrett: I will now dive into more details on our significant progress, along with providing some near-term clinical and regulatory goals, starting with our soft tissue ablation application. Physicians utilize soft tissue ablation in a broad array of procedures, such as those involving the thyroid, liver, breast, as well as many other parts of the body. Nano-PFA has delivered very promising initial clinical results in the soft tissue ablation of benign thyroid nodules via our percutaneous needle electrode, which we call the CellFX percutaneous electrode.

Speaker Change: I will now dive into more details on our significant progress, along with providing some near-term clinical and regulatory goals.

Speaker Change: starting with our soft tissue ablation application.

Speaker Change: Physicians utilize soft tissue ablation in a broad array of procedures.

Speaker Change: such as those involving the thyroid, liver, breast, as well as many other parts of the body.

Speaker Change: Nano-PFA has delivered very promising initial clinical results in the soft tissue ablation of benign thyroid nodules.

Speaker Change: via our Percutaneous Needle Electrode, which we call the CellFX Percutaneous Electrode System.

Burke T. Barrett: The Nano PFA Needle empowers clinicians to achieve non-thermal targeted ablation while offering the potential for a streamlined, minimally invasive procedure compared to surgical resection. To date, we have placed our system at five sites in the United States, and these sites have performed initial patient treatments and evaluations of the system under no-cost 90-day evaluation agreements. Let me provide some additional background details on our soft tissue ablation product. In March, we received U.S. FDA 510K clearance for our novel nanopFAC for use in the ablation of soft tissue in percutaneous and interoperative surgical procedures. This was followed by the first U.S. procedures in May as part of our pilot commercialization program.

Speaker Change: The Nano PFA needle empowers clinicians to achieve non-thermal targeted ablation.

Speaker Change: while offering the potential for a streamlined, minimally invasive procedure compared to surgical resection.

Speaker Change: To date, we have placed our system at five sites in the United States, and these sites have performed initial patient treatments and evaluations of the system under no-cost 90-day evaluation agreements.

Burke T. Barrett: In addition to the clinical experience being gained under this pilot program, we also plan to support investigator-sponsored research to gather additional clinical data and experience. We recently received FDA clearance for a second size of the ablation needle, which we believe will provide our customers with increased treatment options for their patients. Informed by this early clinical experience, we are designing a pivotal clinical study presented to the FDA in order to achieve a specific labeling indication for the treatment of benign thyroid nodules.

Speaker Change: Let me provide some additional background details on our soft tissue ablation product.

Speaker Change: In March, we received U.S. FDA 510K clearance for our novel nano-PFA system.

Speaker Change: for use in the ablation of soft tissue and percutaneous and interoperative surgical procedures.

Speaker Change: This was followed by the first U.S. procedures in May as part of our pilot commercialization program.

Speaker Change: In addition to the clinical experience being gained under this pilot program, we also plan to support investigator-sponsored research to gather additional clinical data and experience.

Speaker Change: We recently received FDA clearance for a second size of the ablation needle, which we believe will provide our customers with increased treatment options for their patients.

Speaker Change: Informed by this early clinical experience, we are designing a pivotal clinical study presented to the FDA in order to achieve a specific labeling indication for the treatment of benign thyroid nodules.

Burke T. Barrett: As I mentioned earlier in this call, we are focused on investing in high-quality clinical and regulatory pathways, and we believe they will unlock further opportunities for our novel devices. We expect to be in a position to initiate a pivotal clinical trial in the first half of 2025 to support a specific labeling indication for the treatment of benign thyroid nodules. Looking ahead, we have additional plans for our proprietary soft tissue ablation device and look forward to sharing updates on our progress in the future.

Speaker Change: As I mentioned earlier on this call, we are focused on investing in high-quality clinical and regulatory pathways, and we believe they will unlock further opportunities for our novel devices.

Speaker Change: We expect to be in a position to initiate a pivotal clinical trial in the first half of 2025 to support a specific labeling indication for the treatment of benign thyroid nodule.

Speaker Change: Looking ahead, we have additional plans for our proprietary soft tissue ablation device and look forward to sharing updates on our progress in the future.

Burke T. Barrett: That leads us to our Surgical Epicardial Ablation App. Ablation is an established standard of care used to treat irregular heartbeats such as atrial fibrillation or AF. PFA represents a breakthrough in ablation technology and is being rapidly adopted for the treatment of AF as a catheter-based or endocardial therapy. However, compared to currently available micro-PFA, which typically operates in the tens to hundreds of microseconds, our Nano PSA, which operates much faster, delivers pulses of electrical energy that are each less than a millionth of a second long, hence the name nanosecond or nanop

Burke T. Barrett: That leads us to our surgical epicardial ablation application. Ablation is an established standard of care used to treat irregular heartbeats such as atrial fibrillation or AF. PFA represents a breakthrough in ablation technology and is being rapidly adopted for the treatment of AF as a catheter-based or endocardial therapy. However, compared to currently available micro-PSA, which typically operates in the tens to hundreds of microseconds, our Nano PSA, which operates much faster, delivers pulses of electrical energy that are each less than a millionth of a second long, hence the name nanosecond or nanop

Speaker Change: That leads us to our surgical epicardial ablation application.

Speaker Change: Ablation is an established standard of care used to treat irregular heartbeats such as atrial fibrillation or AF.

Speaker Change: PFA represents a breakthrough in ablation technologies and is being rapidly adopted for the treatment of AF as a catheter based or endocardial therapy.

Speaker Change: However, compared to currently available micro PFA which typically operates in the tens to hundreds microseconds

Speaker Change: Our Nano PFA, which operates much faster, delivers pulses of electrical energy that are each less than a millionth of a second long.

Burke T. Barrett: In my opinion, Nano-PFA is the next generation PFA technology and has the potential to provide best-in-class ease of use, speed, and clinical performance in the treatment of AF. This is the company's last earnings call. We have received approval from an ethics committee in the Netherlands to conduct a first in human feasibility study, and excitingly, we have successfully treated the first two patients. Our initial procedures went well. We are using this study to provide information on the first and human effectiveness and safety of our device.

Speaker Change: hence the name nanosecond or nano PFA.

Speaker Change: In my opinion, Nano-PFA is the next-generation PFA technology and has the potential to provide best-in-class ease-of-use, speed, and clinical performance in the treatment of AF.

Speaker Change: This is the company's last earning call.

Speaker Change: We have received approval from an ethics committee in the Netherlands to conduct a first in human feasibility study and Excitingly now we have successfully treated the first two patients

Burke T. Barrett: We are using this study to provide information on the first and human effectiveness and safety of our device. This multi-center feasibility study is designed to enroll up to 30 patients, and includes endocardial or catheter-based mapping to confirm efficacy by evaluating chronic isolation at approximately three months post-treatment, in addition to the more traditional clinical study follow-up. In the U.S., we are pleased to have received breakthrough device designation from the FDA for this device.

Speaker Change: Our initial procedures went well. We are using this study to provide information on first-in-human effectiveness and safety of our device. This multi-center feasibility study is designed to enroll up to 30 patients.

Burke T. Barrett: This multi-center feasibility study is designed to enroll up to 30 patients and includes endocardial or catheter-based mapping to confirm efficacy by evaluating chronic isolation at approximately three months post-treatment, in addition to the more traditional clinical study follow-up. In the U.S., we are pleased to have received breakthrough device designation from the FDA for this device. The Breakthrough Device Designation granted by the FDA is an exciting milestone for PULSE and emphasizes the unique potential benefits of Nano-PFA.

