Maxigen Biotech Inc. Integrity, passion and professionalism are not just promises to our customers, but also commitments we make to ourselves. 1
Company profile Company name Maxigen Biotech Inc. (MBI) (Stock code:1783) Established December, 1998 Cap. G.M. Core competency NTD 710 million (USD 23 million) Edward Chang Ph.D Developing, manufacturing, and marketing of biomedical and cosmeceutical skincare products Major product Major Shareholders Medical devices for Orthopedics, Dental, Ophthalmology, and Wound Dressing. Cosmeceutical skincare GIH Group, Mega International Commercial Bank, First Financial Holding, NuVasive Inc.(Nasdaq:NUVA) 2
Milestones 1999 2002 2006 2007 2009 2010 2011 Established R&D center at Yang Ming university. GIH Group invested in MBI. Established Taipei medical devices facility and Tainan skincare facility. Biomedical Products Formagraft, Foramic, ArtiAid, and ViscAid received market approval. Enlisted US NASDAQ listed company, NuVasive, as investor and strategic partner. Taipei biomedical facility passed FDA inspection with no observations. Tainan skin care facility received Taiwan GMP certificate. Biomedical Products - Foramic, ArtiAid and ViscAid received CE mark. Biomedical Product - SurgiAid received FDA approval. 2012 2013 Entered into a technical development agreement with Exactech.(Nasdaq:EXAC) Initiated Public Offering.
Milestones 2007 NuVasive,as investor and strategic partner 2009 passed FDA inspection with no observations. 2009 Won Commendable in the Taiwan Healthcare Industry Innovation and Excellence Awards. 2012 Partnered with Exectech 2013 Contracted with Shanghai Fosun Pharma 2013 IPO 2013 IPO 4
MBI facility location
Medical Devices division 6
Core Technology The core technology of Maxigen medical device was using natural biomaterials such as Collagen, Hyaluronic Acid, Bioceramic to develop the implanted medical device External Artificial Scaffold was used to mimic the environment of ECM Defect Implanted Artificial Scaffold can provide space for cell migration and attachment The defect tissue was then repaired and regenerated. And, Artificial Scaffold was degraded by the enzyme of body
Applications Orthopedics Bone Cement Bone Void Filler Dentistry Bone Graft GTR Wound/Skin Orthopedics Dressing Dermal Filler Ophthalmology Viscosurgical device Gastroenterological Anti-adhesive Dental Gastroenterology Ophthalmology 8
Technology platform Fundamental materials Technology platform Technology protection Application Market Scale(B) Collagen extraction Patent Orthopedics Dental 1.0 High polymer Collagen HA Collagenceramic technology Patent Orthopaedy Skincare 2.0 Ceramic materials Hydroxyapatite β-tricalcium phosphate Absorbable calcium phosphate ceramic technique Cross linked hyaluronic acid Patent Know How Orthopedics Dental Gastroenterology Ophthalmology Orthopedics Dental 2.5 4.5 9
Collagen product line HealiAid /SurgiAid Collagen wound dressing membrane (Taiwan USA Singapore) FormaAid Guided Tissue Regeneration (GTR) membrane in periodontal treatments (Taiwan, Singapore) 10
11 Ceramic bone graft product line Foramic Ceramic bone graft (Taiwan EU Singapore) MaxiBone Calcium Phosphate Ceramic(Taiwan) PRP Macropores (65%) Micropores (35%) Formasetin Bone Void Filler (Taiwan) Completely bone filling in voids or gaps
Collagen/Ceramic materials product line FormaGraft Collagen bone graft substitute (Taiwan, USA) GingivAid Collagen bone graft substitute for dental and orthopedics (Taiwan Singapore) Spinal Fusion
Hyaluronic Acid product line ViscAid /PreviscAid Ophthalmic viscosurgical device (Taiwan, China, EU) ArtiAid /ArtiAid Plus Intra-articular Injection (Taiwan, EU) Cross linking Formaderm Dermal Filler Injection (Taiwan, EU) Before implantation Strengthen enzyme resistance Extending degradation rate Highly structural support After implantation 13
Biomedical materials product list Category Product License Collagen Hyaluronic Acid Ceramic materials SurgiAid Collagen Wound Dressing HealiAid Collagen Wound Dressing FormaAid Collagen Membrane Formagraft Collagen Bone Graft GingivAid Collagen Bone Graft GingivAid Collagen Dental Bone Graft ViscAid Ophthalmic Viscoelastic ArtiAid Intra-articular Injection ArtiAid Plus Intra-articular Injection Formaderm Dermal Filler Injection Formacare External Aesthetic Restoration Foramic Bone Graft Substitute MaxiBone Calcium Phosphate Ceramic Formasetin Bone Void Filler TFDA USFDA, TFDA, HSA TFDA, HSA USFDA, TFDA TFDA TFDA, HSA CE, CFDA, TFDA CE, TFDA CE, TFDA CE, TFDA TFDA CE, TFDA, HSA TFDA TFDA
MBI s Product Pipeline Product Line In Market (Current) In Process (2014~2016) In R&D (2015~2017) Hyaluronic acid crosslinking Formaderm Dermal Filler ArtiAid Intralcular Injection (5- dose) ArtiAid Plus (3-dose) ViscAid Ophthalmic Viscoelastic Formacare Formaderm Series Products (4 products) ArtiBest Intra-articular Injection (1-dose) MaxiGel Anti-adhesive Gel Collagen/ bioceramic FormaAid Collagen Membrane FormaGraft Collagen Bone Matrix GingivAid Collagen Bone Graft MaxiGuide GTR Membrane MaxiCure Bone Graft MaxiCage Resorbable Cage Resorbable bioceramic Formic Bone Substitute MaxiBone Calcium Phosphate Ceramic Formasetin Injectable Bone Filler MaxCement High Performance Cement MaxiSetin Antibiotic Filler Currently, 11 products were commercialized with 18 licenses 13 additional products expected to be commercialized within the next 3 to 5 years
Products launched in Europe Launched Products ViscAid Ophthalmic Viscoelastic ArtiAid Intra-articular Injection ArtiAid Plus Intra-articular Injection Foramic Bone Graft Substitute Products under Registration SurgiAid Collagen Wound Dressing FormaAid Collagen Membrane GingivAid Collagen Bone Graft
Passed US FDA Inspection with No Observation
GMP and ISO 13485 Certifications
MBI Product advantages Core techniques under patent protection. Complied with international biomedical materials standards and regulations. Great effects of therapy and easy on surgical operation. Equipped with the superior quality as worldwide big name companies and competitive prices. Comprehensive product lines and specifications, offering effective solutions. Providing customized product development services.
Maxigen Biotech Inc. Thank you for your attention