SIRRIS. Bioprinting: markets and opportunities. Grégory Nolens. QED AM in Medical November 4th 2014

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1 SIRRIS Bioprinting: markets and opportunities Grégory Nolens QED AM in Medical November 4th 2014

2 Collective centre of the technology industry Non profit organization Industry owned 4,700 industrial interventions (advice, projects, services) Mission Increase the competitiveness of companies of the Agoria sectors through technological innovations 130 experts & high-tech infrastructure within 1,700 different companies whose 75% are SME s 24M EUR turnover 04/11/2014 2

3 Additive Manufacturing Sirris SIRRIS One of the largest machine park in EU 16 engineers and technicians Two locations: Liège (11 p.) and Charleroi (5 p.) Rapid Prototyping / Tooling / Manufacturing Stereolithography (normal & hi-res) Paste polymerization for ceramics and metals (Optoform) 3D Printing of plaster and metal powder Laser sintering of polymeric powder (PA, ): P360 P390 Objet Connex 500: bi-material Laser sintering of metal powder (parts and mould inserts) Electron Beam Melting (Arcam A2) 3D Printing of wax (Thermojet) Vacuum Casting of Alu, Bronze, Zamak Laser Cladding (EasyClad) Selective Laser melting (MTT) Mcor - paper Bi-material FDM system 04/11/2014 3

4 CASE SIRRIS Leading applications of AM in biomedical: Personalized/complex devices Surgery tools In vitro Testing tools Communication tools Physician to Physician/Patient Student/education 04/11/2014 4

5 Personalized implants Poukens Xilloc - Sirris 04/11/2014 5

6 Newly designed implants lattice porous structures Cranial porous implant [SIRRIS-ADD] Finger prosthesis [UMons, Faculté Polytechnique] 04/11/2014 6

surgery In vivo testing for bone integration France

7 Complex implants mass production Spinal case studies in ceramic Porous scaffolds for Spine surgery In vivo testing for bone integration France - Belgium collaboration Tech transfer [Sirris ADD] 04/11/2014 7

8 Surgery tools custom cutting 20-70% surgery time reduction [VISYOS] [VISYOS] CENG 04/11/2014 8

9 Surgery tools custom cutting Surgical Cutting Templates reimbursement problem Surgical guides not reimbursed, but facts are: - 1 min. in surgical theatre (estimated): 60 - Mean of orthopedic surgery duration: 5-12h (18k-44k ) - Surgical guide can reduce: 20-70% of the duration (TBC) - Surgical guide cost: Economy: estimated 3-30k /surgery CENG 04/11/2014 9

10 Testing tools Flexible device for in vitro studies (e.g. arteries) 04/11/

11 Communication/education tools [Sirris ADD] [Sirris ADD] [Sirris ADD] 04/11/

12 The future of bio-manufacturing not so far away! CENG 04/11/

13 The future of bio-manufacturing not so far away! Anthony Atala TED March 2011 CENG 04/11/

14 What s Bioprinting process of printing biologically relevant materials (such as cells, tissues, and biodegradable biomaterials) that will accomplish one or more biological functions cells 3D machine Bio-glue + Scaffolds + cells Tissues 04/11/

15 Bioprinting an emerging technology Bioprinting place in emerging technologies, from the Hype Cycle for Emerging Technologies Gartner 04/11/

16 Printing cells and biomaterials 04/11/

17 Printing cells and biomaterials 3D Bioprinting solutions customized machines EnvisionTech, RegenHU (CH), GESIM (DE), Regenovo (China) 04/11/

18 Printing Cells? Reality Lot of barriers to raise Technical, ethical, validation time, standards, 04/11/

Bioprinting strategy @ SIRRIS Step by step approach: Target most promising

19 Bioprinting SIRRIS Step by step approach: Target most promising and nearest markets Combine existing knowledge to succeed faster 04/11/

20 Market approach interest for companies? Applications: 1. Drug/Cosmetic discovery & Assays 2. Cell therapy + Tissue Engineering 3. Bioproduction 4. In vitro diagnostic & research 5. Food 04/11/