Speaker Change: and includes an endocardial or catheter-based mapping to confirm efficacy by evaluating chronic isolation at approximately three months post-treatment, in addition to the more traditional clinical study follow-up.

Burke T. Barrett: The designation will provide prioritized review of a future pre-market approval application with the FDA. Since receiving the breakthrough device designation, we have also successfully enrolled in the FDA's TAP program, which should provide additional opportunities to expedite our U.S. clinical and regulatory development pathway. The FDA's TAP program was created to expedite patient access to Innovative Medical Devices by providing early, frequent, and strategic communications with the FDA and facilitating engagement with other key parties for developers of devices like Pulse of public health importance.

Speaker Change: In the U.S., we are pleased to have received Breakthrough Device Designation from the FDA for this device.

Burke T. Barrett: The Breakthrough Device Designation granted by the FDA is an exciting milestone for PULSE and emphasizes the unique potential benefits of Nano-PFA. The designation will provide prioritized review of a future pre-market approval application with the FDA. Since receiving the breakthrough device designation, we have also successfully enrolled in the FDA's TAP program, which should provide additional opportunities to expedite our U.S. clinical and regulatory development pathway. The FDA's TAP program was created to expedite patient access to Innovative Medical Devices by providing early, frequent, and strategic communications with the FDA and facilitating engagement with other key parties for developers of devices like Pulse of public health importance.

Speaker Change: The breakthrough device designation granted by the FDA is an exciting milestone for PULSE and emphasizes the unique potential benefits of nano PFA.

Speaker Change: The designation will provide prioritized review of a future premarket approval application with the FDA.

Speaker Change: Since receiving the Breakthrough Device Designation, we have also successfully enrolled in the FDA's TAP program.

Speaker Change: which should provide additional opportunities to expedite our U.S. clinical and regulatory development pathway.

Speaker Change: The FDA's TAP program was created to expedite patient access.

Speaker Change: the innovative medical devices

Speaker Change: by providing early, frequent, and strategic communications with the FDA and facilitating engagement with other key parties.

Speaker Change: who are developers of devices like PULSE of public health importance.

Burke T. Barrett: As announced in early July, we now plan to pursue the PMA application pathway for FDA approval to market, as opposed to the 510k route. Once FDA PMA approval is obtained, we intend to commercialize our nano PFA cardiac surgical system in the United States as a treatment for atrial fibrillation. To support the PMA application pathway, we expect to commence a pivotal clinical trial in early 2025. We plan to present our clinical study design to the FDA for our IDE pivotal study in the near future.

Speaker Change: As announced in early July, we now plan to pursue the PMA application pathway for FDA approval to market, as opposed to the 510K route.

Speaker Change: Once FDA TMA approved, we intend to commercialize our Nano-PFA cardiac surgical system in the United States as a treatment for atrial fibrillation.

Speaker Change: To support the PMA application pathway, we expect to commence a pivotal clinical trial in early 2025. We plan to present our clinical study design to the FDA for our IDE pivotal study in the near future.

Burke T. Barrett: Discussions with the FDA will ultimately determine further details of the study in the timeline. Now, moving on to our catheter-based endocardial AF application. Our third product, currently under development, is focused on delivering next-generation nano-PFA technology, endocardial applications through our 360 cardiac catheter, and is also a treatment for AF. Our first in-human feasibility study is underway in Prague, where we are investigating the safety and efficacy of the catheter's clinical performance. We are pleased to have approval for expanded enrollment of this study from 30 to 60 patients because of the catheter's ease of use.

Speaker Change: Discussions with the FDA will ultimately determine further details of the study and the timeline.

Burke T. Barrett: Now, moving on to our catheter-based endocardial AF application. Our third product, currently under development, is focused on delivering next-generation nano-PFA technology to endocardial applications through our 360 cardiac catheter and is also a treatment for AF. Our first in-human feasibility study is underway in Prague, where we are investigating the safety and efficacy of the catheter's clinical performance. We are pleased to have approval to expand enrollment of this study from 30 to 60 patients. The catheter's ease of use, ability to acutely isolate the pulmonary veins, and case times were all very encouraging in the first 30 treated patients.

Speaker Change: Now, moving on to our catheter-based endocardial AF application.

Speaker Change: Our third product, certainly underdeveloped, is focused on delivering next-generation nano-PFA technology.

Speaker Change: endocardial applications through our 360 cardiac catheter and is also a treatment for AF.

Burke T. Barrett: We have already commenced treatment in this additional 30 patient cohort. In addition to the expanded first in human feasibility study in Prague, we intend to add two other prestigious and well-known clinical sites in the EU to gather additional user experiences and clinical outcomes with our expanded clinical experience and the results of these feasibility studies. We will design a pivotal clinical study to propose to the FDA, and on receiving their feedback and aligning on the final Pivotal Study Protocol, it is our intention to begin a US IDE pivotal clinical study for this indication sometime next year.

Speaker Change: Our first in human feasibility study is underway in Prague where we are investigating safety and efficacy of the catheters clinical performance.

Speaker Change: We are pleased to have approval for expanded enrollment of this study from 30 to 60 patients. The catheter's ease of use...

Burke T. Barrett: Ability to acutely isolate the pulmonary veins and case times were all very encouraging in the first 30 treated patients. We have already commenced treatment in this additional 30 patient cohort. In addition to the expanded first in human feasibility study in Prague, we intend to add two other prestigious and well-known clinical sites in the EU to gather additional user experiences and clinical outcomes with our expanded clinical experience and the results of these feasibility studies.

Speaker Change: ability to acutely isolate the pulmonary veins and case times were all very encouraging in the first 30 treated patients.

Speaker Change: We have already commenced treatment in this additional 30-patient cohort.

Speaker Change: In addition to the expanded first in human feasibility study in Prague, we intend to add two other prestigious and well-known clinical sites in the EU to gather additional user experiences and clinical outcomes.

Speaker Change: With our expanded clinical experience and the results of these feasibility studies, we will design a pivotal clinical study to propose to the FDA.

Burke T. Barrett: We will design a pivotal clinical study to propose to the FDA, and once they receive their feedback and align on the final Pivotal Study Protocol, it is our intention to begin a US IDE pivotal clinical study for this indication sometime next year. Once successfully completed, the pivotal clinical study would provide the foundation for a PMA submission.

Speaker Change: Upon receiving their feedback and aligning on the final Pivotal Study Protocol, it is our intention to begin a US IDE Pivotal Clinical Study for this indication sometime next year.

Burke T. Barrett: Once successfully completed, the pivotal clinical study would provide the foundation for a PMA submission. Altogether, we are excited by the progress made across our three devices, and we are encouraged by the future potential each device holds in providing safe and effective treatments for significant disease states across the body, to support further product and clinical development, future regulatory submissions, and commercial readiness of our three novel devices. We completed a rights-offering fundraising campaign in July.

Speaker Change: Once successfully completed the pivotal clinical study would provide the foundation for a PMA submission.

Burke T. Barrett: Altogether, we are excited by the progress made across our three devices, and we are encouraged by the future potential each device holds in providing safe and effective treatments for significant disease states across the body, to support further product and clinical development, future regulatory submissions, and commercial readiness of our three novel devices. We completed a rights-offering fundraising round in July. We're encouraged that the offering was oversubscribed and provided gross proceeds of $60 million, less expenses related to the rights offering of approximately $250,000. Upon exercise of all the warrants, the company could receive additional proceeds of up to $66 million to cap off what has been a very exciting quarter.

Speaker Change: Altogether, we are excited by the progress made across our three devices, and we are encouraged by the future potential each device holds.

