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Hans Biomed Spine & Orthopedic

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  • 1. Hans Biomed Corp. P/O/W/E/R/P/O/I/N/T Jamie Park Hans Biomed USA, Inc. . c nI , A S U d e m oi B s n a H
  • 2. 01 Company Introduction02 Spine & Ortho Products03 Why? Hans Biomed !!! . c nI , A S U d e m oi B s n a H
  • 3. . c nI , A S U d e m oi B s n a H Introduction Company
  • 4. 1. Company IntroductionHans Biomed Corp. Chief Executive Officer: Mr. Hwang Establishment: 1993 Location: - Headquarter: Seoul - R&D / Production: Techno Valley, Daejeon Employees: Around 80 as of 2011 . c nI , A S U d e m oi B s n a H
  • 5. 1. Company IntroductionHistory (2007~ ) ▶ Production of Silicone (2001~2006) Products and Bone Graft Products. Establishment Daeduk ▶ Bone graft DBM Products Technology Institute and (SureFuse, ExFuse) Development registered FDA and Production Scar (1999~2000) First approved Tissue Bank in ▶ Management Products Korea (Scarclinic) Development and ▶ Sales medical device for Production as first preventing scar and treatment manufacturer in Korea. USA FDA on-site inspection & ▶ Development of Core registration ▶ Cohesive Gel Breast Implant technology & Production (BellaGel) Development and technology Starting to export SureDerm Production. CE certificate acquisition as a first in Asia ▶ Production Success of Human skin SureDerm ▶ List in Korean Stock Market ▶ Open US Office in JU . c nI , A S U d e m oi B s n a H
  • 6. 1. Company Introduction 9th Oct 2009 Listed in KOSDAQ [ CEO of Hans Biomed] . c nI , A S U d e m oi B s n a H
  • 7. . c nI , A S U d e m oi B s n a H y g ol o n h c e T d n a y g ol o n h c e T d n a y r e g r u s k c a b d eli a f l a ti p s o h l u di r o o W -g ni r e e ni g n E ci m a r e C f o e t u ti t s nI a e r o K -g ni r e e ni g n E ci m a r e C f o e t u ti t s nI a e r o K - yregrus citsalp latipsoh ..vinU lanoitaN luoeS- y r e g r u s ci t s al p l a ti p s o h vi n U l a n oi t a N l u o e S -e t u ti t s nI h c r a e s e R y g r e n E ci m o t A a e r o K - s ci d e p o h t r O l a ti p s o H i n U ijl U - T SI A K - T SI A K - r e t n e c n r u B n ai t s e B - r e t n e c n r u B n ai t s e B - y g ol o n h c e T l a ci m e h C f o e t u ti t s nI h c r a e s e R a e r o K - r e t n e c n r u b l a ti p s o H mi S g n u S g n a g n a H - Cooperation research Medical consultant Union / Clinical cooperation / - Euro Skin Bank (Holland) EATB - AlloSource, CTS etc AATB Tissue Bank Cooperation Partner 1. Company Introduction
  • 8. 1. Company Introduction Certification - 1 FDA Registration1. Tissue Establishment Registration2. Product Listing in FDA On- On-site Inspection - 2003. 9 - 2008. 8 . c nI , A S U d e m oi B s n a H
  • 9. 1. Company IntroductionCertification - 2 FL Tissue Bank License1. Got the FL TB License on 18th Nov 20112. Under review NY, CA and MD . c nI , A S U d e m oi B s n a H
  • 10. 1. Company IntroductionCertification - 3 ISO13485 GMP Certificate ISO13485:2003 Certificate Compliance with Medical acquisition device quality management (Quality management system standard certificate) . c nI , A S U d e m oi B s n a H
