Thermi Receives Notice of Complete and Satisfactory Closure of FDA’s “Vaginal Rejuvenation” Inquiry
IRVING, TEXAS (November 15, 2018) – Thermi®, an Almirall, S.A. company, today announced that it has received a notice of completion to a U.S. Food and Drug Administration (FDA) inquiry on products used in “vaginal rejuvenation” procedures.
Thermi received an “It has come to our attention” notice from the FDA on July 24, 2018 regarding specific claims about the company’s ThermiVa® device in the United States. ThermiVa, a non-ablative radiofrequency application, has been cleared by the FDA for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. All Thermi products are marketed in accordance with their FDA-cleared indications, and Thermi supports a professional training program to ensure appropriate use of all ThermiRF® devices.
A non-invasive, non-surgical, non-hormonal treatment, ThermiVa uses temperature-controlled radiofrequency energy to gently heat tissue. The in-office treatment which is cleared by the FDA, is available in more than 36 countries globally and has been used in more than 100,000 procedures worldwide.
“We are pleased to make this announcement and to have worked collaboratively and constructively with the FDA to address their inquiry,” said Thermi VP of Global Medical Affairs, Dr. Tara Margarella. “We will continue to maintain and further develop our relationship to ensure compliance to the agency’s directives and guidance for future clinical indications for use with all of the Thermi® products.”
ThermiVa is supported by clinicians worldwide and Thermi is committed to the continued investment and development of robust clinical programs to demonstrate and validate ThermiVa’s capabilities for various indications.
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®, etc.). 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.
For more information, please visit www.thermi.com
Almirall is a leading skin-health focused global pharmaceutical company that partners with healthcare professionals, applying Science to provide medical solutions to patients & future generations. Our efforts are focused on fighting against skin health diseases and helping people feel and look their best. We support healthcare professionals in its continuous improvement, bringing our innovative solutions where they are needed.
The company, founded in 1943 and with headquarters in Barcelona, is listed on the Spanish Stock Exchange (ticker: ALM). Almirall has become a key element of value creation to society according to its commitment with its major shareholders and its decision to help others, to understand their challenges and to use Science to provide them with solutions for real life. Total revenues in 2016 were 859.3 million euros. More than 2,000 employees are devoted to Science.
To learn more about Thermi and what its technology can offer, please visit www.thermi.com.