Viveve announces FDA approval to conduct PURSUIT trial » 08:3107/0707/07/20
Viveve Medical announced…
Viveve Medical announced that the Company has received approval of its Investigational Device Exemption, or IDE, from the FDA to begin a stress urinary incontinence, or SUI, multicenter, randomized, double-blinded, sham-controlled clinical trial entitled PURSUIT - Prospective U.S. Radiofrequency SUI Trial. Viveve said in a release, "The trial is designed to evaluate the safety and efficacy of Viveve's Cryogen-cooled Monopolar Radiofrequency, or CMRF, treatment versus an inert sham tip for the improvement of SUI in women. In April VIVEVE announced resubmission of the SUI IDE to the FDA to conduct the PURSUIT Trial. In May, the FDA outlined several study considerations that were successfully addressed in an IDE Supplement that VIVEVE submitted to the FDA on June 1."
|Over a week ago|
Viveve files to sell 5.0M shares of common stock for holders 17:3306/1806/18/20
|Over a month ago|
Viveve files to sell 5.06M shares of common stock for holders 16:3205/1405/14/20
Four new option listings and thirteen option delistings on April 20th » 08:3004/2004/20/20
MSGS, ALIM, BASX, CYOU, FVE, MSG, SMTA, TGE, VIVE
New option listings for…
New option listings for April 20th include Pacer US Cash Cows 100 ETF (COWZ), Madison Square Garden Sports Corp (Class A Stock) (MSGS), Pacer Trendpilot 100 ETF (PTNQ), and Pacer Benchmark Data & Infrastructure Real Estate SCTR ETF (SRVR). Option delistings effective April 20th include Alimera Sciences (ALIM), Approach Resources Inc (AREXQ), AU Optronics Corp (AUOTY), Basic Energy Services Inc New (BASX), Changyou com Limited (ADS) (CYOU), VelocityShares 1x Long VSTOXX Futures ETN (EVIX), Freds Inc (FREDQ), Five Star Quality (FVE), Key Energy Services Inc (KEGX), Madison Square Garden Company New (Class A Stock) (MSG), Spirit MTA (SMTA), Tallgrass Energy LP (Class A Stock) (TGE), and Viveve (VIVE).
Viveve provides business update in response to COVID-19 pandemic » 08:1004/1704/17/20
Viveve provided a company…
Viveve provided a company update, including plans to significantly reduce operating expenses and cash burn rate, steps to strengthen its balance sheet and reconfirmation of near-term focus to advance development program for the treatment of stress urinary incontinence, or SUI, in women. In response to COVID-19, Viveve has implemented a range of operational changes designed to support the safety and health of our employees, customers, distribution partners and other contacts as necessary. In addition, the company is implementing a series of significant cost-cutting actions designed to reduce expenses and reposition resources to support the company's current customers and its pivotal clinical development program for cryogen-cooled, Monopolar Radiofrequency, or CMRF, technology in the treatment of SUI. These deliberate actions are tailored to allow the company to re-scale its commercial and operational activities as conditions improve. Viveve also announced a warrant exercise transaction with current company investors and had $9M cash as of the end of the Q1. The financing together with the company's existing cash have strengthened Viveve's balance sheet and provide the resources necessary to maintain the company's business strategy and advance the SUI clinical development plan. The SUI clinical development program and potential label expansion for this indication present an opportunity to address an area of unmet need in women's intimate health for Viveve's CMRF technology. An estimated 25-30 million women worldwide who suffer from the SUI medical condition could potentially benefit from a noninvasive single session treatment with Viveve System, representing an estimated $10B-$12B market opportunity. The reorganized Viveve team is positioned to achieve multiple clinical milestones within the next few months to advance the SUI program. These include the anticipated readout from the three-arm SUI feasibility trial in the late summer of this year and the potential launch of the multicenter, randomized double-blinded, sham controlled SUI trial in the U.S., now entitled PURSUIT pending FDA approval of the company's recently resubmitted IDE. The trial is designed to evaluate the safety and efficacy of Viveve's CMRF treatment versus an inert sham tip for the improvement of SUI in women.
