Patient friendly smart routing therapies for quality of life INVESTMENT PRESENTATION MEDINICE S.A.

Size: px

Start display at page:

Download "Patient friendly smart routing therapies for quality of life INVESTMENT PRESENTATION MEDINICE S.A."

Edward Hancock
5 years ago
Views:

1 Patient friendly smart routing therapies for quality of life INVESTMENT PRESENTATION MEDINICE S.A.

3 Agenda 1 About Medinice 2 Cardio surgical problems and characteristics of Medtech Cardio market 3 Key projects of Medinice 4 Summary 3

Medinice Team Management and project members Sanjeev Choudhary (CEO, Founder) Marta Makuch In medical

treatment and post-op procedures; Co-coordinated over 30+ international randomized clinical trials.

advisory companies i.e.: BCG, Deloitte and A.

Kamil Majcher Over 20 years of experience in investment projects; Over 15 years of start-up experience;

(polish Worked with leading polish economic journals (Rzeczpospolita, alternative exchange market), and

Adrian Mścisz Experienced engineer who specializes in prototyping of medical devices; Co-author of

4 Medinice Team Management and project members Sanjeev Choudhary (CEO, Founder) 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. Kamil Majcher Over 20 years of experience in investment projects; Over 15 years of start-up experience; Associated with Capital markets since the begining of his career Participated in IPO on NewConnect (polish Worked with leading polish economic journals (Rzeczpospolita, alternative exchange market), and advised Parkiet), where he wrote about health related businesses public companies. 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. All rights reserved. Medinice

Medinice Team Scientific Board Prof. Sebastian Stec Cardiologist. Electrophysiologist performing heart ablation and stimulation procedures.

Author of numerous research studies in Poland and U.S. in the field of clinical trials.

Piotr Suwalski Director and member of the supervisory board of ISMICS Europe. Director of Cardiac Surgery team at Central Clinical Hospital of MSWiA in Warsaw.

Paul Gründeman Experienced researcher and inventor. Lecturer and researcher at Beijing PLA Medical School and University Medical Centre Utreht. Experimental cardiologist.

For his accomplishment, ISMIC is awarding Grundeman Innovation Award annually for best inventors worldwide. Prof. Adam Budzikowski Cardiologist.

5 Medinice Team Scientific Board Prof. Sebastian Stec Cardiologist. 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. Selected members Dr Michał Zembala Cardiac surgeon working at the Silesian Center for Heart Diseases specializing in atrial fibrillation (AF) surgeries. Prof. Piotr Suwalski Director 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. Paul Gründeman Experienced 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. 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. Scientific Board ensures substantive support in assessing and development of products. It concentrates renowned professionals from Poland, Netherlands, Italy and United States. All rights reserved. Medinice

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

6 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 1.8+ million $ 1.8 billion Number of procedures worldwide Global revenues of Medtronic from sales of Octopus Movie All rights reserved. Medinice

7 Shareholders 23% Other shareholders 5% Employees 72% Founders 7

8 What we do? Own projects Project Acquisition Development and commercialization 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. All rights reserved. Medinice

9 Fast growing medtech market Global Cardiovascular Disease Market Value (bn USD, GBI Research) 1.8% 146,4 Global medtech sales in cardiology 129,2 (bn USD, Evaluate Ltd.) % Population aged over 55 years old 42,1 62,5 (bn, OECD) 2.9% ,2 1, Source: Global Cardiovascular Devices Market Forecast Visiongain Ltd, EvaluateMedTech World Preview 2016, Outlook to 2022 Evaluate Ltd., BCC Research, GBI Research, World Health Organization, OECD All rights reserved. Medinice

Three business pillars CURRENT OPERATIONS R&D CENTRE MEDI ALFA Developing medical devices acquired from inventors Designing new prototypes with no risk of intellectual property loss.

10 Three business pillars CURRENT OPERATIONS R&D CENTRE MEDI ALFA Developing medical devices acquired from inventors Designing new prototypes with no risk of intellectual property loss. Additional revenue source. 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 All rights reserved. Medinice

11 Effective use of public funding BRIdge Alfa DESCRIPTION Agreement with National Centre for Research and Development has been signed on 8 th December 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. Research and Development Centre DESCRIPTION Medinice S.A. signed an agreement with Ministry of Development in December 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 All rights reserved. Medinice

12 Differences between developing medtech and pharma products MEDTECH PRODUCTS PHARMA PRODUCTS DURATION OF CLINICAL TRIALS COSTS RISK OF FAILURE 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. Conducting preclinical and clinical trials of one product costs around 5 million PLN. 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. All rights reserved. Medinice 2018 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. Average cost of intruducing new medication is estimated at around 600 million USD. Even 60 per cent may constitute to preclinical and clinical trials. 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. 12

