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A novel, low cost biological wound dressing Become the standard of care for at-risk and chronic wounds

Become the standard of care for at-risk and chronic wounds · Global wound healing accounts for 4% of all health cost Wound dressings end user sales: $ 7 billion; CAGR above 10% Chronic

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Page 1: Become the standard of care for at-risk and chronic wounds · Global wound healing accounts for 4% of all health cost Wound dressings end user sales: $ 7 billion; CAGR above 10% Chronic

A novel, low cost biological wound dressing

Become the standard of care for at-risk and chronic wounds

Page 2: Become the standard of care for at-risk and chronic wounds · Global wound healing accounts for 4% of all health cost Wound dressings end user sales: $ 7 billion; CAGR above 10% Chronic

Todays available solutions have many challenges

Our solution

Based on

Eggshell Membrane

Chronic Wounds Today’s treatment

Collagen based

• Treatment of chronic wounds at a significantly lower cost

• Prevents wounds to become chronic

• Reduce healing time

Significant health cost savings

Page 3: Become the standard of care for at-risk and chronic wounds · Global wound healing accounts for 4% of all health cost Wound dressings end user sales: $ 7 billion; CAGR above 10% Chronic

The Wound Care market is large with high growth mainly due to chronic wounds

Global wound healing accounts for 4% of all health cost

Wound dressings end user sales: $ 7 billion; CAGR above 10%

Chronic wounds are due their high incidence and long treatment time (above 30 weeks) the main cost driver

BUT

The National Health Services (e.g. UK) in several countries with socialized health care systems budget for a

zero increase in spending from 2015 to 2020

Biovotec addresses this “contradiction”

# of patients

Page 4: Become the standard of care for at-risk and chronic wounds · Global wound healing accounts for 4% of all health cost Wound dressings end user sales: $ 7 billion; CAGR above 10% Chronic

Disruptive Combination: High Efficiency & Low Price

High EfficacyLow Efficacy

Selling price per vial

DermaRep- $2

- $20

- $5

- $40

Crowded, up to 120 products

Foams/alginates…

Human growth

factor

PDGF

Increase $

- $10

- $100

Page 5: Become the standard of care for at-risk and chronic wounds · Global wound healing accounts for 4% of all health cost Wound dressings end user sales: $ 7 billion; CAGR above 10% Chronic

Biovotec has acquired the IP rights and know how to a unique, low cost in line egg membrane/egg shell separation process presently erected in Norway at Nortura

Eggshell membrane is now available at industrial scale

400+ egg cracker plants world wide

Producing an estimate of

600.000 tof eggshell residue / year

Egg cracker partner

Supplying eggshell residue/year

Purified membrane

100 millionWound dressingsFrom one Eggcracker

Biovotec activates the raw egg shell membrane in its facilities in Ireland

Inexpensive, effective and scalable raw material supply allows for low product cost!

Page 6: Become the standard of care for at-risk and chronic wounds · Global wound healing accounts for 4% of all health cost Wound dressings end user sales: $ 7 billion; CAGR above 10% Chronic

What causes chronic wounds: The vicious cycle

Page 7: Become the standard of care for at-risk and chronic wounds · Global wound healing accounts for 4% of all health cost Wound dressings end user sales: $ 7 billion; CAGR above 10% Chronic

How do we think ESM interacts with the vicious cycle

EMB ActionEMB is a complex protein structure and acts to block the destruction of the body´s own protein tissue in the wound bed by excess MMP proteases produced in the wound

EMB Action

Anti inflammatory extracellular matrix components of EASM assist in dampening inflammation in the wound

EMB ActionEASM is inducing tissueand granulation/tissue repair

Page 8: Become the standard of care for at-risk and chronic wounds · Global wound healing accounts for 4% of all health cost Wound dressings end user sales: $ 7 billion; CAGR above 10% Chronic

Excellent preclinical results with our purified egg shell membrane

0

20

40

60

80

100

120

0 4 8 12 16 20

% W

OU

ND

AR

EA R

EMA

ININ

GDAYS POST-WOUNDING

No treatment

ESM-1

Positive Control

Page 9: Become the standard of care for at-risk and chronic wounds · Global wound healing accounts for 4% of all health cost Wound dressings end user sales: $ 7 billion; CAGR above 10% Chronic

Histological studies confirm wound closure and regenerated tissue quality

Normal skin

Edge of wound

Edge of wound

Extensive re-epithelialisation over the wound surface

Extensive neo-dermal (granulation) tissue throughout wound base

Normal skin

500µm

Edge of wound

Edge of wound

No granulation tissue in central wound area

Normal skin Normal skin500µm

Negative control

ESM treatment

Page 10: Become the standard of care for at-risk and chronic wounds · Global wound healing accounts for 4% of all health cost Wound dressings end user sales: $ 7 billion; CAGR above 10% Chronic

2014 2015 2016 2017/2018

• Commissioning of ESM harvesting plant

• Producing human clinical trial batches

• Performing safety studies• ISO134385

audit/certification• Raised another €1 M• Commercial strategy• Building up of full scale

production supply line

• Initiate and complete CE mark human clinical study

• Application for CE marking• Develop USA approval/clearance

strategy• Estimated Europe Product launch

H1-2018

• Initial equity financingof €0.6 M

• Feasibility study for the use of egg shell membrane in wound healing

• Applied and secured a large 3 year research grant of €2 M from the Norwegian Research Council.

• Conducted extensive “basic research”

• Recruited strong international experienced mgm team/board

• Applied for and obtained SME1 grant

• Raised €0.5 M in private equity• Moved from research to product

development• Conducted an extensive pre-

clinical program • Applied for and obtained €1.3 M

SME grant• On the back of the SME grant

raised another € 2 M• Established the production

facilities for human clinical trials materials

• Three patent applications filed

The combination and interaction of local RD funding and SME grant secured Biovotec’s progress

Page 11: Become the standard of care for at-risk and chronic wounds · Global wound healing accounts for 4% of all health cost Wound dressings end user sales: $ 7 billion; CAGR above 10% Chronic

Some (subjective) main take aways concerning SME funding

The writing of an application for a SME grant takes time but:

It forces you to think to many aspects you have to address the next two years anyhow

The application is a good background information for stakeholders – shareholders/investors etc.

Do apply for the SME grant to get a financial contribution to the things you want to do anyhow!

When obtaining the grant this can be seen as kind of accreditation.

National research authorities are also interested that companies of the respective country obtain such

funding – they celebrate such success which leads to publicity for the company

Professional investors value that the company has obtained an SME grant (external validation of the business

idea)

Reporting on the SME (especially in comparison to the national grant) is excessive (we hand in 32 reports) !

But even this has a good side – all what we do is documented

We would do it over again!