for Healthcare Professionals

Dr. Khairul Idzwan BaharinCEO, Cell Tissue Technology Sdn Bhd

Assoc. Research Fellow, Tissue Engineering Centre, UKMSep 2016

Supported by:

Who Are We?

TISSUE ENGINEERING

CENTRE

Research University

Centre of Excellence

Commercializing Entity

• We are Malaysia’s 1ST Tissue Engineering based company; pioneering in the field of tissue engineering and regenerative medicine

• UKM Medical spin-off Company• Group of passionate medical doctors,

surgeons, healthcare professionals, medical researcher, tissue engineers

• We want to solve problem of organ donation shortage and lack of viable human organs supply for various medical conditions

Who Are We?

High-tech cell culture equipment Temperature, pressure, humidity

control to prevent product alternation

Continuous environment monitoring for product quality

State-of-the-art cGMP lab

Access control Document control BMS & EMS -associated with alarm & notification system

Production Facility

Production Facility

Business & Clinical Advisory

Comprises of medical doctors, specialists and consultants from various disciplines in UKM Medical Centre

Clinical Advisory

Business Advisory

Tissue EngineeringThe Next Big Thing in Medicine

RESEARCH / INDUSTRIAL

COSMETIC/AESTHETICS

MEDICAL

Current Activities & Product Pipelines

PRODUCTS SERVICES

Medical/ Clinical

Aesthetic/ Cosmetic

Equivalent (Research)

MyDermFibroDermKeraDermCryoDermSprayDerm

CelltiFCelltiGrafInjectablesSkin BankBioprintingHair folliclesAutologs Skincare

Skin-in-a-BoxCells for ResearchCryoderm for ResearchAllogenic Spray

Cosmetic Products / Drug TestingWorkshop / trainingClinic / OutletMedical TourismSublicensing

OtherTEMPs

Burn Diabetic ulcer Road accident

Allograft Artificial skin Split Skin Graft(SSG)

1 2 3

• Not easily

available

• ? Halal

• Rejection

• Temporary

• SUPER

EXPENSIVE $$$$

• ? Halal

• Rejection

• Temporary

PAINFUL Conventional Treatment

Limitation of SSG

50-50 uptake

Limited available skin

Complications

Non-healing, extensive

wound

Severe pain +++

Bad cosmesis

Costly

Emotional & physical

TRAUMA!

Alex, 5 year-old boy, son of a hawker, alleged work related injury

Success Stories

Alex, 5 year-old boy, son of a hawker, alleged work related injury

BEFORE AFTER 2 MONTHS

Success Stories

and more….

Chronic diabetes ulcer Post MyDerm™ procedure

and more…

Burn 10% One month post MyDerm™ procedure

All achieved WITHOUT Split Skin Graft (SSG) –Gold Standard Treatment in Hospitals Across the Globe

Introducing MyDerm™

AutologousNo rejection, completely your own cells!

Full thicknessPhysical structure almost like real skin!

Mimic native skin Function almost like normal skin!

Ultimate solution Less pain, faster healing, better looking!

3D–HPD biomaterial Secret recipe for optimized artificial skin!

Award winning product

Proprietary technology

MyDerm™ vs Others- No rejection- Lesser pain / trauma- Non-expensive- Huge size of skin- Adequate protection- Permanent- Easily available- Faster healing- IMPROVE QUALITY OF LIFE!

- Zero rejection- CHEAP- Readily available

MyDerm™ is like treating wound or replacing skin loss with a new skin (organ), only

better!

Direct Comparison

Autologous Bilayer Mimic Native

Organ Structure

MyDerm™ YES YES YESEpicel ?YES NO NO

Apligraf NO YES NO

Laserskin NO NO NO

Dermagraft NO NO NO

Alloderm NO NO NO

Integra NO YES NO

MyDerm™Others

(Epicel, Laserskin, Alloderm, Dermagraft, Apligraf, Integra, etc.)

Artificial human organ Medical device

Permanent skin substitute Temporary skin substitute

Made of own patient/human cells and derivatives

Made from animal, non-patient, other human, synthetics elements

Provides organ replacement elements for treatment

Provides external symptomatic treatment

Better prognosis, lesser long term maintenance

Poorer prognosis, more long term maintenance

Histology?

Cell Cycle?

Cell Function?

Shelf Life?

Cells Expression?

Total Cell?

Gene Expression?

