Icecure Medical Ltd. · NASDAQ:ICCM
Icecure Medical — Investor Presentation (September 2021)
33 slides from Icecure Medical's investor presentation, September 2021
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 Corporate Presentation | Sep. 2021 (NASDAQ & TASE: ICCM) icecure-medical.com 1
Slide 2: Forward Looking Statement
Forward Looking Statement Disclaimer: IMPORTANT: The following applies to this document, the oral presentation of the information in this document by IceCure Medical Ltd. (the “Company”, “we” or “us”) and any question and answer session that follows the oral presentation (collectively, the “Presenta
Slide 3: Our Mission
OUR MISSION: To lead the New Standard of Tumor Cryoablation Therapy 3 3
Slide 4: Introducing ProSense: Non-surgical, Next-Generation Cryoablation Technology
Introducing ProSense®: Non-surgical, Next-Generation Cryoablation Technology • IceCure’s flagship product, ProSense®, is a minimally invasive, non-surgical solution that destroys tumors quickly and painlessly • Utilizing effective liquid nitrogen (LN2) for maximum freezing, safety and efficacy http:
Slide 5: IceCure at a Glance
IceCure at a Glance ProSense® Proprietary Technology with Regulatory Approval • FDA Approval for general minimally-invasive cryoablation applications, specific indications including: Kidney, Liver, Neurology, Fibroadenoma • FDA Breakthrough Devices Designation for T1 invasive breast cancer and/or br
Slide 6: ProSense: Value for All
ProSense®: Value for All Patient Physician Insurer Healthcare Provider ✓ LN2* - Maximum Efficacy ✓ Easy to Use, In-office Procedure ✓ Lower Reimbursement ✓ Patient Demand Drives Expense Vs. Surgery Reimbursement ✓ Non-surgical ✓ Low Risk, Safe Procedure ✓ In-Office Procedure ✓ Faster, In-Office Proc
Slide 7: Covid-19 Impact on Cancer Patients and Hospitals
Covid-19 Impact on Cancer Patients and Hospitals Surgery Delays, Cancellations Healthcare institutions urgently seek new solutions to: & Backlogs ✓ Reduce hospitalization & clinic visits There is a 6-8% increase in the risk of death for every four week delay in ✓ Reduce demands on Emergency Rooms tu
Slide 8: Market Opportunities
Market Opportunities Tumor Ablation US Cryoablation Tumor Ablation Market Expected To Reach Breast Tumors $2.4 Billion in 2026† ~325K new breast cancer patients estimated in 2020* 10% of female pop. est. to have fibroadenomas** $2.4B (CAGR) Potential driven by Breast Cancer Breast Fibroadenoma non/m
Slide 9: Breast Tumor Market Activities
BREAST TUMOR MARKET ACTIVITIES 10
Slide 10: Breast Cancer & Benign Tumors U.S. Strategy
Breast Cancer & Benign Tumors U.S. Strategy Regulatory Strategy ✓ FDA clearance for general minimally-invasive cryoablation applications ✓ FDA clearance for fibroadenoma (benign breast tumors) cryoablation ✓ Completed ICE3 study enrollment, promising interim results presented at 2021 ASBrS Annual Me
Slide 11: ICE3: Landmark U.S. Breast Cancer Trial
Unique Value Proposition ICE3: Landmark U.S. Breast Cancer Trial Largest USA controlled multicenter clinical trial ever performed for LN2 based cryoablation of small, low-risk, early-stage malignant breast tumors as an alternative to surgery Cryoablation potentially represents a dramatic improvement
Slide 12: ICE3: Landmark U.S. Breast Cancer Trial Results
Unique Value Proposition ICE3: Landmark U.S. Breast Cancer Trial Largest USA controlled multicenter clinical trial ever performed for LN2 based cryoablation of small, low-risk, early stage malignant breast tumors as an alternative to surgery 194 19 49 Patients Eligible Hospitals Patients Followed Fo
Slide 13: FDA Granted ProSense Breakthrough Devices Designation
FDA Granted ProSense® Breakthrough Devices Designation FDA Breakthrough Devices Program is intended to help patients receive more timely access to medical devices that have the potential to provide more effective ProSense® Granted Breakthrough Devices treatment or diagnosis for life-threatening or i
Slide 14: Breast Cancer - China Strategy
Breast Cancer - China Strategy Regulatory strategy ✓ Console approved by CFDA ✓ Initiated a registration process for the disposable probes ✓ Approved in Hong Kong Go to market ✓ Soft launch – first consoles were sold in Dec 2019 for independent study for breast cancer to a leading breast cancer hosp
Slide 15: Breast Cancer - Japan Terumo Agreement
Breast Cancer - Japan Terumo Agreement Exclusive strategic distribution agreement with Terumo to accelerate commercialization of ProSense® in Japan, Singapore, and Thailand For >6 years ProSense® has been sold through a Private Import License—now leveraging agreement with Terumo to expand distributi
Slide 16: ProSense is Superior to Competing Thermal Ablation Technologies
ProSense® is Superior to Competing Thermal Ablation Technologies Cryoablation Thermal Ablation IceCure ProSense® (Radiofrequency & Microwave) Pain Minimal to no pain* Very painful Anesthesia Local High amount to general Visualization Excellent contour under Ultrasound & CT Limited visualization Accu
