INVESTMENT PRESENTATION MEDINICE S.A.medinice.pl/en/wp-content/uploads/2018/08/Pezentacja-EN-no-movies.pdf · • Associated with Capital markets since the begining of his career

Patient friendly smart routing

therapies for quality of life

INVESTMENT PRESENTATION

MEDINICE S.A.

Our mission

Patient friendly smart routing

therapies for quality of life

All rights reserved. Medinice 2018 2

Agenda

About Medinice

Cardio surgical problems and characteristics of

Medtech Cardio market

Key projects of Medinice

Summary

3

1

2

3

4

Medinice TeamManagement and project members


Sanjeev Choudhary(CEO, Founder)

• Over 20 years of experience in investment

projects;

• Over 15 years of start-up experience;

• Participated in IPO on NewConnect (polish

alternative exchange market), and advised

public companies.

Marta Makuch• In medical industry since the beginning of her professional

career;

• Has practical knowledge and expertise regarding treatment

and post-op procedures;

• Co-coordinated over 30+ international randomized clinical trials.

Arkadiusz Kleszcz• Over 5 years of experience in advisory and business analytics;

• Worked for renowned advisory companies i.e.: BCG, Deloitte

and A.T Kearney;

• Has start-up experience – cofounder of Faktorama – online

receivables exchange platform.

Adrian Mścisz• Experienced engineer who specializes in prototyping of medical

devices;

• Co-author of several innovative patent-pending inventions.

Bartłomiej Mazurkiewicz• Legal counsel who specializes in public funding and funding of

R&D;

• Provides complex legal service for companies.

Kamil Majcher• Associated with Capital markets since the begining of his career

• Worked with leading polish economic journals (Rzeczpospolita,

Parkiet), where he wrote about health related businesses

Medinice TeamScientific Board


Prof. Piotr SuwalskiDirector and member of the supervisory board of ISMICS Europe.

Director of Cardiac Surgery team at Central Clinical Hospital of MSWiA in

Warsaw. Researcher and innovator. Author of over 200 scientific papers

published in renowned scientific journals around the world.

Prof. Sebastian StecCardiologist. Electrophysiologist performing heart ablation and

stimulation procedures. A doctor with 20+ years of experience. Research

fellow at the University of Rzeszów. Member of the European Society of

Cardiology and of EHRA/SRS. Author of numerous research studies in

Poland and U.S. in the field of clinical trials.

Prof. Paul GründemanExperienced researcher and inventor. Lecturer and researcher at Beijing

PLA Medical School and University Medical Centre Utreht. Experimental

cardiologist. Specialist in the field of cardiovascular diseases.

Co-inventor of Octopus® tissue stabilizer. For his accomplishment, ISMIC is

awarding Grundeman Innovation Award annually for best inventors

worldwide.

Scientific Board ensures substantive support in assessing and development of products. It

concentrates renowned professionals from Poland, Netherlands, Italy and United States.

Selected members

Dr Michał Zembala

Cardiac surgeon working at the Silesian

Center for Heart Diseases specializing in

atrial fibrillation (AF) surgeries.

Prof. Adam Budzikowski

Cardiologist. Electrophysiologist working in

State University of New York. A doctor with

20+ years of experience.

Prof. Gianluigi Bisleri

Cardiac surgeon at Cardiac Surgery Clinic

Brescia. Author of numerous medical

papers.

Michał Labus

Graduate from Wroclaw Medical School.

Doctor at Wroclaw Clinical Hospital.

Prof. Gründeman’s patent set trends in global

cardiac surgery


Octopus® is a device that stabilizes the

tissue on beating heart, allowing the

surgeon to perform minimally invasive

procedures without the use of heart-lung

machine.

Acquisition

UMC Utrecht has sold the rights for

Octopus® in 1997 to Medtronic. The success

story continues…

Movie

1.8+ millionNumber of procedures

worldwide

$ 1.8 billionGlobal revenues of

Medtronic from sales

of Octopus

https://youtu.be/cmC3OH6Nvp8?t=32s

Shareholders

7

72%5%

23%

Employees

Other shareholders

Founders

What we do?


