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INNOVATION IN BIOSOLUTIONS

www.kyungwonmedical.com

We will take off! Towards new dreams, new hope,

and a new tomorrow.

KYUNGWON
MEDICAL
We are opening another chapter in our
history by striving for quality change and
challenge. We will ensure a bright future for
our clients while charting a path into
tomorrow as a leading global enterprise.

Company History
1991~1999

2000~2004

1991. Dec. 30.

Establishment of Kyungwon Medical Co., Ltd

1998. Dec. 05.

Cooperation with Kyunghee Univ. Oriental Medicine Research Center and


Launch Studies on New Medicines

1999. May. 17.

Establishment of In-house Research Center Approved

May. 25.

Establishment of Medical Device Manufacturing Facilities

July. 03.

Approved Acquisition of License for Medical Device Production and Supply


(Peverty Needle, EVD Set, etc.)

2000. May. 29.


Aug . 04.

Calcium-Phosphate Artificial Bone as Osteoconductive and Biodegradable


Bone Substitute Material

Aug. 23.

Trademark Registration of Bone Cement Injection Needle


(No. 0475772)

2002. Feb. 15.


Oct. 26.
2003. Jan. 25.
Mar. 25.
2004. June. 09.

2005~2011

Registration of Copyright for Bone Cement Injection Needle


(No. 0260942)

Registration of a Utility Model for Leech Metallic EVD (No. 0256541)


Acquisition of ISO 9001 Certification
Acquisition of Korea Patent for PolyBone
(Bone Substitute Material) (No. 0371559)
Acquisition of U.S. Patent for PolyBone
(US 6,537,589)
Acquisition of CE Mark (0434) for Percutaneous Vertebralplasty Needle
(Peverty Needle, D.C.O. System)

June. 25.

Acquisition of KFDA Approval for PolyBone Clinical Trial

July. 21.

Clinical Trial of PolyBone in progress


(at Kangnam St. Marys Hospital and Korea Univ. Medical Center at Guro)

2005. Sep. 06.


Nov. 18.
2006. June. 01.
Nov. 22.
2007. Dec. 27.

Acquisition of KFDA approval for Optimum


(Bone Cement)
Acquisition of CE Mark
(PolyBone, Optimum)
Selected for promising export company by SMBA
(Small and Medium Business Administration)
Selected for superior Korean Production medical device by KFDA
Acquisition of FDA approval for PolyBone
(Cement Type)

Jan. 17.

Acquisition of KFDA approval for PolyBone

Aug. 20.

Contract with Hanmimedicare for exclusive distributor of Polybone &


Optimum for Korean market

Oct. 16.

Acquisition of FDA approval for PolyBone


(Granule & Block type)

2010. June. 16.

Acquisition of FDA approval for PolyBone


(Dental Type)

June. 30.
2011. Dec. 26.

Acquisition of FDA approval for TychePedicle Screw System


Headquarters has relocated to Osong Bio-Health Science Technopolis

www.kyungwonmedical.com

PRODUCTS OVERVIEW
BIOLOGICS
100% (-TCP)
BIPHASIC (-TCP 60% + HA 40%)

INTERBODY

04

POSTERIOR LUMBAR INTERBODY FUSION


CERVICAL INTERBODY
SPINAL FIXATION SYSTEM

05

VERTEBRAL
COMPRESSION FRACTURE
BONE CEMENT
BONE CEMENT DELIVERY SYSTEM

PolyBone

-TCP Synthetic Bone Material


Polybone is a revolutionary artificial bone substitute that resorbed and replaced by
natural bone to regenerate bone defects in the entire skeletal system.
PolyBones bone formation mechanism is promoted by polyphosphate ingredient, which
activates BMP and accelerates bone regeneration. This mechanism will achieve the best
results in variety of surgeries involving bone fracture, craniofacial surgery, spine plasty,
oral surgery, etc.

