Recently, the company has completed enrollment in its Viveve 2 sexual function trial during March second week. The study will evaluate the safety and efficacy of its proprietary, cryogen-cooled monopolar radiofrequency technology for the improvement of sexual function in women following vaginal childbirth. The company anticipated a final 12-month data read-out at the end of the first quarter of next year.
The company has experienced fairly significant commercial headwinds in the last half of 2018. However, Viveve Medical continued to see improvement in the headwinds as it moved through the fourth quarter and the first quarter of this year and reiterated its 2019 revenue outlook.
The company is expected to continue to aggressively pursue expanded indications for use in improved sexual function and stress urinary incontinence or SUI in the United States and internationally. This follows its significant advancement in clinical programs during 2018.
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The opportunity for the company has been huge as there remained 12 million to 14 million women worldwide who are candidates for Viveve’s treatment to improve sexual function. This represented a $6 billion to $8 billion total available consumable market opportunity. About 25 million to 30 million women worldwide are bothered by symptoms and leakage associated with SUI and represented $10 billion to $12 billion total available consumable market opportunity.
For the fourth quarter, Viveve Medical reported a wider loss due to higher operating expenses as well as lower revenue. Revenue declined by 12% as the company was able to sell 57 Viveve Systems and about 4,600 treatment tips. Operating expenses rose by 14% due primarily the result of increased efforts to support the commercialization of Viveve’s products in the US and clinical studies in SUI and sexual function.
The company had anticipated reporting continued momentum in system sales and consumable treatment tip utilization in 2019 as Viveve Medical advance its global commercial, regulatory, and market development strategies.
Shares of Viveve Medical ended Monday’s regular session down 28.39% at $0.58 on the Nasdaq. The stock has fallen over 81% in the past year and over 39% in the past three months.