Development

and commercialization

Project Acquisition

Own projects

New Product

Medinice is a unique company operating in the medtech sector in the field of cardiology bringing

together professionals from medical, financial and investment sectors.

Fast growing medtech market

9

42,162,5

2015 2016 2017 2018 2019 2020 2021 2022

Global medtech sales in cardiology

(bn USD, Evaluate Ltd.)

1,2 1,5

2015 2016 2017 2018 2019 2020 2021 2022

Population aged over 55 years old

(bn, OECD)

2.9%

129,2

146,4

2015 2016 2017 2018 2019 2020 2021 2022

Global Cardiovascular Disease Market Value

(bn USD, GBI Research)

1.8%

5.8%

Source: „Global Cardiovascular Devices Market Forecast 2017-2027” Visiongain Ltd, „EvaluateMedTech World Preview 2016, Outlook to 2022”

Evaluate Ltd., BCC Research, GBI Research, World Health Organization, OECD

All rights reserved. Medinice 2018

Three business pillars


CURRENT

OPERATIONS

Developing medical devices

acquired from inventors

R&D

CENTRE

Designing new prototypes with

no risk of intellectual property

loss. Additional revenue

source.

MEDI

ALFA

Investing in new solutions and

devices in the field of

cardiology and cardiac

surgery acquired on the

market

>35 million PLN Value of obtained subsidies and grants

Effective use of public funding

11

BRIdge Alfa Research and Development Centre

DESCRIPTION DESCRIPTION

• Agreement with National Centre for Research

and Development has been signed on 8th

December 2017.

• Grant of 20 million PLN.

• Funds will be spent on development of

innovative solutions

• Founding of 20 new start-ups in medtech and

biotech segment.

• Medinice S.A. signed an agreement with

Ministry of Development in December 2017.

• Grant of 8,2 million PLN.

• Funds for purchase of equipment for R&D

centre.

• Located in „patent bank” region - Aeropolis

Rzeszów/Jasionka.

• Providing R&D services to medtech / biotech

companies


Differences between developing medtech and pharma

products

12

RISK OF FAILURE

DURATION OF

CLINICAL

TRIALS

COSTS

MEDTECH PRODUCTS PHARMA PRODUCTS

• For Class II and III medical devices it is obligatory to

carry out preclinical and clinical trials.

• Clinical trials are divided into two phases. In justified

cases it is possible to skip second phase.

• Clinical trials last approximately 2-4 years.

• Studies on the molecule are divided into

preclinical and clinical trials.

• Clinical trials on humans are split into three

phases.

• Overall duration of clinical phase usually

last for 7-10 years.

• Conducting preclinical and clinical trials of one

product costs around 5 million PLN.

• Average cost of intruducing new

medication is estimated at around 600

million USD.

• Even 60 per cent may constitute to

preclinical and clinical trials.

• Preclinical trials on animals provide accurate

feedback on risk of failure. Positive evaluation of this

phase significantly increase the probability of success.

• Medinice estimates that probability of positive

recommendation for commercialization in clinical trials

phase is around 60 per cent.

• Because of its influence on the entire

body, preclinical trials provide limited

feedback on drugs’ safety.

• Probability of allowing drug to the market is

between 1 and 5 per cent.


Med-iConsole

Cardiac Surgery

Rehabilitation

Wide scope portfolio of products


Diagnostics

Treatment

Cardiology

Cryoapplicator for

minimally invasive

heart ablation

Cryoapplicator with

changable shape of

the active tip

Cryoapplicator with

active

defrosting system

Cannula for

replacement of the

thoracic aortic valve

SpaceMakerTrigeminal valve

cannula

Suction Knife

PacePress

MINIMAX CathAIO

EP Bioptom

Business model

14

0

300

600

1 2 3 4 5 6 7 8 9 10

0

300

600

1 2 3 4 5 6 7 8 9 10

0

300

600

1 2 3 4 5 6 7 8 9 10

REVENUE SHARE

ONE-OFF

PAYMENT

INTERMEDIATE

MODEL

Medinice royalties constituting a certain

percentage of distributor’s revenue

One-off payment for the medical device

One of payment upon

signing the agreement

Royalties constituting a certain

percentage of distributor’s

revenue

OR

OR


Value of medtech projects increases significantly

with its level of advancement


Receiving patent

protection and

prototyping

Finalizing pre-clinical

trials

Finalizing clinical trials and

receiving consent for

market launch

Designing project

concept (idea)

