Viveve's Technology for Women's Sexual Dysfunction Receives Regulatory Approval in 49 Countries


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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On Dec. 1, Viveve Medical Inc. (VIVE:NASDAQ) announced that the results of the VIVEVE I clinical trial were accepted in the Journal of Sexual Medicine, the peer-reviewed journal of the International Society of Sexual Medicine. According to the company, The VIveve Treatment of the Vaginal Introitus to EValuate Efficacy study is the first randomized, single-blinded and sham-controlled trial designed to demonstrate the efficacy and safety of the Viveve Treatment for the treatment of vaginal laxity, which is the result of the over-stretching of the vaginal tissue during childbirth.

Patricia Scheller, CEO of Viveve, noted, "With the publication of the VIVEVE I results, we believe that a new paradigm has been established for the use of energy-based treatments for women's sexual health conditions. Large, randomized, sham-controlled studies have not historically been conducted to demonstrate the safety and efficacy of energy-based procedures in gynecological applications, demonstrating, I believe, a profound lack of regard for the treatment of these significant medical conditions. Viveve will be the first, and, to date, the only company to clinically demonstrate the efficacy and safety of its treatment." The primary author of the article is Michael Krychman, M.D., executive director of the Southern California Center for Sexual Health and Survivorship Medicine.

Viveve also released record third-quarter financial results. Analyst Jeffrey Cohen of Ladenburg Thalmann noted, "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."

Analyst Anthony Vendetti of Maxim Group stated on Nov. 11 that Q3/16 results were ahead of expectations: "We would continue to be buyers of VIVE following its fifth consecutive quarter of double-digit revenue growth driven by the continued regulatory clearances of the Viveve System around the world. . .VIVE reported 3Q16 total revenues of $1.85M, above both our estimate of $1.65M and consensus of $1.55M."

Vendetti highlighted that "3Q16 marked the company'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, respectively. The company also received an FDA 510(k) clearance for electrocoagulation and hemostasis in the U.S., and it has begun commercialization."

Brian Marckx, an analyst with Zacks Small-Cap Research, noted, "the pace of unit placements continues to accelerate as do consumables sales with Q3 marking new records in both the number of consoles and treatment tips sold as well as in total revenue. And there has been a lot of activity on the operational front as well including gaining initial regulatory clearance in the U.S. and Brazil and the September IDE submission seeking approval for the pivotal U.S.-based randomized VIVEVE II study (seeking clearance for a potential game-changing sexual function indication)."

Marckx also observed, "While the most recent quarter was impressive, additional and potentially very significant catalysts recently came online which could have the effect of steepening the already heady revenue curve. This includes regulatory clearance/approval in the U.S. (for general surgical procedures) and Brazil, both of which came in October. These two countries, which according to ISAPS rank #1 (U.S.) and #2 (Brazil) in the world for the combined number of vaginal rejuvenation and labiaplasty procedures performed each year (and combined account for ~23% of all vaginal rejuvenation and labiaplasty procedures around the world), offer fertile ground for Viveve and their newly branded Geneveve system."

Jeffrey Cohen discussed Viveve's U.S. strategy for its Geneveve system: "The Company has plans for dual pathways into the U.S. marketplace of which the first has been approved. In October the FDA granted a 510(k) clearance for general surgical procedures for electrocoagulation and hemostasis." Then, "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 late in early 2017. We would anticipate that the study would take approximately 12-18 months in duration and that the company would be able to commercialize under this label in 2H-2018. 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."

Anthony Vendetti stated, "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. Going forward, we believe management's focus on attaining additional regulatory clearances and hiring a direct sales force, coupled with investments into market awareness, should position it for growth."

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1) Patrice Fusillo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. She owns, or members of her immediate household or family own, shares of the following companies mentioned in this article: None. She is, or members of her immediate household or family are, paid by the following companies mentioned in this article: None.
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