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Hezi Himelfarb CEO IceCureTM Medical Ltd.
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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.
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Cryoablation - Background
Cryoablation is a minimally invasive ultrasound guided treatment that uses extreme cold to freeze and accurately destroy diseased tissue within the tumor zone • Exists more than 30 years – current (old
generation) products are based on high pressure gas, lengthy procedures, mostly done in OR
IceCure’s Cryoablation Innovation: • Compact system • Fast procedures • Can be done in the physician’s office • No pain, no scar, no downtime • More effective treatment (liquid-Nitrogen
based system)
Post Cryoablation:
• Area becomes an irregular accumulation of hypoechoic necrotic debris
• Progressive dissipation/elimination of debris over time
• No artifact that would adversely affect interpretation
Pre –Cryoablation
12 Months Post
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IceCure’s Mission Statement
IceCure’s mission is to provide worldwide, leading, minimally
invasive, innovative, Cryoablation therapies for safe and effective
treatment for women’s health and other medical treatment arenas.
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About IceCure
• 2006: IceCure Medical Ltd established in Israel
• 2007-2010: Development of IceSense3™ for Breast tumors
• 2010-2011: Regulatory approvals for IceSense3™ (FDA,CE, AMAR)
• 2011: Listed in TASE (Tel-Aviv Stock Exchange)
• 2011: IceCure Medical Inc. established, Memphis, TN
• 2011: (Pilot) Commercialization of IceSense3TM in the U.S and other countries
• 2010-2012: Multisite clinical trial for treatment of Fibroadenoma (benign)
• 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN
• 2013: Clinical trial for treatment of Lung cancer in JAPAN
• 2014: ICE3 multisite clinical trial for treatment of early stage Breast cancer in the
U.S.A
Led by experienced management and scientific luminaries with vast multi-disciplinary background
As for Jan. 2015
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Treating Breast Cancer Without Surgery
US Breast Cancer 2015
• 231,840 Invasive (1)
• 60,920 DCIS
• 40,290 Deaths Annually
• $17.2 Billion on Breast Cancer Care is the US
– One of the Largest and Most Visible Areas in Healthcare
• Many Advances in Diagnosis and Tumor Staging
– BRACA
– Genomic Testing
– Radiation/Chemo Protocol
• Trend Towards “Personalized Medicine” (Sentinel Node BX, Radiation, Chemo)
• However the Surgical Approach has not changed Significantly in 20+ Years
– Lumpectomy (Breast Conserving Surgery)
– Mastectomy
– No Triaged Care Path “Treatment begins with Surgery”
4% 20%
35%
41%
Invasive Breast Cancer
<40
<50
50-64
65
48,910
84,210
99,220
Patient Age
Range
(1) American Cancer Society, Inc., surveillance Research, 2015
Gold Standard Early Stage BC Treatments
Are Highly Aggressive
Mastectomy / Lumpectomy
Today, women diagnosed with early stage breast cancer are unually faced with an invasive, expensive, and potentially dangerous surgical
procedure as their only choice
High Risk
Low Risk
This approach is increasingly recognized as aggressive overtreatment, especially in low risk patients
Wide Spread Awareness of
Overtreatment
Screen clipping taken: 9/11/2015
IceSense3TM Addresses Critical Unmet
Needs In Broad Target Population
Mastectomy / Lumpectomy
Non-surgical treatment for “low risk” breast cancer
• Avoids risk associated with surgery
– Walk-in walk-out procedure
– Risk of surgery much higher in elderly population or those suffering from comorbidities
• Zero cosmetic impact
– Alternative treatment for women that prefer non-surgical options
• Cost saving for patients and health care system
– Eliminate OR and associated cost (anesthesia, facility, staff, etc), no breast reconstruction cost
– Office procedure (30 mins )
High Risk
Low Risk
IceCure offers an attractive, simple, solution to a large overtreated population
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IceSence3™ Breast Tumor Procedure
Activate the freeze-thaw-freeze to create the ice-ball, kill the tumor and then warm to smoothly retrieve the needle
Patient walks into the office. Physician identifies the lesion using ultrasound and plan the needle insertion
1: Office Entry
Under local anesthesia inserts the needle in the chosen path under real-time ultrasound guidance
2: Probe Positioning 3: Rapid Cooling
The penetration cut is closed using medical glue, leaving no Scar. The sign disappears after few days
4: Wound Closer
Patient walks home
5: Leaving the Office
Short Patient’s Visit Duration (15min-30min)
Procedure
The IceSense3TM System
The IceSense3TM system provides the physician with full control of the procedure, both automatic and manual
• Compact
• Easy to operate
• LN2 cryogen
• Single probe system
• Optimized for rapid/lethal ice formation
• Intuitive touch-screen user interface
• Multiple user controls
IceSense3TM is the next step in non-invasive cryoablation, from hospital to office
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Competitive Advantage
Office Setting No Yes
Compact Disposable No Yes
Cooling rate Slow Fast
Pressure High Low
Argon Gas Liquid Nitrogen
Procedure Time 20-30 mins 5-15 mins
Cooling Method
IceSense3™ 3rd Generation Technology
Cryoablation 1st Generation Technology
Competitive Advantage (cont’)
Graphic User Interface Intuitive, flexible Old, Limited
Probe Positioning Focused probe positioning Require to penetrate
beyond the tumor
Single operator Pushbuttons/indicators on handle 2 Operators
Office Setting Yes Yes
Flexible protocol Procedure protocol can be changed during the procedure
No
Constant low temperature Yes - Shorter procedure No
Compact Disposable No Yes
IceSense3™ Visica 2™ (2nd generation technology)
End-of procedure release Electricity in the needle (safety)
No Electricity, heated Nitrogen
IceCure’s solution is more accurate, faster, safer, and easier to use than competitors
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• Purchased consoles and probes from IceCure since 2012
• >200 patients treated with IceSense3TM to-date
• >3-7 year follow-up on 130+ patients shows IBTR<1%
• Dr. Fukuma presented his interim results at the American
Society of Breast Surgery (ASBS 2013) meeting in Chicago and
created interest among U.S breast surgeons to be involved in
this innovative treatment
Dr. Fukuma’s Current Research with IceCure in Japan
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• U.S. multi-center study (up to 20 sites), up to 200 patients
• Defined as post-market study in view of the existing FDA
approval (that covers benign and malignant tumors)
• Treatment of early-stage tumors up to 1.5cm
• Patients: 65+ years old
• Funded mostly by the institutions
• IceCure’s objective: establish higher level of comfort and
confidence amongst physicians to adopt this treatment
IceCure’s Landmark ICE3 Breast Cancer Study
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IceCure May Have Answer For The Growing Need!
