INVESTORS PRÉSENTATION CONFIDENTIAL
THE EXCELLENCE OF CERAMICS FOR THE TREATMENT OF BONE INFECTIONS AND BONE METASTASES I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
André KERISIT • Chairman and Founder of I.CERAM Group • More the 30 years of experience in the field of orthopedics Christophe DURIVAULT • Chief Financial Officer of I.CERAM Group • More the 13 years of experience in the field of business planning and fund rising • Ceramics engineer I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
R&D Dr Eric DENES, M.D Infectious Diseases Specialist / Scientific Director • Expert referent in antibiotherapy • Bone and joint infection specialist • Multidisciplinary team for bone and joint infections • More than 60 scientific publications • Member of ESCMID, SPLIF E. POLI, PhD G. LEVEQUE, PhD G. BARRIERE, PhD Chemistry Ceramic Biology I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
OUR IMPLANTATIONS IN 2017 Costa Rica Head Office Branches Distributors I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
100% internal production by using our own industrial Our fondamentals capabilities 15 millions Euros A presence in 8 Turn Over countries of which 2 branches Orthopaedics, 85 000 products Neurosurgery and sold without Thoracic Surgery matério-vigilance Company establishment at Limoges in 2005 World premiere on 19 th of Ester Technopole / The March 2015: Sternoctomy of European Ceramics a metastasis by using a Centre ceramic implant A unique know-how in AL 2 O 3 ceramics I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
Our internal expertise Distribution • Direct selling in France: 10 commercials • 2 Branches • Exclusive or Non-Exclusive Distributors Sterilizing • Packaging • White room ISO 7 • Products Certification • Management 1014 • Process validation • 40 employees : mechanical production centre Fabrication • Ceramics Laboratory • Chemical and Biological Laboratory 13485 Design • Independent scientific committee • 30% of TO re-invested in R&D • Internally managed scientific expertise: 8 doctors and engineers 9001 Listening • A close relationship with surgeons • From your ideas to the creation of the product I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
Continuous Innovation BIFIX PATENT CERAMIL PATENT AKILE TAP BIRDIE STERNUM PATENT PATENT PATENT Cephalic Screw Bioceramics Patent pending Ankle Spine Patent pending 2001 2006 2007 2008 2014 2015 Tn’R PATENT Ceramic + GEL ISIS Ceramic + HAP Hip PATENT PATENT Bioceramic In progress Hip JOINT ARTHROPLASTY OSTEOSYNTHESIS POROUS CERAMIC I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
A WORLD CLASS SCIENTIFIC COMMITTEE Experts from the medical Internationally renown Grouping of 9 and respected environment medical specialties RESEARCHER EXPERTS PRACTITIONERS Genetics Orthopedics Surgery Infectiology Animal Health Dr Frank STURTZ Dr Fabrice Fiorenza Dr Christian MAGE Dr Eric DENES • Head, Dept of Biochemistry and • Surgeon, Orthopedics-Traumathology at • Specialized in animal health Molecular Genetics, Dupuytren Hospital CHRU Limoges • Hospital practitioner • Expert in Pharmacy Limoges • Specialized in infectious and tropical • Specialist on surgical treatment of bones • Expertise in AMM approvals • Founder of Medincell deseases tumors (approval of marketing of new • Specialist in therapeutic delivery of gel • Specialist in antibiotics pharma products) Dr Daniel SETTON Pharmacy • Surgeon, Orthopedics-Traumatology • Former head of CHRU Clinic of Microbiology Pr Marylène VIANA Limoges • Galenic pharmacy Dr Tan-sothea OUK Pharmacology • Emailleurs –Colombier Clinic of • Faculty of Pharmacy of Limoges • Lecturer Limoges • Area of expertise: design of • Bilogical Engineering Dept of Dr Christian WOLOCH pharmaceuticals, provision of active IUT Limousin • Hospital practitioner, Pharm D, PhD Cardiovascular Surgery ingredients • Areas of expertise: Cell Biology, Dept of Pharmacology, Toxicology and Microbiology, Analytical Chemistry Pharmacovigilance Dr François BERTIN • Centre for Biological and Health Organic Chemistry • Thoracic and Vascular Surgeon at Research (CBRS) CHRU Limoges CHRU Limoges Pr Vincent SOL • Director of the Laboratory of Chemical and Natural substances , EA 1069 GDR CNRS 3049: Photoactivable- Photochimiotheraphy Pharmaceuticals (PHOTOMED),GDR CNRS/INRA BioMatPro I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL 10
