Viveve Medical Stock (VIVE) Stock: Should I Buy It Now?

By Amit Chowdhry ● Aug 26, 2020
  • Should you buy the Viveve Medical Inc (NASDAQ: VIVE) stock? Here is some information to help you decide.

Viveve Medical Inc (NASDAQ: VIVE) — a medical technology company focused on women’s intimate health — saw its stock price jump over 48% on Tuesday. The stock price closed at $0.71 compared to a previous close of $0.53. The reason why the stock price jumped is due to positive results from a recent feasibility study.

The company saw positive primary efficacy data from its three-arm 5-month Stress Urinary Incontinence (SUI) feasibility study to compare Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment and a cryogen-only sham treatment to an inert sham treatment for mild to moderate SUI in women. And the company reported positive outcomes from an in-vivo preclinical study that was conducted to validate its new inert sham tip for use in the upcoming pivotal PURSUIT Trial in the U.S.

“We are extraordinarily pleased to report positive results from our 3-arm SUI feasibility study, as well as our in-vivo preclinical study. We believe the combined results from both of these studies support our thesis that the cryogen-cooling treatment tip, used as a sham treatment in our prior LIBERATE-International SUI trial, was likely producing a positive therapeutic effect. The fact that we now have a true inert sham treatment tip provides us more confidence that our upcoming pivotal PURSUIT Trial can achieve its primary efficacy endpoint and position Viveve for a potential SUI indication in the United States,” said Viveve’s chief executive officer Scott Durbin in a statement.

SUI Feasibility Study And The Topline Results

The 3-arm SUI feasibility study was a prospective, randomized, and blinded clinical trial comparing the use of Viveve’s CMRF treatment along with a cryogen-only sham to an inert sham treatment in women with mild to moderate SUI. And the three clinical trial sites in Canada enrolled a total of 36 patients on a 1:1:1 ratio to each of the three study arms. The primary efficacy endpoint — change from baseline in the standardized 1-hour Pad Weight Test at five months post treatment — was positively achieved.

STUDY ARM / Median Change from Baseline 1-Hour Pad Weight Test

CMRF ACTIVE (n=13) / -9.5g (ml)

CRYO ONLY SHAM (n=12) / -6.8g (ml)

INERT SHAM (n=11) / -4.4g (ml)

The median change from baseline in the active CMRF treatment group and the cryogen-only sham treatment group was -9.5 grams and -6.8 grams respectively, compared to -4.4 grams to -4.4 grams in the inert sham treatment group. And the study assessed several secondary endpoints but showed no differentiation between groups. There were no device-related safety issues were reported.

In-Vivo Preclinical Study And Results

In response to the inconclusive results from the company’s LIBERATE International SUI trial, reported in July 2019, Viveve conducted an in-vivo preclinical temperature and immunohistochemistry study to evaluate a new inert sham treatment tip. And the Good Laboratory Practices (GLP) study was initiated in June of this year following several months of engineering, validation, and development work. 

The study assessed both in-vivo tissue temperature changes during treatment, and histopathology at 30-days post-treatment compared to baseline, in three parous ewes using Viveve’s CMRF treatment tip (Active), cryogen-cooling only tip (“Old” sham treatment used in previous SUI study), and a new inert sham treatment tip. 

The histopathology of vaginal biopsies was performed and included the use of a-smooth muscle actin (a-SMA) staining for fibroblast activation and formation. All tissue samples were evaluated by an independent and blinded pathologist.

And the positive preclinical findings demonstrated temperature and immunohistochemistry results that support the validity of the new inert sham tip to provide a true inert or placebo treatment. Only minor tissue temperature change (less than 2 degrees centigrade) was generated by the new inert sham tip and no fibroblast activation was shown through elevated a-SMA staining. And in contrast, the Active and cryogen-cooling sham tips demonstrated significant tissue temperature changes during treatment and increased fibroblast activation 30 days post-treatment.

Details About The U.S. PURSUIT Trial

In July 2020, Viveve received U.S. Food and Drug Administration (FDA) approval of its Investigational Exemption Device (IDE) to conduct the pivotal PURSUIT SUI trial. And the current FDA approved IDE trial is designed to be a randomized, double-blinded, sham-controlled 12-month trial with an enrollment of approximately 240 subjects at up to 24 study sites in the U.S. The subjects will be randomized in a 2:1 ratio to CMRF treatment or to the new sham treatment.

The primary endpoint of the PURSUIT Trial is a comparison of the proportion of patients who experience a greater than 50% reduction in the standardized 1-hour Pad Weight Test at 12-months post-treatment versus the new sham. And the study also includes several secondary endpoints, including the proportion of patients who experience a greater than 50% reduction in the standardized 1-hour Pad Weight Test at 6 months post-treatment, change from baseline in the 1-hour Pad Weight Test at 6 and 12 months, and change from baseline in 3-day bladder voiding diary, Urogenital Distress Inventory-6 (UDI-6), Incontinence Quality of Life (I-QOL), and International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF). And subject safety will be monitored throughout the study.

Viveve Medical Inc (NASDAQ: VIVE): Should I Buy It Now?

Viveve Medical is one of the most actively traded stocks I have seen. The most recent volume was 268 million and the average volume is about 5.1 million. This indicates to me that a lot of day traders and swing traders have been making a lot of bets on the stock going up or down, but only if they knew what they are doing.

This is not the type of stock where you buy a lot of shares and use a buy-and-hold method. Many day traders pay close attention to the candlestick charts on this stock on an hourly basis while the market is open. If you are more of a buy-and-hold investor like I am, then I highly recommend that you put your money into other stocks. But if you are a day or swing trader, then the high volume of trading could be right up your alley.

Disclosure: I wrote this article myself and I do not have any business relationship with any company whose stock I write about. I am not a financial advisor and all articles are my opinion. You should do your own due diligence and consider talking to a financial professional before investing.