Pulse Biosciences, Inc

Greetings and welcome to the Pulse Biosciences third quarter 2023 earnings conference call. 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 a conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Philip Taylor, Investor Relations. 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, November 13, 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. The 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 on the SEC's website. Investors are cautioned not to place undue reliance on forward-looking statements. We disclaim any obligation to update or revise these forward-looking statements. We will also discuss certain non-GAAP financial measures. Disclosures regarding these non-GAAP financial measures including reconciliations with the most comparable gap 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, I would now like to turn the call over to President and Chief Executive Officer Kevin Banahy.

Thank you, Tripp. Good afternoon, everyone, and thank you all for joining us. On today's call, I will be joined by Darren Uecker, Chief Technology Officer and Director, Mitch Levinson, Chief Strategy Officer, and Mike Koffler, Vice President of Finance. Today, I will start by discussing our progress advancing our top corporate priorities. Then I will hand the call over to Darren Uecker to detail our cardiac device development achievement. Mitch Levinson will then describe our extra cardiac business development progress. And then Mike Koffler will review the third quarter financial results before I conclude and open the call for a question and answer session. It was a highly productive third quarter for Pulse Biosciences. In the lab, our CellFX NSPFA technology continues to demonstrate the potential to revolutionize the treatment of atrial fibrillation. In the clinic, CellFX NSPFA is demonstrating the ability to safely and effectively treat benign thyroid nodules. And at the podium, we are pleased to be seeing increased external validation of our technology and presentations from KOLs at various scientific meetings. On the business front, we are excited to have appointed renowned cardiac surgeon, Dr. Nivad, as our Chief Science Officer, Cardiac Surgery. All together, we've done the work in the lab, and it has confirmed our value propositions for CellFX and SPFA. As we share these preclinical results, awareness of the benefit of CellFX and SPFA is growing and attracting industry leaders from across the globe who see the positive impact of their engagement and want to be involved with advancing the technology as quick as possible to deliver improved clinical outcomes to their patients, as well as many others. Our primary focus is on developing a cardiac ablation catheter and a surgical ablation clamp, both utilizing CellFX and SPFA for the treatment of atrial fibrillation, or AF. The clamp 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. Importantly, we remain on track with the development of both the clamp and the catheter. While we previously guided that our milestones would occur in the first half of 2024, With the excellent progress to date, we now believe that they will occur by the end of the first quarter of 2024. Our preclinical testing results have validated our confidence in our cardiac surgical clamp as we prepare to file a 510 submission to the FDA by the end of the first quarter of 2024. And to begin the clinical feasibility study for our cardiac ablation catheter also by the end of the first quarter in 2024. As a reminder, Globally, over 1.2 million catheter and surgical ablations are performed annually, and this is expected to grow by more than 10% year over year. Still, there is a significant runway of adoption for both surgical and catheter techniques because of the safety and efficacy limitations of the current technology. Pulse Biosciences has now demonstrated preclinically with validation by doctors in the lab the technological advancements needed to accelerate adoption of both the clamp and the catheter ablation procedures with our novel proprietary cell effects and SPFA technology. This past quarter, we saw a significant external validation of our novel cell effects proprietary and SPFA technology from predominant cardiac physicians including Dr. Usan Siddiqui and Dr. Nivad, along with leading thyroid surgeons, Dr. Stefano Spiazza and Dr. Ralph Trefano. We are thrilled that at the Global EP Summit in September, Dr. Siddiqui chose our CellFX NSPFA circumferential catheter system to highlight Pulse Biosciences' highly differentiated and advanced solution for electrophysiologists. In addition to our cardiac ablation catheter validation, I am pleased that Dr. Spiazza and Dr. Trofano presented two posters at the American Thyroid Association annual meeting detailing the early results of our clinical study for the treatment of benign thyroid nodules. Specifically, Dr. Spiazza highlighted his participation in our first in human surgical procedures and observations of complete ablations of the cellular tissue without evidence of thermal necrosis or damage to non-cellular structures. Dr. Ralph Trefano found the results extremely compelling and suggested that CellFX NSPFA could be a significant advancement in the treatment of symptomatic benign thyroid nodules. This further validates our belief that CellFX NSPFA is a platform technology that will make a significant impact on patient care. As an additional point of external validation we received in the quarter, we have had multiple surgeons volunteering to join our studies with the purpose of advancing cell effects and SPFA and our novel endofactors in the areas where they are well-respected. We view this positive reception from the medical leaders as confirmation that our cell effects and SPFA technology can have a significant clinical impact in cardiology. We are also encouraged by recent comments and earnings conference calls from companies in the cardiac surgery market and industry analysts as to the size and growth of the cardiac ablation market. and we believe our highly differentiated solution can capture a large portion of this expanding opportunity. Dr. Ad's quote says what we all believe, that Cellifex NSPFA has the potential to not only replace all other energy modalities in cardiac ablation, including radiofrequency and cryo, but due to the speed, safety, and ablation performance of the system, it has the potential to significantly expand the number of patients we treat in cardiac surgery. As awareness of our novel technology spreads throughout the industry, we are also incredibly excited to have Dr. Niv Ad joining our team as Chief Science Officer Cardiac Surgery. Dr. Ad is extremely well-respected cardiothoracic surgeon and will aid us in bringing CellFX NSPFA from the lab to the clinic with his years of clinical and leadership roles in cardiothoracic surgery. Dr. Ad brings unparalleled academic experience helping to launch new medical technologies, which we believe complement very well the clinical experience of our Chief Medical Officer for Cardiac Surgery, Dr. Dan Dunnington. Dr. Ad's experience paired with Dr. Dunnington's industry-leading minimally invasive approach further validates our CellFX NSPFA technology and overall mission to further improve the lives of patients and physicians. Overall, awareness of our preclinical and clinical achievements is leading to external interest in the opportunity to further develop and eventually commercialize our CellFX NSPFA technology platform. These opportunities are only being considered if they align with our business goals to create value by accelerating our timelines to market and facilitating health innovation that has the potential to significantly improve the quality of life for patients. I will now hand the call over to Darren to provide updates for our cardiac device development and preclinical performance.