3. • Traumatic Brain Injury (TBI) occurs
after a hit to the head.
• For example in falls, vehicular
accidents, contact sports, and blasts
• It causes an immediate physical
damage to brain tissue.
• However, it also exposes the healthy
part of the brain to metal ions, free
radicals and inflammation.
• This exposure sets off a chemical
reaction that damages surrounding
healthy tissue.
• The Need: Accurate and rapid
detection of head injuries
4. 48 %
17 %
13 %
8 %
14 % Falls
Assault
Motor vehicle
accidents Being struck by or
against an object
Leading Causes of TBI
TBI: Get the Facts
Other or unknown
cause
Blasts and explosions,
Firearms, Diving, Medical
Procedures
5. TBI – A Global Problem
• About 69 million TBI cases globally *
• 2.8 million in the US **
• 2.5 million in Europe ***
• 0.6 million in Australia
• 0.5 million in Canada
New cases each year
* Devan et al. (2019) J Neurosurg 130: 1080-1097
** Centers for Disease Control and Prevention (CDC)
*** CENTER-TBI EU
90% of cases are mild
traumatic brain injuries
6. Our Solution for Diagnostics
A test strip is dipped in saliva (IndicateTBI) or urine (ProbTBI™)
A B
7. The biochemical test responds to biomarkers that appear in urine and
saliva shortly after brain injury
Easy-to-read
Positive – brain
injury has occurred
Negative – no
brain injury
9. Why is the kit needed?
• No accurate and definite diagnostic
tools exist for brain injuries.
• MRI and CT have low resolution,
scanning is not possible without
electricity.
• Children need anaesthesia for the
process, and they are exposed to
irradiation or contrast dyes.
10. • Medicortex is developing a biomarker
test based on saliva or urine samples
which are less investigated for this
purpose.
• Medicortex is targeting glycoproteins and
cellular enzymes, which are exposed to
each other due to cell damage.
• Medicortex has the know-how to capture
and identify these proteolytic breakdown
products.
*Additional clinical and scientific information can be provided upon signing an NDA
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)
12. Clinical trials
Patients with suspected TBI
Patients with orthopedic injury
Healthy controls
24
16
29
More information at: ClinicalTrials.gov/NCT03306563
Patients with suspected TBI
Healthy controls
12
12
1st Clinical trial: Proof-of-Concept
2nd Clinical trial: TBI vs. Healthy & Orthopedic trauma
No. of patients
• Samples were collected in up to 5 time
points.
• 1st time point <4 h after injury.
• Patient recruiting is complete.
• Sample analysis has been completed.
In collaboration with 3 hospitals:
Samples of plasma, urine and saliva were
collected and analyzed.
Completed
Completed
13. Children with suspected TBI
Healthy control children
28
30
No. of patients
Urine
Saliva
Binding analysis
Biomarker detection
Mass spectrometry
Glycome analysis
3D-structure
2020-Q2 2021-Q2
3rd Clinical trial: Children
Later potential expansion to two other hospitals:
More information at: ClinicalTrials.gov/NCT04288167
Applicability of the biomarker for children’s mild brain
injury will be demonstrated.
Patient recruitment performed at Satasairaala hospital in
Pori.
Samples of urine and saliva were collected at 2 time points.
Sample collection completed in April 2021.
Sample
collection
completed
14. Clinical Trials – Conclusions
• Biomarkers showed statistically significant differences between injured
and healthy subjects – and correspondence with prior animal data results.
• Biomarkers were recognized by their ability to bind to several lectins.
• Individual glycan profiling by mass spectrometry revealed several structures
that were different between injured and healthy.
• Medicortex reached a significant milestone › a proof-of-concept
Analysis of the samples collected in
the second clinical trial was enabled
by a grant received from the US
Department of Defense (DoD) /
U.S. Army Medical Research and
Materiel Command
Analysis of the samples
from the clinical study with
children is supported by
Business Finland.
15. 2nd Clinical Study Summary
Saliva Urine
TBI samples stand out from Healthy as well as from Orthopedic samples in a statistically
significant manner in a biochemical binding analysis (lectins binding to glycans).