Speaker Change: in providing safe and effective treatments for significant disease states across the body.

Speaker Change: to support further product and clinical development, future regulatory submissions, and commercial readiness of our three novel devices.

Speaker Change: We completed a rights-offering fundraising in July.

Burke T. Barrett: We're encouraged that the offering was oversubscribed and provided gross proceeds of $60 million, less expenses related to the rights offering of approximately $250,000. Upon exercise of all the warrants, the company could receive additional proceeds of up to $66 million to cap off what has been a very exciting quarter. In the past few weeks for Pulse, we are thrilled to announce that Paula Violette has been appointed co-chairman of the Pulse Biosciences Board of Directors. She will serve alongside our other co-chairman, Bob Duggan. I've known Paul for over a decade, and I'm highly confident he will be an extremely valuable addition to our team.

Speaker Change: We're encouraged that the offering was oversubscribed and provided gross proceeds of $60 million less expenses related to the rights offering of approximately $250,000.

Speaker Change: Upon exercise of all the warrants, the company could receive additional proceeds of up to $66 million.

Burke T. Barrett: In the past few weeks for Pulse, we are thrilled to announce that Paula Violette has been appointed co-chairman of the Pulse Biosciences Board of Directors. She will serve alongside our other co-chairman, Bob Duggan. I've known Paul for over a decade, and I'm highly confident he will be extremely additive to our team. He has successfully scaled some of the largest global cardiology medtech franchises through driving innovative technology adoption. We're excited to work with him, and I know we will benefit greatly from his invaluable insight. Now, I'll pass the call over to Mike Koffler to provide some financial results for the second quarter of 2020. Thank you.

Speaker Change: To cap off what has been a very exciting quarter in past few weeks for PULSE, we are thrilled to announce that Paula Violette has been appointed co-chairman of the PULSE Biosciences Board of Directors.

Speaker Change: He will serve alongside our other co-chairman, Bob Duggan.

Speaker Change: I've known Paul for over a decade and I'm highly confident he will be extremely additive to our team.

Mike Koffler: He has successfully scaled some of the largest global cardiology medtech franchises through driving innovative technology adoption. We're excited to work with him, and I know we will benefit greatly from his invaluable insight. Now, I'll pass the call over to Mike Koffler to provide some financial results for the second quarter of 2020. Thank you, Burke.

Speaker Change: He has successfully scaled some of the largest global cardiology medtech franchises through driving innovative technology adoption.

Speaker Change: We're excited to work with him and I know we will benefit greatly from his invaluable insight.

Mike Koffler: Now I'll pass the call over to Mike Koffler to provide some financial results for the second quarter of 2024.

Mike Koffler: Thank you, Burke. Today I will highlight our key financial metrics, focusing on our cash position and details on our costs and expenses for the second quarter. Cash and cash equivalents totaled $26.2 million as of June 30, 2024, compared to $58.7 million as of June 30, 2023. Note that the cash balances of June 30, 2024 do not include the $60 million in gross proceeds received from the rights offering that closed in July of 2024. On a pro forma basis, including the cash received from the rights offering, we begin the third quarter with approximately $86 million.

Mike Koffler: Today I will highlight our key financial metrics, focusing on our cash position and details on our costs and expenses for the second quarter. Cash and cash equivalents totaled $26.2 million as of June 30, 2024, compared to $58.7 million as of June 30, 2023. Note the cash balances of June 30, 2024 do not include the $60 million in gross proceeds received from the rights offering that closed in July of 2024. On a pro forma basis, including the cash received from the RITES offering, we begin the third quarter with approximately $86 million.

Mike Koffler: Thank you, Burke. Today I will highlight our key financial metrics focusing on our cash position and details on our costs and expenses for the second quarter.

Mike Koffler: Cash and cash equivalents totaled $26.2 million as of June 30, 2024, compared to $58.7 million as of June 30, 2023.

Speaker Change: Note the cash balances of June 30, 2024, does not include the $60 million in gross proceeds received from the rights offering that closed in July of 2024.

Speaker Change: On a pro-forma basis, including the cash received from the rights offering, we begin the third quarter with approximately $86 million.

Mike Koffler: Cash used in the second quarter of 2024 totaled $8.7 million, compared to $10 million used in the same period in the prior year and $9.5 million used in the first quarter of 2024. In the second quarter of 2024, total GAAP costs and expenses increased by $1.5 million to $11.7 million, compared to $10.2 million in the prior year period. The increase in GAAP costs and expenses was primarily driven by an increase in non-cash stock-based compensation expense, which was $2.1 million in the second quarter of 2024 compared to $1.1 million in the prior year period. To remind everyone, non-GAAP costs and expenses exclude stock-based compensation, depreciation, and amortization.

Speaker Change: Cash used in the second quarter of 2024 totaled $8.7 million compared to $10 million used in the same period in the prior year and $9.5 million used in the first quarter of 2024.

Speaker Change: In the second quarter of 2024, total GAAP costs and expenses increased by $1.5 million to $11.7 million, compared to $10.2 million in the prior year period.

Speaker Change: The increase in GAAP costs and expenses was primarily driven by an increase in non-cash stock-based compensation expense, which was $2.1 million in the second quarter of 2024 compared to $1.1 million in the prior year period.

Mike Koffler: To remind everyone, non-GAAP costs and expenses exclude stock-based compensation, depreciation, and amortization. Total non-GAAP costs and expenses in the second quarter of 2024 increased by $0.6 million to $9.4 million, compared to $8.8 million in the prior year period. The increase in non-GAAP costs and expenses was primarily driven by an increase in headcount to support the advancement of our Nano PFA technology.

Speaker Change: To remind everyone, non-GAAP costs and expenses exclude stock-based compensation, depreciation, and amortization.

Mike Koffler: Total non-GAAP costs and expenses in the second quarter of 2024 increased by $0.6 million to $9.4 million, compared to $8.8 million in the prior year period. The increase in non-GAAP costs and expenses was primarily driven by an increase in headcount to support the advancement of our Nano PFA technology. I will now turn the call back over to Bert. Thank you, Mike. We believe the future of nano PFA energy should be invested in through rigorous clinical and regulatory pathways that can ultimately unlock the full value of the devices we develop as we move product by product, from clinical studies ultimately into commercialization. Joining us now for the question and answer session today is Bob Duggan. Co-Chairman of the Board. Darrin Uecker, CTO and Director, and Kevin Danahy, CCO.

Speaker Change: Total non-GAAP costs and expenses in the second quarter of 2024 increased by $0.6 million to $9.4 million compared to $8.8 million in the prior year period.

Speaker Change: The increase in non-GAAP costs and expenses was primarily driven by an increase in headcount to support the advancement of our Nano PFA technology.

Burke T. Barrett: I will now turn the call back over to Bert.

Speaker Change: I will now turn the call back over to Burke.

Speaker Change: Thank you, Mike.

Burke: We believe the future of nano PFA energy should be invested in through rigorous clinical and regulatory pathways that ultimately can unlock the full value of the devices we develop as we move product by product

Burke: from clinical studies ultimately into commercialization.

Burke T. Barrett: We believe the future of nano PFA energy should be invested in through rigorous clinical and regulatory pathways that can ultimately unlock the full value of the devices we develop as we move product by product, from clinical studies ultimately into commercialization. Joining us now for the question and answer session today is Bob Duggan, Co-Chairman of the Board. Darrin Uecker, CTO and Director, and Kevin Danahy, CCO. Operator, please open the call for questions. Thank you. We will now be conducting a survey.

