FREEZING CANCER IN ITS TRACKS - Next generation cryoablation technology enabling non surgical, in office treatment of cancer tumors
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FREEZING CANCER IN ITS TRACKS Next generation cryoablation technology enabling non‐surgical, in‐office treatment of cancer tumors
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
2
information.
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
MEDICAL DEVICE COMPANY SETTING NEW STANDARDS
founded in 2006 to advance treatment IN MINIMALLY-INVASIVE
of cancerous tumors.
Traded in Tel Aviv stock exchange TUMOR THERAPY
for women’s health
and interventional oncology
INNOVATIVE TECHNOLOGY FLAGSHIP PRODUCT, ProSense™
BASED ON CRYOABLATION for rapid minimally invasive, safe, and
using ultra low freezing temperatures (liquid effective treatment of breast lesions in office
nitrogen) to destroy tumors, without the or ambulatory hospital settings
need for surgery.
28 innovative patents
4
Investment Highlights
Successfully transition from Clinical and R&D to Commercialization
Strong Clinical FDA and CE Wide Market Business model of
Evidence & Cleared (tissue Applications console and
Market Need ablation) consumable probe
Broad IP Portfolio Excellent Patient & 1/2017 - 6/2019
(28 approved & Physician Feedback Sales:
pending patents) $2.3 Million
5
OUR MISSION:
To lead the New Gold Standard Tumor Cryoablation
Therapy by Providing Superior, Safe, Fast and Cost
Effective Minimally-Invasive Treatment
6
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
7
ProSense™ System Advantages
Fastest Cryo procedure Liquid nitrogen for maximum Easy-to-use
available cooling and efficacy, Touch-screen user interface &
(15-40 mins for in-office setting) (no bulky & high risk gas argon storage) customizable procedure
Painless Cosmetically Superior Results Immediate Patient
Cooled site eliminates pain (Minimally invasive alternative, Recovery
no scarring of tissue removal) High patient satisfaction
8
Superior Liquid Nitrogen (LN2) Technology
for Optimal Tumor Destruction
Lower stable
temperature and
faster cooling
rate for larger
crystal lethal
zone
9
ProSense™ Probe Advantages:
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
Recurring revenues from sale of disposable probes
10Competitive Advantage
3rd Generation 2nd generation 1st Generation
IceCure ProSense™ Sanarus Visica 2™ Galil 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
11Superior to Thermal Ablation Technologies
(Radiofrequency & MicroWave)
Cryoablation Thermal Ablation
IceCure ProSense™ (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
12Strong IP and Regulatory Clearance
28
Strong IP Portfolio Regulatory Clearance
28 approved patents Approvals also for Hong-Kong,
surrounding the core technology Thailand, Singapore, Australia, Israel
and countries
in South & Central America,
CFDA (Console only)
13Global Market for Cryo Ablation
Wide Market Applications
Breast Interventional Cryo-
Tumors Radiology Immunology
Kidney Additional
Cancer v future
indications
Breast Malignant Breast Lung Bone (Such as Prostate
Cancer Fibroadenoma Cancer Cancer Cancer)
Technology Platform for Cardiac AF ablation
14PROSENSE™: Win-Win For All
Patient Physician Insurer
Less Invasive Builds on Existing Skills Lower Reimbursement
Treatment & Infrastructure Expenses Vs. Surgery
Safer Faster Treatment, In-Office
& Simpler More Patients Procedure
Enhanced Increased ROI Patient Demand Drives
Quality Of Life Reimbursement
15Addressing Rapidly-Growing Multi-Million Dollar
Global Tumor Ablation Market Opportunity
$1.03 11.2% GROWTH
BILLION
(CAGR) Potential driven by
IN 2018* non/minimal invasive treatments
such as Cryoablation*
Tumor ablation market
Expected to reach Growing Increasing demand Push for cost of care
cancer for non/minimal- reduction by insurers
$2.4 Billion in 2026* burden invasive solutions 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 16Favorable 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
17IceCure Specific Market & Primary Focus:
Targeting Large Women’s Health Opportunity
FIBROADENOMAS 1 in 4 women
in the U.S. is diagnosed with
(BENIGN TUMORS) tumors in the breast or uterus
Over 700K
BREAST CANCER surgeries each year
in the U.S. alone
Patients seek easy, fast solutions with no scarring
18ICE3: Landmark US Breast Cancer Trial
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
206 98% 60 19
Patients treated Recurrence free Patients followed Hospitals
as of Oct 2018 for at least 3 years (Incl. Columbia University Medical
(105 out of 107 who has more Center and Mount Sinai Beth Israel)
than 12 months FU)
100% Safe procedure 95% Patient and doctor 76% Resumed daily lives
No significant device-related adverse satisfaction with cosmetic results within 48 hours of procedure
events or complications have been No scarring or change to the shape All patients released home on the
reported and size of the breast day of the procedure
19ICE3 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)”……
20World wide independent
Breast Cancer Studies
KOLs collecting clinical data for breast cancer cryoablation at:
JAPAN ITALY
2 Medical centers Started 5 medical centers
~ 400 Patients treated successfully – ongoing 25 patients
Less then 1% recurrence
GERMANY HONG KONG -SHENZHEN
Started 1 Hospital Started 2 Hospitals
25 patients 150 patients
21ProSense™: Becoming the Gold Standard
in Fibroadenoma Therapy
Treating 60 patients
fibroadenomas who underwent
successfully since office-based
clinical trials treatment reported:
(ProSense™ cryoablation treatment
began in 2012 under ultrasound guidance)
Minimally invasive, in-office Lesions tended to
alternative to surgical excision. disappear progressively
Strong clinical support from 75% were not palpable
multicenter trial. 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, PhD
22Interventional Radiology:
Expanding Product Line
Over 500,000 new people each year are diagnosed with
kidney, lung and prostate cancer in the U.S. alone!
