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 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 of 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. 2
CARDIAC PROBLEMS – KEY NUMBERS 17 . 9 m 31 % No. 1 23 . 6 m people die for CVDs of total global deaths are cause of death globally: is expected to die as a each year 1 due to CVDs 1 more people die annually result of CVDs in 2030 2 from CVDs than from any other cause 1 Over 20 m The number of catheterization procedures performed in 2018 (global) 3 Source: 1) World Health Organization, May 2017 2) Heart Disease and Stroke Statistics — 2018 Update, American Heart Association, March 2018 3 3) Global Data, 2018
INTERVENTIONAL CARDIOLOGY CARDIOLOGY Non-interventional Cardiac Interventional surgery cardiology cardiology / Rx i The branch of cardiology that utilizes catheter based treatments. 4
CARDIAC CATHETERIZATION 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. The procedure consists of several stages Radial access The artery closure is the last stage of the procedure, performed by the use of a compression device (wrist) Depending on the catheterization method, either radial or femoral artery has to be closed Simplicardiac is addressing the need for ergonomic, safe and simple radial compression device Femoral access (groin) 5
ADVANTAGES OF RADIAL METHOD Femoral method (groin) Radial method (wrist) Reduces the number of serious Generates more complications complications: increases survival rate 1 than the radial method Lowers the likelihood of hospitalization; Requires longer hospitalization; 1-3 majority of patients discharged on the same days after the procedure day 2 Generates more costs because of Generates savings (1 day of hospitalization in the US – hospitalization and complications ca. 2000 USD) 3 Worldwide paradigm shift towards radial method is currently underway. Simplicardiac is capitalizing on this trend. 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 6
Source: data on percent of percutaneous coronary interventions (PCI) performed by 7 trans-radial access from EAPCI White Book <a href="https://www.freepik.com/free-photos- database, 2016, data on file vectors/city">City vector created by freepik - www.freepik.com</a>
Radial access adoption in the US Transradial Interventions as percent of Percutaneous coronary interventions in the US 2007- 2015 30% 27% 25% 20% 15% 10% 5% 2% 0% 2007 2015 2007 2015 8 Source: http://www.sveltemedical.com/techniques/transradial-pci/
SIMPLIRADIAL DEVICE 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) Other technological developments include: Due to patent process, device visualization is Precise combination of medical grade unavailable for public disclosure. transparent and non-transparent plastics, rubbers and silicones ’Design freeze’ animated visualization, (8 elements) technical documentation and 3D-printed final prototype are available for investigation for Adjustable ”clicking” prospective investors under confidentiality mechanism basis. Stabilizing elements Simpliradial- simple, high innovation medical device 9
COMPETITIVE DEVICES Producer cer Product ct Radial Closure Devices Market Share, by Company, 2017 0,80% TR Band 11,90% 13,20% Finale 74,20% D-Stat Terumo Corporation Vascular Solutions (now Teleflex) Merit Medical 10 Abbott Laboratories Source: Global data 2017
MANAGEMENT Andrzej Białkowski -Miler Mariusz Kruk MD, PhD Chief Executive Officer Chief Medical Officer (Inventor) Biotech/MedTech entrepreneur Interventional cardiologist and technological and consultant with >10 years of founder. Professor at the Cardinal experience in the management of all Wyszynski Institute of Cardiology in Anin. stages of technology transfer and start- Frequently awarded for medical and up development. scientific accomplishments. 11
OPERATIONAL TEAM Piotr Bańkowski Annabel Hampshire IP Manager Project Manager Manager supervising the production European Patent Attorney responsible for facility set-up; validation and strategic management of Intellectual Property. certification; clinical trials monitoring. 12
ADVISORY COMMITTEE Jan Skowroń ski, MD, MBA Marcin Szumowski, PhD, MBA Accomplished interventional cardiologist; Founder and CEO of OncoArendi Cardiovascular Associates, Birmingham, Therapeutics and co-founder of Alabama, USA; internationally recognized key Medicalgorythmics. opinion leader. Marcin Szuba, MD, MBA Tomasz Poniński Fund manager with >20 years of A bio-med-tech entrepreneur experience in capital market investments. and investor with experience in growing start-ups from idea inception to IPO. 13
SHAREHOLDER STRUCTURE 5 % 3 % 20 % Mariusz Kruk Paweł Nowicki 16 % Andrzej Białkowski - Miler Jan Skowroński 20 % Tomasz Poniński Paweł Jakubowski 17 % Marcin Szumowski 19 % 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 14
DEVELOPMENT PLAN Product/company divestment Market entry and clinical trials Market clearance Establishing production line 30 months 6 months 15 months There is no need to perform clinical trials before market clearance. 15
AQUISITION – POTENTIAL EXIT FOR INVESTORS Simplicardiac operates in the market that offers liquid exit opportunities for investors. Companies developing closure devices are attractive M&A targets. Value of transaction February 2015 – Raising $ 41 M venture financing by Cardiva Medical Inc. October 2018 – Acquisition of >$ 160 M Essential Medical by Teleflex May 2014 – Acquisition $ 320 M of Access Closure by Cardinal Health July 2017 – Acquisition $ 1 B of Vascular Solutions by Teleflex 16
POTENTIAL BUYERS Global Japan & China 17
OTHER PROJECTS Product code: SC-031 Product code: SC-020 Automatic Compression Device Cardiac catheter limiting blood leakage The device is addressing unmet need for a fully automated and safe wound closure The cutting-edge device, potentially disrupting the Product code: SC-043 market The device is at an early development stage with key patent Modified balloon inflation device pending and technology roadmap established (high pressure syringe) with improved connecting capacity 18
R&D pipeline Conceptual/ IP stage Development stage Certification Market entry SimpliRadial Product code: SC-020 Product code: SC-031 Product code: SC-043 19
Recommend
More recommend
