Pulse Biosciences, Inc

Greetings and welcome to Pulse Biosciences' second quarter 2023 earnings conference call. At this time, all participants are on 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. I would now like to turn the conference over to your host, Philip Taylor. 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 10, 2023 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 and uncertainties are more fully described in our press release issued earlier today and in our filings with the US Securities and Exchange Commission. Our SEC filings can be found on our website or the SEC's website. Investors are cautioned not to place undue reliance on forward-looking statements. We disclaim any obligation to update or revise these forward-looking statements. We will also discuss certain non-GAAP financial measures. Disclosures regarding these non-GAAP financial measures, including reconciliations with the most comparable GAAP measures, can be found in the press release. Please note that this conference call will be available for audio replay on our website at PulseBiosciences.com on the News and Events section on our Investor Relations page. With that, I would now like to turn the call over to President and Chief Executive Officer Kevin Danahy.

Thank you, Tripp. Good afternoon, everyone, and thank you all for joining us. On today's call, I'm excited to be joined by Darren Uecker, Chief Technology Officer, Mitch Levinson, Chief Strategy Officer, and Mike Koffler, the Vice President of Finance. The full breadth of our expert and experienced leadership team will be on display today to highlight the robust progress we are making. In the second quarter, we were appropriately focused on the continued validation of nanosecond pulse field ablation And we continue to build on the science behind cell effects technology to clearly differentiate NSPFA, nanosecond pulse field ablation, from all current PFA technologies, emphasizing the potential for meaningful, improved safety and efficacy with NSPFA. First, I would like to discuss our core opportunity and top priorities. Then I will hand the call over to Darren Uecker to discuss specific cardiac device development and noteworthy performance achievements. Then Mitch Levinson will describe our business development progress and provide exciting news on our first in human experience with benign thyroid nodules, our company's first surgical application for NSPFA. Then Mike Koffler will review our second quarter financial results before I conclude and open the call for a question and answer session. As a reminder, our primary focus is on developing a cardiac ablation catheter and surgical ablation clamp utilizing NSPFA for the treatment of atrial fibrillation, or AF. Clamps will be used during open or minimally invasive heart surgery by cardiac surgeons, and the catheter will be navigated into the heart using standard minimally invasive catheter techniques through large blood vessels by electrophysiologists in the EP lab. There is a clear emerging consensus from treating physicians that PFA is safer and faster than RF and cryo. And we intend to take this a step further with NSPFA by creating a more advanced treatment that has the potential for benefits for patients, surgeons, and clinicians. This is an amazing period in pulse bioscience history. NSPFA is establishing a new standard in efficacy and safety. now being demonstrated in preclinical studies in our first in human surgical procedures. These exciting results follow years of visionary engineering and development. As a reminder, Pulse Bioscience engineers have been designing and understanding NSPFA since 2015 and investing in NSPFA for cardiac applications since 2016. We are unique in the Pulse field ablation space partially because of our development process. We have built the CellFX system from the ground up. Pulse Bioscience engineers first understood the science of NSPFA at a basic electrophysiology level, then created the CellFX console to generate and harness the energy of NSPFA, then took that knowledge and designed electrode endofactors, purposely built to deliver NSPFA energy to create the appropriate tissue response across multiple therapeutic areas. Our command of NSPFA is rooted in 15 years of research at academic and science centers, followed by a half-dozen years of advanced engineering, allowing pulse bioscientists to move at an accelerated pace in preclinical cardiology studies in first-in-human thyroid surgical cases. And the results to date are what we wanted to see. I will let Darren and Mitch fill in the details. As we accelerate our strategic vision in the cardiology device development, the company's focus has been on preclinical validation of our technology for the cardiac surgical clamp and the catheter programs. We remain on track to file an FDA submission for the cardiac surgical clamp in the first half of 2024 and to begin a feasibility study for the cardiac ablation catheter during the same time period. As a supplemental point of validation of our engineering capabilities and to demonstrate our unique mechanism of action on internal organs, we have performed feasibility work in the treatment of benign thyroid nodules and initiated first-in-human studies using novel proprietary NSPFA endofactors. This study was conducted to further validate the mechanism of action and tissue response of NSPFA and internal organs as we advance towards human cardiac tissue. We view the safety and efficacy in demonstrated tissue response data from the thyroid nodule study as an important incremental validation of our product engineering thesis and as the first demonstration of our potential of NSPFA to deliver otherwise not available safety and efficacy in human tissue ablation. Based on these results, we see external interest in opportunities to further develop our technology platform beyond cardiology. We are entertaining and evaluating inbound inquiries through partnerships or licensing agreements that align with our corporate goals. I will now hand the call off to Darren to discuss the progress we have made on our cardiology device development and their initial preclinical performance.