>2.5M new cases of lung 478K new cases of kidney
cancer globally by 2025 cancer globally by 2025
vs. 2M in 2018 (CAGR of 1.8%). vs. 403K in 2018 (CAGR of 2.4%).
23Lung Cancer:
Ongoing Independent Trial in Japan
ENCOURAGING >300 PATIENTS
Treated to date
EARLY
EVALUATION 100% Overall survival rate
after ProSense™ therapy vs. ~78% after
radiation at three-year follow-up on
~30 T1mi +T1a +T1b cancer patients
(Renal Cancer: Ongoing trial and
collaborative clinical research, Israel
EARLY 93 PATIENTS
With 108 small kidney masses
TREATMENT (≤ 4cm) treated
SUCCESS 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.
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
View full poster > 25Bone Cancer Palliative treatment
Reducing pain in less than 10 minutes:
ITALY SPAIN
2018 2019
Started treating patients Started treating patients
26Future: CryoImmunology Studies underway
investigating Cryoablation with Immunotherapy
Collaborations:
Memorial Sloan Kettering Case University
Cancer Center and Cleveland clinic
Breast Cryoimmunology
(BMS)
27Support 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
28Global Acceptance of IceCure Technology
29Growth 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
30Disruptive Future Technology
To Widen Market Application
Creation of a Faster treatment
MULTIPROBE of larger-multiple
to handle various tumors in
different organs
types of tumors
315-Year USA Roadmap
Timeline 2019 2023
Sales & Marketing Initial sales Expanding partnerships, sales distribution abilities
Next Generation Single Probe ProSense™ console technology &
R&D pipe line Development of Multi-probe console - Q4/2021
Regulatory FDA for Breast Cancer - 2021
Initiating BC Registry trial
Clinical trial expansion
ICE3 Multisite Study Interim results - 2021
Collaborating with medical societies
Reimbursement CPT3 - Q2/2019 in order to obtain CPT1
Rights offering -
Finance Q3-4/2019 Potential Nasdaq listing*
*Subject to compliance with Nasdaq requirements5-Year Roadmap strategic markets
Timeline 2019 2023
China CFDA – Explore options to obtain probe approval
Teaming with distributors
Terumo Strategic BC Clinical PMDA approval expected Initiating application for BC
Japan partnership Q3/2019 Study (by Terumo) 2021 – 2023 (Terumo) Reimbursement (Terumo)
Collecting clinical data with
KOLs (Germany, Italy and France)
Europe and ROW Teaming with new distributors
Regulatory approvals in some territories
Reimbursement in some territoriesGo-to-market strategy: USA
Collaborate with medical Collaborate with
Specific FDA 510k
societies to accelerate strategic partners and
for Breast Cancer
adoption (Registry) licensing opportunities
Direct sales to ~ 800 Direct sales to Distributors
Apply via ASBrS IDNs (Integrated (with existing business
for CPT code Delivery Networks) and connections to):
targeting 10 largest • Breast Surgeons
• GYN
• Breast Radiologists
• Interventional Oncologists
34Terumo – 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
35Financial Highlights
$40 Million
Raised to Date
($7.6 Million Raised in 2018 from 29% Fully diluted basis
new and existing investors) Public (as of Sep 1,2019)
$3.3 Million cash balance
as of June 30, 2019 56.5%
Epoch
investments
Oct 2019 - Rights offering of up to $3.2 (Li Haixiang)
9%
Million ESOP
$18 Million current market cap
3%
Institutional
investors
36Huge Market Interest for
IceCure-Based Solutions
$110 Million in 2016 $4.2 Billion in 2018 $185 Million in 2019
Britain's BTG acquired Israeli tumor Boston Scientific Varian Medical Systems acquired
freezing company, Galil Medical acquired BTG for $4.2 Endocare, Scion Medical (Argon & Helium)
Cryoablation from Healthtronic (USA)
$200 Million in 2018 $85 Million in 2018 $125 Million in 2018
Merit Medical acquired “Cianna Hologic acquired “Faxitron Bioptics” Hologic acquired “Focal Therapeutics”
Medical” (a leader in wire-free (Leader in Digital Specimen (implantable marker for breast
breast localization) Radiography) conserving surgery)
37Why invest in IceCure?
Wide Market FDA and CE Clinically Validated
Applications; Cleared Technology:
$2.4 Billion Tumor (soft tissue Conducting Acclaimed
Ablation Market ablation) ICE3 Trial
by 2026
Excellent Superior LN2 Started sales
Patient Technology 2017- Jun 2019
& Physician $2.3 with
with Strong IP Strong Growth
Feedback Portfolio Potential
38Strong Leadership
with Proven Track Record
Ron Mayron, Chairman of the Board Elisabeth Sadka – VP Clinical, Regulatory & QA
Served for 20 years in several positions at Over 20 year experience in Cryoablation (Galil Medical)
Teva including as VP – Israel & Africa &
CEO of Teva Israel
Eyal Shamir, CEO Tlalit Bussi Tel-Tzure – VP BizDev & Marketing
Over 15 years as CEO of medical device Over 15 years experience of Sales, BizDev & Marketing
companies (B-Cure laser, Hanita Lanses etc.) in medical devices
Ronen Tsimerman, CFO and COO Naum Muchnick – VP R &D
Over 13 years as CFO of public and Over 14 years with GE Ultra Sound
private companies
39MAKING PROSENSE™
THE GOLD STANDARD
FOR CRYOABLATION
TREATMENT
THANK YOU
Eyal Shamir – CEO
E: eyals@Icecure-medical.com
Ronen Tsimerman – CFO\COO
E: ronent@Icecure-medical.com
T: 972-4-623-0333
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