Serene Medical, a medical device pioneer in RF technology, has recently completed enrollment of its prospective multi-center trial evaluating the effectiveness of the Serene RF System.
The Serene clinical trial, which began in February 2015 includes five sites in the U.S. and two sites in Australia. This year long study is designed to evaluate the Serene RF System’s ability to effectively improve the appearance of dynamic moderate to severe glabellar lines and sustain long-term aesthetic results.
Throughout the trial over 75 patients will serve to validate aesthetic benefits and support the subsequent launch of the Serene RF System which is planned for release in late 2016.
"The excitement and positive responses that have been received to-date from physician partners and their patient base is proof that the aesthetic market is ready for an alternative protocol to what is currently available," says Bankim Mehta, CEO and President of Serene Medical.
"With the complete enrollment of the study of the Serene RF System, we look forward to demonstrating how this device, using novel combinations of bi-polar radiofrequency and nerve stimulation technologies, provide long-lasting and toxin free results."
Trevor Moody, Serene Board Member and Managing Director at M.H. Carnegie & Co., with a 25 year career commercializing and funding innovative medical devices, said that the Serene RF system represents an exciting and revolutionary approach to the treatment for glabellar lines. "Physicians and patients will soon benefit from this important new technology."
Serene Medical has received clearance from the Food and Drug Administration (FDA) to market its Serene Radio Frequency System. Efforts to obtain the CE mark for European commercialization are currently under way.
The Serene RF System utilizes a novel, patent protected, radiofrequency technology for locating and treating nerves that cause dynamic wrinkles. The Serene System provides patients immediate visible results and a natural looking, long-duration effect compared to neurotoxin injections. The multicenter study is currently being conducted to document clinical outcomes.