Pulse Biosciences, Inc

Greetings, and welcome to the Pulse Biosciences fourth quarter 2023 earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Tripp Taylor, Investor Relations. Thank you, sir. 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, March 28, 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 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 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, 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 this call. I am excited to be here today with our team, including Darren Uecker, Chief Technology Officer and Director, Mitch Levenson, Chief Strategy Officer, and Mike Koffler, Vice President of Finance. Our accomplishments in 2023 and early this year have been focused on our proprietary, designed, and engineered Cellifex NSPFA energy delivery system and the three novel end-of-factor devices designed to deliver our CellFX NSPFA energy to different tissues in the body. We are pleased with our success. Today, I will highlight each of the three surgical opportunities we are currently focused on at Pulse Biosciences. The CellFX NSPFA percutaneous electrode, the NSPFA surgical clamp, and the NSPFA 360-degree cardiac catheter. I will then hand the call over to Darren to provide a detailed product update on our cardiac device programs, and then Mitch will provide specific non-cardiac development progress. Finally, Mike will review our fourth quarter and end of year 2023 financial results before I conclude and open the call for a question and answer session. First, I want to focus on the CellFX NSPFA percutaneous electrode. The percutaneous electrode, or PERC electrode, is designed for the surgical soft tissue ablation, leveraging our proprietary designs an engineered CellFX NSPFA energy delivery system. The CellFX NSPFA energy creates potential patient benefit and surgeon value in the treatment of soft tissue nodules. We believe CellFX NSPFA has the potential to provide hospitals and treating physicians with a new and exciting alternative for patients with a broad range of soft tissue nodules in need of therapy. In November, 2023, Dr. Stefano Spiazza, leading thyroid surgeon and chief of endocrine surgery division at Napoli Hospital Del Mare in Naples, Italy, completed our initial trial of 30 patients on the application of Celefex NSPFA percutaneous electrode for the treatment of benign thyroid nodules. He presented his excellent results in February at the 2024 NACET annual meeting. Additionally, the percutaneous thyroid nodule study will be shared in detail via the podium presentation later this year, demonstrating extremely promising feasibility results. In November of 2023, Pulse Biosciences concluded its preclinical studies and submitted a pre-market notification 510K with the U.S. FDA for clearance to commercialize the cell effect NSPFA percutaneous electrode. In March 2024, we received FDA 510K clearance for our CellFX NSPFA percutaneous electrode system with a soft tissue ablation indication. Regarding the CellFX NSPFA surgical clamp, the NSPFA surgical clamp is specifically designed for general ablation of cardiac soft tissue, leveraging our proprietary designed and engineered CellFX NSPFA energy delivery system to be used by cardiothoracic surgeons during open or minimally invasive cardiac procedures. Our Chief Medical Officer, Dr. Gann Dunnington, and Chief Science Officer, Dr. Nivad, have been instrumental in driving our progress in cardiac device development, preclinical work design, and the FDA application process. In December of 2023, we filed a pre-market notification, 510K, for our CellFX NSPFA cardiac plan. We believe CellFX NSPFA offers significant potential advantages over current energy modalities in the cardiac surgical space. Lastly, I want to discuss the CellFX NSPFA 360 degree cardiac catheter. The catheter is designed for the use by electrophysiologists to isolate and ablate the pulmonary veins of the left atrium. We believe our unique and intended design of the CellFX NSPFA cardiac catheter allows physicians the versatility and flexibility in one single design to perform pulmonary vein isolation as well as enable important posterior wall isolation. Multiple key opinion leaders, KOLs, are creating increasing awareness of the benefits of our novel cell effects NSPFA cardiac catheter throughout the clinical community and presenting its potential at predominant medical meetings. Podium presentations and addition of new key opinion leaders are helping us build momentum as we execute on KOL development and clinical plans. Recently, on the podium at the AF Symposium on February 2nd, Dr. Vivek Reddy featured the CellFX NSPFA 360 degree cardiac catheter and showcased the first in human cases in a presentation that was well received by Dr. Reddy's colleagues in the audience. We expect to have a strong presence at the Heart Rhythm Society, HRS, May 16th to May 19th in Boston. We are pleased to report that we have completed 60-day post-procedure evaluations in February 2024, generated from the first in human catheter feasibility study. The very good news is that the remaps look almost identical to the immediate post-procedure maps, which demonstrates the early on durability of high-quality lesions that our CellFX NSPFA 360-degree cardiac catheters are able to produce. These positive results were well received by all involved, including patients, physicians, and supporting staff. We plan to complete enrollment of our initial first in human feasibility study of 30 subjects in the coming months. We also plan to initiate a study to support CE-MARC filing, which will complement our KOL development in the European markets. Each of the CellFX NSPFA devices we have discussed has the potential to evolutionize current standards of care in comparison to speed, efficacy, adverse events, and overall treatment outcomes. I will now hand the call off to Darren to provide updates on our cardiac device development, including progress made in the lab and clinic.