Serene completes patient enrolment in first clinical trial of RF system to treat Glabellar Lines

19 January 2016 (Last Updated January 19th, 2016 18:30)

US-based Serene Medical has completed patient enrolment in its prospective multi-centre trial evaluating the effectiveness of its Radio Frequency (RF) System to treat Glabellar Lines.

US-based Serene Medical has completed patient enrolment in its prospective multi-centre trial evaluating the effectiveness of its Radio Frequency (RF) System to treat Glabellar Lines.

The year-long clinical trial is being carried out at five sites in the US and two sites in Australia.

The trial will assess the system's ability to effectively improve the appearance of dynamic moderate to severe glabellar lines and sustain long-term aesthetic results.

The Serene RF System uses a new, patent protected, radio-frequency technology for locating and treating nerves that cause dynamic wrinkles.

"Compared to neurotoxin injections, the new system will provide patients immediate visible results."

Compared to neurotoxin injections, the new system will provide patients immediate visible results and a natural looking, long-duration effect.

The company noted that throughout the trial more than 75 patients will serve to validate aesthetic benefits and support the subsequent launch of the Serene RF System, which is scheduled to be launched later this year.

The Serene Radio Frequency System has also secured marketing approval from the US Food and Drug Administration (FDA).

Currently, the company is in process of securing the CE Mark for European commercialisation of the system.

Serene Medical president and CEO Bankim Mehta said: "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.

"With the complete enrolment 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."

According to the company, the multicentre trial is currently being conducted to document clinical outcomes.

Serene Board Member and M.H. Carnegie & Co managing director Trevor Moody said: "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."

The company noted that the first application of Serene technology is planned for the aesthetic market, while other therapeutic applications are being explored.