Speaker Change: Joining us now for the question and answer session today are Bob Duggan, co-chairman of the board.

Speaker Change: CTO and Director, and Kevin Danahy, CCO.

Operator: Operator, please open the call for questions. 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. The Carf Mission Tone will indicate your line. You may press star two, if you would like to. Participants using speaker equipment, it may be necessary to pick up the handset before. One moment, please, while we... Our first question comes from the line of Anthony Petrone with Mizzou. Michael Sieg.

Speaker Change: Operator, please open the call for questions.

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 yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing these star keys.

Speaker Change: Thank you. We will now be conducting a question and answer session.

Speaker Change: 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 yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing these star keys.

Operator: One moment, please, while we poll for questions. Our first question comes from the line of Anthony Petrone with Mizuho Group. Please proceed with your question.

Speaker Change: One moment please while we poll for questions.

Speaker Change: [inaudible]

Speaker Change: Our first question comes from the line of Anthony Patron with Mizuho Group. Please proceed with your question.

Anthony Petrone: Thank you. Congratulations on the progress in the second quarter to the team.

Anthony Petrone: Thank you. Congratulations on the progress in the second quarter here to the team. Maybe first to start with on the cardiac surgical claim side of the equation, and the company. Thank you. Thank you. You went through the TAP program initially, and you received breakthrough designation. You have a couple of cases that are done here already. So maybe one, just on the...

Speaker Change: Thank you. Congratulations on the progress in the second quarter here to the team. Maybe first to start with on the cardiac surgical clamshell to the equation.

Anthony Petrone: Maybe first to start with on the cardiac surgical clamps out of the equation. The company, you know, went through the TAP program initially, and you received breakthrough designation. You have a couple of cases that are done here already. So maybe one, just on the case side of the equation.

Operator: Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation.

Speaker Change: The company you know went through the TAP program initially and you receive breakthrough designation. You have a couple of cases that are done here already.

Operator: If anyone should require operator assistance and conference, please press star zero on your telephone heatpad. As a reminder, just conference is being recorded.

Anthony Petrone: The case side of the equation is, Two of the benefits of the clamp side, using cell effects as a backdrop, or speed of the surgery, but also nerve sparing. Just wondering if you can go over some of the feedback from these initial cases. How fast was the surgery done? How safe was it?

Speaker Change: So maybe one, just on the case side of the equation, two of the benefits on the clamp side, using cell effects as a backdrop, or speed of the surgery, but also nerve sparing.

Trip Taylor: It is not my pleasure to introduce your host, Trip Taylor of Investigations. Thank you. You may begin. 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. August 12, 2024 only, and will include board-looking statements and opinion statements, including predictions, estimates, plans, expectations, and other similar information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties.

Anthony Petrone: Two of the benefits on the clamp side using cell effects as a backdrop are speed of the surgery and nerve sparing. Just wondering if you can go over some of the feedback from these initial cases. How fast was the surgery done? How safe was it?

Speaker Change: Just wondering if you can go over some of the feedback from these initial cases.

Speaker Change: How fast was the surgery done?

Anthony Petrone: What was the side effect profile, if any, of these patients? And then secondly, commencing the trial in 2025, it's 510K clearance. Maybe just a little bit as we look ahead to what is gonna be needed to secure 510K, what will the next phases of this study look like? And then I'll have a follow-up. Thanks.

Speaker Change: How safe was it? What was the side effect profile, if any, of these patients? And then secondly,

Anthony Petrone: What was the side effect profile, if any, of these patients? And then secondly... commencing the trial in 2025. It's 510k clearance. Maybe just a little bit as we look ahead to what is going to be needed to secure 510K, what will the next phases of this study look like, and then I'll have a follow-up. Hi Anthony, it's Burke.

Speaker Change: commencing the trial in 2025. It's a 510K clearance. Maybe just a little bit as we look ahead to what is gonna be needed to secure 510K, what will the next phases of this study look like, and then I'll have a follow-up. Thanks.

Trip Taylor: These risks and uncertainties are more fully described in our press release issued earlier today and in our filings with the US Securities and Exchange Commission. RSEC filings can be found on our website or on the SEC's website. Investors are cautioned not to place undue reliance on board-looking statements. We describe any obligation to update or revise these board-looking statements. We will also discuss certain non-gap financial measures, disclosures regarding these non-gap financial measures, including reconciliations with the most comparable gap measures can be found in the press release.

Burke T. Barrett: Hi Anthony, it's Burke. Thanks for your questions. So based on the extensive preclinical data, there are many advantages of Nano-PFA in cardiac surgical ablation compared to the standard of care today, which is RF. One of them you mentioned is speed, but others are the ability to make consistent transmural or full thickness through the thickness of the heart lesions because of the way the energy is transferred. And the form factor of the clamp, the use of it in the surgeon's hands, is very similar to what they're familiar with from an RF point of view. So the energy itself is non-thermal, and as you said, it's expected to be not nerve-sparing or safe with collateral tissue.

Burke T. Barrett: Thanks for your questions. Based on the extensive preclinical data, there are many advantages of Nano-PFA in cardiac surgical ablation compared to the standard of care today, which is RF. One of them you mentioned is speed, but others are the ability to make consistent transmural or full thickness through the thickness of the heart lesions because of the way the energy is transferred.

Speaker Change: Hi Anthony, it's Burke. Thanks for your questions.

Speaker Change: So, based on the extensive preclinical data, there are many advantages of nano-PFA in cardiac surgical ablation compared to the standard of care today, which is RF.

Speaker Change: One of them you mentioned is speed, but others are the ability to make consistent transmural or full thickness through the thickness of the heart lesions.

Operator: 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.

Speaker Change: because of the way the energy is transferred.

Burke T. Barrett: And the form factor of the clamp, the use of it in the surgeon's hands, is very similar to what they're familiar with from an RF point of view. So the energy itself is non-thermal, and as you said, it's expected to be not nerve-sparing or safe with collateral tissue. I'm not gonna comment on a lot of the specific details of the two procedures because two is a small number and we're just starting, but the device performed as expected. It performed well.

Speaker Change: And the form factor of the clamp, the use of it in the surgeon's hands is very similar to what they're familiar with from an RF point of view.

Burke Barrett: With that, I would now like to turn the call over to President and Chief Executive Officer Burke T. Barrett. Good afternoon everyone, and thank you for joining us.

Speaker Change: So the energy itself is non-thermal, and as you said, it's expected to be not nerve-sparing or safe.

Burke Barrett: I'm glad to be on my first PulseBio Sciences earnings call since being appointed President and CEO of Pulse in May of this year. Today I'll provide updates on our continued business progress and then Mike Hoffler, Vice President of Finance, will review certain second quarter 2024 financial results. Then Bob Duggan, Co-Chair of the Board, Aaron Euker, Chief Technology Officer and Director, and Kevin Danahee, our Chief Commercial Officer, will join me for a question and answer session.

Burke T. Barrett: I'm not gonna comment on a lot of the specific details of the two procedures because two is a small number and we're just starting. But the device performed as expected. It performed well.

Speaker Change: with collateral tissue. I'm not going to comment on a lot of the specific details of the two procedures because two is a small number and we're just starting. But the device performed as expected. It performed well. The procedures were very efficient.

Burke T. Barrett: The procedures were very efficient, and certainly, the clinicians involved in the procedure were excited by the performance of the device. When it comes to the pathway, the regulatory pathway for approval in the U.S., while the company initially submitted and had discussions with the FDA on a 510K submission for cardiac surgery, we made the decision to pursue a specific indication, not just for cardiac surgery, but for the treatment of atrial fibrillation, and that is the primary reason why we will be discussing with the FDA shortly a pivotal clinical study design.

