In a Feb. 12, research note, Maxim Group analyst Anthony Vendetti reported that Viveve Medical Inc. (VIVE:NASDAQ) announced, on Jan. 31, 2018, the results of a pilot trial of its cryogen-cooled monopolar radiofrequency (CMRF) technology as therapy for stress urinary incontinence.
"At 12 months, 89% and 100% of the nine patients who completed the protocol showed an improvement when compared to baseline, with a 40% and 51% mean improvement across each of the two endpoints, respectively," Vendetti relayed. Study patients did not have any safety issues with the device.
Vendetti added that Maxim Group finds these results positive and encouraging for stress urinary incontinence, which "represents an additional $10–12 billion global market opportunity."
Based on those recent study findings, VIVE plans to submit an Investigational Device Exemption (IDE) to the FDA and conduct two more trials "in pursuit of FDA, Health Canada and CE Mark approval of its device for the temporary improvement of mild to moderate stress urinary incontinence symptoms," clarified Vendetti. Both will be randomized, double blind and sham controlled. LIBERATE in the United States will enroll up to 200 patients at as many as 25 sites, whereas LIBERATE in Canada will encompass as many as 100 patients enrolled at up to 10 locations.
Vendetti reported that Viveve closed a public offering on Feb. 12. Viveve generated a net of $32.4 million from the $34.5 million public offering of 11.5 million shares at $3 per share. He said the capital should fund the biotech through year-end 2019, which includes execution of the VIVEVE II study, slated to start in Q1/18. Along with supporting that trial, the proceeds are expected to be used for further research and development and product commercialization.
Regarding the VIVEVE II study, Vendetti purported that "the potential to gain an expanded U.S. Food and Drug Administration approval for the improvement of female sexual function, in addition to its current indication for electrocoagulation and hemostasis, represents the most important growth opportunity for the company."
Maxim Group maintains its Buy rating and $11 per share price target on Viveve; shares are now trading at roughly $4.40. Vendetti added, "Our price target implies shares trading at 14.2 times our 2018 enterprise value/revenue estimate, which we believe is justified due to the company's defensible technological position and significant growth potential."
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1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
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Disclosures from Maxim Group, Viveve Medical, Feb. 12, 2017
I, Anthony Vendetti, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report.
The research analyst(s) primarily responsible for the preparation of this research report have received compensation based upon various factors, including the firm’s total revenues, a portion of which is generated by investment banking activities.
Maxim Group makes a market in Viveve Medical, Inc.
Maxim Group managed/co-managed/acted as placement agent for an offering of the securities for Viveve Medical, Inc. in the past 12 months.
Maxim Group received compensation for investment banking services from Viveve Medical, Inc. in the past 12 months.
Maxim Group expects to receive or intends to seek compensation for investment banking services from Viveve Medical, Inc. in the next 3 months.