  • 11. 1. Company IntroductionCertification - 4 KFDA Tissue Bank Approval Korea first tissue bank, Tissue bank establishment approval (no.1) . c nI , A S U d e m oi B s n a H
  • 12. . c nI , A S U d e m oi B s n a H Patent 1. Company Introduction
  • 13. 1. Company Introduction Hans Biomed Daeduk Institute . c nI , A S U d e m oi B s n a H
  • 14. 1. Company Introduction Hans Daeduk Institutes • Establishment : June 2002 • Total Area : 11,337 m2 • Total Floor Area: 2,517 m2 - 1st Floor: Silicone Polymer Product - 2nd Floor: Skin Graft Product - 3rd Floor: Bone Graft Product Main Facilities • D.I. water manufacturing system • Freeze drier for clean room • EO gas & Irradiation • High Pressure Steam • Ultra lower freezer storage • Histologic laboratory • Silicone Injection Molding facility • Mass Drying facility for the silicone • Quality management and Inspection facility . c nI , A S U d e m oi B s n a H
  • 15. 1. Company Introduction3rd Floor: Bone Graft Product . c nI , A S U d e m oi B s n a H
  • 16. 1. Company Introduction2nd Floor: Skin Graft Product . c nI , A S U d e m oi B s n a H
  • 17. 1. Company IntroductionMain Facility - 1 D.I. water Freeze Dryer Bone Grinder manufacturing system . c nI , A S U d e m oi B s n a H
  • 18. 1. Company IntroductionMain Facility - 1 Deep Freezer Clean Bench Auto Clave . c nI , A S U d e m oi B s n a H
  • 19. 1. Company Introduction USA Branch: HansBiomed USA, Inc. Address : 140 Sylvan Ave, Englewood Cliffs, NJ 07632 TEL: (201) 224 2333 . c nI , A S U d e m oi B s n a H
  • 20. . c nI , A S U d e m oi B s n a H Products Spine & Ortho
  • 21. 2. Spine & Ortho ProductsProduct list & FDA Status 510K HCTP FDBA - - DFDBA - Pedi-Stick, OsteoGrow FDBA+DFDBA - - DBM SureFuse - DBM W/C ExFuse - Flex BellaFuse, BellaFuse Inserter - Cancellous Bone - SureChip, Block, (FDBA) Block Bone Sponge - Genesis Sponge Machined Bone Graft - SureCerv, SureLumb ADM - AlloCover . c nI , A S U d e m oi B s n a H
  • 22. 2. Spine & Ortho Products 100% Allograft Bone Products (FDA Approved) Classified 100% Allograft Skin Products Allograft (FDA Approved) Products Medical Device (Under 510k Review) . c nI , A S U d e m oi B s n a H
  • 23. 2. Spine & Ortho Products 100% Allograft Bone Products (FDA Approved) Part Ⅰ. Genesis sponge (Demineralized Cancellous Block) Part Ⅱ. Pedi-Stick (DBM Stick) Part . OsteoGrow (Demineralized cortical bone Filler) . c nI , A S U d e m oi B s n a H
  • 24. Genesis Sponge 1) Cancellous Bone 2) Product: Genesis Sponge Block & Filler 3) Form: Block / Chip 4) Characteristic: Sponge like properties Specification . c nI , A S U d e m oi B s n a H
  • 25. Genesis Sponge Indication - Spinal fusion and general orthopedic surgeries - Any bone defect area where the malleable bone void filler needed - Dental reconstruction Instruction for Use . c nI , A S U d e m oi B s n a H
  • 26. Pedi-Stick 1) Stick Type 100% Demineralized Cortical Bone 2) Right size to the Pedicle Hole 3) Osteoinduction 4) High Biocompatibility Instruction for Use Specification . c nI , A S U d e m oi B s n a H
  • 27. . c nI , A S U d e m oi B s n a H Surgical Case Pedi-Stick
  • 28. OsteoGrow 1) 100% Demineralized Cortical Bone Chip 2) Osteoinduction 3) Osteoconduction 4) High Biocompatibility Specification . c nI , A S U d e m oi B s n a H
