Viveve Medical, Inc.

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 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 SEC, which are also available on the company’s Web site.

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. I would now like to turn the conference call over to Scott Durbin, our CEO.

Thank you, Jeannie. Good afternoon everyone and thanks for joining us today.

I'd like to begin the call this afternoon with a summary of our second quarter results and milestones. Finally, I'd like to highlight the trajectory of our SUI clinical development program, discuss important upcoming milestones and provide our perspective for our business going forward.

To begin during the second quarter of this year, Viveve's business operations were significantly impacted by the COVID-19 crisis, particularly in the United States. In response the significant organizational realignment and operational efficiencies, designed to reduce cash burn that were initiated late in the first quarter have continued throughout the second quarter.

These measures were required in response to the unprecedented health and economic challenges caused by the COVID-19 crisis. The health, safety and well being of our employees, customers, distribution partners and other contacts took priority.

Like most companies across all industries, the majority of our employees continue to work remotely and adhere to strict health and safety protocols when they are in our offices, or contractor facilities. Additionally, due to an estimated 70% to 80% of our customers temporarily closing or dramatically reducing services and staff in their medical practices, Viveve's U.S.

commercial team was significantly reduced and the entire organization refocused to support current customers and advance our pivotal stress urinary incontinence or SUI clinical development program. I am pleased to report that these deliberate yet dramatic measures have proven effective in their intent to support customers significantly reduce costs and preserve cash.

And I am equally pleased to report that despite the challenges caused by the COVID-19 crisis during the second quarter, our organization achieved significant regulatory and clinical milestones. I will expand further on the importance of these milestones in my upcoming remarks but to highlight them; they are FDA clearance of our IDE to conduct the pivotal pursuit trial for improvement of SUI in women.

The continued advancement of our SUI 3-arm feasibility trial, targeted for readout in the coming weeks and regulatory approval of our 2.0 system in Thailand. The achievement of these milestones was previously announced via press releases and filings.

Today, we also reported total revenue for the second quarter of 2020 of $704,000. As of June 30, 2020, the company has a growing installed base of 855 Viveve systems.

Nearly 100 of the total 481 Viveve systems in the U.S. have been placed under the new recurring revenue model that was implemented in the United States in June of 2019.

The number of system placements within the inaugural 12-month period, notwithstanding the significant five months commercial disruption caused by the COVID-19 crisis, including a greatly reduced Viveve's sales team is evident of the models traction as physicians more readily adopt our CMRF technology into their practices. We anticipate increasing success of the recurring revenue model in the future due to the model scalability, lower selling costs and potential to improve profitability dramatically.

Internationally, our installed base has grown to 374 Viveve systems sold through the company's distribution partners without significant change or impact to the international business model. As the COVID-19 crisis evolves and as clinic practices reopen elective procedures, increasing conditions continue to improve Viveve is well positioned to rescale its operational and commercial activities as warranted.

Additionally, through several financing efforts, we strengthened Viveve's balance sheet in the second quarter to provide the resources necessary to maintain our business strategy and continue to advance our critical SUI clinical development program. The ultimate goal of these actions has been to create long-term value by supporting our existing customers and aspiring to achieve a U.S.

label for SUI. Our SUI program is now the focus of the entire Viveve organization, SUI is a condition that affects an estimated 25 million to 30 million women worldwide and represents a massive $10 billion to $12 billion total available consumable market opportunity.

Today there are a few effective non-invasive treatments that exists to reduce leakage as a result of SUI. In fact, the current spectrum of therapeutic options for women is limited to physiotherapy at one end of the spectrum, such as key goals or electrical muscle stimulation designed to strengthen the pelvic floor musculature, to surgical approaches at the highly invasive end of the spectrum such as bulking agents, pessarys, or sling procedures.

Viveve has demonstrated in three previous clinical studies that are single, non-invasive and durable CMRF treatment, which can be done in approximately 45 minutes, safely improves SUI symptoms and significantly reduces leakage for women without SUI. The recently announced FDA IDE clearance to conduct our U.S.

pursuit trial represents a significant regulatory milestone and achievement for the company. Completion and readout of our 3-arm SUI feasibility study targeted in the next few weeks also represents a major near term catalysts that we believe will set the course for the company going forward.

The current 3-arm SUI feasibility study compares our cryogen-cooled monopole radiofrequency treatment and a cryogen-only sham treatment to a totally inert sham treatment for the improvement of SUI in women. This prospective randomized single blind study is being conducted at three clinical sites with a planned enrollment of approximately 36 subjects randomized on a one-to-one-to-one ratio to each of the three study arms.

The primary efficacy endpoint is the mean change from baseline in the standardized and objective one-hour Pad Weight test at five months post treatment. The primary goal of this trial is to demonstrate directional separation between the treatment arms and the inert sham or true placebo arm of the study.

A positive data readout from this short-term feasibility study in the next few weeks will strongly support initiation of our pivotal pursuit trial in the United States. The importance of the U.S.

pursuit trial, its design and implications for our future cannot be overstated. initiation of this pivotal U.S.

trial pending a positive readout from the SUI feasibility study will enable the company to continue its strategic pursuit for U.S. label expansion of our CMRF technology for an SUI indication.

The FDA approved pursuit trial will be a multicenter, randomized, double blind and sham controlled study. The primary efficacy endpoint is the one-hour Pad Weight test at 12 months post treatment.

Enrollment is intended to be approximately 240 subjects at up to 24 study sites in the United States. Randomized in a two-to-one ratio subjects in the active arm will receive our CMRF treatment, subjects in the control arm will receive a clinically inert sham treatment.

And it's incredibly important for me to emphasize the comparative treatments in the activity and control groups in the pursuit trial. Unlike previously completed SUI trials, specifically our liberate international study; the sham treatment that will be administered to the control group will be a clinically inert or a true sham treatment.

The minimal RF or radiofrequency energy and the cryogen-cooling delivered by our new sham treatment tip will be at subclinical and therapeutic levels and thereby should not induce a true treatment response in subjects in the control group. Initiation of the pursuit trial is targeted in the fall of this year, pending the readout of the SUI feasibility study in a few weeks.

As the COVID-19 crisis continues to evolve and present challenges to our commercial and business operations. It is the talent and dedication of all members of the Viveve organization and our dedication to our customers that has effectively enabled us to meet and address these challenges.

In spite of the uncertain duration of the pandemic and the severe cost cutting actions executed during the second quarter, the entire organization is resolute in its focus to support our customers and advance our SUI clinical programs through important upcoming steps and milestones. A positive readout from the SUI feasibility study in the next few weeks will provide tremendous confidence and the ability of the pursuit trial to achieve positive results and position Viveve for a potential U.S.

SUI indication in the future, again, a market opportunity that is several billion dollars large. As a result of our focus and dedication, I remain confident that the company can continue to successfully navigate the changing commercial conditions.

And know that the professionalism and perseverance demonstrated by the entire Viveve organization will position our company in the future as a global leader in stress urinary incontinence. I'd like to thank everyone today for participating in our second quarter conference call.

Operator, this is the end of our prepared remarks. Thank you so much.