freezing cancer in its tracks - icecure-medical.com · and interventional oncology medical device...
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FREEZING CANCER IN ITS TRACKSNext generation cryoablation technologyenabling non‐surgical, in‐office treatment of cancer tumors
DKC1000001 rev D
Forward Looking Statement
This presentation does not constitute an offering to purchase or sale securities of IceCure Medical Ltd. ("the Company") or an offer to receive
such offerings. The presentation's sole purpose is to provide information. This presentation was prepared by the Company. The information
included in the presentation and any other information provided during the presentation ("the Information") does not constitute a base for
investment decisions and does not comprise a recommendation, an opinion or a substitute to the investor's sole discretion. The information
provided in the presentation concerning the analysis of the Company's activity is only an extract and in order to receive the full image of the
Company's activity and the risks it is facing, one should review the Company's reports to Israeli Security Authority and Tel Aviv Stock Exchange
(the “Public Information”). This presentation may include information which was not presented and/or was presented differently than the way
presented in the Public Information. The Company is not responsible and will not be held responsible for damages and/or any losses that
might be caused as a result of using the information. The presentation may contain forward-looking statements as defined in the Israeli
securities law, 5728-1968. All forward-looking statements in this presentation are not facts and are made based on Company's current and
subjective expectations, evaluations and forecasts. Forward-looking statements are not certain, cannot be estimated in advance and mostly are
not under the control of the Company. They and they may differ materially, in part or in whole, as a result of different factors including, but not
limited to, the Company's risk factors, changes in market condition and general environment and in external factors which influence the
Company’s activity, which cannot be estimated in advance and are not under the control of the Company. and in the competitive and business
environment, regulatory changes, changes in the manufacturing costs, competitive devices development, the Company's ability to raise funds,
changes in currency or the occurrence of one of the Company's risk factors. The results and achievements of the Company in the future may be
materially different than those presented in the presentation. In addition, forward-looking forecasts and evaluations are based on information
current held by the Company while preparing the presentation. The Company does not undertake any obligation to update forward-looking
forecasts and evaluations made herein so they would reflect events and/or circumstances that could appear after preparing this presentation.
Some of the market and clinical information is based on external publications such as National Cancer Institute or other publicly available
information. Although the Company believes that these external independent sources are reliable as of their respective dates, the information
contained in them has not been independently verified and the Company cannot assure as to the accuracy or completeness of this
information.2
Introducing ProSense™: Next generation cryoablation technology
• Minimally Invasive Solution –No surgery
• Destroys tumors quickly and painlessly
• Effective liquid nitrogen (LN2) for maximum freezing, safety and efficacy
FDA & CE cleared for tissue ablation
3
Company & Product Description
SETTING NEW STANDARDS IN MINIMALLY-INVASIVE TUMOR THERAPYfor women’s healthand interventional oncology
MEDICAL DEVICE COMPANYfounded in 2006 to advance treatmentof cancerous tumors.Traded in Tel Aviv stock exchange
INNOVATIVE TECHNOLOGY BASED ON CRYOABLATIONusing ultra low freezing temperatures (liquid nitrogen) to destroy tumors, without the need for surgery. 28 innovative patents
FLAGSHIP PRODUCT, ProSense™for rapid minimally invasive, safe, and effective treatment of breast lesions in office or ambulatory hospital settings
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Investment HighlightsSuccessfully transition from Clinical and R&D to Commercialization
Broad IP Portfolio (28 approved &
pending patents)
