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171123 presentation ram siddappa hcm medical (smb meeting)

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Presentation on HCM Medical by Ram Siddappa, SMB meeting November 23, 2017 at Novio Tech Campus Nijmegen

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Hightech Contract Manufacturing – Medical B.V.
Kerkenbos 10-113, Nijmegen
Ram Siddappa, PhD, MBA
Product Development Manager, HCM-Medical
Sr. Business Development & Licensing Manager, TTO, Erasmus MC
Use of Allografts & Xenografts for clinical applications
Super Critical CO2 (scCO2) Technology for decellularisation, API
impregnation & Sterilisation
Founders
Company Vision
Development and production of niche products for third parties whereby
through new technologies solutions are provided for faster healing of the
patients with oncological applications as an important priority.
Company Mission
HCM-Medical BV, is a contract manufacturer, that in close collaboration with the
customer develops products and implements technologies for the purpose of
manufacturing unique and hightech medical products.
► Business Driven by “state of the art” technology
► Focus on medical implants with unique properties for niche applications.
► High level of customer satisfaction supported by added services:
- Product Development
- Validation and Registration
Bone Graft Substitutes Market: Dental & Orthopedic Applications
Bone Graft Substitutes Market: Dental & Orthopedic Applications

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171123 presentation ram siddappa hcm medical (smb meeting)

  • 1. Hightech Contract Manufacturing – Medical B.V. Kerkenbos 10-113, Nijmegen Ram Siddappa, PhD, MBA Product Development Manager, HCM-Medical Sr. Business Development & Licensing Manager, TTO, Erasmus MC
  • 2. Use of Allografts & Xenografts for clinical applications Super Critical CO2 (scCO2) Technology for decellularisation, API impregnation & Sterilisation
  • 4. Company Vision Development and production of niche products for third parties whereby through new technologies solutions are provided for faster healing of the patients with oncological applications as an important priority. Company Mission HCM-Medical BV, is a contract manufacturer, that in close collaboration with the customer develops products and implements technologies for the purpose of manufacturing unique and hightech medical products. ► Business Driven by “state of the art” technology ► Focus on medical implants with unique properties for niche applications. ► High level of customer satisfaction supported by added services: - Product Development - Validation and Registration
  • 5. Bone Graft Substitutes Market: Dental & Orthopedic Applications
  • 6. Bone Graft Substitutes Market: Dental & Orthopedic Applications
  • 7. Bone Graft Substitutes Market: Dental & Orthopedic Applications
  • 8. Core Technology: Super Critical CO2 (scCO2) Technology •Penetrating capability of a gas •Washing abilities of liquid
  • 9. Super Critical CO2 (scCO2): Applications •Extraction of cholesterol and other lipids from egg yolk. •Milk fat fractionation •Extraction of lipids and cholesterol from meat and fish products •Extraction of natural colorings from several foodstuffs. •Extraction, refining and fractionation of oils and vegetable fats. •Extraction and fractionation of natural flavorings. •Extraction of antioxidants. •Decaffeinating of coffee and tea •Dealcoholisation of drinks. Raventos et al Food Sci Tech Int 2002;8(5):0269–16 Food Industry Kankala, et al. Adv. Healthcare Mater. 2017, 6, 1700433 “Supercritical Fluid Technology: An Emphasis on Drug Delivery and Related Biomedical Applications” Pharma and Biotech Industry:
  • 10. scCO2 applications in allografts and Xenograft processing 1.Allograft and Xenograft deceullarisation, sterilization using scCO2 for dental and orthopedic applications 1.A. Membranes for dental applications 1.B. Membranes for Cardiovascular applications 1.C. Bone grafts 2.Endotoxin removal from medical devices 3.Sterilization of sensitive proteins, injectable using scCO2 4.Impregnation of medical devices with APIs
  • 11. 1.Allograft and Xenograft deceullarisation, sterilisation using scCO2 for dental & orthopedic applications
  • 12. 1.b: Membranes (Bovine Pericardium) for Cardiovascular applications INSPIRISRESILIAAortic Valve Carpentier-Edwards PERIMOUNT Magna Mitral Ease Heart Valve Glutaraldehyde deceullularised bovine pericardium Shang et al. (2017) Aldehyde reduction in a novel pericardial tissue reduces calcificationusing rabbit intramuscular model J Mater Sci Mater Med. 2017; 28(1): 16. Tod TJ et al (2016)The associationof bound aldehyde content with bioprosthetictissue calcification J Mater Sci Mater Med. 2016 Jan;27(1):8. Deceullularise using scCO2 and test calcification for cardiovascular application
  • 13. 1.c: scCO2 processing of Bone Allo and Xenografts for Orthopaedic applications
  • 14. 2. Endotoxin removal from medical devices scCO2 for Endotoxin removal from implantable medical device
  • 15. 3. Sterilization of sensitive proteins, injectable using scCO2
  • 16. • We used biomaterials coated with rh-proteins, xenografts membranes and spiked with 106 Bacteria • Sterilized using scCO2 protocol with additives • Tested for sterility • we have successfully achieved 106 Sterility Assurance Level (SAL) scCO2-sterilisation study results scCO2-sterilisation opportunities • Opens wide opportunity to sterilize, temperature and radiation sensitive biomaterials and recombinant proteins • Currently testing bioactivity of some recombinant proteins sterilized using scCO2
  • 17. 4. Impregnation of medical devices with APIs:
  • 18. 5. Other Products and Technologies Products Tissues: Soft tissue and Hard tissues • Cleaning of human and animal tissues for the purpose of tissue reconstruction in orthopaedics, dental, cardiovascular, dermatology, trauma, urological, etc. applications. Biological molecules • Purification of collagen from animal tissue and production of collagen products & constructs for multiple applications.
  • 19. HCM-Medical Business opportunities Development Support in production and feedback in product development Registration Support and feedback in regulatory processes Commercialization Production, packaging and distribution Licenses required: 1. HumanTissue license (IGZ) 2. ISO13485 MedDev (Notified Body)
  • 20. Business challenges Client request for Product X opportunities IP/Patent Unique know-how Business plan Investors New CO. B.V Investors Investors Product/success CMO Scientific challenges Client request for New product Process and scientific knowledge New/Novel product New/improved process Establishment of “own products” New/novel solutions € CMO Client's Need Basic Costs New products R&D
  • 21. Ram Siddappa, PhD, MBA Product Development Manager HCM – Medical B.V. Kerkenbos 10113 6546 BJ Nijmegen www.hcm-medical.com 024-206 2971 Ph: +31(0)649305041 E: r.siddappa@hcm-medical.com