Burke T. Barrett: The procedures were very efficient, and certainly the clinicians involved in the procedure were excited by the performance of the device. When it comes to the pathway, the regulatory pathway for approval in the U.S., while the company did initially submit and had discussions with the FDA on a 510K submission for cardiac surgery, we made the decision to pursue a specific indication, not just for cardiac surgery, but for the treatment of atrial fibrillation.

Speaker Change: and certainly the clinicians involved in the procedure were excited by the performance of the device.

Speaker Change: When it comes to the pathway, the regulatory pathway for approval in the U.S., while the company did initially submit and had discussions with the FDA on a 510k submission,

Burke Barrett: To begin, I want to briefly describe why I joined Pulse. I've been in the medical device space for more than 35 years, with a majority of that time spent pioneering medical devices and focusing my last 20 years on cardiology devices. I believe Pulse's Pulse field ablation approach, called NANOPFA, has the potential to be more transformative than any other innovation I've worked on throughout my career. When you consider all the currently available treatments that use heat, cold radiation, and other approaches to kill undesirable cells in the body, and the fact that NANOPFA has the potential to compete with, and perhaps even someday supplant, many of these currently available treatments, that translates to Pulse having the opportunity to significantly improve many patient lives.

Speaker Change: for cardiac surgery, we made the decision to pursue a specific indication not just for cardiac surgery, but for the treatment of atrial fibrillation.

Burke T. Barrett: And that is the primary reason why we will be discussing with FDA shortly a pivotal clinical study design. For this kind of device, the pathway to market for a specific indication of treatment of AF is a so-called PMA pathway. Again, both of those pathways would require some sort of pivotal clinical study, which will be conducted, but the actual application that will go to the FDA after the study is complete will not be a 510 K. It will be a PMA.

Speaker Change: And that is the primary reason why we will be discussing with FDA shortly a pivotal clinical study design.

Burke T. Barrett: For this kind of device, the pathway to market for a specific indication of treatment for AF is the so-called PMA pathway. Again, both of those pathways would require some sort of pivotal clinical study, which we'll conduct, but the actual application that will go to the FDA after the study is complete will not be a 510K; it will be a PMA. We believe there are significant benefits.

Speaker Change: For this kind of device, the pathway to market for a specific indication of treatment of AF is a so-called PMA pathway.

Speaker Change: Again, both of those pathways would require some sort of pivotal clinical study.

Speaker Change: which will conduct, but the actual application that will go into the FDA after the study is complete will not be a 510K, it will be a PMA. We believe there are significant benefits.

Burke T. Barrett: We believe there are significant benefits. Once we have a successful pivotal clinical study and a PMA approval to be able to sell and market and, importantly, train specifically as a treatment for atrial fibrillation, what should happen when we have that approval and we have the specific indication? We should see quicker adoption in the marketplace because we can sell, market, and train specifically for the use of the device in the treatment of atrial fibrillation.

Burke Barrett: This is possible because NANOPFA has the potential to kill cells in a better way than heat, cold radiation and even currently available micro-PFA. It's the core of what Pulse does, and as we will describe in a moment, it is showing great promise in the three product lines currently being studied clinically. Beyond these three current products for product lines, I believe that Nano-PFA energy has the potential to advance the standard of care for the treatment of multiple other disease states and disorders across the human body. The technology is solidly protected with intellectual property and know-how.

Burke T. Barrett: Once we have a successful pivotal clinical study and a PMA approval to be able to sell and market the device and, importantly, train specifically as a treatment for atrial fibrillation, what should happen when we have that approval and we have the specific indication? We should see quicker adoption in the marketplace because we can sell, market, and train specifically for the use of the device in the treatment of atrial fibrillation. That's helpful as a backdrop, but maybe on the soft tissue ablation front, the perkypaint, announcing pivotal trials expected in 2025, but you're targeting benign thyroid nodules. Maybe just a little bit about that market opportunity and why the decision on that specific initiative, soft tissue ablation. Percutaneous Electrode Decision to go more narrow in terms of that indication, specific to benign thyroid nodules.

Speaker Change: Once we have a successful pivotal clinical study and a PMA approval to be able to sell

Speaker Change: and Markit, and importantly, Trane.

Speaker Change: specifically as a treatment for atrial fibrillation.

Speaker Change: what should happen when we have that approval and we have the specific indication.

Anthony Petrone: That's helpful as a backdrop, but maybe on the soft tissue ablation front, the percutaneous electrode system, announcing pivotal trials expected in 2025, but you're targeting benign thyroid nodules. Maybe just a little bit about that market opportunity and why the decision on that specific initiative, soft tissue ablation, and Percutaneous Electrodecision to go more narrow in terms of that indication, again, specific to benign thyroid nodules.

Speaker Change: That's helpful as a backdrop, but maybe on the soft tissue ablation front, the percutaneous electrode system.

Burke Barrett: The last reason I joined Pulse is because of the fantastic employees and stakeholders associated with Pulse. The culture of Pulse is patient focus, results oriented, and transparent. It's a true privilege to work alongside and support the great Pulse team. Pulse team is rapidly advancing this next generation Nano-PFA technology. We have all the foundational elements in place to drive adoption through up to technology, including the scientific expertise in intellectual property and industry and product know-how.

Speaker Change: Announcing pivotal trials expected in 2025, but you're targeting benign thyroid nodules.

Speaker Change: Maybe just a little bit about that market opportunity and why the decision on that specific initiative, soft tissue ablation,

Speaker Change: with the percutaneous electrode decision to go more narrow in terms of that indication, again, specific to benign thyroid nodules.

Burke T. Barrett: So, the company went through a process over the last three years of very thoughtfully and carefully analyzing the possible indications, applications, and markets, if you will, to deliver Nano-PFA, which included not only market size but the relative clinical performance of the current standard of care devices, ease of utilization of Nano-PFA, and so on. And the benign thyroid nodule opportunity within the soft tissue ablation opportunity became one of the very exciting markets.

Speaker Change: Sure. So the company went through a

Burke Barrett: Pulse Biosciences is the pioneer organization focusing on bringing its Nano-PFA technology to patients. Since commencing work in it approximately ten years ago, the pre-company scientific genesis of Pulse's Nano-PFA states back another decade for the founding of the company. Today, Pulse has generated massive amounts of pre-clinical and initial clinical data, demonstrating the effects of differentiated Nano-PFA energy across different tissue types in the human body. This includes the approximately six thousand human dermatological skin lesions treated using our cell-effect system with a strong safety profile.

Speaker Change: The possible indications, applications, markets, if you will, to deliver nano-PFA.

Speaker Change: which included not only market size, but the relative clinical performance of the current standard of care devices.

Speaker Change: ease of utilization of nano PFA and so on. And the benign thyroid nodule opportunity is within the soft tissue ablation opportunity became one of the very exciting markets.

Burke T. Barrett: There is a significant number of people that have benign thyroid nodules. It's estimated to be as many as 1.3 million people worldwide, and the two main options to treat these benign thyroids, which are, they become large. And so there's a cosmesis effect. Obviously, you can see them. But also, as they grow, they put pressure on the surrounding structures and nerves, and they become painful. And the two main options are to have a surgical resection, which not only leaves a scar but may leave the patient needing to have Lifetime Hormone Replacement Therapy or to do nothing.

