Clinical Data

Safe & Effective

  • Safe
  • Better viscoelasticity
  • Long term biostability
  • Easy injectability

 

HA Dermal Filler : Graft/prosthesis, biomaterial

safety of Cross-linking agent (BDDE)

[GC analysis: BDDE detection test]

Safety of pre-filled syringes

Result from Drug Testing and Research
Institute of Korea report
(KFDA designated test agency)

• Because of 3D structure of the particle
configuration by Our unique manufacturing
process, the intensity of HAifeel is strong and it
has long lasting anti-wrinkle effect.
• It can be checked by Haluronidase Resistance
Test of Haifeel and comparing other HA fillers.

  • Haifeel(시험군)
  • R제품(대조군)
  • Product name : HAifeel
  • Medical Device – Grade 4 (Highest Grade)
  • Graft/prosthesis, biomaterial

Stability testing -2 years
KFDA examination and self-study from research institutions to specify parallel

Features of HAifeel

Biological safety

Cytotoxicity test
Sensitization Test
Intradermal test
Acute toxicity test
Pyrogenic substances (Endotoxin) test
Reverse Mutation Test
Chromosome aberration test
Test 12 weeks transplantation
Sterility testing

biological safety tests performed on all items
over the appropriate decision in Korea Testing
& Research Institute (KTR) and Korea
Environment & Merchandise Testing Institute
(KEMTI) designated by Korea Food and Drug
Administration(KFDA).

Removal Process for cross Q gel -linking agent
by adopting enhanced manufacturing
process, HAifeel BDDE content is less
than FDA standards for each LOT
production is carefully controlled.

We have a thorough safety inspection for HA • TopPac syringe LL
fillers as well as syringes.

Performance test of pre-filled syringes

biological safety testi of pre-filled syringes

  • SCHOTT, Germany

 

  • TopPac syringe LL

• pH : Physiological neutral
• Osmotic : Similar range of normal saline

Lower HA loss weight (%)
Increased the HA filler retention period of the body

the 3D structure of cross-linked particles
created by our unique manufacturing process
having various particle sizes.It can be selected
by in accordance with the wrinkles status of
patient.

3D structure of cross-linked
particles can be varied and
uniformly in manufacturing
technology has been
patented in domestic and
overseas

Domestic 10-2010-0097884 (2010.10.07)
PCT PCT/KR2011/006443 (2011.08.31)

Clinical test progression of HAifeel

◆ Clinical test approved by KFDA (2010. 5. 25. )
◆ Clinical test in progress: 2 General Hospital (2010 0.8 ~ 2011 0.7.)
◆ Safety and efficacy clinical report demonstrating IRB approval confirmed

Result of Clinical Test

HAifeel treated at the nation’s major general
hospitals through a comparative clinical efficacy
and safety have been proven to improve
wrinkles.

■ Method :
Multi test, Randomized, Single blind,
Comparative clinical test design response
■ Target :
Over 20 years of age and gender 68 people which
have the bilateral nasolabial fold symmetry
corresponding WARS 3 points or 4 points

  • Haifeel(시험군)
  • R제품(대조군)

WSRS : Wrinkle Severity Rating Scale