$$$$$$

$$$

$

1 to 2 years 1 year 1 to 2 years

Prototyping and filling

for patent protection

Choosing partner for

performing pre-clinical

trials and filing report to

Bioethical Commission

Undergoing clinical trials,

receiving CE certificate

and consent for entering

the market

< 2 years <3 years < 5 years

Strategic objectives

16

Cooperation with the best specialists including scientists, doctors

and entrepreneurs

Acquiring new projects with high commercialization potential

Commercialization of Medinice’s projects

International presence. Cooperation with foreign companies

and universities, participation in conferences

Obtaining the leading position on the Polish MedTech market in

cardiology and cardiac surgery

Transfer to the main trading floor of WSE

Agenda

About Medinice




Summary

17

1

2

3

4

Cardiovascular diseases are the most frequent

cause of death

1,90%

2%

2,20%

2,20%

2,30%

2,50%

3,20%

4,40%

4,40%

5,80%

6,50%

16,30%

32,30%

HIV/AIDS

Digestive system disease

Kidney failure

tuberculosis

Liver failure

Car accidents

Diarrhea

Dementia

Lower respiratory tract infections

Diabetes

Respiratory failure

Cancer

Cardiovascular disesases

18Source: Institute for Health Metrics and Evaluation.

Causes of death worldwide (2016)

Market Potential


World

33 million Number of people who suffer from atrial

fibrillation

USA

131 millionNumber of citizens with at least one heart

related health problem1

6 millionNumber of citizens suffering from atrial fibrillation

(50 percent of which requires ablation procedure)1

24 millionNumber of citizens who will have coronary

artery disease1

Source: New American Heart Association

Untreated atrial fibrillation can cause significant

health related problems


BUMPING HEART

BREATING PROBLEMS

FATIGUE

STROKE

PREMATURE DEATH

HEART FAILURE

Atrial fibrilation is the most frequent heart disorder

Ablation can be very effective in atrial fibrillation

(AF) treatment


Diagnostics RehabilitationTreatment

ECG results confirms

atrial fibrilation

Therapy is fitted for individual case:

(by advancement):

Heartbeat has been

stabilized.

Pharmacotherapy

Catheter ablation

Minimally invasive surgery

Ablation procedure with use of catheter

placed in heart through catheter sheath

in femoral artery

Surgery through „key-holes”

Absolute indication for ablation surgery in ineffectiveness, intolerance or unwillingness to take any

one of prescribed antiarrhythmic drug.!

Conducting minimally invasive procedures speeds up the

process of convalescing patients


Open heart surgery Minimally invasive

surgery

• Requires cutting skin and sternum;

• The wound is set open to provide the surgeon

with good access to the heart and

surrounding area;

• After the surgery the sternum is joined and skin

is sewn;

• Long rehabilitation after the procedure.

• The operator inserts catheters through 3 small

holes (‘key-holes’) and performs the surgery;

• Quick recovery after the procedure.

Agenda

About Medinice




Summary

23

1

2

3

4

Key products


PACEPRESS

• A pressure dressing used in the

implantation of medical devices

for cardiac electrotherapy;

• Prevents hemorrhagic

complications.

COOLCRYO

• Freezes dysfunctional areas of

heart;

• Used in minimally invasive

procedures;

• Applied in cardiosurgical

treatment of arrhythmias.

DESCRIPTION

MINIMAX

• Electrode for heart diagnostics

and RF ablation treatment;

• Uses 3D mapping techniques;

• For minimally invasive procedures.

DESCRIPTION DESCRIPTION

Device is undergoing clinical trials

(Utreht Medical Centre).

Device is under preparation for

clinical trials.

Device is in the final phase of CE

certification.

All products are under patent protection – Medinice has submitted applications for patent protection in

Poland, European Union and the United States

High demand for medical procedures and efficient devices is

reflected in the value of M&A transactions


The Spectranetics Corporation

• Spectranetics is a leader in

vascular intervention to treat

coronary and peripheral

artery disease, as well as

minimally invasive removal of

implanted pacemaker and

implantable cardioverter

defibrillator (ICD) leads.