Wide scope portfolio of products Cardiology Cardiac Surgery Diagnostics

Knife Cannula for replacement of the thoracic aortic valve Trigeminal

Cryoapplicator with changable shape of the active tip Cryoapplicator with

13 Wide scope portfolio of products Cardiology Cardiac Surgery Diagnostics EP Bioptom Treatment MINIMAX CathAIO Med-iConsole SpaceMaker Suction Knife Cannula for replacement of the thoracic aortic valve Trigeminal valve cannula Cryoapplicator for minimally invasive heart ablation Cryoapplicator with changable shape of the active tip Cryoapplicator with active defrosting system Rehabilitation PacePress All rights reserved. Medinice

14 Business 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 OR OR Royalties constituting a certain percentage of distributor s revenue REVENUE SHARE ONE-OFF PAYMENT INTERMEDIATE MODEL All rights reserved. Medinice

15 Value of medtech projects increases significantly with its level of advancement Designing project concept (idea) Receiving patent protection and prototyping Finalizing pre-clinical trials Finalizing clinical trials and receiving consent for market launch < 2 years <3 years < 5 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 $ 1 to 2 years 1 year 1 to 2 years All rights reserved. Medinice

on the Polish MedTech market in cardiology and cardiac surgery Cooperation with the best specialists including

16 Strategic objectives 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 Cooperation with the best specialists including scientists, doctors and entrepreneurs Acquiring new projects with high commercialization potential Transfer to the main trading floor of WSE 16

17 Agenda 1 About Medinice 2 Cardio surgical problems and characteristics of Medtech Cardio market 3 Key projects of Medinice 4 Summary 17

18 Cardiovascular diseases are the most frequent cause of death Causes of death worldwide (2016) Cardiovascular disesases 32,30% Cancer 16,30% Respiratory failure Diabetes Lower respiratory tract infections Dementia Diarrhea Car accidents Liver failure tuberculosis Kidney failure Digestive system disease HIV/AIDS 6,50% 5,80% 4,40% 4,40% 3,20% 2,50% 2,30% 2,20% 2,20% 2% 1,90% Source: Institute for Health Metrics and Evaluation. 18

Market Potential USA 131 million Number of citizens with at least one heart related health problem 1 24 million Number of citizens who will have coronary artery disease 1 6 million Number of citizens

19 Market Potential USA 131 million Number of citizens with at least one heart related health problem 1 24 million Number of citizens who will have coronary artery disease 1 6 million Number of citizens suffering from atrial fibrillation (50 percent of which requires ablation procedure) 1 World 33 million Number of people who suffer from atrial fibrillation Source: New American Heart Association All rights reserved. Medinice

20 Untreated atrial fibrillation can cause significant health related problems BUMPING HEART BREATING PROBLEMS FATIGUE STROKE HEART FAILURE PREMATURE DEATH Atrial fibrilation is the most frequent heart disorder All rights reserved. Medinice

Ablation can be very effective in atrial

procedure with use of catheter placed in

artery Minimally invasive surgery Surgery

Absolute indication for ablation surgery

21 Ablation can be very effective in atrial fibrillation (AF) treatment Diagnostics Treatment Rehabilitation ECG results confirms atrial fibrilation Therapy is fitted for individual case: (by advancement): Heartbeat has been stabilized. Pharmacotherapy Catheter ablation Ablation procedure with use of catheter placed in heart through catheter sheath in femoral artery Minimally invasive surgery Surgery through key-holes! Absolute indication for ablation surgery in ineffectiveness, intolerance or unwillingness to take any one of prescribed antiarrhythmic drug. All rights reserved. Medinice

Conducting minimally invasive procedures speeds up the process of convalescing patients Open heart surgery Requires cutting skin and sternum; The wound is set open to provide the surgeon with good

22 Conducting minimally invasive procedures speeds up the process of convalescing patients Open heart 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. Minimally invasive surgery The operator inserts catheters through 3 small holes ( key-holes ) and performs the surgery; Quick recovery after the procedure. All rights reserved. Medinice

23 Agenda 1 About Medinice 2 Cardio surgical problems and characteristics of Medtech Cardio market 3 Key projects of Medinice 4 Summary 23

24 Key products COOLCRYO MINIMAX PACEPRESS DESCRIPTION Freezes dysfunctional areas of heart; Used in minimally invasive procedures; Applied in cardiosurgical treatment of arrhythmias. DESCRIPTION Electrode for heart diagnostics and RF ablation treatment; Uses 3D mapping techniques; For minimally invasive procedures. DESCRIPTION A pressure dressing used in the implantation of medical devices for cardiac electrotherapy; Prevents hemorrhagic complications. 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 All rights reserved. Medinice

25 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 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 Medical Inc. in 2013 roku. Payment in two rounds 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 All rights reserved. Medinice