i.ceram : Une solution chirurgicale thérapeutique INNOVANTE Evolution de la chirurgie : Généralisation de la chirurgie micro-invasive et ambulatoire Mise en stérilité Mise en stérilité 7 Conception I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL 10 CONFIDENTIEL
I.CERAM : experts IN BIOCERAMICS CERAMIL POROUS CELLULAR ALUMINA CERAMIL PRODUCTS’RANGE : AI₂O₃ § CERVICAL CAGE § BLOCKS FOR CERVICAL CORPORECTOMY § INTERSOMATIC CYLINDRE (CLOWARD TECHNIQUE) § INCLINED CERVICAL CAGE § TREPAN CAPS § LUMBAR CAGE § TIBIAL OSTEOTOMY WEDGE THE RANGE OF POROUS CELLULAR ALUMINA § DIEDRAL WEDGE BIOCERAMIC § CALCANEUM WEDGE 1 mm 1 mm POROSITY OF ALUMINA BIOCERAMICS HUMAN BONE POROSITY I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
2015 :The first world PREMIERE implantation OF a CERAMIC sternum 20H DU 23/06/15 MATINALE 24/06/15 MATINALE 25/06/15 CHU de Limoges – 19 mars 2015 - Opération done by Dr François Bertin • A LOSS OF THE RISK OF INFECTION, • A MECHANICAL RESISTANCE PERFECTLY MANAGED, • A DURABLE BONE INTEGRATION, • A REGAINED PLASTICITY OF THE THORAX, • A REDUCTION OF THE TIME OF OPERATION, • A QUALITY OF LIFE FOR THE PATIENT. I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
Material colonisation H+2 H+4 H+8 H+24 Adhesion Beginning of Biofilm over all the Bacteria release biofilm formation surface I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
I.CERAM : Une Rupture thérapeutique sur ce marché IMPLANT CÉRAMIQUE + ANTI-INFECTIEUX IMPLANT CÉRAMIQUE Zone métastasique ou infectée LE PREMIER IMPLANT OSSEUX ACTIF I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
In vitro release I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
Contribution of porous ceramic >> Surgery Proven biocompatibility Optimal size of pores Inertness Low bacterial adhesion Possibly less infection Acts as a scaffold I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
Indications Infection Tumor I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
In vivo release Preliminary results Local dosages Samples in Redon drains placed above muscle flap (not directly in contact of the sternal prosthesis) H1 : 1400 mg/L (i.e. 175 times the dose required for an MCI of 1 µ g/ml) H24 : 395 mg/L (i.e. 50 times the dose required for an MCI of 1 µ g/ml) Blood samples No detection of gentamicin from H1 to H48 for 2 patients I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
The seven first implantations OF a CERAMIC sternum Sex Age Body mass time (Hours) Complications Delay to discharge Operation Follow up Indication Risk factors ASA Type of surgery (years) Index after surgery (Days) (Months) Radio-induced Complete 1 F 55,1 Malignancy 22,5 3 4 None 41 22 sarcoma replacement Breast cancer metastasis & skin Malignancy, Diabetes Complete 2 F 53,9 24,6 3 6 Hematoma 36 15 mellitus replacement localisation following a biopsy Lung cancer with Surgical site radiotherapy including Sternal disunion infection without Complete 3 M 61,5 after aortic valve strenal area (2007), 26,3 4 4 132 17 replacement prosthesis replacement Diabetes mellitus, Active infection smoker (55PA), COPB Manubrial breast Malignancy, Tabac Hemi-sternum 4 F 37,9 19,3 3 2,5 None 19 10 cancer metastasis (40PA) replacement Sternal disunion after coronary Diabetes mellitus, Complete 5 M 68,1 bypass and deep 29,8 3 4 None 20 7 obesity, COPB replacement sternal wound infection Sternal disunion after coronary Diabetes mellitus, Complete 6 M 77,8 bypass and deep obesity, COPB, HTA, 32,6 3 2 None 25 3 replacement sternal wound Prostate cancer infection Clavicle and Hemi-sternum 7 F manubirum 41,9 Malignancy 21,9 3 2 None 5 2 replacement neoplasia I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL 19
Nowadays I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
Tomorrow , a a ago, ng time ag A long impreg3able dly impreg3abl sedly suppose sup clever er a clev to a nks t fell thank town fel town t;ic ick t; I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
FUTUR OF PRODUCTS I.CERAM Développements Actual Products I.CERAM | Investors Presentation | 18 and 19 th April 2017 CONFIDENTIAL
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