• Acquired by Philips in 2017.

Endosense

• Focused on improving the

efficacy, safety and

accessibility of catheter

ablation for the treatment of

cardiac arrhythmias.

• Its product, TactiCath, is the

industry’s first force-sensing

ablation catheter.

• Acquired by St.Jude MedicalInc. in 2013 roku. Payment in

two rounds - 170 millionUSD i

165 million USD.

CryoCath Technologies Inc.

• Medical technology

company with cryotherapy

products to treat cardiac

arrhythmias.

• Arctic Front is a minimally

invasive cryo-balloon

catheter designed

specifically to treat Atrial

Fibrillation.

• Acquired by Medtronic in 2008 for approx. 450 million

USD.

Company valuation

1.9 billion EUR

Company valuation

335 million USD

Company valuation

450 million USD

CoolCryo


Description:

Based on unique technologies, which allows to perform the

ablation procedures at as low as -160OC. It allows to perform

minimal invasive cryoablation (using very narrow access to

heart by using videothoracoscopy technique).

Benefits:

• Movable cover to adjust duration of cooling;

• Cheap and accessible cooling medium;

• Lower temperature of cooling(-160OC) is significantly more

effective and safer than standard procedure

COOLCRYO ADVANTAGES

CoolCryo advantages

27

EFFECTIVENESS

TEMPERATURE

COST OF

PROCEDURES

• Currently used devices reach relatively high

temperatures (minimum of -60OC to -80OC);

• Reaches lower temperatures

(from -160OC to -180OC);

CURRENT PROCEDURE

• Developed and expensive equipment

(m.in. coolant compressor);

• Expensive disposable applicator

(even couple thousands euro);

• Expensive cooling medium.

• Relatively cheap solution, not requiring

expensive equipment which makes it more

accessible for third world countries;

• It employs cheap and widely accessible

cooling medium.

• Invasive open-heart procedure (requires to cut

sternum);

• Relatively high temperature (only down to

-80OC), freezing tissues last longer.

• Minimally invasive procedure (no need to cut

sternum);

• Low temperature shortens the time of

procedure.


CoolCryo timeline

Final report from

preclinical trials

Final report from

clinical trials

Patent and Prototype

4Q2016

Chronic Study

4Q2017 4Q2019

Trials on

2 animals

Clinical Trials

4Q2020

CE certificate and

FDA approval

CE Cert.

Conducting first phase of

preclinical trials

Clinical trials on humans

were planned for 12

months.

Medinice will file an

application to receive CE

certificate and FDA approval

2Q2021

Acute Study

IIQ2018

Conducting extended

second phase of

preclinical trials consistent

with FDA requirements.

Study

report


MiniMax


Description:

Universal, cooled electrode for ablation, stimulation and

diagnostics. Compared to existing solutions it has additional

diagnostic rings, allowing to better determine the location in

3D system. The electrode is fitted with a solution to minimize

the risk of perforating the heart (force sensing)

Benefits:

• Better navigation without the use of X-Ray (minimizing the

use of radiation), which makes it safe for pregnant women

and childeren;

• Flexible electrode with force sensing system;

• Small size fitted for use with children;

• Combined features of diagnostical and ablation electrode

allows savings.

Limiting the use of fluoroscopy is a new trend increasing the

comfort and effectiveness of treatment


What is fluoroscopy?

• It is x-ray radiography;

• Used to determine the location of the

electrode in the body during the

procedure;

• Requires continuous radiation of the

patient during the procedure resulting in

the increase of the risk of cancerous

mutations.

Solutions developed by

Medinice S.A. use 3D mapping

systems

• Allows to create heart map and defining

dysfunctional areas;

• Minimizes or eliminates radiation.

MINIMAX ADVANTAGES

MiniMax advantages

31

DURATION

NAVIGATION

SAFETY

• Use of X-ray radiation for determining lacation

of electrode in patient’s heart.

• Use of 3D mapping system;

• Additional diagnostic rings enable faster and

more precise location of the electrode in

patient’s body.

