The document discusses the urgent need for improved diagnostic tools for bleeding disorders, particularly emphasizing the hemolysis biochip developed by Enzyre. This disposable point-of-care device aims to provide fast and accurate assays for various bleeding disorders, addressing a significant public health concern as determined by the CDC. The World Federation of Hemophilia supports this initiative, aligning it with their mission to enhance diagnosis and treatment accessibility globally.

1. Guido Maertens, CEO
Waander L. van Heerde, CSO

2. Enzyre will stop patients bleeding to death!
➢ In patients with bleeding disorders
➢ In hemodynamic unstable patients
➢ In acute traumatic situations
➢ Induced by medication (antithrombotics)

3. US-CDC: Tens of millions of people are at risk!
• Number 3 cause of death overall !!
• Most deaths in an acute hospital
setting (approx. 17%)
• Managing blood loss limited due to
lack of proper near patients diagnostic
tools
Source: Centers for Disease Control and Prevention

4. By introducing a disposable point of care biochip

5. Light
(X)n-H-N S
N
S
N CO2H
H2N-
H2N-
luciferase,
ATP, Mg2+
USP 1:
Platform to detect
enzymatic reactions USP 2: Real time Global Assays
& Quantitative Factor Assays
enzyme
containing
sample
Enzyme-specific aminoluciferin
Oxy-luciferin
aminoluciferin
USP 3: Simple
and cheap
All in one, no
additional tools
Technology: Chemiluminescent-based detection
IP: Chemiluminescence-based haemostasis assay WO2012096566

6. Enzyre Product: disposable multichannel device
Advantages:
✓ Small blood volume
✓ Disposable
✓ Stand alone
✓ Multichannel
✓ Fast
✓ Accurate
✓ Consumer friendly
✓ Inexpensive

7. Multiple assays in just one device
Quantitative assay Global assayExample Hemophilia Biochip

8. WFH: Call to Action & Support Letter
PRESIDENT
Alain Weill
VICE-PRESIDENT MEDICAL
Glenn Pierce
VICE-PRESIDENT FINANCE
Barry Flynn
BOARD OF DIRECTORS
Ampaiwan Chuansumrit
Saliou Diop
Vincent Dumez
Magdy El Ekiaby
Cesar Garrido
Cedric Hermans
Barbara Konkle
Dawn Rotellini
Carlos Safadi Márquez
Deon York
FOUNDER
Frank Schnabel
PATRON
Jan-Willem André de la Porte
CEO
Alain Baumann
1425, boul. René-Lévesque Ouest
Bureau 1200
Montréal, Québec H3G 1T7
Canada
T 514.875.7944
F 514.875.8916
wfh@wfh.org
www.wfh.org
Enzyre
Transistorweg 5
6534 AT Nijmegen
The Netherlands
Thursday, 28th of June 2018
Concerns: Support letter for the hemostasis biochip project of Enzyre
To whom it may concern,
The “World Federation of Hemophilia” (WFH) is a global network of national member
organizations representing the interests of people with hemophilia and other inherited
bleeding disorders in 140 countries. The WFH has the vision that one day, all people
with a bleeding disorder will enjoy a more certain future filled with promise, no matter
where they live.
Our next three-year strategy gives priority to improve the diagnosis and access to
treatment for all people with inherited bleeding disorders. This will require to build
capacity and awareness through information exchange, education and training. We aim
at identifying an additional 50,000 people with inherited bleeding disorders by 2022
with 50% of them living in the worlds’ poorest regions.
Additionally, we released a Call to Action in which we acknowledge the urgent need to
develop a diagnostic device for hemophilia that is reliable, easy to use and affordable.
The WFH believes that the project ‘hemostasis biochip’ initiated by Enzyre could be of
great support to meet this Call to Action. The goal of this company is in line with the
ambition of the WFH to improve diagnosis and access to treatment.
Please do not hesitate to contact us should you have any further questions.
With kind regards,
Alain Weill Alain Baumann
President, World Federation of Hemophilia CEO, World Federation of
Hemophilia

9. Competitors
Large Static Platforms
Multiple Assays
Large sample
No global assays
Point of Care
Single assay
Venous/Capillary blood
Cartridges/Apparatus
Hospital, GP, home
PoC Platforms
Multiple Assays
Capillary blood
Disposable
Small sample size
80’s-90’s Zero’s Enzyre solution

10. Investments and deliverables:
Technology
Investment
€3.8 M Proof of Principle
Deliverables:
✓ Sensitive sensor
✓ Substrates
✓ Global assays for
thrombin and plasmin
✓ Preprototype
€0.6 M start Enzyre
Deliverables:
✓ Business Plan
✓ Project plan with 2 yrs
roadmap to biochip
✓ Quantitative assays
✓ Partners contracted
✓ Team installed
€6M functional biochip:
• € 1M blood collection device
• € 1M microfluidics
• € 1M sensor & PCB
• € 1M substrates reagents
• € 1M integration
Business Case enrollment
2nd generation biochip
Opportunities:
• Other business cases
beyond coagulation
• Additional assays
• Reduction in cost price
Clinical
program
✓ Clinical validation with
preprototype
• € 1M Clinical validation with
Biochip
Financing ✓ PIDON (PPS) ✓ € 125k equity/mezzanine
✓ € 400k corporate
✓ € 75k loans
• Investors (milestone based)
• Innovation Loan (match 60%)
• Grant (EFRO)(match 60% per
partner, Enzyre €1.5M)
• Business case
dependent licensing
• Return on revenues
2021-2025
Completed Completed
2008-2013 2017-2018 2019-2020

11. Markets and growth
Proof of Concept:
Hemophilia
0.4x106 chips
7 channels
Cost price ±100 €
Hemodynamic
Intensive Care
Existing market
+3.3x106 chips
10 channels
Cost price ± 50 €
Anticoagulants
+45x106 chips
8 channels
Cost price ± 20 €
1
10
100
1000
Estimatedbiochips(M)
Hemophilia Hemodynamic Intensive Care Anticoagulant
Estimated Market size
>2 B€/yr

12. Partners: Micro environment at the Novio Tech Campus
Enzyre
Mercachem/Chiralix: 1 km
Radboud University/ RadboudUMC: 2 km
Micronit: 125 km
Seventh Sense Biosystems: Boston Area

13. Patient
participation
Constructive technology assessment

14. Enzyre Team:
Guido Maertens, CEOWaander van Heerde, PhD, CSO
Mark van Geffen, PhD
Chris van den Brink, Advisor
Anneke Sijbers, PhD
Lisa van Engelshoven, BSc
Danique Steeghs, BSc

15. Ultimate goal: Platform technology