Slide 17: ProSense: Advanced Cryoablation Technology
ProSense®: Advanced Cryoablation Technology Superior Liquid Nitrogen (LN2) Technology 3rd Generation 2nd generation 1st Generation IceCure Sanarus Visica Galil Medical for Optimal Tumor Destruction ProSense® 2™ EndoCare Tumor Destruction Method Liquid nitrogen Liquid nitrogen Argon gas Constantly Co
Slide 18: Business Model – Revenue Generators
Business Model – Revenue Generators Console and consumable probe business model Direct sales and via distributors ✓ Direct sales to hospitals, clinics and doctor offices ✓ Reselling to distributors: ✓ Used as a mobile device in different hospitals, clinics, doctor offices in Europe Console related r
Slide 19: Well-Financed to Advance Commercialization of ProSense
Well-Financed to Advance Commercialization of ProSense® CASH • Cash balance of $15.4M (as of Sept. 29, 2021) Private placement of ordinary shares of $15M REVENUE • 2020 rev of $3.9M, +138% versus 2019 Private placement from three accredited • H1/2021 rev of $2.1M, +12% versus investors (Alpha Capita
Slide 20: Proven Leadership Team
Proven Leadership Team Ron Mayron, Chairman of the Board Shay Levav – VP Clinical, Regulatory & QA Served for 20 years in several positions at Nearly 20 years’ experience in regulatory and quality Teva including as VP – Israel & Africa & assurance in the healthcare sector CEO of Teva Israel Eyal Sha
Slide 21: Company Highlights
Company Highlights ICE3 Trial Collaboration with Well positioned for future FDA and CE Exclusive distribution ASBrS for registry BC specific Cleared agreement with trial and update of commercialization Terumo Corporation guidelines Wide Market Excellent Patient Advanced LN2 Successful transition CPT
Slide 22: Thank You
PROSENSE® FREEZE CANCER IN ITS TRACKS THANK YOU Eyal Shamir – CEO E: eyals@Icecure-medical.com Ronen Tsimerman – CFO\COO E: ronent@Icecure-medical.com T: 972-4-623-0333 22
Slide 23: Appendices
Appendices Interventional Radiology Fibroadenoma 23 23
Slide 24: IceCure's Target Geographies & Markets
IceCure’s Target Geographies & Markets USA* Japan*** 42K 74K 325K Liver cancer patients Kidney cancer patients New breast cancer 71K 92K 139K patients in 2020 Kidney & liver New breast Lung cancer Fibroadenoma, Est. cancer patients cancer patients patient 10% of female in 2020 86K New breast Europe*
Slide 25: Interventional Radiology
Interventional Radiology Pain care for bone cancer metastasis 431K worldwide kidney cancer cases in 2020* (CAGR of 2.4%) CPT2 reimbursement in the USA CE approval, actively being used for • Ongoing trial and collaborative procedures in EU clinical research in Israel • FDA approval for kidney and liv
Slide 26: Interventional Radiology: Expanding Product Line
Interventional Radiology: Expanding Product Line Over 500,000 new people each year are diagnosed with kidney, lung, liver 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
Slide 27: Interventional Radiology - USA Strategy
Interventional Radiology - USA Strategy Regulatory Strategy ✓ FDA approval for general minimally-invasive cryoablation applications ✓ FDA approval for kidney and liver, as of Dec 2019 ✓ FDA granted ProSense® Breakthrough Devices Designation for proposed indications, including for use in the treatmen
Slide 28: Renal Cancer: Ongoing Trial and Collaborative Clinical Research, Israel
Renal Cancer: Ongoing Trial and Collaborative Clinical Research, Israel Results presented at 2019 EAU 120 PATIENTS With 139 small kidney masses View full Poster (≤ 4cm) treated 93% Lack of enhancement Results published in 2019 in on CT or MRI in (42 of 45) of cases at 1 year follow-up. Investigators
Slide 29: Bone Cancer Palliative Treatment
Bone Cancer Palliative Treatment Reducing pain in less than 10 minutes: ITALY SPAIN FRANCE One of the most important benefits coming from the last two years using IceCure cryoablation among the older ablation devices is that the treatment is completely unpainful. It means that usually the patient do
Slide 30: Lung Cancer: Ongoing Independent Trial in Japan
Lung Cancer: Ongoing Independent Trial in Japan >300 PATIENTS Results published in 2019 in Treated to date 100% Overall survival rate after ProSense® therapy vs. ~78% after View full Publication radiation at three-year follow-up on ~30 T1mi +T1a +T1b cancer patients (<2cm mass) Led by Dr. Hiroaki No
Slide 31: 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 32: ICE3 - Changing the Treatment Landscape
ICE3 - 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. Particip
Slide 33: ProSense: Becoming the Standard in Fibroadenoma Therapy
ProSense®: Becoming the 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 alt
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