Viveve Medical, Inc.

Good afternoon and welcome to the VIVV full year 2021 financial results and corporate update conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. Please note this event is being recorded. I will now turn the call over to Jeannie Swindle, VIVV's Senior Director of Corporate Communications.

Thank you, Operator, and welcome, everyone. Before we begin, we would like to remind you that this conference call may contain forward-looking statements regarding future events or the future financial performance of the company. Any statement that is not a statement of historical fact is a forward-looking statement. This includes remarks about the corporation's timing, progress, and results of its clinical trials, fluctuation of global market economic conditions, impact of the novel coronavirus on clinical development, regulatory review and clearances, manufacturing, system placements and utilization, projections, expectations, plans, beliefs, and prospects. These statements are based on judgments and analysis as of the date of this conference call and are subject to numerous important risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties are described more fully in the company's annual report on Form 10-K and other filings made with the Securities and Exchange Commission, which are also available on the company's website. Also, any forward-looking statements represent management's view only as of the date of this conference call and should not be relied upon as representing management's views as of any subsequent date. Speaking on today's call will be Scott Durbin, the V's Chief Executive Officer, and Jim Robbins, Senior Vice President of Finance and Administration. I will now turn the call over to Scott Durbin

Thank you, Jeanne. Good afternoon, everyone. We appreciate you joining us for our call on this St. Patrick's Day in the United States. I'll begin our call this afternoon with a brief business summary and then have Jim Robbins provide the 2021 year-end financial results. I will then provide a detailed corporate update. To begin, 2021 was a transformational year for Vaviv. attributable to the significant advancement of our stress urinary incontinence or SUI clinical development program, namely initiation and completion of full enrollment in our U.S. Pivotal Pursuit Trial for SUI in Women. Achievement of this critical milestone was the focus of our entire organization in 2021. The fact that many clinical trials were delayed or halted during the past year due to the continuing impact of COVID-19 precautions and patient concerns, highlights the extraordinary work performed by our entire team and our investigational sites to enroll, randomize, and complete these phases of this landmark trial. I will also add that it speaks to the high level of interest from women living with incontinence who are actively seeking a non-invasive treatment option. The success of our SUI program continues to be our focus as we execute the final phase of our pursuit trial throughout 2022 towards a top line readout anticipated at year end with the ultimate goal of obtaining a new commercial SUI indication in the future if the results are positive. I will expand on our clinical and commercial progress following Jim's report of our financial results. But importantly, VIV is in a strong financial position with the capital resources to support operations into early 2023, including the planned completion of the Pursuit Trial. In 2022, our strategic focus continues to be to successfully execute the currently underway Pursuit Trial and achieve a positive topline data readout anticipated at the end of the year, And if positive, preparing to commercially launch the first FDA-approved, patent-protected, endovaginal dual-energy office-based treatment for urethral hypermobility to improve SUI in women. Secondly, continuing to focus our commercial and market development efforts in the U.S. and Asia Pacific regions through the expansion of our installed base targeting urology, urogynecology and gynecology core specialties. And third, supporting our customers with successful initiatives to continue to drive increased consumable treatment tip utilization and sales. With that, I will now turn the call over to Jim Robbins.