Pulse Biosciences, Inc

Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to the Pulse Biosciences first 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. Should you require operator assistance during the conference, please press star zero to signal an operator. Please note this conference is being recorded. I will now turn the conference over to your host, Tripp 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, May 11, 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'm excited to highlight a significant addition to our executive team, as well as discuss how the team plans to advance and achieve our corporate objectives. I will then turn the call over to our Chief Technology Officer, Darren Uecker, to share updates regarding our product development and regulatory initiatives. Mike Koffler, Vice President of Finance, We'll review our first quarter financial results before I conclude and open the call for a question and answer session. I want to open this call by highlighting our leadership team. We are proud to have assembled a world-class team and organizational structure designed to accelerate and broaden the application of our innovative technology. Just this month, we announced the appointment of Dr. Gann-Donaton as Chief Medical Officer focused on our cardiothoracic application. Dr. Dunnington is a renowned cardiothoracic surgeon specializing in complex minimally invasive procedures. He is a leader in pioneering novel, less invasive technologies that improve the lives of patients with atrial fibrillation. Dr. Dunnington compliments our leadership team at a critical point for our technology. We look forward to his guidance as we advance the clinical and regulatory programs for our portfolio of cardiac devices. Dr. Donington will work closely alongside Chief Technology Officer Darren Uecker and Chief Strategy Officer Mitch Levinson. Mitch is a medical device industry veteran with a track record of successfully bringing new technologies and products to market across a variety of medical specialties. He is on the call and will participate in Q&A. Pulse Biosciences is on a path to deliver beneficial, first-in-kind therapeutic effects that have yet to be achieved within the current pulse field ablation market. The platform nature of our technology enables multiple clinical possibilities. We continue to look, listen, and evaluate opportunities outside of cardiac. If and when something important manifests, We will share it with you, our shareholders, on a timely basis. Our top focus remains developing a cardiac ablation catheter and surgical ablation clamp utilizing NSPFA for the treatment of atrial fibrillation, or AF. There is a clear emerging consensus from treating physicians that PFA is safer and faster than RF and cryo. And we believe that we can take this a step further by creating a more advanced treatment that will benefit both patients and clinicians. Preclinical evidence suggests NSPFA can potentially offer a leading safety and efficacy profile in comparison to traditional thermal ablation modalities and even newer PFA technologies. The ability to penetrate this $8 billion market will lead Pulse towards long-term value creation for patients, providers, and shareholders. We are working to develop several devices that will deliver NSPFA to cardiac tissue. On our last call, we unveiled two goals that align with our heightened corporate focus. One, to develop and advance our cardiac plan through the appropriate FDA regulatory path, and two, to complete all catheter products and regulatory milestones required to treat initial clinical study patients. Achieving these goals should lay the groundwork for long-term success in the cardiology space and support a viable business model. We plan to accomplish these milestones during the first half of 2024. We are proud of our achievements throughout the first quarter. We recently completed the pre-submission meeting with the FDA for our cardiac ablation plan and are in the process of finalizing our regulatory pathway. We are continuing our preclinical studies to support first in human trials with our catheter device, and we have three related abstracts accepted at the 44th annual Heart Rhythm Society meeting. I will now turn it over to Darren to discuss the technology and the product roadmap.