CURRENT PROCEDURE

• Few electrodes (for ablation and diagnosis) may

be utilized during the procedure. Insertion of any

of these increases the risk of complications.

• X-Ray radiation increases the risk of cancer

mutations for patient and the team.

• One device for diagnostics and treatment limits

the risk of complications;

• 3D mapping system minimalize or eliminates the

need of use of X-ray (suitable for pregnant

women and children).

• Inserting and removing electrodes prolongs the

procedure.

• One common electrode for diagnostics and

ablation shortens time of procedure.

COST OF

PROCEDURE

• Utilizing of several electrodes, which costs

between $1.000 and $3.000.

• One common electrode for diagnostic and

ablation, which decreases the costs of the

procedure.


MiniMax timeline

32

Final report from

preclinical trials

Final report from

clinical trials

Finilizing the first phase

of clinical trials

Patent and Prototype

2016 2Q2018

Preclinical Trials

4Q2018

Clinical Trials (Two Phases)

2Q2020 3Q2021

CE certificate and

FDA approval

CE Cert.

Extended preclinical trials in

accordance with FDA requirements.

Clinical trails are planned for 2 years

and are divided into two phases.

Medinice will file an

application to receive CE

certificate and FDA approval

1Q2022

Ready product for

preclinical trials


PacePress


Description:

An innovative pressure bandage used after medical device

implantations in heart electrotherapy (e.g. pacemaker) in

order to prevent hemorrhagic complications.

Benefits:

• Adjustable pressure force

• Less tissue trauma

• Fully adjustable harness for different patients

• Reduces the risk of hematoma.

PACEPRESS ADVANTAGE

PacePress advantages

34

COST OF

PROCEDURE

COMFORT

SAFETY

• Current procedure of dressing after

implantation of ICD/PM devices recommends

immobilizing patient and applying pressure on

implantation area using i.e. sandbags and

plaster.

• It does not immobilize the patient, therefore

improving his comfort and allows him to

perform everyday activities.

CURRENT PROCEDURE

• Current products have low efficiency in

preventing hemorrhagic complications (incl.

hematoma).

• Anatomically adjusted shape of PacePress

harness, universal mounting and pressure

control limits the risk of complications.

• Long hospitalization;

• In case of complication additional surgery may

be required.

• Decreasing the risk of complications lowers the

probability of additional surgery and costs;

• Shorter hospitalization – pacjent may be

released with PacePress device.


PacePress timeline

35

Filing documents to

the office for sales

approval

Report from

clinical trials

CE certificate

Patent and prototype

2014 2Q2015

CE application

2Q2018 3Q2018 4Q2018

Licensing or sale of

PacePress

The company prepares

documentation for CE certification

1Q2019

Successful testing of

PacePress

1Q2017

Ready product

Clinical trials


Medinice intends to acquire a stake in promising projects

from the University Medical Center Utrecht

• Multipurpose inflatable device improving

thoracoscopic access;

• Facilitates access and manoeuvring space

for endoscopic devices;

• Applicable for minimally invasive

procedures.


SpaceMaker ® – space for surgery

• Knife for applying a well-defined cut in

human tissue;

• Use of vacuum allows to perform fast cut

with no risk of collateral damage to

underlying tissue;

• Allows insertion of the device in hard to

reach areas in various procedures.

Suction Knife® – heart access

Potential partners


Bandages

Ablation devices (i.e.: crioapplicators, RF electrodes, catheters)

Strenghts and opportunities


• Professional, experienced management

team;

• Partnership with public sector institution

and scientific unit;

• Innovative solutions in cardiology and

cardiac surgery;

• Fast pace of medtech market

development – 5,7% CAGR1).

• More than 35 million PLN subventions

• 13 projects under development

• 7 projects with patent protection

Medinice in numbers

38

Thanks to a large contact base and collaboration with research centers and universities

Medinice faces an opportunity for dynamic growth in global medtech market

Note: 1) „EvaluateMedTech World Preview 2016, Outlook to 2022” Evaluate Ltd.


www.medinice.pl

Documents

INVESTMENT PRESENTATION MEDINICE S.A.medinice.pl/en/wp-content/uploads/2018/08/Pezentacja-EN-no-movies.pdf · • Associated with Capital markets since the begining of his career