R2 Technologies’ Glacial Rx System Receives New FDA Indication

R2 Technologies Inc., a leader in CryoAesthetic medical devices, has announced that its in-office system, Glacial Rx, FDA-cleared to remove benign lesions and temporarily reduce pain, swelling and inflammation, is now the first and only dermal cooling system FDA-cleared for general dermabrasion, scar and acne scar revision, and tattoo removal, permanently changing the aesthetics industry.
 
“This additional FDA clearance is a huge win, and not an easy feat. It took innovation, dedication, time, and resources,” says Tim Holt, R2 chief executive officer. “It couldn’t have been possible without our amazing team and strategic partners. The clearance had an exceptional outcome in which we went from being part of one classification, among hundreds of other devices, to being placed in our very own FDA-issued product code. This is further proof that our product is so novel, it warrants a completely new category.”
 
“R2 has been at the forefront of the med-esthetics space since inception with its unmatched technology and continues to lead advancements in the industry. We are excited to see the company break boundaries yet again with its latest indication,” says David Present, MD and Cherine Eldumiati Plumaker, R2’s chairman and vice chairman respectively.
 
In conjunction with the commercial launch, R2 looked within its team of industry veterans, including the inventors of the Glacial Rx technology, Rox Anderson, MD; Dieter Manstein MD, PhD; and Henry Chan, MD, PhD, to create its newly established Scientific Advisory Board. By continuing to have these highly regarded pioneers as an integral part of the company, R2 stands out amongst the competitive medical aesthetics market as an industry frontrunner.
 
“With the appointment of our new Scientific Advisory Board, R2 is tapping into years of knowledge and expertise to launch new groundbreaking innovations, develop a superior product pipeline, and leverage technical insights to secure new clinical indications and expansion opportunities,” says Holt.
 
Launched in March 2021, Glacial Rx’s presence in the U.S. has grown significantly. R2 is continuing to take orders from aesthetic providers who want to offer this revolutionary treatment in-office.