NEW YORK, NY / ACCESSWIRE / May 27, 2015 / SeeThruEquity, a leading independent equity research and corporate access firm focused on smallcap and microcap public companies, today announced it has initiated coverage of Viveve Medical, Inc. (OTCQB: VIVMF) with a Price Target of $1.41.
The report is available here: VIVMF Initiation Report. SeeThruEquity is an approved equity research contributor on Thomson First Call, Capital IQ, FactSet, and Zack’s. The report will be available on these platforms. We also contribute our estimates to Thomson Estimates, the leading estimates platform on Wall Street.
Based in Sunnyvale, CA, Viveve is a women’s health company focused on the commercialization of the Viveve System, an innovative medical device for the treatment of vaginal laxity resulting from childbirth, aging, and other traumas. Vaginal laxity is the most frequently reported post-delivery physical change for women, and represents a potential addressable market of nearly $7Bn for Viveve. The Viveve System appears well suited to emerge as a leading treatment for post-partum vaginal laxity. It is synergistic with kegel exercises, addressing the vaginal introitus – tissue that is not muscular but collagen based – and offers a safe, in-office alternative to invasive surgical treatments. We see several potential catalysts for Viveve over the next 18 months, as it commences commercial launch in four regions outside the U.S. and pursues regulatory approvals in the US, China, and several other new foreign markets.
“The Viveve System is synergistic with kegel exercises, addressing the vaginal introitus – tissue that is not muscular but collagen based – and offers a safe, in-office alternative to invasive surgical treatments. The technology is supported by a strong patent portfolio, which consists of an exclusive perpetual license agreement with Ed Knowlton (Thermage). On May 13, 2015, Viveve announced that it is raising $12mn through a private placement led by Stonepine Capital LP that included participation from management and existing insiders. We see the raise a key strategic milestone that will enabled the company to fund aggressive commercialization efforts in countries where Viveve is already available though select distributors. With its balance sheet shored, we see several potential catalysts in 2015 for Viveve as it pursues commercial launches in Europe and other already-approved geographies, and approaches regulatory milestones in the United States, China and new international markets,” stated Ajay Tandon, CEO of SeeThruEquity. “We are initiating coverage with a 12-month price target of $1.41 per share.”
Additional highlights from the report are as follows:
A non-invasive, effective treatment for vaginal laxity
The Viveve System uses patented, reverse-thermal gradient radio frequency (RF) technology to tighten the tissues of the vaginal introitus in a painless, 30-minute, in-office procedure that is convenient for patients and requires no anesthesia. The technology is supported by a strong patent portfolio, which consists of an exclusive perpetual license agreement with Ed Knowlton (Thermage). Viveve has already conducted two human clinical studies, which have shown the treatment also appears to be highly effective for restoring vaginal tightness to pre-childbirth levels, with 88% of women reporting a statistically significant (mean 68% improvement) increase in vaginal tightness as long as 12 months after the treatment. In March Viveve completed enrollment for VIVEVE 1, the first ever randomized, sham-controlled clinical study for vaginal laxity. The study will evaluate the safety and effectiveness of the Viveve System on up to 113 women in Europe and Canada.
Set for commercial launch in 2015
Viveve is poised to generate nice revenue growth in 2015E. Currently the company is commencing commercial launches in Japan, Canada, Hong Kong, the Middle East, and Europe. The company has been actively adding distribution and co-marketing partners in these geographies, and we were pleased to see the distribution partnership announced with CoachHouse Medical in the UK in February as well as agreements with NeoAsia PTE, Ltd. and Dalton Medical, B.V. for parts of Europe and Southeast Asia in the last month. We see 2015E as a year of accelerating growth from a small revenue base, and estimate the company will report revenues of $2.2mn in 2015E from orders in these first markets.
Plan to target $7Bn global opportunity by 2019
Viveve has outlined a three-phase global commercialization strategy, which should enable it to more than triple its addressable market by the end of 2019. The company’s existing markets represent a $2.4Bn annual addressable market, according to management, and Viveve will increase this figure to $4.1Bn by commencing commercial operations in select countries in Latin America (including Brazil) and Southeast Asia. We see the strategy as prudent and enabling growth while the company fulfills the more stringent regulatory requirements to market its products in China and the United States. Viveve is pursuing a de novo 510K pathway for FDA approval in the United States, and has proposed that the Viveve System be indicated for the treatment of the vaginal introitus after childbirth to improve sexual function. We expect the company to file its IDE submission by the end of 2015E. Viveve estimates an addressable market of $7Bn per year from vaginal laxity caused by vaginal birth delivery. Longer term, we also expect the company to pursue treatments for vaginal laxity caused by aging, as well as targeting doctors who pursue aesthetic treatments, which management believes could potentially double the market opportunity.
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About Viveve, Inc.
Viveve, Inc., the operating subsidiary of Viveve Medical, Inc., is a women’s health company passionately committed to advancing new solutions to improve women’s overall well-being and quality of life. The company’s lead product, the Viveve(R) System, is a non-surgical, non-ablative medical device that remodels collagen and restores tissue. The Viveve System treats the condition of vaginal laxity, which is the result of the over-stretching of tissue during childbirth that can result in a decrease in physical sensation and sexual satisfaction. Physician surveys indicate that vaginal laxity is the number one post-delivery physical change for women, being more prevalent than weight gain, urinary incontinence or stretch marks. The Viveve Treatment uses patented, reverse-thermal gradient radiofrequency technology to tighten the tissues of the vaginal introitus (opening) and requires only a 30-minute out-patient treatment in a physician’s office. The Viveve System has received regulatory approval in Europe, Canada and Hong Kong and is available through physician import license in Japan. It is currently not available for sale in the U.S.
For more information, please visit Viveve’s website at www.viveve.com.
About SeeThruEquity
SeeThruEquity is an equity research and corporate access firm focused on companies with less than $1 billion in market capitalization. The research is not paid for and is unbiased. We do not conduct any investment banking or commission based business. We are approved to contribute our research to Thomson One Analytics (First Call), Capital IQ, FactSet, Zacks, and distribute our research to our database of opt-in investors. We also contribute our estimates to Thomson Estimates, the leading estimates platform on Wall Street.
For more information visit www.seethruequity.com.
Contact:
Ajay Tandon
SeeThruEquity
info@seethruequity.com
SOURCE: SeeThruEquity
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