1/2017 - 6/2019 Sales:
$2.3 Million
FDA and CE Cleared (tissue
ablation)
Wide Market Applications
Excellent Patient & Physician Feedback
Strong Clinical Evidence &
Market Need
Business model of console and
consumable probe
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OUR MISSION:
To lead the New Gold Standard Tumor Cryoablation Therapy by Providing Superior, Safe, Fast and Cost Effective Minimally-Invasive Treatment
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ProSense™ - How it works
• Performed under guided CT or in office setting by ultrasound
• Probe is inserted into the tumor
• Liquid nitrogen going through single use probe generates sub-zero temperatures to turn the tumor into an ice ball
• Freeze-thaw-freeze cycle destroys the targeted tumor tissue immediately
• Adjacent healthy tissue left undamaged
• Necrotic debris is eventually absorbed by the body
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ProSense™ System Advantages
Fastest Cryo procedure available
(15-40 mins for in-office setting)
Liquid nitrogen for maximum cooling and efficacy,
(no bulky & high risk gas argon storage)
Easy-to-useTouch-screen user interface &
customizable procedure
Immediate Patient Recovery
High patient satisfaction
PainlessCooled site eliminates pain
Cosmetically Superior Results(Minimally invasive alternative,
no scarring of tissue removal)
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Superior Liquid Nitrogen (LN2) Technology for Optimal Tumor Destruction
Lower stable temperature and faster cooling rate for larger lethal zone
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ProSense™ Probe Advantages:
Recurring revenues from sale of disposable probes
Various probe sizes, designed for targeted ice ball (tailored to the size of the ablation zone)
Efficiency and safety maximized
Only one probe to navigate vs. multiple probes in Argon systems
Only tip gets cooled for targeted tissue destruction
Environmentally and storage friendly with small disposable component
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Competitive Advantage
3rd GenerationIceCure ProSense™
2nd generationSanarus Visica 2™
1st GenerationGalil Medical EndoCare
Tumor Destruction Method Liquid nitrogen Liquid nitrogen Argon gas
Office Setting
Procedure Time 5-40 mins 10-30 mins 30-60 mins
Cooling Rate Fast Medium Slow
Pressure Low Low High
Single Operator 2 operators 2 operators
Compact Disposable × ×
Intuitive, flexible user interface Limited Limited
Customizable procedure Limited Limited
Probe positioning Focused Focused Penetrates beyond the tumor
Procedure release Heated Nitrogen Electricity in needle Electricity in needle
Temperature Constantly low (-160⁰C) Not constant Constantly medium (-120⁰C)
Cost of procedure Low Low High
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Superior to Thermal Ablation Technologies (Radiofrequency & MicroWave)
CryoablationIceCure ProSense™
Thermal Ablation(RF & MW)
Pain Minimal to no pain Very painful
Anesthesia Local High amount to general
Visualization Ultrasound & CT MRI only
Accuracy Very high Low
Immune Response Positive effect None
Procedure Time 5-40 min 30 – 60 mins
Equipment Size Floor top console Tabletop
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Strong IP and Regulatory Clearance
Approvals also for Hong-Kong,Thailand, Singapore, Australia, Israel
and countries in South & Central America,
CFDA (Console only)
Regulatory Clearance28 approved patents
surrounding the core technology
Strong IP Portfolio
28
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v
Global Market for Cryo AblationWide Market Applications
Cryo-Immunology
Interventional Radiology
Kidney Cancer
Additional future
indications (Such as Prostate
Cancer)
Lung Cancer
Bone Cancer
Breast Tumors
Breast Malignant Cancer
Breast Fibroadenoma
Technology Platform for Cardiac AF ablation 14
PROSENSE™: Win-Win For All
Patient Physician Insurer
Less InvasiveTreatment
Safer& Simpler
EnhancedQuality Of Life
Builds on Existing Skills & Infrastructure
Faster Treatment, More Patients
Increased ROI
Lower Reimbursement Expenses Vs. Surgery
In-OfficeProcedure
Patient Demand Drives Reimbursement
15
Addressing Rapidly-Growing Multi-Million Dollar Global Tumor Ablation Market Opportunity
$1.03 BILLION
IN 2018*
11.2% GROWTH(CAGR) Potential driven by non/minimal invasive treatments such as Cryoablation*
Tumor ablation marketExpected to reach
$2.4 Billion in 2026*