16. Biomarker detection on a strip
Demonstration on biomarker detection on a nitrocellulose strip using colloidal gold label
Healthy TBI
Saliva samples
Visual outlook Measured darkness of spots
Urine samples
17. A case study – Testimonial
• It´s winter in Turku, Finland
• A person is jogging, slips on the icy sidewalk and hits his head, losing
consciousness for a few minutes
• Magnetic Resonance Imaging (MRI) is performed immediately after
the injury at the local hospital
• No clinical observations of recent brain injury were found
• The “healthy” patient was sent home
• Medicortex performs biomarker analysis of patient’s urine and saliva
• High levels of biomarkers were detected, similar to those of confirmed
TBI-patients (see the next slide)
18. Biomarker results
Examples on three biomarker levels in saliva and urine, relative increase over the average healthy level
19. The case study – second MRI
MRI scanning was repeated after the biomarker results
• MRI showed frontal cranial hemorrhage and minor blood degradation
products that were not detected in the first MRI
• Radiologist stated that alterations may be related to the recent head
injury
Illustration of MRI findings in TBI
(not from the case study)
Left – normal Right - TBI
20. Idea and
hypothesis
Preclinical
data
1st Clinical
trial
2nd Clinical
trial
Prototype
device
Regulatory
application
3rd Clinical
trial
From an Idea to the Product
R&D plan for kit development 2021/Q2 2021/Q3 2021/Q4 2022/H1 2022/H2
Pediatric clinical sample collection (FI)
Pediatric clinical sample collection (IL, SWE)
Pediatric sample analysis & reporting
Strip test development & optimization
Medical prototype device development
Clinical evaluation of the prototype
Initiation of regulatory process
Clinical evaluation of the final product
New patent applications
Depends on sufficient funding
21. Financial and Development Milestones
*We are expecting a total cost of 5 M€ for completion of the entire project described above
PHASE
PRE-CLINICAL
STUDIES
FIRST CLINICAL
STUDY
SECOND CLINICAL
STUDY
PEDIATRIC CLINICAL
STUDY
PROTOTYPE
DEVELOPMENT
VALIDATION
AND APPROVAL
TASKS
Studies
completed with
laboratory
animals
12 patients with TBI
and 12 healthy were
studied
A clinical study with
total of 69 subjects in
three groups
Multicenter clinical study
with children (<18 yrs) in
3 hospitals and 3
countries
The ProbTBI™ test
will be incorporated
into a user-friendly
kit
The ProbTBI™ kit
will be tested in
clinical trial by end-
users
MILESTONES
Novel TBI
biomarkers were
discovered
Demonstrated
biomarkers’
diagnostic potential
in patients
Diagnostic potential
was proven with mild
injury cases samples
soon after the injury
Applicability of the test
for children’s mild brain
injury will be
demonstrated
Design of the kit
and readiness for
manufacturing
established
The test will be
validated and data
collected for the
CE-mark approval
FUNDING
NEEDED (M€)*
1.0 2.5 2.5
STATUS Completed Completed Q1/17 All samples analysed Q2/20 – H1/21 Q1/20 – Q1/22 Q1/22 – Q4/22
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
24. Market Potential
Traumatic Brain Injury diagnostic global market is expected to reach $3 billion by 2028
*Market growth can be related to increase in population, population getting older, many more vehicles on the road and extra leisure time to get engaged with risky
activities. As well as enhanced clinical classification and diagnostics.
Source:
Cognitive Market
Research (2021)
26. Medicortex' patents for the
biomarker and diagnostics
1. Prognostic and Diagnostic Glycan-based Biomarkers of Brain
Damage
• European Patent No. 3283880
• US Patent No. 10,739,335
• Canada and Israel allowable (patent number pending)
2. Non-invasive brain injury diagnostic device
• PCT-application WO/2018/154401, has entered into national phases
• Utility model granted in China and Australia
3. Device and method for detecting of brain injury in a subject
• PCT-application WO/2021/099677
4. A method for determining a lectin-binding glycan indicative to
traumatic brain injury
• PCT-application No. PCT/FI2021/050091
27. Medicortex' patents for the
drug development
Multivalent compounds for use in the treatment and prevention
of brain damage
• US patent No. 9,975,846
• Finnish patent No. 127 024
• Israeli patent No. 251 407
• European patent No. 3201173
Conjugates and conjugates for use in preventing or treating of
brain damage and neurodegenerative diseases
• PCT-application WO/2021/038125
29. Equity up to now
• More than 2 M€ from the founder and 215 private investors.
