Hyafilia

Hyafilia

Hyafilia no lido


Negotiable Min Order Quantity Unit

Required Quantity
Place of Origin
South Korea
Brand name
Hyafilia Filler
Payment Terms
D/A,D/P,L/C,MoneyGram,Others,T/T,Western Union
Production method
Available
Shipping / Lead Time
Negotiable / Negotiable
Keyword
dermal filler, ha filler, dermal injection
Category
Medical Devices

A&J GLOBAL BRIDGE

Membership
PRO
Country / Year Established
South Korea South Korea / 2017
Business type
Trading Company
Verified Certificate

6

Product name Hyafilia Certification -
Category Medical Devices Ingredients -
Keyword dermal filler , ha filler , dermal injection Unit Size -
Brand name Hyafilia Filler Unit Weigh -
origin South Korea Stock 100
Supply type Available HS code -

Product Information

 

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.

 

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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

 

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Medical device

Class Ⅲ

KFDA approval (May, 2013)

Graft/prosthesis, biomaterial

· B04230.01 (4) 4.JPG

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) 5.JPG

 

Gel type

HA Conc. : 20 mg/ml (2%)

High viscosity gel : 2,700,000 cP

Injection Force : 10 N 6.JPG

Proven safety and efficacy

Through multicenter clinical trial, safety and efficacy of HyaFilia have been proven.

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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)

 

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HyaFilia Safety Test

 

Residual BDDE in HyaFilia

 

10.JPG

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.

 

 

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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.

 

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Conclusion

HyaFilia used to improve nasolabial fold is considered as an effective and safe medical device.

 

HyaFilia Series Information

 

Manufacturing process

 

 

 

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B2B Trade

Price (FOB) Negotiable transportation Air Transportation,Negotiation Other
MOQ Negotiable Leadtime Negotiable
Payment Options D/A,D/P,L/C,MoneyGram,Others,T/T,Western Union Shipping time Negotiable

A&J GLOBAL BRIDGE

Country / Year Established
South Korea South Korea / 2017
Membership
PRO
Business type
Trading Company

6

President
Jon Cho
Address
Duksoro116bun-gil 49, Hyundai Hometown #102-1001, Namyangju-si, Gyeonggi-do, Korea
Product Category
Medical Devices
Year Established
2017
No. of Total Employees
1-50
Company introduction

 

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