HISTOPATHOLOGICAL COMPARISION
(BEAGLE DOG, 6 WEEKS)

Radiological analysis of bone regeneration

Product A

PolyBone

Radiological analysis of bone regeneration


180

Bone regeneration(mm2)

160

PolyBone
Product A
Control

140
120
100
80
60
40
20
0

Implantation time (week)

KEY FEATURES & BENEFITS


Fast bone reconstruction and regeneration
Excellent biocompatibility and biodegradability
Various product types and sizes to fit diverse clinical indications
Interconnected macroporous structure provides better osteogenesis
Ideal hardening time (less than 5 min) and no exothermic reaction
Multilayer augmentation
Works well under wet condition-Low dissolving
into blood and body fluids

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CLINICAL INDICATIONS AND CASES


Neurosurgery

Repair of neurosurgical burr holes, craniotomy cuts and other cranial defects
Restoration or augmentation of bony contour in the craniofacial skeleton
Augmentation and smoothing contours of skeletal irregularities

Cranial defect site(pterion) with the treatment of


PolyBone (POD 1 year)

Repair of Oro-antral Fistula.Lt with


PolyBone (POD 1 year)

MVD Case with PolyBone


(POD 1 year)

Orthopedic Surgery

Filler for bony voids, gaps of the skeletal system, or defects that are not intrinsic to the stability of
bony structure in the extremities, spine, and pelvis.

Treatment of surgically or traumatically created osseous defects.


Packed or placed into the site and may be combined with autogenous blood, bone marrow or saline.
Bone filler for revision of the artificial hip joint, knee joint, shoulder joint, and other joints

Forearm fracture surgery


with PolyBone

Tibia fracture surgery with


PolyBone

Bone fusion with PolyBone (POD 6 months)


(CT imagination-right)

Dental Surgery

Placing implant

After grafting with PolyBone

PRODUCT TYPE
Powder type

Block type (Stick & Cervical)

Granule type

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07

Calpore

Biphasic Synthetic Bone Material


Calpore is an excellent biocompatible and bioactive bone graft substitute. The Calpore is a
novel biphasic artificial bone substitute composed of 60% beta-tricalcium phosphate and
40% hydroxyapatite, which is highly bioactive and mechanically stable composition. Calpore
presents the multi-porous structure, including, macro, interconnected, and micro porosities
that rapidly triggering the biochemical exchanges for bone ingrowth and reconstruction.

MULTI-POROUS STRUCTURE

Interconnected porous structure

Macro porosity
(200~500 m, Higher than 75%)

Micro porosity (<10 m)

KEY FEATURES & BENEFITS


Fast bone reconstruction and regeneration
Excellent biocompatibility and biodegradability
Various product types and sizes to fit diverse clinical indications
Interconnected macroporous structure provides better osteogenesis
P
 rovide a scaffolding for new bone formation to allow blood vessels
& cells to grow into the ceramic.
M
 acroporosity provides a space in which bone ingrowth can occur
by osteoconduction
M
 icroporosity provides a vehicle promoting uptake of fluid & cells
into matrix by capillary action

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CLINICAL INDICATIONS AND CASES


Spine

Filler for bony voids, gaps of the skeletal system, or defects that are not intrinsic to the stability
of bony structure in the extremities, spine, and pelvis.

Immediate post op

Post op 1 M

Post op 6 M

Post op 12 M

08
Orthopedic Surgery

T reatment of surgically or traumatically created


osseous defects.
Packed or placed into the site and may be combined
with autogenous blood, bone marrow or saline.
B
 one filler for revision of the artificial hip joint, knee
joint, shoulder joint, and other joints

Dental Surgery

Exposure of fixture thread due to severe bone


destruction was observed (white arrow).

Grafted CalPore on the bone


defect (white arrow).

