Viveve Medical Inc.

Viveve Medical, Inc. is a women's intimate health company passionately committed to advancing new solutions to improve women's overall well-being and quality of life. The internationally patented Viveve® System, that delivers the GENEVEVE™ treatment, incorporates clinically-proven cryogen-cooled, monopolar radiofrequency (CMRF) technology to uniformly deliver volumetric heating while gently cooling surface tissue to generate robust neocollagenesis in one 30-minute in-office session.

International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function indications from over 55 countries. Consistent with these approvals, Viveve is seeking an Investigational Device Exemption from the U.S. Food and Drug Administration (FDA) to conduct a pivotal study on use of the device for improvement in sexual function. Currently, in the United States, the Viveve System is cleared by the FDA for general surgical procedures for electrocoagulation and hemostasis.

InControl Products by Viveve are FDA cleared medical devices that treat stress, urge, and mixed incontinence conditions and products to improve pelvic floor strength. Viveve exclusively distributes InControl Medical's products to healthcare providers in the United States.

Expert Comments:

Jeff Cohen, Ladenburg Thalmann (3/19/18)
"This morning, Viveve Medical Inc. announced U.S. Food and Drug Administration approval of the investigational device exemption application to conduct the VIVEVE II clinical trial. . .it is anticipated to begin enrollment in H2/18. . .VIVEVE II will evaluate safety and efficacy as the primary endpoints of the cryogen-cooled monopolar radiofrequency technology in treatment of vaginal introitus in women following vaginal childbirth."

Jeff Cohen, Ladenburg Thalmann (3/16/18)
"Viveve Medical Inc.'s revenue for 2017 was $15.3M. . .systems placed during Q4/17 were 80, bringing the total systems placed for 2017 to 227 as compared to our estimates of 80 and 226. . .the company's cash as of Q4/17 was $20.7M."

Anthony Vendetti, Maxim Group (3/16/18)
"Viveve Medical Inc.'s Q4/17 revenue of $5.1M was up 108% year over year. . .80 Geneveve systems shipped in Q4/17, including 57 in North America, bringing the total commercial installed base to 444 systems. The company also sold approximately 2,600 consumable treatment tips in Q4/17."

Jefferson Research (3/16/18)
"Viveve Medical Inc. is showing strong cash flow quality and earnings quality, and valuation suggests a lower amount of price risk. . .operating cash flow increased during Q4/17 to -$8M from -$9M. . .the cash flow quality rating for the company remains strongest as the debt coverage quality quarter over quarter and cash flow return on investment quality quarter over quarter weakened in Q4/17."

Anthony Vendetti, an analyst with Maxim Group, shared the results both of a pilot study for stress urinary incontinence and of a recent equity raise by this company.
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Anthony Vendetti, Maxim Group (2/12/18)
"Viveve Medical Inc. completed a $34.5M public offering of 11.5M shares at $3/share. We believe the net capital raised is sufficient to fund the company through 2019E. . .Viveve announced positive results from a pilot trial study of its cryogen-cooled, monopolar radiofrequency technology for the treatment of stress urinary incontinence."

Brian Marckx, Zacks Small-Cap Research (2/7/18)
"Last week Viveve Medical Inc. announced that, based on positive results from a small pilot study, it expects to forge ahead with stress urinary incontinence clinical programs, with U.S. and outside of the U.S. registration studies planned. . .supporting clinical evidence from randomized, sham-controlled studies and U.S. Food and Drug Administration marketing approval would significantly increase robustness of the marketing message and overall awareness building potential." -Zacks Small-Cap Research

A company marketing a product designed to enhance women's sexual function announced preliminary financial results for Q4/17 that caught the attention of several analysts.
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Following the company's release of its latest financial report, three analysts weighed in on the results.
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Maxim Group reported on this firm's Q3/17 earnings, as well as its progress in obtaining international regulatory clearances for its medical system.
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More Expert Comments

Experts Following This Company

Gregory Chodaczek, Analyst – Sterne Agee
Jeff Cohen, Analyst – Ladenburg Thalmann
Josh Jennings – Cowen & Co.
Brian Marckx, CFA – Zacks Small-Cap Research
Anthony Vendetti – Maxim Group

The information provided above is from analysts, newsletters, the company and other contributors.

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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