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Hibaea

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1

Feature

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Adhesion Process

An adhesion is a band of scar tissue that binds together anatomic surfaces which are
normally separated from each other.

Given a tissue injury, Macrophages forms the As the adhesion The existing
the healing process basis of adhesion and develops, blood adhesions develops,
takes place in a closely fiblin matrix develops, vessels increase and so the distinction
orchestrated cascade to leading to multiplying structurally organize. from the tissue
repair the damage fibroblasts and becomes unclear and
: macrophages, angiogenesis begins. forms dense bands.
fibroblasts, fibrin matrix
etc.

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Function of Anti-adhesion

When anti-adhesion Most of the cells that Mesothelial cell has A layer rich in
barrier is placed cover the wound tissue been shown to play a Mesothelial Cells
between the surface are role in anti-adhesion forms a natural anti-
wounded tissue macrophages. adhesion surface
surfaces, it acts as a Mesothelial Cells do not and prevents the
physical barrier, yet exist on the wound formation of new
preventing adhesion surface. adhesions.
formation during the
healing of the wound.

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Characteristics

Hibarry which developed its


own technology in Korea provide optimum
anti-adhesion effect.

Ingredient Hyaluronic Acid (including Cross-linked Hyaluronic Acid)

Storage At room temperature(1~30°C), Protect from light, Protect from freezing

Shelf life 2 years from date of manufacture

Purpose of use As a deep cavity wound dressing, Primarily reducing adhesion during spinal surgery

Package 1.5 mL / 3.0 mL / 5.0 mL / 10.0 mL per prefilled Syr.

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Characteristics of components

COOH CH2OH
O O

O O
OH
OH
OH NHAc

• Only HA (Hyaluronic acid : HA): Components in vivo.


• Because of using the Cross-linked Hyaluronic acid, maintenance a certain period
in the body.
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Characteristics of Hibarry

Pure Hyaluronic acid


Excellent biocompatibility and biodegradability

Other Hibarry
Cross-linked Hyaluronic acid
Appropriate anti-adhesion retention time
• Using the Cross-linked Hyaluronic acid
: Maintenance a certain period in the body.
High viscosity ·High molecular weight
• Using the high molecular weight and high viscosity
Flow prevention when applied & catch the target correctly
undiluted solution : Optimal role of physical barriers

• Dose not contain synthetic substances ;


Endotoxin-free · Protein-free CMC(Carboxymethyl cellulose), HES(Hydroxyethyl starch),
Safety, Minimize adverse Alginate Excellent biocompatibility.

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Compare with other products

TRADE NAME HIBARRY GUDIEX-SOL OXIPLEX MEDICURTAIN

Classification Class III Class III Class III Class III

Hyaluronic acid Ethylene oxide


Ingredient Hyaluronic acid + + Hyaluronic acid
+ carboxymethyl cellulose carboxymethyl
+
Cross-Linked HA Hydroxyethyl starch
(CMC) cellulose (CMC)

Viscosity 3733cPs
2340 cPs
(63% high viscosity)

✓ Pure ✓ Synthetic substances ✓ Synthetic subs


Feature
Hyaluronic acid (CMC)
✓ Synthetic subs
✓ Instability
(HES Contain)
✓ Excellent Viscosity ✓ Polymer +
simple mixed solution ✓ High viscosity
✓ Instability
✓ Excellent
Biocompatibility ✓ Low viscosity ✓ High Price

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Physical-chemical Properties Test

Content Limit Result


Transparent
Appearance Pass
solution
Identification
murex Pass
(Glucuronic acid)
pH 6.8 ~ 7.6 7.49

Volume in container ≤ 5.0mL 5.3 mL

Limiting viscosity 19.5~45dl/g 34.2 dl/g

Osmolarrity 270~350mOsm/kg 295 mOsm/kg

BDDE -content 2ppm ≤ -

HA-content 7.0~9.0mg/mL 8.14mg/mL


EO ≤ 25ppm
EO gas -content ECH ≤ 25ppm -
EG ≤ 250ppm
COA by KEMTI
Evaluation/Comment Pass
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Biocompatibility Test

Content Limit Result

Cytotoxicity Pass KEMTI

Delayed Hypersensitivity Pass KEMTI

Intracutaneous Reactivity Pass KEMTI

Acute Systemic Pass KEMTI

Pyrogen Pass KEMTI

Reverse mutation Pass KEMTI

Chromosomal aberration Pass KEMTI

Implantation (12 weeks) Pass KEMTI

Sterility test Pass KEMTI

COA by KEMTI
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Pre-clinical Test: Efficacy Test

Tensile strength 4.23±0.48 3.24±1.03 3.22±0.65

Distance of
1.86±0.69 1.48±0.66 0.97±0.58
adhesion form
Infiltration of
inflammatory 2.80±0.45 1.80±0.84 1.80±0.45
cells
Collagen
2.60±0.55 1.80±0.45 1.60±0.89
proliferation