Worldwide Recognition

Regulatory Framework

GUIDANCE DOCUMENT AND GUIDELINES FOR REGISTRATION OF CELL AND GENE THERAPY

PRODUCTS (CGTPs) IN MALAYSIA

by National Pharmaceutical Control Bureau (NPCB), Ministry Of Health Malaysia

January 2015

IN MALAYSIA

MyDerm Certifications

Australian Code of GMP, Human Blood & Tissues, TGA 2000

Good Manufacturing Practice for Medicinal Products, PIC/S September 2009

ISO 14644-1:1999 Classification of Air Cleanliness

How is MyDerm™ Produced?

CLINICAL APPLICATION

Bilateral Infected Wound with Failed SSG 2o to 45%

Burns Injury

Brief Hx (before MyDermTM)• 14 y/o boy

• + underlying dyslexia since 8 y/o complicated with Major Depressive Disorder

• Sustained 15% burn injury over L leg 7/12 prior to admission

• Treated in BP Hospital as 2nd & 3rd degree burn > regular dressing + antibiotics, before AOR discharge for alternative medicine

• + worsening wound complicated with infection

• Seen in a private hospital -> SSG done on 18/10/14 (RM30k), harvested from R thigh onto L popliteal & thigh wound bed poor wound healing (very low uptake)

The pain…

On Admission

On Admission (cont)• DOA: 13/01/14 (DOD: 23/05/14)

• O/E: Febrile, bed-ridden, muscle waste

• Hx of keloid / hypertrophic scar

• Wound:

• Patches of SSG at burn site

• Pus discharge

• Minimal bleeding

• Slough

• Foul smelling

• Poor healing at donor wound• Ix: high CRP, anemic, + swab C&S: Klebsiella, Staph.

Day 0• Wound size: 960.0cm2

Day 24

• 735.5cm2 (23.7%)

Day 35

• 338.5cm2 (64.8%)

Day 56

• 84.5cm2 (91.1%)

Day 84• 42.25cm2 (95.5%)

Admission vs Discharge

AFTER

BEFORE

Day 93

• 8.6cm2 (99.1%)

Now• 0cm2 (100%)

Now

He Survived!

SKN 006Item Details

Gender Male

Age 22

Nationality Malaysian

Health condition Healthy/ Average smoker

Cause of Injury Motor Vehicle Accident –degloving injury of right leg

No of Day in production 35 days

Biopsy size and size 6cm2/ Groin

MyDerm Transplanted 2

Outcome SuccessfulFull healing 42 days post-implantation

Probable Cause (If Any) -

Comments (If Any) Young and healthy

PRELIMINARY DATA

Day 0

Day 0

PRELIMINARY DATA

Day 7Day 7

Day 14

PRELIMINARY DATA

Day 28

Day 35

PRELIMINARY DATA

Day 48

Day 56

PRELIMINARY DATA

SKN 007Item Details

Gender Male

Age 44

Nationality Bangladeshi

Health condition Healthy / Average smoker

Cause of Injury Workplace injury –fracture tibia

No of Day in production 40 days

Biopsy size and size 6cm2/ Groin

MyDerm Transplanted 1

Outcome SuccessfulComplete healing 35 days post-implantation

Probable Cause (If Any) -

Comments (If Any) No underlying medical problems

PRELIMINARY DATA

Day 0

Day 7

PRELIMINARY DATA

Day 14

Day 21

PRELIMINARY DATA

Day 28

Day 35

PRELIMINARY DATA

SKN 014Item Details

Gender Male

Age 8

Nationality Malaysian

Health condition Healthy

Cause of Injury Burn

No of Day in production 39

Biopsy size and size 6cm2/ Groin

MyDerm Transplanted 3x 96cm2 (single layer)

Outcome SuccessfulDay 49 post-implantation (100% wound closure)

Probable Cause (If Any) -

Comments (If Any) -

PRELIMINARY DATA

PRELIMINARY DATA

Day 7PRELIMINARY DATA

Day 21

PRELIMINARY DATA

Day 35

Day 49

PRELIMINARY DATA

How It Works?

x YOU

We teach you how to

do this (sublicense)

You send the patients to Malaysia

You send the biopsy to

Malaysia and we send MyDerm to you via medical

courrier

We Want to Hear From You!

We accept referral to HUKM

We can arrange MyDermTM grafting ay your place

Join our MyDermTM Training in 2017

Want to be our distributors?

Want to collaborate with us?

Further information?

Let’s Talk!

www.cell-tissue.com

www.mydermskin.com

Thank you©2016 Dr. Khairul Idzwan Baharin (DK)

Cell Tissue Technology Sdn. Bhd.

All Rights Reserved.