  • 29. 100% Allograft Skin Products (FDA Approved) . c nI , A S U d e m oi B s n a H
  • 30. SureDerm Characteristic Application1. Becomes patients own tissue 1. Small Ligament reinforcement of2. No Immune response the hand and foot3. Biocompatible and Elastic 2. Tendon and Rotator Cuff4. Recommend to store in refrigerator Augmentation5. 2 years shelf life 3. Chronic and Acute Defect Wound . c nI , A S U d e m oi B s n a H
  • 31. SureDerm Usage 1. Rehydration: Put SureDerm in the normal saline for 10 minutes 2. Put SureDerm’s dermal side to the defected part Distinguish Dermal Side How to distinguish Dermal Side - When you moisten rehydrated SureDerm with patient’s blood, the dermal side becomes red clearly. - Fix the derma side to face patient’s body. . c nI , A S U d e m oi B s n a H
  • 32. Medical Device(Under 510k Review) . c nI , A S U d e m oi B s n a H
  • 33. SureFuse 1) Demineralized Bone Matrix 2) Product: SureFuse II 3) Type: Gel, Putty 4) Characteristic: - High Osteoinductive Ability - High Viscosity - Easy to Handle . c nI , A S U d e m oi B s n a H
  • 34. ExFuse 1) Demineralized Bone Matrix with Cancellous 2) Characteristic: - Containing Cancellous Bone, High Osteoconductive Ability and Easy to Handle etc . c nI , A S U d e m oi B s n a H
  • 35. BellaFuse 1) Demineralized Bone Matrix Flex 2) Product: BellaFuse 3) Type: Flex 4) Characteristic: Enhanced Usability . c nI , A S U d e m oi B s n a H
  • 36. . c nI , A S U d e m oi B s n a H Hans Biomed !!! Why?
  • 37. 1. High Quality and Safe1. Tissue Donors from AlloSource & CTS2. All products are approved in Korean FDA3. Passed FDA on-site inspection twice4. Registered Product in FDA as HCT/P5. Under process 510k - SureFuse, ExFuse and BellaFuse Flex . c nI , A S U d e m oi B s n a H
  • 38. 2. Market Leader in Korea 1. First Commercial & Leading Tissue Bank 2. Many Experience of OEM supply with Big companies- OS/NS Products - Dental Product- Revenue: $600 M Hans - Revenue: $100 M Biomed- NS Products - Silicone Products- Revenue: $50 M - Revenue: $ 300 M 3. Reasonableness 1. Diverse Products Line 2. Better Price than Competitors 3. Quick reaction and meet Customer Needs . c nI , A S U d e m oi B s n a H
  • 39. . c nI , A S U d e m oi B s n a H noissecer ot eud yregrus tnalpmi decudeR • .enobotua fo esu desaerceD • stcudorp tekram etutitsbuS wen hctiws ot tnatculer resu-dnE • tfarG enoB eht ni htworg retsaF • srotitepmoc yb )srotcaf htworG( .gniga noitalupop snoitcudortni tcudorp weN • ot eud esac RBG desaercnI • noititepmoc .noisserped ot eud stneitap gnitsixe ot eud reirrab yrtne hgiH • yb tnemyap rewol gniriuqeR • tfargollA ni dnamed desaercnI •THREAT OPPORTUNITY BIomed SWOT of Hans stcudorP wen gnipoleved yltnatsnoC • ytilicaF gnirutcafunam ssalc-dlroW • srotitepmoc rojam ot erapmoc slairT lacinilC dna srepaP • srepap dna slairT lacinilC fo kcaL • noitacifitreC ADF • seitisrevinu dna srotcerid )S/M tfargollA citsemod lanoiger htiw pihsnoitaler woL • ni 1.oN deknaR(tcudorP nevorP • tekram S.U eht ni ssenerawa woL • ssenevititepmoc ecirP • pu-eniL tcudorP suoiraV • WEAKNESS STRENGTH SWOT Analysis
  • 40. . c nI , A S U d e m oi B s n a H

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