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 well-being and quality of life.
The globally patented Viveve® System, that delivers the GENEVEVE™ treatment, remodels and restores vaginal collagen using cryogen-cooled, monopolar radiofrequency (CMRF) energy-based technology in a single 30-minute out-patient session.
International regulatory clearances have been received for vaginal laxity and/or improvement in sexual function indications from over 50 countries. Consistent with these approvals, Viveve has submitted an IDE to the 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:

Brian Marckx, Zacks Equity Research (8/21/17)
"One of the major operational items of interest since Viveve Medical Inc.'s Q1 update is an agreement with InControl Medical LLC (ICM). . .for VIVE to serve as exclusive distributor of that company's innovative incontinence therapy devices to U.S. healthcare providers. . .ICM's products are the same as VIVE's existing target customers. . .ICM's products should provide a relatively seamless add-to-the-bag opportunity for Viveve's direct reps. . .management further commented that results of the ex vivo study were extremely good , that their meeting with FDA was very successful and that they believe their preclinical protocol will be acceptable by FDA."

Anthony Vendetti, Maxim Group (8/11/17)
"We believe Viveve Meeical Inc.'s Phase 3 trial is on track for a readout of data in mid-2019, and continue to be encouraged by the strong U.S. sales performance (60% of total systems sold) under its current indication. . .VIVE reported 2Q17 total revenues of $3.08M, up 97.7% y/y. . .gross margin of 40.3%, up 600bps y/y. . .management met with the FDA, and they expect to resubmit the investigational device exemption (IDE) to the FDA by early September. If the protocol is approved, the company should commence the Phase 3 trial by the end of 2017."

Jeff Cohen, Ladenburg Thalmann (8/11/17)
"We believe that Viveve Medical Inc. is currently in discussion with the agency and that a formal IDE would be submitted in the coming months such that a study (VIVEVE II) would commence in late 2017. . .the study would take approximately 12-18 months in duration and that the company would be able to commercialize under this label in 2H18 or early 2019. The study is likely to enroll approximately 250 with 20 to 25 sites. We believe that this claim would eventually prove to further open up the potential marketplace from aesthetics to also include gynecological physicians."

Brian Marckx, analyst with Zacks Small-Cap Research, reports that a $20 million loan received by a U.S.-based medical device company could further fuel growth.
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Brian Marckx, Zacks Equity Research (7/11/17)
"Viveve Medical Inc. is off to a strong start, we expect domestic sales to accelerate throughout 2017. . .VIVE hopes to eventually gain FDA clearance of the Viveve System for an indication related to the improvement of sexual function. While we had hoped the pivotal study would begin this year, that timeline may now be pushed to 2018 given that FDA recently asked for additional safety related data. . .there's several reasons why we expect international sales to pick up throughout 2017 including the agreement with their distributor in China, requiring that company to purchase at least 75 units this year"

Viveve Medical's Q1/17 results beat expectations, an accomplishment that was welcomed by several industry analysts.
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Gregory Chodaczek, B. Riley & Co. (5/12/17)
"Viveve Medical Inc. reported revenue of $3.04MM, $265,000 higher than we had expected. . .for the quarter, the company sold 42 Viveve Systems, 29 of which were sold in the U.S., and 2,200 disposable treatment tips. . .Viveve announced it had received an expanded indication for the Viveve system in South Korea which now includes for the treatment of vaginal laxity. . .the company has regulatory approvals in 54 countries and expects another 14 regulatory approvals by the end of the year."

Jeff Cohen, Ladenburg Thalmann (5/12/17)
"We reiterate our Buy rating for Viveve Medical Inc. and price target of $22.00 for VIVE. The company has plans for dual pathways into the U.S. marketplace of which the first has been approved. . .the second approach that the company plans to pursue would entail a clinical proven pathway (trial) for approval which would likely be for the treatment of vaginal tissue to improve sexual function. We believe that the company is currently in discussion with the agency and that a formal IDE would be submitted in the coming months such that a study (VIVEVE II) would commence in late 2017."

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