Growing cancer burden
Increasing demand for non/minimal-invasive solutions
Push for cost of care reduction by insurers and payers
*Estimated, according to Grand View Research, Inc. (https://www.grandviewresearch.com/industry-analysis/tumor-ablation-market)Data is for all tumor ablation technologies and indications, including Cryoablation, RF, MW and others. The information herein has not been independently verified by the company 16
Favorable Market Trends
Constant improvement in cancer early detection
Increasing cancer burden – due to:
• World population growth
• Increasing life expectancy
• Environment polluting
Global MIS market growth is driven by:
• Rapidly increasing demand from the patients
• Increasing surgical need from rising geriatric population
Insurers and Payers are pushing for cost of care reduction while improving quality of patient care
Enhanced patients outcomes – improved quality of life
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IceCure Specific Market & Primary Focus: Targeting Large Women’s Health Opportunity
Patients seek easy, fast solutions with no scarring
FIBROADENOMAS (BENIGN TUMORS)
1 in 4 women in the U.S. is diagnosed with tumors in the breast or uterus
BREAST CANCEROver 700K surgeries each year in the U.S. alone
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ICE3: Landmark US Breast Cancer Trial
206Patients treated
60Patients followed for at least 3 years
19Hospitals
(Incl. Columbia University Medical Center and Mount Sinai Beth Israel)
76% Resumed daily lives within 48 hours of procedure
All patients released home on the day of the procedure
95% Patient and doctor satisfaction with cosmetic results
No scarring or change to the shape and size of the breast
100% Safe procedureNo significant device-related adverse
events or complications have been reported
The largest USA controlled multilocation clinical trial ever performed for nitrogen-based cryoablation of small, low-risk, early stage malignant breast tumors without subsequently removing them
98%Recurrence free as of Oct 2018
(105 out of 107 who has more than 12 months FU)
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ICE3 is Changing the Treatment landscape
American Society of Breast Surgeons (ASBrS) Oct 2018 Guidelines:
“Cryoablation is currently approved for treatment of benign and malignant soft tissue tumors. FDA. Currently, there are no specific technologies that have FDA approval for breast tumors. Participation in registries and clinical trials evaluating the use of these technologies with and without surgical excision of a breast malignancy is advised as early data emerges on their efficacy “
Feedback from 2018 Radiology Society of North America (RSNA) Annual Meeting:
Dr. Kenneth R. Tomkovich, M.D: …”Cryoablation - the destruction of cancer cells through freezing - shows early indications of effectiveness in treating women with low-risk breast cancers, according to research being presented today at the annual meeting of the Radiological Society of North America (RSNA)”……
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World wide independent Breast Cancer Studies
2 Medical centers~ 400 Patients treated successfully – ongoingLess then 1% recurrence
Started 5 medical centers 25 patients
Started 2 Hospitals150 patients
KOLs collecting clinical data for breast cancer cryoablation at:
Started 1 Hospital 25 patients
JAPAN ITALY
GERMANY HONG KONG -SHENZHEN
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ProSense™: Becoming the Gold Standard in Fibroadenoma Therapy
Treating fibroadenomas successfully sinceclinical trials began in 2012
60 patients who underwent office-based treatment reported:(ProSense™ cryoablation treatment under ultrasound guidance)
Minimally invasive, in-office alternative to surgical excision.
Strong clinical support from multicenter trial.
Lesions tended to disappear progressively
75% were not palpable at 12-month follow up
Overview of benign breast disease | Author: Michael S Sabel, MD, Section Editor: Anees B Chagpar, MD, MSc, MA, MPH, MBA, FACS, FRCS(C) | Deputy Editor: Wenliang Chen, MD, PhD22
Interventional Radiology:Expanding Product Line
Over 500,000 new people each year are diagnosed with kidney, lung and prostate cancer in the U.S. alone!
478K new cases of kidney cancer globally by 2025
vs. 403K in 2018 (CAGR of 2.4%).
>2.5M new cases of lung cancer globally by 2025
vs. 2M in 2018 (CAGR of 1.8%).
