Cellulize® is the
most powerful green light technology for non-invasive fat reduction
and cellulite. Using the photonic energy of light, Ward Photonics
the most powerful, innovative treatments for obesity,
aesthetics, and dermatology. Our products use photobiomodulation as the mechanism of
action to effect natural cellular response in the skin and
fat, thereby reducing the amount of fat and improving the
skin's appearance. In addition, the massager component helps with cellulite.
Cellulize® is 490 times more powerful than the prior green laser technology. Output intensity/ Irradiance of Cellulize® is 95.14 mW/cm2, compared to 0.20 mW/cm2 for the 532nm Verju green laser. Cellulize® has 150 light emitting diodes (LEDs) that emit visible light at nominal wavelength of 532nm ± 3nm (visible green light spectrum) and a spectral bandwidth of 10nm. Cellulize® delivers a uniform dose to an area up to 23" x 17". FDA clearance K180338 details the indications for use and supporting documentation.
A clinical study was conducted in support of the FDA submission
for Cellulize® (see ClinicalTrials.gov NCT03647748). The study was a double-blind, placebo-controlled randomized evaluation of the effect of
Cellulize® for aesthetic use for the non-invasive reduction in fat layer for body contouring and reduction of cellulite. A total of 52 patients participated in the study (25 Active
Cellulize®, and 27 Placebo Control). Patients were all female with a median age of 42.5 years old with a range of patient ages from 18 years to 69 years old. Ethnic origin of the patients were represented from Asian, African American, Caucasian, Latino, and Pacific Islander. Cumulative circumferences of waist, hip, left and right thighs for each patient was calculated before and after treatment.
The main points concluded as a result of the study include that Cellulize® causes immediate inch loss in subjects after a regimen of six treatments of 32 minutes (8 minutes on each of four positions) compared to individuals subjected to a placebo device for an equivalent treatment. In a typical regimen, patients lost an average cumulative 2.67 inches of circumference compared to placebo average of 0.5 inch. This meets the anticipated primary outcome measure “Average Change in Inches of Total Circumference Measurements for effect of Cellulize®, a LED 532nm green light low level laser system for aesthetic use for the non-invasive reduction in fat layer for body contouring from baseline measurements, and after treatment.” Shown below is a graphical summary of inch loss for patients in the Cellulize® active group and the Placebo control group respectively.
While durability of effect is also impacted by extrinsic factors after treatment such as diet, it was demonstrated that subjects were more likely to show continued inch loss upon following up with each subject at 7 days and again at 14 days. In general, patients undergoing active Cellulize® 532nm green light continued losing some inches, with an average continued loss of an addition 1.20 inches for a total average inch loss of 3.87 inches where average placebo measurements after 14 days yielded a net gain (not a loss) of 0.875 inches. This implies that the green light treatment meets the expected primary outcome of demonstrated durability of effect after short-term follow up of 2-weeks.