Viveve Medical Inc.

Viveve, Inc. is a women's health company committed to enhancing women's lives by providing clinically proven, high quality products that improve their overall health and well-being.

Viveve's lead product, the globally patented, non-surgical Viveve® System, is a revolutionary medical device that remodels and restores vaginal collagen using reverse-thermal gradient radiofrequency technology in a single 30-minute out-patient session. The Viveve System has regulatory approval in many countries globally and is available through physician import license in Japan.

Expert Comments:

Brian Marckx, Zacks Equity Research (1/30/17)
"Viveve Medical Inc. recently crossed what we characterize as a major milestone with the entry of the Viveve System into the U.S. market and the recent announcement last week that they have begun deployment of their initial domestic sales force. While other energy-based devices targeted to the U.S. vaginal laxity market have preceded Viveve's entry, none are FDA- cleared for an indication related to that use. . .the Viveve System is the only device that has demonstrated significant efficacy for the improvement in vaginal laxity and/or sexual function."

The last several months have been active ones for Viveve: The results of the VIVEVE I clinical trial were accepted for publication in the Journal of Sexual Medicine, third-quarter financial results beat expectations, and the Viveve system has received regulatory approvals in Brazil, U.A.E. and Lebanon and FDA 510(k) clearance in the U.S.
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Brian Marckx, Zacks Equity Research (11/16/16)
"Viveve Medical Inc.'s randomized clinical study results confirmed earlier findings that Viveve System significantly improves sexual function and reduces vaginal laxity. This marketing study, along with data from previous studies and the recent significantly beefed-up distribution is expected to help accelerate the roll-out of the Viveve System. . .Geneveve is now cleared for sale in 49 countries and the company expects to have approval in another two to four by the end of this year."

CapitalCube (11/14/16)
"Viveve Medical Inc. reports financial results for the quarter ended September 30, 2016. . .VIVE's gross margins widened from 28.60% to 37.37% compared to the same period last year, operating (EBITDA) margins now -248.89% from -528.08%."

Jeff Cohen, Ladenburg Thalmann (11/14/16)
"Viveve Medical Inc. announced financial results from Q3-2016. . .revenues increased 217% on an annual basis and 19% sequentially as the company's commercial activities continue to gain traction in a variety of worldwide markets with a current base of 162 systems. . .VIVE received 9 regulatory approvals during 2016, which brings totals to 34 countries, and ongoing efforts in 16 more countries of which at least two more are expected by the end of the year. . .VIVE has plans for dual pathways into the U.S. marketplace of which the first has been approved."

Anthony Vendetti, Maxim Group (11/11/16)
"3Q16 marked Viveve Medical Inc.'s second quarter of commercial sales in China, and the APAC region continues to exhibit the most strength, followed by the Middle East, Europe, and Latin America, comprising roughly 65%, 25%, 6%, and 4% of sales. . .VIVE received an FDA 510(k) clearance in the U.S., and it has begun commercialization. . .we view the company's recent regulatory clearances as significant milestones (i.e. S. Korea, Brazil, and the U.S.), as approval in these countries represents large market opportunities. . . we believe management's focus should position it for growth."

Brian Marckx, Zacks Equity Research (10/13/16)
"Viveve Medical Inc. continues to make substantive progress towards their quest to commercialize the Viveve System in the U.S. In late September the company submitted an IDE to FDA seeking approval to commence VIVEVE II, a pivotal U.S.-based study expected to support an eventual regulatory filing seeking clearance for an indication related to improvement in sexual function. . .so assuming FDA concurs with a proposed FSFI endpoint and eventual FDA clearance for the treatment. . .in our opinion, could be a game-changer for Viveve."

More Expert Comments

Experts Following This Company

Gregory Chodaczek, Analyst – Sterne Agee
Jeff Cohen, Analyst – Ladenburg Thalmann
Charles Haff – Craig-Hallum Capital
Brian Marckx, CFA – Zacks Small-Cap Research
Anthony Vendetti – Maxim Group

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Investing Highlights
First clinically efficacious technology addressing a $7B market opportunity with limited to no competition
Seasoned medical device executive team with a history of significant successes
Highly undervalued stock with >90% ownership from high quality, institutional healthcare investors
catalyst Calendar