Viveve (NSDQ:VIVE) said on Tuesday it launched a trial exploring the safety and efficacy of its cryogen-cooled monopolar radiofrequency tech designed to treat stress urinary incontinence in women. The new Liberate trial will look to enroll 100 subjects at up to 10 sites in Canada, with patients randomized in a two-to-one ratio for active and sham treatments. […]
Viveve wins FDA nod to continue Viveve II trial
Viveve (NSDQ:VIVE) said yesterday it won FDA clearance to continue enrollment in its Viveve II trial exploring the safety and efficacy of its Viveve system for improving sexual function in women following vaginal childbirth. The approval came based off sufficient evidence to support continued enrollment and a lack of subject protection concerns which would preclude continuation, the […]
Viveve settles IP suit against Thermigen
Viveve (NSDQ:VIVE) said this week it inked a settlement and licensing agreement with Thermigen and associated defendants to resolve a patent litigation claiming Thermigen improperly used Viveve intellectual property with its ThermiVa system. The resolution clears up all pending disputes between the companies, according to an SEC filing from Englewood, Colo.-based Viveve, and grants Thermigen a non-exclusive, […]
Viveve closes $32m offering
Viveve (NSDQ:VIVE) said today it closed a $32.4 million offering with funds slated to support continued research and development and commercialization of its products. The Englewood, Colo.-based company said it sold a total of 11.5 million shares of stock at $3 per share, including shares sold during the full exercise of an underwriters option to purchase […]
Viveve touts sub-analysis results from Viveve system vaginal laxity trial
Viveve (NSDQ:VIVE) today announced results from a sub-analysis of its Viveve 1 trial exploring the use of the Viveve system for treating vaginal introitus in women with sexual dysfunction, touting improvements on the Female Sexual Functions Index. The Englewood, Colo.-based company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus. Sub-analysis results […]
Viveve prices $30m offering
Viveve (NSDQ:VIVE) late last week priced an upcoming offering, looking to raise $30 million to support its Viveve system. The Sunnyvale, Calif.-based company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus. Viveve said it plans to offer approximately 7.5 million shares of stock at $4 per share, with a 30-day underwriter’s […]
Viveve Medical reports success treating vaginal laxity
Viveve Medical recently published the results of a clinical study of its Viveve I treatment in the Journal of Sexual Medicine, showing that women who received the treatment reported being more likely to have no vaginal laxity. The Viveve Treatment of the Vaginal Introitus to Evaluate Efficacy study is one of the first studies to study […]
Viveve moves headquarters to Colorado
Viveve (NSDQ:VIVE) said today it is relocating its corporate headquarters to Englewood, Colo. from Sunnyvale, Calif. The company said it signed a lease agreement for a new facility in Englewood, with physical relocation planned for the end of the 1st quarter of 2017, pending the build-out of the office and warehouse facilities. “Last year was a […]
Viveve wins FDA 510(k) for its Viveve System
Viveve (NSDQ:VIVE) said today it won FDA 510(k) clearance for its Viveve System, now cleared for use in general surgical procedures for electrocoagulation and hemostasis. The company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus. “FDA 510(k) clearance for the Viveve System represents a major milestone in our efforts to […]
Viveve hits the market Down Under
Viveve (NSDQ:VIVE) said today it it won regulatory clearance from Australia’s Therapeutic Goods Administration for its Viveve non-surgical treatment for post-partum laxity of the vaginal introitus. The Sunnyvale, Calif.-based company said it inked a distribution partnership deal in Australia and New Zealand with medical product supplier Device Consulting, which will support the regional distribution of the Viveve […]
Viveve lands S. Korea regulatory clearance for Viveve System
Viveve (NSDQ:VIVE) said today it won regulatory approval from the Ministry of Food and Drug Safety in South Korea for its Viveve non-surgical treatment for post-partum laxity of the vaginal introitus. The company said it already inked an exclusive distribution partnership in South Korea with JOYMG, a medical device distributor in the region. “The receipt of market approval […]
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