Soosoofill enhances safety by using pharmaceutical-grade, high-purity hyaluronic acid — the same standard used in ophthalmic formulations.
To minimize side effects, endotoxin levels are strictly controlled to below 0.04 IU/mg, exceeding even the stringent requirements of CE medical device regulations.
Soosoofill minimizes side effects by employing a proprietary cleaning process that applies the optimal time and ratios to remove residual BDDE (1,4-Butanediol diglycidyl ether) and manufacturing degradation byproducts. This ensures extremely low endotoxin levels and undetectable BDDE residues for enhanced safety.
What is BDDE?
BDDE (1,4-Butanediol diglycidyl ether) is a chemical used to enhance the viscoelasticity and durability of hyaluronic acid.
According to the PSUR (Periodic Safety Update Report) submitted after market release, no serious adverse events have been reported. Minor side effects such as mild swelling and pain resolved completely without any special treatment.
The reported adverse events amounted to only 0.00081% of total sales, confirming this product as a safe medical device (2017-2023)
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Soosoofill utilizes 2CM Technology™ (Two-Crosslinking Method), combining physical and chemical crosslinking to minimize the amount of BDDE chemical additives while achieving complete crosslinking of the BDDE used.
This process creates a safe gel with superior viscoelasticity.
The MoD (Degree of Modification) value is a requirement for safety confirmation.
Soosoofill’s MoD is about one-quarter the level of other monophasic fillers, making it safer by significantly reducing the risk of side effects caused by BDDE.
What is MoD?
The degree of deformation of the hyaluronic acid molecule caused by BDDE bound to the hyaluronic acid molecule (including both fully crosslinked BDDE and pendant-type BDDE).
Soosoofill delivers satisfying treatment results by reducing the risk of migration after injection through its excellent complex viscosity and cohesiveness.
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According to the WSRS (Wrinkle Severity Rating Scale) evaluation conducted by independent evaluators and investigators, the test group showed an improvement in wrinkle depth comparable to that of the control group.
The WSRS scores for wrinkle improvement are rated on a scale from 1 (none) to 5 (very deep wrinkles).
Figure 1. Mean WSRS change from baseline at 8, 16, and 24 weeks, assessed by independent evaluators and investigators.
According to the GAIS (Global Aesthetic Improvement Scale) assessment of treatment satisfaction by subjects, the satisfaction levels of the test group and the control group were found to be similar.
The GAIS score, which evaluates aesthetic satisfaction after wrinkle improvement treatment, is rated on a scale from 1 (no change) to 5 (very much improved).
Figure 2. Mean GAIS change at 8, 16, and 24 weeks, assessed by subjects.
DERMAL FILLERS
DERMAL FILLERS
DERMAL FILLERS
DERMAL FILLERS
DERMAL FILLERS
DERMAL FILLERS
DERMAL FILLERS
DERMAL FILLERS