Drug/Cosmetic Discovery and Assays Facts: Drug

problem Animal use: 10-100 Mio in US/year

21 Drug/Cosmetic Discovery and Assays Facts: Drug Discovery and Assays 90-95% of drugs approved on animal (mouse, rabbit, etc.), was not for human lot of money lost, ethic problem Animal use: Mio in US/year European Comission banning: FULL on cosmetic (2013), next pharma? 04/11/

22 Drug Discovery and Assays Drug X Applications: Drug screening w/o animal & less deviations Disease tissue Pharmaceutical and Cosmetic area (Big companies and subcontractors) Treated tissue Organovo s targeted market 04/11/

23 Drug Discovery and Assays Applications: Biocompatibility assays w/o animals (ISO) Improvement of existing models Artificial skin Irritation testing 04/11/

24 Cell Therapy & Tissue engineering Facts: Cell Therapy Cell therapy industry market (autologous) [Markets and Markets] 04/11/

25 Cell Therapy & Tissue engineering Facts: Cell Therapy High potential for Small defect repair But spatial limitations 04/11/

26 Cell Therapy & Tissue engineering Raise cell therapy barrier of Large defect repairing (= scaffold) 04/11/

27 Cell Therapy & Tissue engineering Repairing large defects by combining Stem Cells + Biomaterial Scaffold + = 1st step to bioprinting + 04/11/

28 Biotechnolgies & Bioprocess Facts: More and more treatments using biomolecules instead of small drugs: BioPharma / Biological Therapy (protein, peptide, antibody, etc.) Produced with cells Very expensive products: cost reduction through production [PharmPro] 04/11/

29 Biotechnolgies & Bioprocess (Bioproduction) Application Biomolecule production: 2D 3D Pure and higher production Cost reduction, bigger productions Enlarge areas [university of Virginia] 04/11/

30 In vitro diagnostic and Research Biomarker Biosensors Drug kinetic Pathogen reaction Blood brain barrier biosensor 04/11/

31 Food & Agriculture New food process? Focus on food player with Life Science approach: biomaterial ( e.g. Tissue engineering) 04/11/

Standards Medical Device (MD) Magic Scaffold ------ Synthetic non-active implant scaffold MD Directive Regulation proposal General MD standards (ISO

32 Standards Medical Device (MD) Magic Scaffold Synthetic non-active implant scaffold MD Directive Regulation proposal General MD standards (ISO 13485, 10993, ) Specific standards for applications/material (e.g. ISO bone filling with Ca-P) Faster and easier to label than Drugs 04/11/

33 Standards Advanced therapy medicinal products ATMP Magic Cells Regulation 1394/2007 Drug like procedure long clinical procedure (6-10 years, +post market) heavy process constrains 04/11/

34 Standards Magic Tissue Incubating cells + scaffold ATMP? 04/11/

35 Standards Magic Scaffold MD Magic Cells Combined during surgery ATMP 04/11/

36 innovation Conclusion Suggested steps to Bioprinting Print biomaterial and cells Print «exotic» biomaterial validate it add cells Print biomaterial add cells Time to market 04/11/

37 Bioprinting R&D players in Europe few and others 04/11/

Sirris Additive Manufacturing: Contact Grégory NOLENS, PhD Department of Additive Manufacturing Mail: gregory.nolens@sirris.

38 Sirris Additive Manufacturing: Contact Grégory NOLENS, PhD Department of Additive Manufacturing Mail: Mobile: Skype: gnolens SIRRIS Rue Auguste Piccard, 20 B-6041 GOSSELIES BELGIUM «Medical Additive Manufacturing & Rapid Prototyping» «Sirris» CENG 04/11/

SIRRIS ADD department. Additive Manufacturing

SIRRIS ADD department. Additive Manufacturing SIRRIS ADD department Additive Manufacturing thierry.dormal@sirris.be ADD capacities & competencies SIRRIS ADD (1990 2011) 15 engineers and technicians Two locations: Liège (10 p.) and Charleroi (5 p.)