Speaker Change: There's a significant number of people that have benign thyroid nodules. It's estimated to be as many as 1.3 million people worldwide. And the two main options...

Burke Barrett: To my knowledge, Pulse has the largest library of high-quality pre-clinical images during the effects of various Nano-PFA energy delivery parameters on numerous types of tissue. Importantly, this solid scientific foundation should lead to accelerated product and clinical development timelines. We are currently focused on developing the path to commercializing devices for soft tissue ablation, epicartial or surgical ablation, and endocardial or catheter ablation. In each of these three clinical categories, there are significant areas of unmet need where Nano-PFA has potential to improve upon currently available products in terms of overall user experiences and patient outcomes.

Burke T. Barrett: Those are the two primary approaches, and we believe that providing a tool that can shrink benign thyroid nodules without the risk of thermal spread to the surrounding structure, like various cranial nerves, the trachea, the vocal cords, and other things that are in proximity to the thyroid represents a great opportunity for nano-PFT.

Speaker Change: to treat these benign thyroids, which are, they become large.

Burke T. Barrett: But also, as they grow, they put pressure on the surrounding structures and nerves, and they become painful. And the two main options are to have a surgical resection, which not only leaves a scar but may leave the patient needing to have Lifetime Hormone Replacement Therapy or to do nothing. Those are the two primary approaches, and we believe that providing a tool that can shrink benign thyroid nodules without the risk of thermal spread to the surrounding structure, like various cranial nerves, the trachea, the vocal cords, and other things that are in proximity to the thyroid represents a great opportunity for nanopFM.

Speaker Change: And so there's a cosmesis effect. Obviously you can see them, but also as they grow they put pressure on the surrounding structures and nerves and they become painful. And the two main options are to have a surgical resection.

Speaker Change: which not only leaves a scar but may leave the patient needing to have lifetime hormone replacement therapy or to do nothing. Those are the two primary approaches.

Speaker Change: and we believe that providing a tool that can shrink benign thyroid nodules without the risk of thermal spread

Speaker Change: to the surrounding structures, like various cranial nerves, the trachea, the vocal cords, and other things that are in proximity to the thyroid, represents a great opportunity for nanopFA.

Burke Barrett: Our general approach to developing products using Nano-PFA is to produce compelling clinical data to clearly demonstrate the performance of each product. Investing in understanding and bringing wide awareness to the science of Nano-PFA as well as demonstrating clinical performance in a compelling way will, we believe, ultimately leading to more streamlined regulatory review pathways, more differentiated and competitive products, and allow us to compete well in multiple markets from a reimbursement point of view.

Anthony Petrone: That's helpful. And the last one for me, I'll hop back in, is just when you think about 2025 here now and the capitalization efforts you have. The 510K for benign, for PTN, we could call it that. And then you have, obviously, surgical ablation on the clamp side and also pursuing catheter ablation, specifically nano PFA 360 catheter ablation. So it's three studies being pursued concurrently in 2025, maybe just an update on looking at the proforma cash balance, assuming $60 million in proceeds from the rights offering. You know, how well capitalized the company is to handle the three concurrent studies.

Anthony Petrone: And the last one for me, I'll hop back in, is just when you think about 2025 here now. Capitalization efforts you have. The 510K for benign for PTN. Call it, then you have served the ablation on the clamp side and also pursuing catheter ablation.

Speaker Change: That's helpful. And the last one for me, I'll hop back in, is just when you think about 2025 here now.

Speaker Change: and the capitalization efforts you have.

Speaker Change: The 510K for benign for for for PTN we could we could call it and then you have obviously Surgical ablation on the clamp side and also pursuing catheter ablation

Anthony Petrone: So it's three studies being pursued concurrently in 2025. Um, maybe just an update on looking at the Pro Forma Cash Balance, $60 million in proceeds from the rights offering, and how well capitalized the company is to handle the three concurrent studies. Thanks. So historically, in recent quarters, the average cash burn has been about $9 million per quarter.

Burke Barrett: Clinical data is and will continue to be an important currency at Pulse. Consistent with our plan to invest heavily in compelling clinical data, we plan to pursue regulatory pathways that allow us to label our products with specific indications for you. In the U.S, these pathways may include 5, 10 Ks with clinical data, so-called the Novo classification requests or PMA application, and this will vary by indication. In general, seeking specific labeled indications is part of the regulatory approval process, while sometimes taking more time has the following benefits.

Speaker Change: specifically nano-PFA360 catheter ablation. So it's three studies.

Speaker Change: being pursued concurrently in 2025. Maybe just an update on looking at the pro forma cash balance.

Speaker Change: assuming 60 million in proceeds from the rights offering, you know, how well capitalized the company is to handle the three concurrent studies. Thanks.

Burke T. Barrett: Thanks. You're welcome. So.

Burke T. Barrett: So historically, in recent quarters, the average cash burn has been about $9 million per quarter. Obviously, cash burn will go up as we enter the active phases of these three different studies. We haven't provided information yet about the anticipated cash burn in the future because much of the spend will depend on the actual study design, the number of sites, the number of patients, and the timing of the start of the study.

Speaker Change: You're welcome

Speaker Change: So, historically in recent quarters, the average cash burn has been about $9 million per quarter.

Burke Barrett: First, the gathered clinical evidence gives clinicians, patients, and other stakeholders increased confidence in the device's safety and effectiveness profile. Second, it will allow for marketing the device's specific treatment option, rather than as a tool that supports a general tissue type, and that's only a general indication statement. And third, it will generally permit more flexibility to market, sell, and train users for a specific approved indication that can enable quicker, quicker clinician adoption and market penetration, as well as the democratization of adoption and use when the device is in well-trained hands.

Burke T. Barrett: Obviously, cash burn will go up as we enter the active phases of these three different studies. We haven't provided information yet about the anticipated cash burn in the future because much of this spend will depend on the actual study design, the number of sites, the number of patients, and the timing of the start of the study. We do anticipate that the burn rate will go up. We have said that we believe that the cash on hand today will take us into 2026. And that's without any exercise of the warrant from the Rights Offering.

Speaker Change: Obviously, cash burn will go up as we enter the active phases of these three different studies.

Speaker Change: We haven't provided information yet about the anticipated cash burn in the future because

Speaker Change: Much of the spend will depend on the actual study design, the number of sites, the number of patients, and the timing of the start of the study.

Burke T. Barrett: But we do anticipate that the burn will go up. We have said that we believe that the cash on hand today will take us into 2026. And that's without any exercise of the warrant from the Rights Office.

Speaker Change: We do anticipate that the burn will go up. We have said that we believe that the cash on hand today will take us into 2026.

Burke T. Barrett: And it looks like there are no further questions at this time. I would like to turn the floor back over to Burke Barrett for his closing remarks.

Speaker Change: Thank you.

Speaker Change: And that's without any exercise of the warrants.

Speaker Change: from the Wrights Offering.

Speaker Change: Thank you.

Burke T. Barrett: And it looks like there are no further questions. I would like to turn the floor back over to Burt Barrett. I want to thank the Pulse team for a fantastic quarter. I want to thank you all for calling in and listening to the update. And we look forward to providing more updates.

Speaker Change: Thank you.

Burke Barrett: This is a very exciting time for Pulse. We had an extremely productive second quarter. Some key highlights include, we have delivered major progress on our three devices, completing our first U.S, soft tissue ablation cases following FDA clearance, receiving breakthrough device designation from the U.S. FDA, enrolling an FDA's TAP program and completing the first and human cases for the company's cardiac surgery. We also expanded our leadership team, moved our headquarters to Miami, Florida, while maintaining our Hayward office, and significantly strengthened the balance sheet through our successful rights offering, which transacted in early Q3.