PRODUCT TYPE
Block type (Stick & Cervical)

Granule type

09

Tyche

Spinal Fixation System

Low profile
Provides 40 variable angular movement
Allows simple 3D corrections

Minimizes any neural damage


Provides maximum pull-out strength

Self-tapping

INSTRUMENTS
The Tyche spinal fixation system is made up of all
ergonomically designed instrumentation providing mechanical
support and stability in vertebral surgery.
(Custom Design Available)

Reduction screw
Provide controlled and gradual anatomical
reduction and simply break off to remove it

Maximizes locking performance


Contributes to overall low-profile.

Easy locking process

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EASY & SIMPLE REDUCTION OF SPONDYLOLISTHESIS


1

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Tyche

Lumbar Expandable Cage

Revolutionary Technology Promotes Natural Lordosis


Were changing the world of spinal cage fixation.
Tyche Lumbar Expandable Cage expands when implanted to promote the spines natural lordosis.
It provides a strong bone-to-cage interface, reducing migration risk.
This one of a kind cage made of a lightweight and biocompatible titanium is strong enough to
withstand even the most demanding loads on the spine. It is also simple and easy to implant.
With Tyche Lumber Expandable Cage, youll never look at cage implants the same way again.

INDICATION FOR USE


The primary indication for use of the Tyche intervertebral
body fusion device is for painful, degenerative disc disease,
persisting for at least 6 months despite intensive
conservative care.
A positive concordant discogram is helpful in determining
which patients might benefit from an interbody fusion.

Biomechanical Laboratory Test Confirm Strength


When fully expanded, Tyche Lumbar
Expandable Cage withstands the following loads:
9 mm cage expanded to 11 mm
11 mm cage expanded to 13 mm
13 mm cage expanded to 15 mm
15 mm cage expanded to 17 mm

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The Only Round Shaped Expandable Cage System


with These Exclusive Features and Benefits:
Cylindrical shape expands in disk space and upper & lower sides become flat
External surface ridges stabilize setting and provide a strong bone anchor
Expansion creates large inner volume for more bone graft area
Four large opening promote better graft integration
2(upper and lower) expose a large area between end-plates and graft
2(lateral) enable fusion between implants
4 different sizes are available for most clinical situations

State-of-the-art instruments accelerate implantation

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13

ORDERING INFORMATION
Cat. No.

Description

KEC 0911

Cage Assembly, PLIF, 9mm x 24mm

KEC 1113

Cage Assembly, PLIF, 11mm x 24mm

KEC 1315

Cage Assembly, PLIF, 13mm x 24mm

KEC 1517

Cage Assembly, PLIF, 15mm x 24mm

Higher technology that adapts to the


spine and the surgeon

Tyche

Prefilled Cervical Cage System


Composition of Tyche Cervical
Tyche Cervical = 100% beta-tricalcium phosphate

Macro porous Structure

X-ray tomography

Tyche Cervical = beta-tricalcium phosphate 60% + hydroxyapatite 40%


60 % -Tricalcium phosphate
Fast osteoconduction

40 % Hydroxyapatite
Mechanical stability

Tyche Cervical Cage is an Anterior Cervical Interbody Fusion Device


Prefilled with Synthetic Bone Substitute, PolyBone (100% TCP) or Calpore
(60% -TCP and 40% HA), Consist of PEEK-OPTIMA and Spikes made of Titanium

Indication for Use


Herniated disc with disc compression
Degenerative disc diseases and instabilities
Spondylolisthesis

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PEEK WITH 100% -TCP

PEEK WITH -TCP 60% + HA 40%

Prefilled with Synthetic Bone Substitute


Sharp teeth ensure stability and migration of the cage
Maximized Bone Fusion by Osteoconductive
Titanium spikes enables secure positioning of the cage
Anatomical design

Convex

14
15

Lordotic

Parallel

ORDERING INFORMATION
Type

Width (mm)

Height (mm)

Length (mm)

Angle ( )

Parallel

11,13,15,17

4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14

10, 12, 14, 16

Lordotic

11,13,15,17

4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14

10, 12, 14, 16

Convex

11,13,15,17

4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14

10, 12, 14, 16

OptiBone

Bone Cement

SPECIAL FEATURES
Medium Viscosity
Ideal Setting Time
Improve the Flowage of Dough
Lowered Degree of Heat Sensitivity

CLINICAL CASES

Pre-OP CT

Post-OP CT

OptiBone Injection

OptiBone APPLICATION
CASE : Female
74 years old
Lumbar (L3)
Osteoporotic Compression Fracture

Pre-OP Lat.

