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INVATIN: PREVENTING STROKE; SAVING LIVES
An Israeli MedTech company offering a First-in-Class standard of care to stroke prevention
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STROKE
Stroke
Stroke is a medical condition in which poor blood flow to the brain due to emboli or bleeding, resulting in death or disabilities
2 main types of stroke:1. 87% ischemic, due to disturbed blood flow2. Hemorrhagic, due to bleeding
2nd leading cause of death
Leading cause of disability in adults
worldwide
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Occurrence: ~800,000 new or recurring strokes annually
Death toll: One every ~4 minutes
Direct annual costs: $34 Billion
Indirect annual costs: $68.5 Billion
STROKE: A GROWING NEED FOR PREVENTION
Total Global Stroke 104.2 million people per year
Of them 82.4 million developedIschemic stroke
Stroke in the US
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WHO IS AT RISK OF DEVELOPING STROKE?
Age > 65 years People with cardiac disorders: heart failure Atrial Fibrillation
Previous stroke event
Hypercoagulability state
Comorbidities
High blood pressure Diabetes Vascular Diseases
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ISCHEMIC STROKE STANDARD OF CARE
1. Anti-Coagulants Main problem:
• Poor adherence < 50% Risk of bleeding
2. Left Atrial Appendix Closure Device (LAACD)Main problem:
• Procedural complications
• Inapplicable in many patients
• Only for Atrial fibrillation patients
More than 15% of treated patients are
at high risk of complications and have no means of
stroke protection!!!
Two main therapeutic options for continuously preventing ischemic stroke are available today
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THE SOLUTION: SYNAXIS BY INVATIN LTD
Implanted using a minimally invasive delivery system
Synaxis: A novel Stroke Prevention Device (SPD) designed to divert blood clots away from the brain
A dedicated filtering unit of cutting-edge materials (prevent neo-intima proliferation and thrombosis)
A straightforward aortic arch implantation procedure
A designated aortic arch implant
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SYNAXIS: AN ULTIMATE SOLUTION HIGH RISK STROKE PATIENTS
SYNAXISby
*>1mm
Synaxis prevents 100% of clinically significant blood clots* from reaching the brain!
Synaxis ensures long-term patency while conserving blood pressure and flow patterns
First-in-Class
solution to stroke prevention
Saves lives by
preventing stroke in high-risk patients
Reduce treatment
costs and reliance on home care
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SYNAXIS UNIQUE FEATURESSynaxis provides a superior minimally invasive approach for continuous stroke prevention
Applicable in all patients at risk for embolic stroke (all causes)
Optimal solution for non-compliant patients on AC’s*
Simple and standard implementation procedure
Reduced cost vs current therapy **
* Anti Coagulants; ** combined 5 years cost
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SYNAXIS: PRE-CLINICAL EVIDENCE – COMPUTATIONAL FLOW DYNAMICS
• A complex and detailed Computational Flow Dynamics (CFD) model of Synaxis was developed to demonstrate the feasibility of the concept
• The promising results were published at TCT 2019
• The results led the company towards conducting the next phase of In Vitro studies
Presentation at TCT 2019 (San Francisco)
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SYNAXIS: PRE-CLINICAL EVIDENCE – IN VITRO PULSATION MODEL
IN VITRO MODELING –Published Oct 2019Demonstrating Synaxis efficacy in:
• Flow Hemodynamic conservation
• No adverse pressure modulation
• 100% Emboli diversion rate!
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SYNAXIS: PRE-CLINICAL EVIDENCE – IN VITRO FLOW MODELING
Without Synaxis:>30% of blood clots reach the brain=stroke
With Synaxis:No blood clots (0%) pass to the aortic branches
Synaxis device
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SYNAXIS: PRE-CLINICAL – ANIMAL TEST SUMMARY
• Syanxis was tested in
– 3 acute
– 1 chronic (1 month)
• Blood thrombi were injected to the left atrium, to demonstrate Synaxis cranial protection
Pig model–160 Kg
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SYNAXIS: PRE-CLINICAL – ANIMAL ACUTE STUDY
SYNAXIS in place
Embolic Trajectory
Route
No Brain Infarcts on
CT
• No changes in blood flow to the brain after implantations
• 100 % of injected emboli were diverted away from the Brain!
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SYNAXIS: PRE-CLINICAL – ANIMAL CHRONIC STUDY (1 MONTH)
• Unaltered -Blood flow and hemodynamics• Filtering unit was intact and fully functioning
SYNAXIS Filter in place
“No significant coverage of the filter mesh with thrombus or embolized material” Prof . Renu Virmani - CVPAT LLC
In collaboration with
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THE STROKE PREVENTION MARKET JUST GOT BIGGER !!!