Speaker Change: And it looks like there are no further questions at this time.

Speaker Change: I would like to turn the floor back over to Burke Barrett for closing remarks.

Burke T. Barrett: I want to thank the Pulse team for a fantastic quarter. I want to thank you all for calling in and listening to the update, and we look forward to providing more updates and talking to you all again next quarter. Thank you.

Operator: And this concludes today's conference. We thank you for your participation. You may disconnect your line at this time.

Burke Barrett: I want to thank the Pulse team for a fantastic quarter. I want to thank you all for calling in and listening to the update. And we look forward to providing more updates and talking to you all again next quarter. Thank you.

Speaker Change: And this concludes today's conference. We thank you for your participation. You may disconnect your line at this time.

Speaker Change: Thanks for watching!

Burke Barrett: As you may know, the exercise of warrants issued in the rights offering could bring into the company up to an additional $66 million. Notably, the company has the ability to redeem half of these warrants with the potential to raise up to $33 million if our volume-weighted share price is at $16.50 or more for 20 consecutive trading days.

Burke Barrett: I will now dive into more details on our significant progress, along with providing some near-term clinical and regulatory goals, starting with our soft tissue ablation application. Physicians utilize soft tissue ablation in the broad array of procedures, such as those involving the thyroid liver breast, as well as many other parts of the body. Nano-PFA has delivered very promising initial clinical results in the soft tissue ablation of benign thyroid nodules via our percutaneous needle electrode, which we call the cell FX percutaneous electrolysis.

Burke Barrett: The Nano-PFA needle empowers clinicians to achieve non-stermal targeted ablation while offering the potential for a streamlined, minimally invasive procedure compared to surgical resection. To date, we have placed our system at five sites in the United States, and these sites have performed initial patient treatments and evaluations of the system under no cost 90-day evaluation agreement.

Burke Barrett: Let me provide some additional background details on our soft tissue ablation product. In March, we received US FDA 510K clearance for our novel Nano-PFA system for use in the ablation of soft tissue and percutaneous and interoperative surgical procedures. This was followed by the first US procedures in May as part of our pilot commercialization program. In addition to the clinical experience being gained under this pilot program, we also plan to support investigator-sponsored research to gather additional clinical data and experience.

Burke Barrett: We recently received FDA clearance for a second size of the ablation needle, which we believe will provide our customers with increased treatment options for their patients. Informed by this early clinical experience, we are designing a pivotal clinical study for the sense of the FDA in order to achieve a specific labeling indication for the treatment of benign thyroid nodules. As I mentioned earlier on this call, we are focused on investing in high quality clinical and regulatory pathways, and we believe they will unlock further opportunities for our novel devices. We expect to be in a position to initiate a pivotal clinical trial in the first half of 2025 to support a specific labeling indication for the treatment of benign thyroid nodules.

Burke Barrett: Looking ahead, we have additional plans for our proprietary soft tissue ablation device and look forward to sharing updates on our progress in the future.

Burke Barrett: That leads us to our surgical epicardial ablation applet. Ablation is an established standard of care used to treat irregular heartbeats such as hetero-fibrillation or AF. PFA represents a breakthrough in ablation technologies and is being rapidly adopted for the treatment of AF as a catheter-based or endocardial therapy. However, compared to currently available micro-PFA, which typically operates in the tens to hundreds micro seconds, our nano-PFA, which operates much faster, delivers pulses of electrical energy that are each less than a millionth of a second long, hence the name nano-second or nano-PFA.

Burke Barrett: In my opinion, nano-PFA is the next generation PFA technology and has the potential to provide best-in-class ease of use, seed, and clinical performance in the treatment of AF. Since the company's last earning call, we have received approval from an ethics committee in the Netherlands to conduct a first-in-human feasibility study, and excitingly, now we have exceptionally treated the first two patients. Our initial procedures went well. We are using this study to provide information on first and human effectiveness and safety of our device.

Burke Barrett: This multi-center feasibility study is designed to enroll up to 30 patients and includes an endocardial or catheter-based mapping to confirm efficacy by evaluating chronic isolation at approximately three months post-treatment in addition to the more traditional clinical study follow-up. In the U.S, we are pleased to ever see breakthrough device designation from the FDA for this device. The breakthrough device designation granted by the FDA is an exciting milestone for Pulse and emphasizes the unique potential benefits of NANO-PFA.

Burke Barrett: The designation will provide a prioritized review of a future pre-market approval application with the FDA. Since receiving the breakthrough device designation, we have also successfully enrolled in the FDA's TAP program which should provide additional opportunities to expedite our U.S, clinical and regulatory development pathway. The FDA's TAP program was created to expedite patient access to innovative early frequent and strategic communications with the FDA and facilitating engagement with other key parties for developers of devices like Pulse of public health importance.

Burke Barrett: As announced in early July, we now plan to pursue the PMA application pathway for FDA approval to market as opposed to the 510K route. Once FDA PMA approved, we intend to commercialize our NANO-PFA cardiac surgical system in the United States as a treatment for atrial fibrillation. To support the PMA application pathway, we expect to commence a pivotal clinical trial in early 2025. We plan to present our clinical study design to the FDA for our IDE pivotal study in the near future. Discussions with the FDA will ultimately determine further details of the study in the timeline.

Burke Barrett: Now, moving on to our catheter-based endocardial AF application. Our third product, certainly underdeveloped, is focused on delivering next-generation NANO-PFA technology to endocardial applications through our 360 cardiac catheter and is also a treatment for AF. Our first and human feasibility study is underway in Prague where we are investigating safety and efficacy of the catheter's clinical performance. We are pleased to have approval for expanded enrollment of this study from 30 to 60 patients.

Burke Barrett: The catheter's ease of use, ability to acutely isolate the pulmonary veins and case signs were all very encouraging in the first 33 patients. We have already commenced treatments in this additional 30 patient cohort. In addition to the expanded first and human feasibility study in Prague, we intend to add two other procedures and well-known clinical sites in the EU together additional user experiences and clinical outcomes. With our expanded clinical experience and the results of these feasibility studies, we will design a pivotal clinical study to propose to the FDA.

Burke Barrett: On receiving their feedback and aligning on the final Pivotal Study Protocol, it is our intention to begin a USID Pivotal Clinical Study or this indication sometime next year. Once exceptionally completed, the Pivotal Clinical Study would provide the foundation for a PMA submission.

Burke Barrett: All together, we are excited by the progress made across our three devices and we are encouraged by the future potential each device holds. In providing safe and effective treatments for significant disease states across the body.

Burke Barrett: To support further product and clinical development, future regulatory submissions and commercial readiness of our three novel devices, we completed a rights offering fundraising in July. We're encouraged that the offering was oversubscribed and provided gross proceeds of 60 million less expenses related to the rights offering of approximately $250,000. Upon exercise of all the warrants, the company could receive additional proceeds of up to $66 million.

Burke Barrett: To cap off what has been a very exciting quarter and past few weeks for Pulse, we are thrilled to announce that Paul Leviolet has been appointed co-chairman of the Pulse Biosciences Board Director. He will serve alongside our other co-chairman, Bob Duggan. I've known Paul for over a decade and I'm highly confident he will be extremely additive to our team. He had successfully scaled some of the largest global cardiology med tech franchises through driving innovative technology adoption. We're excited to work with him and I know we will benefit greatly from his invaluable insights.

