Icecure Medical Ltd. · NASDAQ:ICCM
Icecure Medical — Investor Presentation (December 2019)
40 slides from Icecure Medical's investor presentation, December 2019
Slide 1: Freezing Cancer in Its Tracks
FREEZING CANCER IN ITS TRACKS Next generation cryoablation technology enabling non‐surgical, in‐office treatment of cancer tumors DKC1000001 rev D
Slide 2: Forward Looking Statement
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 info
Slide 3: Introducing ProSense: Next generation cryoablation technology
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
Slide 4: Company & Product Description
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™
Slide 5: Investment Highlights
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 appr
Slide 6: Our Mission
OUR MISSION: To lead the New Gold Standard Tumor Cryoablation Therapy by Providing Superior, Safe, Fast and Cost Effective Minimally-Invasive Treatment 6
Slide 7: ProSense - How it works
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
Slide 8: ProSense System Advantages
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
Slide 9: Superior Liquid Nitrogen Technology for Optimal Tumor Destruction
Superior Liquid Nitrogen (LN2) Technology for Optimal Tumor Destruction Lower stable temperature and faster cooling rate for larger lethal zone 9
Slide 10: ProSense Probe Advantages
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
Slide 11: Competitive Advantage
Competitive 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 Lo
Slide 12: Superior to Thermal Ablation Technologies
Superior 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
Slide 13: Strong IP and Regulatory Clearance
Strong 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) 13
Slide 14: Global Market for Cryo Ablation: Wide Market Applications
Global 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 14
Slide 15: ProSense: Win-Win For All
PROSENSE™: 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 Reimbursem
Slide 16: Global Tumor Ablation Market Opportunity
Addressing 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
Slide 17: Favorable Market Trends
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 fro
Slide 18: Targeting Large Women's Health Opportunity
IceCure 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 scarrin
Slide 19: ICE3: Landmark US Breast Cancer Trial
ICE3: 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 Hos
Slide 20: ICE3 is Changing the Treatment Landscape
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. Partici
Slide 21: World wide independent Breast Cancer Studies
World 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 Start
Slide 22: Becoming the Gold Standard in Fibroadenoma Therapy
ProSense™: 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 t
Slide 23: Interventional Radiology: Expanding Product Line
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! >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 (
Slide 24: Lung Cancer: Ongoing Independent Trial in Japan
Lung 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 (<2cm mass) Led by Dr. Hiroaki Nomori, M.D., Ph.D., Cha
Slide 25: Renal Cancer: Ongoing trial and collaborative research, Israel
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
Slide 26: Bone Cancer Palliative treatment
Bone Cancer Palliative treatment Reducing pain in less than 10 minutes: ITALY SPAIN 2018 2019 Started treating patients Started treating patients 26
Slide 27: Future: CryoImmunology Studies underway
Future: CryoImmunology Studies underway investigating Cryoablation with Immunotherapy Collaborations: Memorial Sloan Kettering Case University Cancer Center and Cleveland clinic Breast Cryoimmunology (BMS) 27
Slide 28: Support from Experts
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 stu
Slide 29: Global Acceptance of IceCure Technology
Global Acceptance of IceCure Technology 29
Slide 30: Growth Initiatives
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 generat
Slide 31: Disruptive Future Technology To Widen Market Application
Disruptive 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 31
Slide 32: 5-Year USA Roadmap
5-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 Regi
Slide 33: 5-Year Roadmap strategic markets
5-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
Slide 34: Go-to-market strategy: USA
Go-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 busin
Slide 35: Terumo – IceCure Strategic Exclusive Distribution
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
Slide 36: Financial Highlights: $40 Million Raised to Date
Financial 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
Slide 37: Huge Market Interest for IceCure-Based Solutions
Huge 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) Cryoab
Slide 38: Why invest in IceCure?
Why 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 Str
Slide 39: Strong Leadership with Proven Track Record
Strong 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
Slide 40: Making ProSense the Gold Standard for Cryoablation
MAKING 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 40
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