Viveve resubmits IDE to FDA to begin PURSUIT trial » 08:3604/1504/15/20
Viveve Medical announced…
Viveve Medical announced that the company has resubmitted its investigational device exemption, or IDE, to the FDA for approval to begin a stress urinary incontinence, or SUI, multicenter, randomized, double-blinded, sham-controlled trial now entitled, PURSUIT. The trial is designed to evaluate the safety and efficacy of Viveve's CMRF treatment versus an inert sham tip for the improvement of SUI in women. Following the original IDE submission to conduct a U.S. SUI trial, Viveve completed multiple rounds of discussions with the FDA. Based on these discussons, the resubmitted IDE addresses specific protocol requests and provides positive results from additional in vivo animal safety testing requested by the FDA. The results of the LIBERATE-International SUI study, reported in August of 2019, demonstrated significant and durable improvement across all study endpoints, including nearly an 80% reduction in leakage as measured by one-hour Pad Weight Test at six months. As reported however, patients in the sham arm of the study also demonstrated significant improvement. Based on a significant indiction of efficacy in the treatment arm, Viveve rapidly launched a short-term 3-arm SUI feasibility trial, utilizing a completely inert sham tip, under an approved Investigational Testing Application by the Canadian Ministry of Health. Initiated in January, the SUI feasibility trial completed enrollment in March, and is targeted for readout in late summer of this year. If positive, the results of the SUI feasibility trial could support the launch of the pivotal PURSUIT trial in the U.S. for the improvement of SUI in women.
|Over a quarter ago|
Viveve announces VIVEVE II trial did not meet primary endpoint » 08:4004/0904/09/20
Viveve announced topline…
Viveve announced topline results from the VIVEVE II clinical trial. VIVEVE II is a multicenter, randomized, double-blinded, sham-controlled study to evaluate the safety and efficacy of the company's proprietary, cryogen-cooled monopolar radiofrequenc, or CMRF, technology for the improvement of sexual function in women following vaginal childbirth. The VIVEVE II study did not meet its primary endpoint of demonstrating a statistically significant improvement in the mean change from baseline in total Female Sexual Function Index score at 12 months. The study included 220 subjects that successfully completed 12-month follow-up. Subjects were randomized in a 1:1 ratio for the active and the sham treatments at 17 clinical sites in the United States. Adjusted mean change for the active group was 9.8 and the adjusted mean change for the sham group was 9, a difference of 0.8. There were no serious device-related adverse events reported. The treatment groups were well balanced, and the number of subjects lost to follow-up was as expected. In light of the VIVEVE II trial outcome and the current COVID-19 pandemic, the company is currently evaluating strategic alternatives, as well as actively assessing its current organization and cost structure.
Viveve 2.0 system issued licence by Health Canada » 14:2804/0804/08/20
A post to the website of…
A post to the website of Health Canada shows that the Viveve 2.0 system was issued a licence in Canada on April 6. Reference Link
Viveve receives registration clearance from Taiwanese FDA for CMRF system, tips » 08:3403/2603/26/20
Viveve announced registration clearance from the Taiwanese FDA for the company's next-generation Viveve 2.0 Cryogen-cooled Monopolar Radiofrequency, or CMRF, system and consumable treatment tips for use in general surgical procedures for electrocoagulation and hemostasis.
Viveve announces completion of participation in VIVEVE II trial » 08:3203/1203/12/20
Viveve announced that all…
Viveve announced that all patients have now completed participation in the VIVEVE II pivotal FDA clinical trial. VIVEVE II is a multicenter, randomized, double-blinded, sham-controlled study to evaluate the safety and efficacy of the company's proprietary, Cryogen-cooled Monopolar Radiofrequency technology for the improvement of sexual function in women following vaginal childbirth.