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ENCOURAGING EARLY EVALUATION
>300 PATIENTS Treated to date
Lung Cancer:Ongoing Independent Trial in Japan
100% Overall survival rate after ProSense™ therapy vs. ~78% after radiation at three-year follow-up on ~30 T1mi +T1a +T1b cancer patients (<2cm mass)
Led by Dr. Hiroaki Nomori, M.D., Ph.D., Chairman of the Department of General Thoracic Surgery, Kameda Medical Center, Japan. (from July 2019 –Chairman of the Department of General Thoracic Surgery Kashiwa medical center)
Hiraki T. Lung Radiofrequency Ablation: Educational Lectures (EL2-1); Cryomedicine 2017: The 44th Annual Meeting of the Japanese Society for Low Temperature Medicine.
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EARLY TREATMENT SUCCESS
93 PATIENTS With 108 small kidney masses (≤ 4cm) treated
Renal Cancer: Ongoing trial andcollaborative clinical research, Israel
Led by Prof. Ofer Nativ, Head of the Urological Department, Bnai Zion Medical Center, Israel and Dr. Robert Sachner, Head of Interventional Radiology, Bnai Zion Medical Center, Israel
93% Lack of enhancement on CT or MRI in (42 of 45) of cases at 1 year follow-up.
Investigators found the ProSense™ system to be safe, effective and without serious adverse events.
View full poster > 25
Bone Cancer Palliative treatment
Reducing pain in less than 10 minutes:
2018Started treating patients
2019Started treating patients
SPAINITALY
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Collaborations:
Future: CryoImmunology Studies underway investigating Cryoablation with Immunotherapy
Memorial Sloan Kettering Cancer Center
Breast Cryoimmunology(BMS)
Case University and Cleveland clinic
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Support from Experts:
“I have been using the ProSense™ system for all my cryoablation procedures for the past year. I have plenty of experience using the typical argon-based systems – and IceCure offers several advantages over those systems.
First, the rate of freeze is much faster. We know from studies this is important to enhance the anti-cancer immune response from cryoablation. Second, the cost per procedure is less, not only because you can achieve larger ablation zones with a single needle, but also because liquid nitrogen is less expensive than gases needed for the other systems.
I feel that the fast freezing and consistent ablation provided by the ProSense™ system is essential to our work in generating a systemic immune response combining cryoablation with the injection of immunotherapy.”
Jason R. Williams, MD, Director of Interventional Oncology, Williams Cancer Institute, Atlanta, GA and Mexico City, Mexico
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Global Acceptance of IceCure Technology
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Growth Initiatives
Expand Go-to-Market activities, focusing on strategic markets
Identify collaboration opportunities with global strategic partners
Expand clinical data and file for regulatory approval in strategic markets
Increase R&D and engineering efforts to create new solutions:
• Next generation single probe console
• Multi-probe console for large \ multiple tumors
Reimbursement plans in selected territories
Expand the use of system to other tumor indications
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Disruptive Future Technology To Widen Market Application
Creation of a MULTIPROBE to handle various types of tumors
Faster treatment of larger-multipletumors in different organs
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5-Year USA Roadmap
Timeline 2019 2023
R&D pipe line
Regulatory
Clinical trial expansion
Reimbursement Collaborating with medical societies in order to obtain CPT1
Sales & Marketing Initial sales
Finance Potential Nasdaq listing*
Next Generation Single Probe ProSense™ console technology & Development of Multi-probe console - Q4/2021
FDA for Breast Cancer - 2021
CPT3 - Q2/2019
Initiating BC Registry trial
ICE3 Multisite Study Interim results - 2021
Rights offering -Q3-4/2019
Expanding partnerships, sales distribution abilities
*Subject to compliance with Nasdaq requirements
