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INVESTOR PRESENTATION MAY 2019 DISCLAIMER This presentation is - - PowerPoint PPT Presentation

As simple as possible, but not simpler INVESTOR PRESENTATION MAY 2019 DISCLAIMER This presentation is for discussion purposes only and does not constitute an offering in any way or any jurisdiction. Reproduction and communication of this


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INVESTOR PRESENTATION

MAY 2019

As simple as possible, but not simpler

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DISCLAIMER

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This presentation is for discussion purposes only and does not constitute an offering in any way or any jurisdiction. Reproduction and communication of this document in any form or manner is strictly prohibited. This document has not been independently verified and the authors are not liable for any claims or obligations whatsoever that may be attributable to this document. This document is strictly private and confidential and remains the property of the authors. All investors should seek independent and competent advice on the suitability of this opportunity in meeting their investment needs before making a decision to invest in this opportunity. This presentation may contain forward-looking statements which reflect Simplicardiac’s management views with respect to, among other things, Simplicardiac’s operations and financial performance. These forward-looking statements are identified by the use of words such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “seeks,” “approximately,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version

  • f these words or other comparable words. Such forward-looking statements are subject to various risks and
  • uncertainties. Accordingly, there are or will be important factors that could cause actual outcomes or results to

differ materially from those indicated in these statements. Simplicardiac’s management undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.

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SLIDE 3

CARDIAC PROBLEMS – KEY NUMBERS

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17.9m

people die for CVDs each year1

Source: 1) World Health Organization, May 2017 2) Heart Disease and Stroke Statistics — 2018 Update, American Heart Association, March 2018 3) Global Data, 2018

31%

  • f total global deaths are

due to CVDs1

  • No. 1

cause of death globally: more people die annually from CVDs than from any other cause1

23.6m

is expected to die as a result of CVDs in 20302

Over 20m

The number of catheterization procedures performed in 2018 (global)3

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SLIDE 4

Non-interventional cardiology / Rx

INTERVENTIONAL CARDIOLOGY

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Cardiac surgery Interventional cardiology

The branch of cardiology that utilizes catheter based treatments.

i

CARDIOLOGY

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CARDIAC CATHETERIZATION

Simplicardiac is addressing the need for ergonomic, safe and simple radial compression device The procedure consists of several stages The artery closure is the last stage of the procedure, performed by the use of a compression device

Cardiac catheterization is a procedure used to diagnose and treat CVDs. During cardiac catheterization a long thin tube called a catheter is inserted into blood vessels via a groin or a wrist to the heart.

5 Depending on the catheterization method, either radial

  • r femoral artery has to be closed

Femoral access

(groin)

Radial access

(wrist)

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ADVANTAGES OF RADIAL METHOD

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Source: 1) Circulation: Cardiovascular Quality and Outcomes. 2012;5:454–462 2) Sunil Rao, Update on US transradial access adoption at TCT 2015. Diagnostic and Interventional Cardiology, October 30, 2015. 3) Catheter Cardiovasc Interv2011 May 4. doi: 10.1002/ccd.23052

Femoral method (groin)

Generates more costs because of hospitalization and complications Generates more complications than the radial method Requires longer hospitalization; 1-3 days after the procedure

Worldwide paradigm shift towards radial method is currently underway. Simplicardiac is capitalizing on this trend. Radial method (wrist)

Lowers the likelihood of hospitalization; majority of patients discharged on the same day2 Generates savings (1 day of hospitalization in the US –

  • ca. 2000 USD)3

Reduces the number of serious complications: increases survival rate1

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SLIDE 7

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Source: data on percent of percutaneous coronary interventions (PCI) performed by trans-radial access from EAPCI White Book database, 2016, data on file

<a href="https://www.freepik.com/free-photos- vectors/city">City vector created by freepik - www.freepik.com</a>

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Radial access adoption in the US

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2% 27% 0% 5% 10% 15% 20% 25% 30% 2007 2015

Transradial Interventions as percent of Percutaneous coronary interventions in the US 2007- 2015

2007 2015

Source: http://www.sveltemedical.com/techniques/transradial-pci/

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Stabilizing elements Precise combination of medical grade transparent and non-transparent plastics, rubbers and silicones (8 elements) Adjustable ”clicking” mechanism The main idea is the unique, ergonomic design of the product - it is the only compression device on a worldwide basis using intuitive way of closing vessel wounds with finger(s)

SIMPLIRADIAL DEVICE

Other technological developments include:

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Simpliradial- simple, high innovation medical device

Due to patent process, device visualization is unavailable for public disclosure. ’Design freeze’ animated visualization, technical documentation and 3D-printed final prototype are available for investigation for prospective investors under confidentiality basis.

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SLIDE 10

COMPETITIVE DEVICES

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TR Band

Producer cer

Source: Global data 2017

Radial Closure Devices Market Share, by Company, 2017 74,20% 13,20% 11,90% 0,80%

Terumo Corporation Vascular Solutions (now Teleflex) Merit Medical Abbott Laboratories

Product ct

Finale D-Stat

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MANAGEMENT

11 Biotech/MedTech entrepreneur and consultant with >10 years of experience in the management of all stages of technology transfer and start- up development.

Andrzej Białkowski-Miler

Chief Executive Officer

Interventional cardiologist and technological

  • founder. Professor at the Cardinal

Wyszynski Institute of Cardiology in Anin. Frequently awarded for medical and scientific accomplishments.

Mariusz Kruk MD, PhD

Chief Medical Officer (Inventor)

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OPERATIONAL TEAM

12 European Patent Attorney responsible for strategic management of Intellectual Property.

Annabel Hampshire

Manager supervising the production facility set-up; validation and certification; clinical trials monitoring.