Angiogenesis 2.40±0.55 1.40±0.89 1.60±0.55


* SCMC: sodium carboxymethyl cellulose: anti-adhesion effect materials

▪ All test contents are significant


▪ The adhesion process prevented clearly by BNCH-202
▪ Journal of Veterinary Clinics (Vol. 28. No.1)

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The Synopsis of Clinical Study

▪ Title
A clinical study to evaluate the efficacy and safety of BNCH-202 for
prevention of adhesion after spinal surgery

▪ Methods
Controlled, Multicenter, Single-blind

▪ Institutes
Yonsei University
Catholic Medical University
Gacheon Medical University
Korea University

▪ Sample size (76 people)


Control group 38 people, Test group 38 people

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Certification

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Application Fields

Neuro surgery Spine-related surgery / Larminectomy & Discectomy

General surgery Thyroid surgery / Breast-related surgery

Plastic surgery Hand, foot micro-surgery / Tissue reconstructive surgery

Orthopedic surgery Spine-related surgery / Hand, foot, shoulder and trauma disease surgery

Endoscopic and open surgery of the Uterus and attached to the uterine
Obstetrics & Gynecology
disease / Cesarean/ Curettage (Incomplete missed abortion)

Thoracic surgery Cardiac surgery

ENT Sinusitis, Otitis media

Dentistry Neck dissection / Washing liquor jaw joint

Urology Incision of prostate / Urinary tract surgery / Urethral stricture repair

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Application Fields

Thesis Title Anti-adhesion barrier reduces adhesions after laparoscopic surgery for adhesiolysis

Journal Fertility and Sterility® Vol.88, No. 5, November 2007

Design A double-blind, randomized, controlled study, conducted at 16 referral centers.


402 Patients returned for second laparoscopy within 4~8 weeks
Patients
Adept(n=203) LRS(n=199)
LRS stands for lactated Ringer’s solution
At first laparoscopy, 100ml irrigant every 30mins during surgery 1 liter instilled at the end of surgery
Method
After 28 to 56 days later, 2ND laparoscopy for assessment

Results * adhesion reduction – Adept 49%, LRS 38%


* reduction in AFS score among infertility patients – Adept 53%, LRS 30%
AFS score stands for American Fertility Society
Efficacy * free of de novo adhesion – Adept 53%, LRS 43%
* the mean reduction in incidence of adhesions with Adept was 4.38+-3.70 versus 2.95=-3.35
for LRS patients

Safety * Adverse events occurred in 19 patients(8 Adept patients, 25 event; 11 LRS patients, 19 events)
This study demonstrated that use of Adept as an irrigant and postoperative instillate reduces adhesions aft
Discussion
er laparoscopic gynecologic adhesiolysis.

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Application Fields

Thesis Title Anti-adhesive effect of Anti adhesion barrier after Endoscopic sinus surgery

Journal Korean J Otolaryngology 2005;48:1478-83

Design Randomized and double blinded

Patients 44 patients (experimental group, Anti adhesion barrier applied on Merocel®, n=22)
(control group, NS applied on Merocel®, n=22)

Method At the end of endoscopic sinus surgery, 6ml Anti adhesion barrier was applied on Merocel® and repeatedly
applied on the middle meatus after removal of Merocel
As a control group normal saline was allied instead of Anti adhesion barrier

Results The groups with the Anti adhesion barrier treatment showed lower adhesion formation than the
Efficacy
control

Safety The safety profile of the patients was normal at 4 weeks postoperatively

Anti adhesion barrier may be an efficacious and safe material in decreasing the incidence of adhesion after
Conclusions
sinus surgery

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Application Fields

Thesis Title Efficacy of anti-adhesive barriers in secondary thyroidectomy : An Experimental study

Journal Laryngoscope, 114:1668-1673, 2004

Design Controlled, randomized study

Patients 28 male Wistar Albino rats that underwent right subtotal thyroidectomy were assigned
Group 1:Seprafilm(n=10), group 2:Interceed(n=10) and group 3:the control group(n=8)

Method After surgery, .5* .5 cm sheet of seprafilm and interceed were inserted between the trachea and the muscles
And the control group are not given any substance
After 14 days, surgical fields were evaluated for the adhesion formation.

Results Control group: all surgical fields needed to be dissected with instruments
Seprafilm group: 6 of 10 subjects had no adhesions
Efficacy 4 out of 10 needed dissection
Interceed group: 3 of 10 subjects had no adhesions.
6 out of 7 needed blunt, 1 of 7 needed sharp dissection
Safety -
Seprafilm® and Interceed® were found to be effective in preventing adhesions in re-operative thyroid surgery in
Conclusions
an animal model

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Contact

Address : 4th floor Cheongsong-plaza, 7, Yangjipyeon 2-ro, Uiwang-si, Gyeonggi-do, Korea


Tel : +82 70 8891 2407 (Direct) / +82 10 2045 4641 (Mobile)
E-mail : [email protected]
Attn : Dong-Gyu LEE / Head of Department

©2020 This document is confidential and property of BMI Korea All Rights Reserved.
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