INVATIN: PREVENTING STROKE; SAVING LIVES · Presentation at TCT 2019 (San Francisco) 9 ... Q4 2021...

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0 INVATIN: PREVENTING STROKE; SAVING LIVES An Israeli MedTech company offering a First-in-Class standard of care to stroke prevention

Transcript of INVATIN: PREVENTING STROKE; SAVING LIVES · Presentation at TCT 2019 (San Francisco) 9 ... Q4 2021...

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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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[email protected]

Thank you

Preventing Stroke Saving Lives