CoolCryo Description: Based on unique technologies, which allows to perform the

It allows to perform minimal invasive cryoablation (using very narrow access to

Benefits: Movable cover to adjust duration of cooling; Cheap and accessible

26 CoolCryo Description: Based on unique technologies, which allows to perform the ablation procedures at as low as -160 O C. 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(-160 O C) is significantly more effective and safer than standard procedure All rights reserved. Medinice

27 CoolCryo advantages COOLCRYO ADVANTAGES CURRENT PROCEDURE TEMPERATURE Reaches lower temperatures (from -160 O C to -180 O C); Currently used devices reach relatively high temperatures (minimum of -60 O C to -80 O C); COST OF PROCEDURES Relatively cheap solution, not requiring expensive equipment which makes it more accessible for third world countries; It employs cheap and widely accessible cooling medium. Developed and expensive equipment (m.in. coolant compressor); Expensive disposable applicator (even couple thousands euro); Expensive cooling medium. EFFECTIVENESS Minimally invasive procedure (no need to cut sternum); Low temperature shortens the time of procedure. Invasive open-heart procedure (requires to cut sternum); Relatively high temperature (only down to -80 O C), freezing tissues last longer. All rights reserved. Medinice

28 CoolCryo timeline Trials on 2 animals Study report Final report from preclinical trials Final report from clinical trials CE certificate and FDA approval 4Q2016 4Q2017 IIQ2018 4Q2019 4Q2020 2Q2021 Patent and Prototype Acute Study Conducting first phase of preclinical trials Chronic Study Conducting extended second phase of preclinical trials consistent with FDA requirements. Clinical Trials Clinical trials on humans were planned for 12 months. CE Cert. Medinice will file an application to receive CE certificate and FDA approval All rights reserved. Medinice

29 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. All rights reserved. Medinice

of the patient during the procedure resulting in the increase of the risk of cancerous mutations. Solutions developed by Medinice S.A.

30 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. All rights reserved. Medinice

31 MiniMax advantages MINIMAX ADVANTAGES CURRENT PROCEDURE NAVIGATION Use of 3D mapping system; Additional diagnostic rings enable faster and more precise location of the electrode in patient s body. Use of X-ray radiation for determining lacation of electrode in patient s heart. SAFETY 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). 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. COST OF PROCEDURE One common electrode for diagnostic and ablation, which decreases the costs of the procedure. Utilizing of several electrodes, which costs between $1.000 and $ DURATION One common electrode for diagnostics and ablation shortens time of procedure. Inserting and removing electrodes prolongs the procedure. All rights reserved. Medinice

32 MiniMax timeline Ready product for preclinical trials Final report from preclinical trials Finilizing the first phase of clinical trials Final report from clinical trials CE certificate and FDA approval Q2018 4Q2018 2Q2020 3Q2021 1Q2022 Patent and Prototype Preclinical Trials Extended preclinical trials in accordance with FDA requirements. Clinical Trials (Two Phases) Clinical trails are planned for 2 years and are divided into two phases. CE Cert. Medinice will file an application to receive CE certificate and FDA approval All rights reserved. Medinice

PacePress Description: An innovative pressure bandage used

(e.g. pacemaker) in order to prevent hemorrhagic

Benefits: Adjustable pressure force Less tissue trauma

33 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. All rights reserved. Medinice

34 PacePress advantages CURRENT PROCEDURE PACEPRESS ADVANTAGE COMFORT 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. SAFETY 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. COST OF PROCEDURE 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. All rights reserved. Medinice

35 PacePress timeline Successful testing of PacePress Ready product Filing documents to the office for sales approval CE certificate Report from clinical trials Licensing or sale of PacePress Q2015 1Q2017 2Q2018 3Q2018 4Q2018 1Q2019 Patent and prototype CE application The company prepares documentation for CE certification Clinical trials All rights reserved. Medinice

Medinice intends to acquire a stake in promising projects from the

applying a well-defined cut in human tissue; Use of vacuum allows to

Allows insertion of the device in hard to reach areas in various

SpaceMaker space for surgery Multipurpose inflatable device improving

36 Medinice intends to acquire a stake in promising projects from the University Medical Center Utrecht Suction Knife heart access 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. SpaceMaker space for surgery Multipurpose inflatable device improving thoracoscopic access; Facilitates access and manoeuvring space for endoscopic devices; Applicable for minimally invasive procedures. All rights reserved. Medinice

Strenghts and opportunities Medinice in numbers

Partnership with public sector institution and

and cardiac surgery; More than 35 million PLN

with patent protection Fast pace of medtech market

Thanks to a large contact base and collaboration with

opportunity for dynamic growth in global medtech

38 Strenghts and opportunities Medinice in numbers Professional, experienced management team; Partnership with public sector institution and scientific unit; Innovative solutions in cardiology and cardiac surgery; More than 35 million PLN subventions 13 projects under development 7 projects with patent protection Fast pace of medtech market development 5,7% CAGR 1). 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. All rights reserved. Medinice