Pulse Biosciences, Inc

Ladies and gentlemen, greetings and welcome to the Pulse IOSciences fourth quarter 2022 earnings conference call. At this time, all participant lines 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, Krip Taylor, Investor Relations. Please go ahead.

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 30, 2023 only, and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations, and other 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 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 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 will discuss our nanosecond pulse field ablation, NSPFA, development progress, and our 2023 corporate objectives. I will then turn the call over to our Chief Technology Officer, Darren Uecker, to provide a detailed overview of our core technology and product development initiatives. Then I will review our fourth quarter financial results before concluding and opening the call for a question and answer session. Pulse Bioscience is going where we believe no company has gone before, accomplishing beneficial, first-of-a-kind effects that have yet to be achieved in the world of pulse field ablation. Our technology has consistently demonstrated a high degree of safety, efficacy, and outcomes. In addition to the significant positive impact on patients, the knowledge gained during our previous FDA clearances has given us the present-time confidence and vision to pursue the use of NSPFA on the human heart. Our FDA clearance in the treatment of over 6,000 patients with tissue-related positive results in skin proved the viability of our technology, paving the way for differentiated cardiac applications. Our proprietary NSPFA technology has the potential to be disruptive in a unique, demonstrable, and consistent manner. While it's still early days and preclinical testing is ongoing, we are encouraged by our progress to date. 2022 was a pivotal year for Pulse Biosciences. We announced a strategic shift in reprioritizing our efforts to focus on the most compelling opportunities for the application of our proprietary nanopulse stimulation technology. Building upon our R&D work in cardiology that began several years ago, our top focus is now on developing multiple devices to deliver nanosecond pulse field ablation, or NSPFA, to cardiac tissue for the treatment of atrial fibrillation. We made this decision based on our existing preclinical evidence that suggests NFPFA can potentially offer a leading safety and efficacy profile compared to thermal ablation modalities and newer PFA technologies. The treatment of AF atrial fibrillation is a large and established high-growth market. We believe our ability to take share in this $8 billion market represents the most efficient path towards long-term value creation and a viable business model. We have adjusted our strategy and team to best pursue this opportunity. I could not be more excited to lead the company through this pivotal time. I am confident we have the technology, the team, and strategy in place to maximize the impact of NSPFA and create substantial value for patients, physicians, and stakeholders. Our complete existing understanding of NSPFA's impact on sales compared to thermal destruction led us to investigate cardiac tissue ablation early on. Initially, we sponsored and provided equipment to university research. Once the feasibility of the mechanism of action was proven in animal cardiac tissue, we initiated our own R&D projects. These included the development and preclinical testing of a cardiac ablation clamp for the use in cardiac surgery and a cardiac ablation catheter for the use in electrophysiology. I will let Darren discuss the details of the technology and product development progress shortly, but I first want to provide context around the AF market and why we have prioritized this application for the technology going forward. The treatment of AF represents, in a broad sense, one of the largest and fastest growing markets in medical technology. Over 1.2 million catheters and surgical ablations are performed annually, and this is expected to grow by more than 10% annually due to an aging population, patient awareness, epidemiology, increased clinical evidence, and technical advancements supporting treatment improvements and intervention. We expect, through the parallel development of our clamp and catheter devices, we can realize important technical, clinical, and eventual marketing synergies. Pulse Bioscience's portfolio of devices is both a demonstration of the versatility of cell effect system and an opportunity to address emerging collaboration between surgeons and electrophysiologists treating atrial fibrillation. There is a clear emerging consensus from treating physicians that PFA is thought to be safer and faster than the present-time treatment options, but we believe we can do better. Our goal is to change how physicians treat and view AF atrial fibrillation, and in the process, provide greater value to patients, physicians, and cardiac centers. In the present time, we have focused the organization on two main goals to advance our NSPFA technology for the treatment of AF. One, we intend to develop and advance our cardiac clamp through the appropriate FDA regulatory path. and two, complete all catheter product and regulatory milestones required to treat our early patients. Our goals are clear, and we understand they require time, know-how, patience, and experience to execute properly. We are focused on long-term success and building the foundation for a viable business over the coming years. I will now turn it over to Darren to discuss the technology and product roadmap.