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

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

3. Founders

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