A Natural, Safe and Long-lasting Beauty Filler
A Dermal Filler Made by Korean No.1
HyaFilia has been developed and made by CHA Hospital Group, which is well-known as the best women medical institute in Korea, and also,
CHA Hospital Group has its own the premium aesthetic medical facility as known as the luxurious anti-aging treatment center for celebrities.
Based on its expert technology and plenty of experiences in women's medical and anti-aging field, CHA Meditech Co.,Ltd. the manufacturer of
HyaFilia, has developed a hyaluronic acid dermal filler called HyaFilia to fulfill the expectation of Korean aesthetic market.
What is HyaFilia?
HyaFilia is used for temporary improvement of wrinkles by injecting it into the skin layer around the facial wrinkles.
It is a colorless and transparent gel-type product with viscoelasticity composed of a stabilized non-animal hyaluronic acid.
HyaFilia is tissue reconstructive material that intended to be used for facial tissue augmentation.
It is recommended that the product be used for the correction of moderate to severe facial wrinkles, folds, and acne scars.
Characteristics of HyaFilia
Medical device |
KFDA approval (May, 2013) Graft/prosthesis, biomaterial · B04230.01 (4) |
Non-animal hyaluronic acid |
Usage of HA produced by bacterial fermentation (Streptococcus equi) Biocompatibility · Non-toxic · Non-immunogenic
|
BDDE Crosslinked HA |
BDDE cross-linked HA ·To overcome the short biodegradability of natural HA ·Improvement of the sustainability Biphasic gel (Duration : 6-12 Month)
|
Gel type |
HA Conc. : 20 mg/ml (2%) High viscosity gel : 2,700,000 cP Injection Force : 10 N |
Proven safety and efficacy |
Through multicenter clinical trial, safety and efficacy of HyaFilia have been proven. |
Comparison between HA fillers / Efficacy Test
Comparison between HA fillers
|
Classification |
HyaFilia |
R-product |
J-product |
|
Composition |
hyaluronic acid |
hyaluronic acid |
hyaluronic acid |
|
Crosslinking agent |
BDDE |
BDDE |
BDDE |
|
Total HA concentration (mg/ml) |
20 |
20 |
22~26 |
|
Complex viscosity(cP) |
2.7 x 106 |
2.8 x 106 |
0.9 x 106 |
|
Swelling ratio(ml/g) |
4 |
2.8 |
3.8 |
|
Injection force(N) |
10 |
9 |
13 |
|
Endotoxin (EU/m) |
Less than 0.25 |
Less than 0.5 |
- |
*Hyafilia has similar chemical and physical features with R-product and J-product which are currently dominating the filler market, However, in the aspect of its swelling degree and enzyme stability, HyaFilia outweighs other products.
Efficacy Test
From the internal duration test using mouse, HyaFilia had longer durability than J-product and similar durability with R-product. From the histological test,HyaFilia showed superior result within the material remaining for 4months and connective tissues. Plastic surgery division of Korea University Medical college (April, 2010)
|
|
HyaFilia Safety Test
Residual BDDE in HyaFilia
Animal Studies Safety
Safety
Safety The following biocompatibility and toxicology tests were conducted on HyaFilia.
|
Test Title |
Test Number |
Test Standards |
Test Result |
|
Acute Systemic Toxicity Test |
SNUH 0800401 |
ISO 10993-11 |
Pass |
|
Subchronic Subcutaneous Toxicity and Implantation Test in Rat - 13 Weeks |
SNUH 0800402 |
ISO 10993-11 ISO 10993-6 |
Pass |
|
Cytotoxicity Test |
SNUH 0800403 |
ISO 10993-5 |
Pass |
|
The Guinea Pig Maximization Test |
SNUH 0800404 |
ISO 10993-10 |
Pass |
|
Hemolysis Test |
SNUH 0800405 |
ISO 10993-4 |
Pass |
|
lntracutaneous Reactivity Test |
SNUH 0800406 |
ISO 10993-10 |
Pass |
|
Pyrogen Test |
SNUH 0800407 |
USP29 |
Pass |
|
Bacterial Reverse Mutation Assay |
SNUH 0800408 |
ISO 10993-3 |
Pass |
|
In vitro Chromosome Aberration Test |
SNUH 0800409 |
ISO 10993-3 |
Pass |
|
In vivo Micronucleus Test |
SNUH 0800410 |
ISO 10993-3 |
Pass |
Testing Period - February 2009 Testing Institution Medical Device Evaluation Center, Clinical Research Institute, Seoul National University Hospital, Korea |
HyaFilia Clinical Data
Efficacy Evaluation
Primary Efficacy Evaluation
HyaFilia is non-inferior compared to R-product
WSRS average difference between R-product applied area and HyaFilia applied area was -0.03±0.75.
The lowest value of single one-sided 97.5% confidence interval regarding WSRS result was -0.22.
As this was bigger value than -0.29 which was the non-inferiority limit in this trial, HyaFilia's non-inferiority was proved.
Secondary Efficacy Evaluation
Patient's Satisfaction Level
Patient's Satisfaction Level : Among GAI average value evaluated by subject on the 8th, 16th, and 24th week, HyaFilia's satisfaction
level was higher than R-product on the 8th and 24th week. However, it is not statistically significant.
Conclusion
HyaFilia used to improve nasolabial fold is considered as an effective and safe medical device.
HyaFilia Series Information
Manufacturing process