Post-OP Lat.

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Self-Curing Bone Cement for Vertebroplasty


Pathological fractures of vertebral body due to osteoporosis, cancer,
or benign lesions using vertebroplasty or kyphoplasty procedures.

CHEMICAL COMPOSITION
POWDER

LIQUID

Poly [(methyl methacrylate)-co-(butyl methacrylate)]

68% w/w Methy methacrylate

Benzoyl peroxide

2% w/w N,N-Dimethyl-p-toluidine

Barium sulfate

30% w/w Hydroquinone

99.5% w/w
0.5% w/w
70 ppm

Exothermic Temperature()

EXOTHERMIC TEMPERATURE COMPARISON


100

16

80

17

60

SIGNIFICANTLY LOW
EXOTHERMIC TEMPERATURE

40

20

OptiBone has significantly low exothermic


temperature compared to competitive products
as shown in the graph on the left

OptiBone

COMPRESSIVE STRENGTH COMPARISON

Compressive Strength (MPa)

100

80

60

IDEAL LEVEL OF COMPRESSIVE PRESSURE

40

20

OptiBone

OptiBone has acheived the ideal level in terms


of compressvie strength as the bone cement
compared to competitive products as shown in
the graph on the left

Bone Cement
Delivery System
Peverty Needle
KEY FEATURES &
BENEFITS

EFFICACY

Introduce and position Peverty Needle into pertinent vertebral body


under the guidance of C-arm or other imaging device.
Inject bone cement into punctured vertebral body

Stabilization
Analgesic effect
Facilitate surgery
Antitumor effect

SIZE

Article No.

Gauge(mm)

Length(cm)

KW1011

10

11

KW1011N

10

11

KW1211

12

11

KW1015

10

15

KW1411

14

11

Other sizes are available on demand.


For more information or ordering the Peverty Needle, contact Kyungwon Medical Co., Ltd.

CLINICAL FIGURE

1. Osteoporotic bursting fracture


(L1, L2) <79/F>

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2. Metastatic Spine Tumor(Lung Cancer) in Cervical Vertebra


<72/M>

Left : Plain lateral x-ray demonstrating severe C3 osteolytic lesion


Right : Peverty Needle is placed into C3 vetebral body and bone cement is injected

3. Osteoporotic compression fracture


<75/F>

The procedure of bone cement injection (top left, top right, bottom left, bottom right)

SURGICAL TECHNIQUE
A
 nterolateral for Cervical Level.
T ranspedicular for Lumbar Level.
E xtrapedicular for Thoracic Level.
T he approching method is used when needle tip can easily encroach the spinal canal and is
difficult to place in the vertebral body in axial view due to the narrow and small transverse angle
of the pedicle.
T herefore, it can place the needle tip at the medial of the vertebral body in more convergent
position so that bone substitute material(PMMA, bone cement, e.g.) can easily cross the mid-line
with the uni-lateral approach. In addition, it can reduce the encroachment of the spinal canal.

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Manufacturer
KYUNGWON MEDICAL CO.,LTD.
765, Jeongjungyeonje-ro, Osong-eup
Cheongwon-gun, Chungbuk, Korea.
Tel. 82-2-2113-8696
Fax. 82-2-2113-8699

www.kyungwonmedical.com

Worldwide Exclusive Distributor


Q-TECH INNOVATION CO.,LTD.
Suite 601, World Meridian Venture Center, 60-24
Gasan-dong, Geumcheon-gu, Seoul, Korea 158-801.
Tel. 82-2-553-4034

www.qtech1.com

Distribution opportunity
info@kyungwonmedical.com

INNOVATION IN BIOSOLUTIONS