U.S. Breast Cancer Cases Expected to Increase by as Much as 50 Percent
by 2030
PHILADELPHIA — The total number of breast cancer cases in the United States is forecast
to be 50 percent greater in 2030 than it was in 2011, when invasive and in-situ or screening-
detected cancers are counted together, and this increase is driven mostly by a marked
increase in cases of estrogen receptor (ER)–positive tumors and in women older than 70,
according to research presented here at the AACR Annual Meeting 2015, April 18-22.
“Managing this clinical burden will present a huge challenge,” said Philip S. Rosenberg,
PhD, a senior investigator in the division of cancer epidemiology and genetics at the
National Cancer Institute (NCI). “The one silver lining is that we expect fewer ER–negative
tumors, which include the most difficult-to-treat HER2-positive and triple-negative subtypes.”
According to Rosenberg, during the next several decades, 40 million American women who
were born between 1946 and 1964 will face high absolute risks for postmenopausal breast
cancer.
Footprint in Place -
Significant Existing Installed Base
Rockwood Clinic, Spokane, WA
St Johns (JWCC) Santa Monica, CA
Everett Clinic, Everett, WA
Epicare San Francisco, CA
Breastlink Laguna Hills, CA
University of AZ Tucson, AZ
Yavapai Hospital Phoenix, AZ
Dr Souzan El-Eid Las Vegas, NV
Dr Ted Potruch Las Vegas, NV
Karmanos Detroit, MI
Cincinnati Breast Surgeons Cincinnati, OH
West Clinic Memphis, TN
Breast Care Dallas, TX
Wheaton Franciscan Milwaukee, WI
NE Surgical Trumbull, CT
Indiana University Indianapolis, IN
RMI Flint, MI
Thomas Jefferson Philadelphia, PA
CentraState Medical Freehold, NJ
Beth Israel New York, NY
Naples Community Naples, FL
South Coast Dartmouth, MA
NE GA Surgical Dalton, GA
Breast Specialty Care Albuquerque, NM
Madica Medical Albuquerque, NM
MSKCC New York, NY
Green = KOL / strategic account
Broad installed base provides KOLs with hands-on experience using IceSense3TM
Regulatory Clearance In US And EU
• FDA 510k and CE mark 2010-2011
• Broad clearance
• Gynecology, general surgery, oncology, urology
• Clearance includes – Ablation of cancerous or malignant tissue
– Ablation of benign tumors
– Ablation of fibroadenoma
– Palliative treatment of tumors
• Hong-Kong and Thai clearance 2014-2015
• CFDA clearance for the system has been received, in advanced process for the disposable probes
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ProSense™ in Interventional Oncology
• Interventional oncology is an emerging field in cancer care that
is intended to complement existing treatment modalities
• It uses image-guided technology to directly target solid tumors
• Typical indications include: • Lung
• Liver
• Kidney
• Prostate
• The LN technology allows faster and more efficatious
treatment than any other cryo or heat ablation.
• The ProSenseTM that was recently launched will be, together
with some specific accessories, a cryoablation platform for
treatment of various Interventional Oncology indications.
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Other Cryoablation Opportunities
• Cryo-immunology • Pre-clinical and clinical data suggests a strong anti-tumor
immune response can be generated through the use of Cryoablation in diverse organs.
• In studies comparing Cryoablation to other modalities, the systemic immune response is substantially greater with freezing than surgical excision, radiofrequency ablation or other heat-based ablation technologies.
• Drug companies are starting to combine drug treatment and cryoablation in their clinical studies
• Cardiology – Atrial Fibrillation (AF) • Current cryoablation catheters for cardiac Atrial and Ventricular
Arrhythmias (PAF/VT) ablation use older technologies
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• Develop the Chinese market (in advanced process with CFDA)
• Expand the use of IceSense3TM in breast tumor treatment
through commercial sales and clinical studies globally
• Penetrate new markets in Asia and Europe
• Create strategic partnerships with corporations active in
interventional oncology
• Expand the technological capabilities of IceCure’s superior
cryoablation technology towards new applications
Summary: IceCure’s Strategy