Exhibit 99.1

 

 

 

Viveve Reports Fourth Quarter and Full Year 2018 Financial Results

 

 

ENGLEWOOD, CO -- March 14, 2019 -- Viveve Medical Inc. (NASDAQ: VIVE), a medical technology company focused on women's intimate health, today reported financial results for the three months and full year ended December 31, 2018.

 

“2018 was a year of solid progress even as we worked to address some considerable challenges. We grew revenue despite facing significant market headwinds in the second half of the year that affected the entire women’s intimate health industry.  We also continued our paths forward in our clinical programs as we advanced our U.S. sexual function trial and launched our programs in stress urinary incontinence (SUI) with Viveve’s cryogen-cooled, monopolar radiofrequency (CMRF) technology,” said Scott Durbin, Viveve’s chief executive officer. “In January, we also realigned our organization to reduce expenses and focus on our core initiatives of expanding system placements, increasing treatment tip utilization, reducing cost of goods and completing our clinical development programs in female sexual function and SUI.”

 

2018 and Recent Business Highlights

 

 

Achieved continued growth in global revenue: Reported 2018 total revenue of approximately $18.5 million from the sale of 259 Viveve Systems and over 18,000 disposable treatment tips, representing a 21% year-over-year revenue increase.

 

Advanced and fully enrolled U.S. clinical trial for the improvement of sexual function in women: Following U.S. Food and Drug Administration (FDA) approval of the Investigational Device Exemption (IDE) and successful review of patient safety data submitted to the Agency, Viveve received approval to proceed to full patient enrollment in late December 2018. In March 2019 Viveve completed enrollment of 250 patients in VIVEVE II, our U.S. multi-center randomized, double-blind, sham-controlled trial for improved sexual function in women.

 

Advanced clinical programs in stress urinary incontinence (SUI): Reported positive 12-month results from a pilot study and separate feasibility study using the Viveve System for the treatment of SUI. Viveve initiated and completed patient enrollment in the LIBERATE-International trial with results expected in the third quarter of 2019. The company also worked closely with FDA throughout 2018 to define the data needed in 2019 to support starting a U.S. registration study for SUI.

 

Introduced an enhanced technology platform: Successfully executed the initial launch of Viveve 2.0., the company’s next generation system, with the potential to deliver improved gross margins in 2019.

 

Expanded awareness of Viveve’s CMRF technology: Data was reported in more than 20 clinical publications and presented by gynecology, urology, women’s intimate health and aesthetic physician opinion leaders at 15 leading global medical conferences and meetings.

 

Successfully protected Viveve’s IP estate: Announced a favorable settlement of the company’s patent infringement litigation, further protecting Viveve’s intellectual property portfolio.

 

Expanded Board: Appointed two new, independent, and seasoned commercial executives to Viveve’s Board of Directors; Steven Basta and Karen Zaderej.

 

 

The following information was filed by Viveve Medical, Inc. (VIVE) on Thursday, March 14, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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