5-Year Roadmap strategic markets
China
Japan
Europe and ROW
Timeline 2019 2023
CFDA – Explore options to obtain probe approval
BC ClinicalStudy (by Terumo)
Terumo Strategicpartnership Q3/2019
PMDA approval expected 2021 – 2023 (Terumo)
Initiating application for BC Reimbursement (Terumo)
Collecting clinical data withKOLs (Germany, Italy and France)
Reimbursement in some territoriesRegulatory approvals in some territories
Teaming with new distributors
Teaming with distributors
Go-to-market strategy: USA
Collaborate with strategic partners and licensing opportunities
Collaborate with medical societies to accelerate adoption (Registry)
Specific FDA 510kfor Breast Cancer
Apply via ASBrSfor CPT code
Direct sales to ~ 800 IDNs (Integrated Delivery Networks) targeting 10 largest
Direct sales to Distributors (with existing business and connections to):• Breast Surgeons• GYN• Breast Radiologists• Interventional Oncologists
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Terumo – IceCure Strategic Exclusive Distribution
• Japan – 86,500 new breast cancer incidence in 2018
• Terumo corporation: $ 23B market cap, $ 5.6B annual revenue
• Terumo has exclusive distribution of ProSense for breast cancer in Japan & Singapore for 5 years after receiving regulatory approval in Japan
• Terumo will be responsible for Japanese regulation and reimbursement
• $ 1M proceeds to IceCure for exclusivity and collaboration of knowledge
• Initial order of $ 3M of ProSense and probes, delivery until end of Q1/2020
• $ 1M proceeds based on regulation and reimbursement milestones
• $ 8.2M minimum purchase quantity
• Following regulatory approval in Thailand, Negotiating for exclusive distribution rights
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Financial Highlights
$40 MillionRaised to Date($7.6 Million Raised in 2018 from new and existing investors)
$3.3 Million cash balance as of June 30, 2019
Oct 2019 - Rights offering of up to $3.2 Million
$18 Million current market cap
29%Public
56.5%Epoch
investments (Li Haixiang)
9%ESOP
3%
Institutional investors
Fully diluted basis(as of Sep 1,2019)
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Huge Market Interest for IceCure-Based Solutions
$110 Million in 2016Britain's BTG acquired Israeli tumor
freezing company, Galil Medical
$4.2 Billion in 2018Boston Scientific
acquired BTG for $4.2
$185 Million in 2019Varian Medical Systems acquired
Endocare, Scion Medical (Argon & Helium) Cryoablation from Healthtronic (USA)
$200 Million in 2018Merit Medical acquired “CiannaMedical” (a leader in wire-free
breast localization)
$85 Million in 2018Hologic acquired “Faxitron Bioptics”
(Leader in Digital Specimen Radiography)
$125 Million in 2018Hologic acquired “Focal Therapeutics”
(implantable marker for breast conserving surgery)
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FDA and CE Cleared
(soft tissue ablation)
Excellent Patient
& Physician Feedback
Superior LN2 Technology
with Strong IP Portfolio
Why invest in IceCure?
Started sales 2017- Jun 2019
$2.3 with Strong Growth
Potential
Clinically Validated Technology:
Conducting Acclaimed ICE3 Trial
Wide Market Applications;
$2.4 Billion Tumor Ablation Market
by 2026
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Strong Leadershipwith Proven Track Record
Ronen Tsimerman, CFO and COO
Over 13 years as CFO of public and private companies
Ron Mayron, Chairman of the Board
Served for 20 years in several positions at Teva including as VP – Israel & Africa & CEO of Teva Israel
Elisabeth Sadka – VP Clinical, Regulatory & QA
Over 20 year experience in Cryoablation (Galil Medical)
Tlalit Bussi Tel-Tzure – VP BizDev & Marketing
Over 15 years experience of Sales, BizDev & Marketing in medical devices
Naum Muchnick – VP R &D
Over 14 years with GE Ultra Sound
Eyal Shamir, CEO
Over 15 years as CEO of medical device companies (B-Cure laser, Hanita Lanses etc.)
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MAKING PROSENSE™ THE GOLD STANDARD FOR CRYOABLATION TREATMENT
THANK YOU
Eyal Shamir – CEOE: [email protected]
Ronen Tsimerman – CFO\COO E: [email protected]
T: 972-4-623-0333 40