Piotr Bańkowski

Project Manager IP Manager

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ADVISORY COMMITTEE

13 Accomplished interventional cardiologist; Cardiovascular Associates, Birmingham, Alabama, USA; internationally recognized key

  • pinion leader.

Jan Skowroński, MD, MBA

Fund manager with >20 years of experience in capital market investments.

Marcin Szuba, MD, MBA

Founder and CEO of OncoArendi Therapeutics and co-founder of Medicalgorythmics.

Marcin Szumowski, PhD, MBA

A bio-med-tech entrepreneur and investor with experience in growing start-ups from idea inception to IPO.

Tomasz Poniński

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SHAREHOLDER STRUCTURE

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Future re sharehold holder r struct cture ure may include lude an incent ntive ive plan n for the key operat rational ional team and advisory sory committee tee members

20% 20%

Mariusz Kruk Andrzej Białkowski- Miler

17%

Tomasz Poniński Marcin Szumowski

19%

Paweł Nowicki Jan Skowroński Paweł Jakubowski

16%

5% 3%

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DEVELOPMENT PLAN

6 months 15 months 30 months

Establishing production line

Market entry and clinical trials Product/company divestment

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Market clearance

There is no need to perform clinical trials before market clearance.

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AQUISITION – POTENTIAL EXIT FOR INVESTORS

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Simplicardiac operates in the market that offers liquid exit opportunities for investors. Companies developing closure devices are attractive M&A targets.

>$160M

October 2018 – Acquisition of Essential Medical by Teleflex

Value of transaction

$1B

July 2017 – Acquisition

  • f Vascular Solutions

by Teleflex

$320M

May 2014 – Acquisition

  • f Access Closure

by Cardinal Health

$41M

February 2015 – Raising venture financing by Cardiva Medical Inc.

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POTENTIAL BUYERS

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Japan & China Global

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OTHER PROJECTS

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Automatic Compression Device

The device is at an early development stage with key patent pending and technology roadmap established The device is addressing unmet need for a fully automated and safe wound closure The cutting-edge device, potentially disrupting the market

Product code: SC-020 Product code: SC-031

Cardiac catheter limiting blood leakage

Product code: SC-043

Modified balloon inflation device (high pressure syringe) with improved connecting capacity

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R&D pipeline

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Development stage Certification Market entry Conceptual/ IP stage

Product code: SC-031 Product code: SC-043 SimpliRadial Product code: SC-020

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HIGHLIGHTS

20 Simplicardiac develops unique solutions supporting cardiac catheterization with significant competitive advantages The interventional cardiology market value is estimated at $15bn with CAGR >8% 3 Cardiovascular diseases (CVDs) are the most common global cause of deaths - account for 31% of all deaths worldwide1 Cardiac catheterization is a basic diagnostic and therapeutic procedure carried out as a part of interventional cardiology -

  • ver 20m procedures performed in 20182

Members of Management Team and Advisory Committee are recognized specialists for their business and science accomplishments: Andrzej Białkowski-Miler, MSSTC - Chief Executive Officer, Co- founder Biotech/MedTech entrepreneur and consultant Mariusz Kruk, MD, PhD – Chief Medical Officer, Co-founder Interventional cardiologist and technological founder of Simplicardiac Jan Skowroński, MD, MBA, shareholder Interventional cardiologist; internationally recognized key opinion leader. Marcin Szumowski, PhD, MBA, Co-founder Bio-med-tech investor and entrepreneur Tomasz Poniński, Co-founder Bio-med-tech investor and entrepreneur

1) World Health Organization, May 2017 2) Global Data, 2018 3) Global Interventional Cardiology Market - Analysis and Forecast, 2018-2027, October 2018

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CONTACT

Andrzej Białkowski-Miler

tel.: +48 601 650 081 e-ma mail: a.bialkow

  • wski

ski-miler@simp simplica cardiac.p c.pl Józefa i Jana Rostafińskich St. 4 02 02-593 3 Warsa saw

As simple as possible but not simpler

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APPENDIX

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INTERVENTIONAL CARDIOLOGY MARKET

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14.69 24.96

2017 2027

The global interventional cardiology market value in 2017- 2027 (billion USD)

17.90 23.70

2017 2030

The number of CVD deaths in 2017-2030 (million people)

Source: Global Interventional Cardiology Market - Analysis and Forecast, 2018-2027, October 2018 Source: Heart Disease and Stroke Statistics — 2018 Update, American Heart Association, March 2018

CAGR:

According to the latest data (2018) from The American Heart Association, cardiovascular disease (CVD) was the cause of the death of 17.9 million people in the world (growth of 12.5% since 2005). The global interventional cardiology market comprises of more than 400 products from >100 companies.

CAGR:

2.2% 8.4%

CAGR:

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CERTIFICATION

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Europe USA CE mark FDA/510k

Certification can be obtained without clinical trials if there are similar products on the market. Clinical assessment may be carried out on the basis of existing literature relating to these devices.

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IP PROCESS

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PRELIMINARY TEST OF SIMPLIRADIAL

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Results indicate that SimpliRadial set up is 2.5x faster than the other devices. SimpliRadial set up time did not differ between operators which was not the case with the other two devices. Company specialists performed a comparative evaluation of the SimpliRadial device with RADstat and TR-Band - the artery compression devices available on the market. Three naive operators performed a simulation of a radial artery closure procedure using the aforementioned devices. Times taken to put on the devices were compared and a statistical analysis was performed (ANOVA and Student’s t-test).