The Stroke prevention market is growing exponentially
SYNAXISStroke Prevention Device (SPD)
This new segment of Stroke prevention have an immediate $5 Bnmarket potential
2018 2025
$28.7 Bn
$43 Bn
SP: Stroke Prevention
$5 Bn
SPD
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SYNAXIS: A NEW MARKET SEGMENT WITH ANTICIPATED RAPID GROWTH
Synaxis market size estimates are based on the following assumptions:
~15-20% no compliance
& bleeding
Market Size: $43 Bn24 million patients On Anti Coagulation Therapy
$10 Bn untapped market , 7.7% CAGR
~3 Mn patients at high risk of bleeding
$5 Bn immediate market ~200k – 300k patients
~7- 13% Stroke High risk
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25 1,330
8,038
17,302
31,203
55,050
75,957
0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
80,000
90,000
2024 2025 2026 2027 2028 2029 2030
Units sold
SYNAXIS ANNUAL UNIT SALES PROJECTIONS
• ~7% market share within the first 5 years
• over 100k procedures done by the first 4 years
• Unit Target Price – 25 K $
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THE LEADERSHIP TEAM
Dr. Udi Nussinovitch, MD, PhDFounder, CSO and Chairman of the Board
Experienced cardiology fellow, skilled in medical devices development and cardiovascular research. Director of the Applicative Cardiovascular Research Center (ACRC), Meir Medical Center, Israel.
Dr. Elon Reshef, DVMCEO
20 years of experience in R&D, clinical and business development from medical device companies such as Eqlibra Medical, Allium Medical, MindGuard,Biosense-Webster, BiolineRX and many more.
Selected partners and investors
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BACKED BY AN ACCOMPLISHED SCIENTIFIC ADVISORY BOARD
Michael R. Jaff, MDHarvard Medical School
• Professor of Medicine (Cardiology)
• President of Newton-Wellesley Hospital (NWH)
• Associate Professor of Medicine (Cardiology);
• Director, Cardiac Catheterization Laboratories;
• Director, Vascular Medicine Fellowship, Interventional Cardiology Program;
• Medical Director, Vascular Medicine -YNHH, Internal Medicine
Carlos Mena-Hurtado, MD
Yale New Haven Health System
• Head of Cardiology (emeritus), Meir Medical Center, Israel
• Director (emeritus), Cardiac Catheterization Laboratories
Morris Mosseri, MD
Tel Aviv University, Israel
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POTENTIAL PARTNERS
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SYNAXIS IS IN THE PATH OF THE FOLLOWS SUCCESS STORY FROM OTHER STROKE PREVENTION DEVICE
“Synaxis’s impact on stroke prevention will benefit millions of patients world wide” Prof.Morris Mosseri, MD Head of Cardiology (emeritus), Meir Medical Center, Israel
LAACDs: Left Atrial Appendage Closure Devices
~100,000 procedures to date in 550 US centers, at $25,000 / unit
WATHCMAN™ was acquired by BSX in 2011 for ~$375 Mn
LAACDs market size: 2018: $500 Mn -
2025: $2 Bn
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MILESTONES
R&D
Commercial
GLP + V&VFIM: US Early feasibility IDE 3 sites
EU study,Single-arm, 10 sites
IDE US Single-arm, 10 sites
Synaxis next Gen. study launch US and EU
Q4 2021 Q1 2022 Q2 2022 Q4 2022 Q2 2023 Q4 2024 Q2 2025 Q3 2025 Q2-3 2026 Q3 2027 Q1-2 2028
IDE + CE submissions
CE Mark PMA US Codes
China and Asia product launch
Marketing US + EU
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EXPECTED FINANCIALS
Activity Capital required
R&D Expansion of R&D team
$15 million
Legal and regulatoryPreparation for FDA / EMA regulatory requirements (including RA and QA systems and capabilities)
$1 million
Clinical trialsConduction of clinical trials in the US and the EU, 2022 - 2025
$12 million
Marketing, Sales, General & AdministrativeExpansion of Business Development activities, outreach and expanded operation for 2020-2025
$6 million
Total capital required: $34 million
1. Currently raising Round A: $10 million
• Pre-clinical stage
• Preparation for the clinical stage
• FIH
• Preparation for regulatory submissions and IP establishment
2. Round B: $24 million in Q3 of 2023
• Clinical trials in the US and the EU
• Continuous R&D improvement and business development
• Marketing approval in EU
InVatin is seeking two rounds of investments during 2020 to 2023
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SYNAXIS: SUMMARIZING THE OPPORTUNITY
Synaxis prevents stroke in high-risk patients, who have no other alternative today
Synaxis creates an entirely novel segment of $5 Bn potential in Stroke prevention market
Taking stock from Stroke prevention device, Synaxis is estimated to reach a 7% market share within 5 years
Synaxis is backed by world-renowned cardiologists and Israeli Innovation authority and Galil Ofek Accelerator
InVatin Ltd. is seeking Round A investments of $10 Mn – a unique opportunity for getting a competitive advantage in the next stage within a highly lucrative market
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