Upload
others
View
0
Download
0
Embed Size (px)
Citation preview
A novel, low cost biological wound dressing
Become the standard of care for at-risk and chronic wounds
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
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
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
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!
What causes chronic wounds: The vicious cycle
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
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
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
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
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!