+ All Categories
Home > Documents > Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage...

Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage...

Date post: 14-Oct-2020
Category:
Upload: others
View: 1 times
Download: 0 times
Share this document with a friend
22
1 Hezi Himelfarb CEO IceCure TM Medical Ltd.
Transcript
Page 1: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

1

Hezi Himelfarb CEO IceCureTM Medical Ltd.

Page 2: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

2

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.

Page 3: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

3

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

Page 4: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

4

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.

Page 5: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

5

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

Page 6: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

6

Treating Breast Cancer Without Surgery

Page 7: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

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

Page 8: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

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

Page 9: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

Wide Spread Awareness of

Overtreatment

Screen clipping taken: 9/11/2015

Page 10: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

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

Page 11: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

11

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

Page 12: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

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

Page 13: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

13

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

Page 14: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

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

Page 15: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

15

• 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

Page 16: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

16

• 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

Page 17: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

17

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.

Page 18: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

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

Page 19: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

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

Page 20: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

20

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.

Page 21: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

21

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

Page 22: Hezi Himelfarb CEO IceCure Medical Ltd. · • 2012: Clinical trial for treatment of early stage Breast cancer in JAPAN • 2013: Clinical trial for treatment of Lung cancer in JAPAN

22

• 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


Recommended