171123 presentation ram siddappa hcm medical (smb meeting)

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

Core Technology: Super Critical CO2 (scCO2) Technology

Penetrating capability of a gas

Washing abilities of liquid

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):026916

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:

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

1.Allograft and Xenograft deceullarisation, sterilisation using scCO2 for dental & orthopedic

applications

1.b: Membranes (Bovine Pericardium) for Cardiovascular applications

INSPIRIS RESILIA Aortic 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 calcification using rabbit intramuscular model J Mater Sci Mater Med. 2017; 28(1): 16. Tod TJ et al (2016)The association of bound aldehyde content with bioprosthetic tissue calcification J Mater Sci Mater Med. 2016 Jan;27(1):8.

Deceullularise using scCO2 and test calcification for

cardiovascular application

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5174141/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5174141/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5174141/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5174141/https://www.ncbi.nlm.nih.gov/pubmed/26610931https://www.ncbi.nlm.nih.gov/pubmed/26610931https://www.ncbi.nlm.nih.gov/pubmed/26610931https://www.ncbi.nlm.nih.gov/pubmed/26610931https://www.ncbi.nlm.nih.gov/pubmed/26610931

1.c: scCO2 processing of Bone Allo and Xenografts for Orthopaedic

applications

2. Endotoxin removal from medical devices

scCO2 for Endotoxin removal from implantable medical device

3. Sterilization of sensitive proteins, injectable using scCO2

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

4. Impregnation of medical devices with APIs:

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.

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)

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

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: [email protected]