IRVING, Texas, May 2, 2017 /PRNewswire/ -- ThermiGen, LLC, an innovative aesthetics and women's health medical device company, is pleased to announce their newest indication for the ThermiRF® Temperature Controlled Radiofrequency System. The ThermiVa® procedure for treatment of soft tissue for vulvovaginal laxity is now available in the European market. ThermiRF, with its many aesthetic applications, is available in 25 countries around the world; with the introduction of the ThermiVa® procedure in Europe being the most recent, and a significant achievement in the company's ongoing global expansion.
"Approval for the ThermiVa application in Europe is a significant step in continuing Thermi's global reach in the aesthetics and women's health markets. We continue to work to expand and provide patient access to this innovative application. Launching the ThermiVa procedure for vulvovaginal laxity in Europe is the key focus for Thermi's newly formed EU sales team. We are enthusiastic about the opportunity to work with physicians to bring this new solution to their patients," states Andy Moulton, EMEA Aesthetics Commercial Director for Thermi.
According to a 2012 article published in International Urogynecology Journal; an international survey of 563 obstetrician gynecologists showed that 84% of respondents have patients who experience vaginal laxity, and 95% believe this laxity negatively affects their patients' sexual function1. In a recent Thermi multi-center clinical study, more than 93% of women treated reported improvement in vulvovaginal laxity; and subjects also reported statistically and clinically significant improvement in sexual functioning; while sustained improvement in both laxity and sexual satisfaction was reported through 360 day follow up. The study also employed the Female Sexual Function Index (FSFI); which utilizes nineteen questions to evaluate subject change across Desire, Arousal, Lubrication, Orgasm, Satisfaction and Pain; and subjects reported improvement across all six domains2.
The ThermiVa® procedure uses a proprietary temperature controlled radiofrequency device to stimulate remodeling of dermal and epidermal tissue in the vulvovaginal anatomy for women who are experiencing symptoms related to vulvovaginal laxity. Symptoms of vulvovaginal laxity vary, but can be associated with diminished sexual satisfaction, orgasmic dysfunction, dyspareunia, reduced lubrication, and stress urinary incontinence. Procedures are performed in an office setting and have minimal downtime for patients. The disposable ThermiVa® electrode is designed to comfortably treat internal and external structures.
"We are motivated by the findings of this study and our latest approval in Europe. We embrace the work ahead of us to properly educate the market on our technology; and we are grateful to have to opportunity to partner with leading physicians around the world, and to provide women with new and effective solutions," says Vladimir Paul-Blanc, President & General Manager of Thermi.
Thermi®, an Almirall Company, is a leading global manufacturer of temperature controlled radiofrequency technology. The company's flagship product is ThermiRF, a platform technology that uses temperature as an endpoint for various minimally and non-invasive applications (ThermiTight®, ThermiRase®, ThermiSmooth® Face, ThermiVa®). Thermi also offers the Thermi250™ device as the newest innovative RF for body. Founded in 2012, Thermi is a US based company with its headquarters in Irving, Texas and R&D in Boston, MA.
Almirall is a global pharmaceutical company with a strong focus in Dermatology and Aesthetics with the mission of providing valuable medicines and medical devices to you and future generations. Our R&D is focused on Dermatology, with a wide range of programs including key indications. Through our innovative products, agreements and alliances, our work covers the entire drug value chain. Almirall is continually growing as a specialist company in a wide range of skin diseases, in order to cover our customers unmet needs.
Founded in 1943, headquartered in Barcelona, Spain, Almirall is listed on the Spanish Stock Exchange (ticker: ALM) and it has become a source of value creation for society due to its vision and the commitment of its long-standing major shareholders. In 2016, its revenues totaled 859.3 million euros and, with more than 2.000 employees, it has gradually built up a trusted presence across Europe, as well as in the US.
For more information, please visit www.almirall.com
1 Vaginal laxity: a poorly understood quality of life problem; a survey of physician members of the International Urogynecological Association (IUGA) Int Urogynecol J (2012) 23:1435-1448
2 Clinical Evaluation Report TF-THE-003 CER, ThermiGen, LLC 2016
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