• Current pre-money valuation 10.7 M€. Price 6.40 €/share.
New equity & Financing
• Current emission Q3/2021. Investment round target 5 M€.
• Investment of 5 M€ will guarantee the investor ~30% of the company
equity.
Subsidies
• Total of 1.5 M€ in grants
• 70 k€ in awards
30. Total Investment Required
2021–2023
Investment needed for the entire
project 5 M€ will enable:
• Clinical proof of biomarker’s paediatric
applicability – samples collected
• Development and establishment of the
biochemical configuration of the assay
• Kit prototype manufacturing and
validation in clinical experiments
• Initiation of the regulatory process
31. Ownership following an investment
A new investment of 5 M€ will give Investor 30%* of the company’s
share equity.
39%
27.2%
3.8%
30%
Dr. Adrian Harel
The new
investment (5 M€)
Private Swedish Investor Other Shareholders
The proportion (%) is based on the
current number of company’s
shares. The final-% may slightly
vary depending on the total
number of shares issued at the
time of the emission.
32. From 2014–2021 increase in value
0.0
2.0
4.0
6.0
8.0
10.0
12.0
0
2
4
6
8
10
12
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 Q1/2021
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
33. Acquisitions and Buy-Outs
Some examples in the range of <60 M€
Data from www-pages, press releases and reports
Target company / Acquired by:
0 10 20 30 40 50 60
Coastal Genomics / Yourgene
Sienna Cancer Diagnostics / Bard1
Genelex / Invitae
Uman Diagnostics / Quanterix
UrSure / OraSure
Exalenz Bioscience / Meridian Bioscience
Trapelo Health / NeoGenomics
Transaction Value Approx. (M€)
34. Board of Directors
• Chairman of the Board - Adrian
Harel, PhD, MBA
• Member Mårten Kvist, MD, PhD,
Associate Professor, Medical Director,
Finland
• Member Tom Palenius, MSc, Interim
CEO, Turku Science Park Oy
35. Scientific and Clinical Advisory Board
Timo Kurki, MD, PhD, Associate Professor.
Neuroradiologist, Chief of Medical
Imaging, Terveystalo Oy, Finland.
Antti Kaipia, MD, PhD, Associate
Professor, Chief, Department of Urology,
Tampere University Hospital.
Markku Tuominen, MD, PhD, Chief
Physician and CEO, Medisport Oy, Finland.
Heikki Rauvala, Chairman of the SAB,
Professor, Neuroscience Center,
University of Helsinki, Finland.
Lauri Kangas, PhD, Associate
Professor, Pharma Scientific Adviser,
Chief Scientific Officer, Finland.
Risto O. Roine, Professor in
Neurology and Chief Physician,
Division of Clinical Neurosciences,
University of Turku and Turku
University Hospital
36. The Team
CEO, Founder
Adrian Harel
PhD, MBA
Medical Director
Mårten Kvist
MD, PhD, Docent
Head of R&D
Lasse Välimaa
PhD
Clin. Coordinator
Oskar Haavisto
BSc
Intl. Business Dev.
Tomas Ward
MBA
Product Manager
Begum Utz
PhD
Financial and
Legal Services
Marjukka Iitti
Accounting
Iiro Hollmén
LL.M. Attorney-at-
law
PwC Auditor
Laboratory Assistant
Venla-Mari Nurmi
BSc
Research Assistant
Jesper Lindholm
BSc
37. Medicortex in
the Press
2
Medicortex Announces Receiving a 1.1 Million Dollars
Research Grant from the US Department of Defense
3
Completion of Clinical Trial - a Significant
Achievement for Medicortex Finland
4 Finnish companies awarded EU grants
5
Medicortex Finland Oy Announces the Advancement in Clinical Trial
for Detection of Mild Traumatic Brain Injury in Children
6
Medicortex Finland Announces Patent Approval for
Underlying Technology of Drug Development Plan
7 Medicortex Finland Announces Agreement with Pro-Lab
1
Medicortex Finland Oy Announces Issuance of a Patent in
the United States
38. Concussion in sports and Medicortex test
Concussion in army personnel and Medicortex test
