References:

* Results from a prospective and non-randomised interventional study where HArmonyCa™ was injected in the preauricular region of 15 women. The primary endpoint were the volumetric changes at Day 180. Secondary endpoints included changes in facial tension vectors, time to filler tissue integration and safety profile.⁵

† Ultrasound and elastography examinations were performed using the Samsung HT 30 ultrasound machine and the ElastoScan HS30/XH30 respectively (Samsung Healthcare Global). When compared to baseline, an increase in density, viscoelasticity, and firmness of the tissue was observed at 60 days and then confirmed at 90 days after treatment. At 180 days after treatment an increase in collagen in the treated areas was confirmed.⁵

‡ Vectra® H2 (Canfield Scientific, Inc.) was used to assess skin lift and tightening by measuring the changes in FTV at 60, 90, and 180 days after treatment. As compared to pre-treatment values, FTV significantly increased at all timepoints with a median (interquartile-range) increased by 2.2 (1.6– 2.2) mm and 2.0 (1.7–2.2) mm in the right and left side, respectively p < 0.0001 each, 180 days after treatment.⁵

§ HArmonyCa™ can be injected in the preauricular area and in the ascending and descending branches of the jaw.^1,5

** A post marketing clinical follow up of safety and performance of HArmonyCa™ (N=62).¹¹

†† Performance evaluation using the 5-point Likert Scale User Satisfaction Questionnaire. Data presented is from the early follow up satisfaction cohort (N=62).¹¹

‡‡ Assessment of general appearance of subjects compared to baseline using the GAIS scale resulted in 91.6 % of subjects graded as showing any improvement. The mean GAIS score for treatment with HArmonyCa™ Lidocaine fell between “improved” and “much improved”, demonstrating clinical effectiveness of the dermal filler (N=48).¹¹