Michael Koffler: Now I'll pass the call over to Mike Coffler, provide some financial results for the second quarter of 2024. Thank you, Burke. Today I will highlight our key financial metrics focusing on our cash position and details on our cost and expenses for the second quarter. Cash and cash equivalence total 26.2 million as of June 30, 2024 compared to 58.7 million as of June 30, 2023. Note the cash balance as of June 30, 2024 does not include the 60 million in gross proceeds received from the rights offering the close in July of 2024.

Michael Koffler: On a pro form of basis, including the cash received from the rights offering, we begin the third quarter with approximately 86 million. Cash used in the second quarter of 2024 total 8.7 million compared to 10 million used in the same period in the prior year and 9.5 million used in the first quarter of 2024. In the second quarter of 2024 total gap costs and expenses increased by 1.5 million to 11.7 million compared to 10.2 million in the prior year period.

Michael Koffler: The increase in gap costs and expenses was primarily driven by an increase in non-cash stock based compensation expense which was 2.1 million in the second quarter of 2024 compared to 1.1 million in the prior year period. To remind everyone, non-gap costs and expenses include stock based compensation, depreciation and amortization. Total non-gap cost and expenses in the second quarter of 2024 increased by 0.6 million to 9.4 million compared to 8.8 million in the prior year period. The increase in non-gap costs and expenses was primarily driven by an increase in headcount support advancement of our nano-PFA technology.

Burke Barrett: I will now turn the call back over to Burke. And through rigorous clinical and regulatory pathways, that ultimately can unlock the full value of the devices we developed as we move product by product from clinical studies, ultimately into commercialization.

Trip Taylor: Joining us now for the question and answer session today are Bob Duggan, co-chairman of the board, Darrin Uecker, CTO and director, and Kevin Danahy, CCO. So, operator, please open the call for questions. Thank you. We will now be conducting any question and answer session. If you would like to ask a question, please press the star 1 on your telephone keypad. A confirmation tone will indicate a line as in the question queue.

Trip Taylor: You may press star 2 if you would like to remove yourself from the queue. For participating in speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment please, while we pull for questions.

Anthony Petrone: Our first question comes from the line of Anthony Patron with Musuhogu, please proceed with your question. Thank you. Congratulations on the progress in the second quarter here to the team.

Burke Barrett: Maybe first to start with on the cardiac surgical claims out of the equation. The company went through the TAP program initially and you received breaks through the designation. You have a couple of cases that are done here already. So maybe one, just on the case side of the equation, two of the benefits on the clam side using cell effects as a backdrop or speed of the surgery but also nerve sparing. Just wondering if you can go over some of the feedback from these initial cases.

Burke Barrett: How fast was the surgery done? How safe was it? What was the side effect profile of any of these patients? And then secondly, commencing the trial in 2025. It's a 510K clearance. Maybe just a little bit as we look ahead to what is going to be needed to secure 510K. What will the next phases of this study look like? And then I'll follow up. Thanks. Hi, Anthony. It's Burke. Thanks for your questions.

Burke Barrett: So based on the extensive preclinical data, there are many advantages of NANO-PFA in cardiac surgical ablation compared to the standard of care today, which is RF. One of them you mentioned is speed, but others are the ability to make consistent transmural or full thickness through the thickness of the heart lesions, because of the way the energy is transferred, and the form factor of the clamp, the use of it in the surgeon's hands is very similar to what they're familiar with from an RF point of view.

Burke Barrett: So the energy itself is non-thermal, and as you said, it's expected to be not nerve-sparing or safe with collateral tissue. I'm not going to comment on a lot of the specific details of the two procedures because two is a small number and we're just starting, but the device performed as expected, it performed well. The procedures were very efficient, and certainly the clinicians involved in the procedure were excited by the performance of the device.

Burke Barrett: When it comes to the pathway, the regulatory pathway for approval in the U.S., while the company did initially submit and had discussions with the FDA on a 510K submission for cardiac surgery, we made the decision to pursue a specific indication not just for cardiac surgery, but for the treatment of atrial fibrillation. That is the primary reason why we will be discussing with FDA shortly a pivotal clinical study design. For this kind of device, the pathway to market for a specific indication of treatment of AF is a so-called PMA pathway.

Burke Barrett: Again, both of those pathways would require some sort of pivotal clinical study, which will conduct, but the actual application that will go into the FDA after the study is complete will not be a 510K, it will be a PMA. We believe there are significant benefits. Once we have a successful pivotal clinical study and a PMA approval to be able to sell and market and importantly train specifically as a treatment for atrial fibrillation, what should happen when we have that approval and we have the specific indication? We should see quicker adoption in the marketplace because we can sell, market, and train specifically for the use of the device and the treatment of atrial fibrillation.

Burke Barrett: That is helpful as a backdrop, but maybe on the soft tissue ablation front, the perkytane select road system, announcing pivotal clinical trials expected in 2025, but you are targeting benign thyroid nodules. Maybe just a little bit about that market opportunity and why the decision on that specific initiative soft tissue ablation with the perkytane select road decision to go more narrow in terms of that indication against specific to benign thyroid nodules. Sure.

Burke Barrett: So the company went through a process over the last three years of very thoughtfully and carefully analyzing the possible indications, applications, markets if you will to deliver nano PFA which included not only market size, but the relative clinical performance of the current standard of care devices, ease of utilization of nano PFA and so on. And the benign thyroid nodule opportunity is within the soft tissue ablation opportunity became one of the very exciting markets.

Burke Barrett: There is a significant number of people that have benign thyroid nodules. It's estimated to be as many as 1.3 million people worldwide. And the two main options to treat these benign thyroid which are, they become large. And so there's a cosmicis effect, obviously you can see them. But also as they grow, they put pressure on the surrounding structures and nerves and they become painful. And the two main options are to have a surgical resection which not only leaves a scar, but may leave the patient needing to have lifetime hormone replacement therapy or to do nothing.

Burke Barrett: Those are the two primary approaches. And we believe that providing a tool that can shrink benign thyroid nodules without the risk of thermal spread to the surrounding structures like various cranial nerves, the trachea, the vocal cords and other things that are in proximity to the thyroid represents a great opportunity for nano-PFA. That's all for the last one for me. I'll hop back in. It's just when you think about 2025 here now, in the capitalization efforts, you have the 510K for benign for PTN, we could call it and then you have obviously surgical ablation on the clamp side and also pursuing catheter ablation, specifically nano-PFA 360 catheter ablation.

Burke Barrett: So it's three studies being pursued concurrently in 2025. Maybe just an update on looking at the pro forma cache balance, assuming 60 million in proceeds from the rights offering, you know, how well capitalized the company is to handle the three concurrent studies. Thanks, you're welcome. So historically in recent quarters, the average cache burn has been about 9 million per quarter. Obviously, cache burn will go up as we enter the active phases of these three different studies.

Burke Barrett: We haven't provided information yet about the anticipated cache burn in the future because much of the spend will depend on the actual study design, the number of sites and number of patients, and the timing of the start of the study. But we do anticipate that the burn will go up. We have said that we believe that the cache on hand today will take us into 2026. And that's without any exercise of the warrants from the rights offering. Thank you.

Operator: And here it looks that Darryl knows for other questions at this time.

Burke Barrett: I would like to turn the floor back over to Bert Barrett for close remarks. I want to thank the Paul's team for a fantastic quarter. I want to thank you all for calling in and listening to the update and we look forward to providing more updates and talking to you all again next quarter.

Burke Barrett: Thank you. Thank you Thank you very much Thank you very much

Q2 2024 Pulse Biosciences Inc Earnings Call

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