3. •
•
•
•
•
• The Need: Accurate and rapid detection
of head injuries
Traumatic Brain Injury (TBI)
4. 48 %
17 %
13 %
8 %
14 % Falls
Assault
Motor vehicle
accidents Being struck by or
against an object
Leading Causes of TBI
Other or unknown
cause
Blasts and explosions,
Firearms, Diving, Medical
Procedures
5. TBI – A Global Problem
•
•
•
•
•
New cases each year
90% of cases are mild traumatic brain
injuries
•
11. Preclinical results indicated the existence of
unique biomarkers following a head injury
Control animals (no injury)
Head injured animals
Biomarker elevation after injury
(fluoresent detection)
Intensity
increase
(2
parallel
spots/biomarker)
14. Clinical Trials – Conclusions
•
•
•
• Medicortex reached a significant milestone
Analysis of the samples
from the clinical study with
children is supported by
Business Finland.
19. The case study – second MRI
MRI scanning was repeated after the biomarker results
•
•
20. From an Idea to the Product
Clinical evaluation of the final product
21. Financial and Development Milestones
PHASE
PRE-
CLINICAL
STUDIES
FIRST CLINICAL
STUDY
SECOND
CLINICAL STUDY
PEDIATRIC
CLINICAL STUDY
PROTOTYPE
DEVELOPMENT
VALIDATION
AND
APPROVAL
TASKS
™
™
MILESTONES
FUNDING
NEEDED
(M€)*
2.5 2.5
STATUS
22. ProbTBI™ Kit advantages
Fast Easy to use
Mobility Patient friendly
No radiation or
contrast agent
exposition
Affordable
Can be sold as
"off the shelf" product
ProbTBI™
Kit
28. New chemical entities (NCE)
YR1/Q1 YR1/Q2 YR1/Q3 YR1/Q4 YR2/Q1 YR2/Q2 YR2/Q3 YR2/Q4 YR 3 YR 4 YR 5
Synthesis
Physico-chemical characterization
Kinetic solubility and stability testing
Ex-vivo testing for plasma half-life
In-vitro functionality testing
Testing of metal ion binding capabilities
Testing of anti-oxidative capacity
In-vitro toxicity
Ex-vivo efficacy testing
In-vitro evaluation of BBB penetration capabilities
In-vitro proof of concept/efficacy
Ex-vivo brain tissue evaluation
In-vivo efficacy and pharmacology testing
In-vivo therapeutic index estimation/efficacy
In-vivo toxicology: dose escalation and MTD
Regulatory application
Detailed R&D Roadmap For Drug
development
30. Patents for the biomarker and diagnostics
1. Prognostic and Diagnostic Glycan-based Biomarkers of Brain
Damage
•
•
•
•
2. Non-invasive brain injury diagnostic device
•
•
3. Device and method for detecting of brain injury in a subject
•
4. A method for determining a lectin-binding glycan indicative to
traumatic brain injury
•
31. Patents for the drug development
Multivalent compounds for use in the treatment and prevention
of brain damage
•
•
•
•
Conjugates and conjugates for use in preventing or treating of
brain damage and neurodegenerative diseases
•
Patent for COVID-19 diagnostics
Method for determining coronavirus and kit for the same
•
33. Equity up to now
•
•
Pre-IPO share issue
•
•
•
Subsidies
•
•
34. Use of Funds 2022–2024
Near-future investments will be used
for diagnostic kit development:
•
•
•
•
35. From 2014-2021 increase in value
0
2
4
6
8
10
12
14
Valuation
(M€)
Price
per
Share
(€) Value Creation
Valuation (M€) Price per Share
Paediatric Clinical Trial
Prototype development
Q3/2014 Q3/2015 Q2/2016 Q4/2016 Q4/2017 Q4/2018 Q3/2019 Q3/2021
Funding from
Tekes and new
Investors
DoD
funding
Human Clinical
Trials in three
hospitals
First Human Clinical Trial
Positive clinical results
Crowdfunding
Positive
preclinical
results
